UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

x

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

For the quarterly period ended June 30, 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 July 31, 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

 

 

June 30, 2015

 

 

December 31, 2014

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

30,907,953

 

 

$

23,222,296

 

Other assets

 

1,302,579

 

 

 

1,219,873

 

Total current assets

 

32,210,532

 

 

 

24,442,169

 

Property and equipment, net

 

40,523

 

 

 

47,365

 

Deferred financing costs

 

-

 

 

 

105,563

 

Other assets

 

904,102

 

 

 

583,464

 

Total assets

$

33,155,157

 

 

$

25,178,561

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

452,201

 

 

$

322,002

 

Accrued compensation and benefits

 

290,740

 

 

 

334,527

 

Accrued liabilities

 

78,625

 

 

 

632,670

 

Total current liabilities

 

821,566

 

 

 

1,289,199

 

Warrant Liability

 

2,894,871

 

 

 

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

   June 30, 2015 and December 31, 2014, respectively

 

9,025

 

 

 

6,360

 

Additional paid-in capital

 

95,356,197

 

 

 

84,632,209

 

Accumulated deficit

 

(65,926,502

)

 

 

(61,346,926

)

Total shareholders’ equity

 

29,438,720

 

 

 

23,291,643

 

Total liabilities and shareholders’ equity

$

33,155,157

 

 

$

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)

 

 

For the Three

Months Ended

June 30, 2015

 

 

For the Three

Months Ended

June 30, 2014

 

 

For the Six

Months Ended

June 30, 2015

 

 

For the Six

Months Ended

June 30, 2014

 

Revenues

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

2,236,817

 

 

 

1,460,044

 

 

 

4,235,436

 

 

 

3,159,804

 

Stock based compensation

 

224,135

 

 

 

128,548

 

 

 

429,964

 

 

 

312,650

 

General and administrative

 

926,637

 

 

 

838,232

 

 

 

1,823,309

 

 

 

1,703,634

 

Total expenses

 

3,387,589

 

 

 

2,426,824

 

 

 

6,488,709

 

 

 

5,176,088

 

Loss before other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

and income taxes

 

(3,387,589

)

 

 

(2,426,824

)

 

 

(6,488,709

)

 

 

(5,176,088

)

Interest income

 

5,653

 

 

 

3,150

 

 

 

8,910

 

 

 

6,504

 

Financing expense

 

-

 

 

 

(24,600

)

 

 

(88,939

)

 

 

(24,600

)

Change in fair value of

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

warrant liability

 

227,206

 

 

 

249,134

 

 

 

1,989,162

 

 

 

(166,933

)

Loss before income taxes

 

(3,154,730

)

 

 

(2,199,140

)

 

 

(4,579,576

)

 

 

(5,361,117

)

Income taxes

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(3,154,730

)

 

$

(2,199,140

)

 

$

(4,579,576

)

 

$

(5,361,117

)

Loss per share

$

(0.03

)

 

$

(0.04

)

 

$

(0.05

)

 

$

(0.09

)

Weighted average number

   of shares basic and diluted:

 

90,254,823

 

 

 

58,535,936

 

 

 

84,070,845

 

 

 

58,047,016

 

 

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)

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

429,964

 

 

 

 

 

 

429,964

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(4,579,576

)

 

 

(4,579,576

)

Balance at June 30, 2015

 

 

90,254,823

 

 

$

9,025

 

 

$

95,356,197

 

 

$

(65,926,502

)

 

$

29,438,720

 

 

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)

 

 

For the Six

Months Ended

June 30, 2015

 

 

For the Six

Months Ended

June 30, 2014

 

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss

$

(4,579,576

)

 

$

(5,361,117

)

Adjustments to reconcile net loss to net cash used in

   operating activities:

 

 

 

 

 

 

 

Depreciation

 

13,285

 

 

 

23,917

 

(Gain) loss on disposal of assets

 

-

 

 

 

(4

)

Change in fair value of warrant liability

 

(1,989,162

)

 

 

166,933

 

Financing expense

 

88,939

 

 

 

24,600

 

Stock-based compensation

 

429,964

 

 

 

312,650

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

Other assets

 

(403,344

)

 

 

(203,265

)

Accounts payable

 

130,199

 

 

 

(239,131

)

Accrued liabilities

 

(597,832

)

 

 

(40,955

)

Net cash used in operating activities

 

(6,907,527

)

 

 

(5,316,372

)

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchase of property and equipment

 

(6,443

)

 

 

(3,600

)

Proceeds from sale of property and equipment

 

-

 

 

 

400

 

Net cash used in investing activities

 

(6,443

)

 

 

(3,200

)

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

-

 

 

 

1,045,000

 

Proceeds from issuance of common stock and warrants net of

   offering costs

 

14,599,627

 

 

 

2,289,316

 

Net cash provided by financing activities

 

14,599,627

 

 

 

3,334,316

 

Increase (decrease)  in cash and cash equivalents

 

7,685,657

 

 

 

(1,985,256

)

Cash and cash equivalents, beginning of period

 

23,222,296

 

 

 

27,646,351

 

Cash and cash equivalents, end of period

$

30,907,953

 

 

$

25,661,095

 

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, which were formed during 2014.  

The Company has been primarily engaged in the acquisition of certain intellectual property, together with development of its immunotherapy product candidates and the recent clinical testing activities for one of its immunotherapy 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 3 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 ICT-107 Phase 3 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 June 30, 2015, the Company had an accumulated deficit of $65,926,502. 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 June 30, 2015 and for the three and six month periods ended June 30, 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 June 30, 2015, the Company had working capital of $31,388,966, 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 immunotherapy 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 balances 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 June 30, 2015 and December 31, 2014, the Company had $29,436,720 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 depre ciated 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 operat ions 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 fai r 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 – The Company has in effect an equity incentive plan under which stock options and awards have been granted to employees, key consultants and non-employee members of the Board of Directors. The Company is 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. The Company has 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. The Company evaluates 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:

 

 

Six months
Ended
June 30, 2015

 

 

Six months
Ended
June 30, 2014

 

Risk-free interest rate

 

1.81

%

 

 

2.18

%

Expected dividend yield

 

None

 

 

 

None

 

Expected life

 

6.6 Years

 

 

 

5.5Years

 

Expected volatility

 

94.2

%

 

 

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 six months ended June 30, 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 June 30, 2015, the Company had 12,020,536 shares of authorized and unreserved 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 d eferred 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 current ly 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 June 30 , 2015 and December  31, 201 4 , 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 June 30 , 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, 20 10 for the state and December 31, 201 1 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 the Company’s 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. 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

9


average number of common shares outstanding. Common share equi valents (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 l oss per share, totaled 39,032,089 shares and 19,710,598 shares at June 30 , 2015 and 201 4 , 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:

 

 

June 30, 2015

 

  

December 31, 2014

 

Computers

$

65,520

 

  

$

59,076

 

Research equipment

 

143,184

 

  

 

143,185

 

 

 

208,704

 

  

 

202,261

 

Accumulated depreciation

 

(168,181

)

  

 

(154,896

)

 

$

40,523

 

  

$

47,365

 

Depreciation expense was $6,592 and $11,283  for the three months ended June 30, 2015 and 2014, respectively. Depreciation expense was $13,285 and $23,917  for the six months ended June 30, 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 (the Original License Agreement). 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.

On May 13, 2015, the Company entered into an Amended and Restated Exclusive License Agreement (the Amended License Agreement) with Cedars-Sinai to amend and restate the terms of the Original License Agreement.

Pursuant to the Amended License Agreement, the Company acquired an exclusive, worldwide license from Cedars-Sinai to certain patent rights and technology developed in the course of research performed at Cedars-Sinai into the diagnosis of diseases and disorders in humans and the prevention and treatment of disorders in humans utilizing cellular therapies, including dendritic cell-based vaccines for brain tumors and other cancers and neurodegenerative disorders. Under the Amended License Agreement, the Company will have exclusive rights to, among other things, develop, use, manufacture, sell and grant sublicenses to the licensed technology.

The Company has agreed to pay Cedars-Sinai specified milestone payments related to the development and commercialization of ICT-107, ICT-121 and ICT-140. Among other milestone payments, the Company will be required to pay to Cedars-Sinai specified milestone payments upon commencement of the first Phase III clinical trial for the Company’s first product and upon first commercial sale of the Company’s first product. If both of these milestones are met, the required milestone payments will total $1.1 million. The Company will pay Cedars-Sinai single digit percentages of gross revenues from the sales of products and high-single digit to low-double digit percentages of the Company’s sublicensing income based on the licensed technology.

10


The Amended License Agreement will terminate on a country-by-country basis on the expiration date of the last-to-expire licensed patent right in each such country. Either party may terminate the Amended License Agreement in the event of the other party’s material breach of its obligations under the Agreement if such breach remains uncured 60 days after such party’s receipt of written notice of such breach. Cedars-Sinai may also terminate the Amended License Agreement upon 30 days’ written notice to the Company that a required payment by the Company to Cedars-Sinai under the Amended License Agreement is delinquent.

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 June 30, 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 2 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 2 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 1 trial that provides for payments of approximately $2.3 million until completion of the services described therein.

All of the above contracts are cancelable upon 60 days written notice, therefore, there is no long term commitment.

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 immunotherapy 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 Company 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 non refundable 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 milesto ne 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 2 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 stem 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.

See Note 9 – Subsequent Events

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 immunotherapy for the treatment of newly diagnosed glioblastoma.

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.

PCT, LLC

On June 11, 2015, the Company entered into a Services Agreement with PCT, LLC, a Caladrius Company (PCT), a subsidiary of Caladrius Biosciences, Inc.

Pursuant to the terms of the Agreement, PCT will provide current good manufacturing practice (cGMP) services for the Phase 3 manufacture of ICT-107 and Phase 2 manufacture of ICT-121. PCT will provide, among other things, a controlled environment room on a semi-dedicated basis and qualified personnel to conduct runs as the parties mutually agree in writing and schedule. PCT’s facilities are registered with the FDA for testing; packaging; processing; storage; labeling and distribution of Peripheral Blood stem and Somatic Cell therapy products, and maintain cGMP-compliant quality systems.

12


The Company has agreed to pay monthly fees in connection with the use of a controlled environment room on a semi-dedicated basis and monthly fees for PCT personnel performing services under the Agreement.

Services to be performed under the Agreement terminate on the earlier of (i) December 31, 2018, (ii) the date the parties mutually agree, (iii) at any time following the earlier of the one year anniversary of the date on which the Company notifies PCT that services in the semi-dedicated controlled environment room are to commence and August 1, 2016, on the last day of the month following at least 120 days’ written notice from the Company to PCT, or (iv) the last day of the month following at least 60 days’ written notice from the Company to PCT that the Company has received a clinical hold issued by the FDA ordering the Company to suspend clinical trials for ICT-107. 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.

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 six months ended June 30, 2015, the Company issued an aggregate of 775,000 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 six months ended June 30, 2015, the Company issued 260,000 restricted shares of the Company’s common stock.  These shares will vest in March 2017.  

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 $50,000 and $49,000 for the six months ended June 30, 2015 and 2014, respectively.

Future minimum rentals under the operating lease are as follows:

 

Years ending December 31,

 

Amount

 

2015

 

 

51,075

 

2016

 

 

68,432

 

Total

 

$

119,507

 

 

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 the Company issues or is deemed to issue additional shares of 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 June 30,

13


2015 , the Company 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 June 30 , 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 or six months ended June 30 , 2015.

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 4,761,478 common shares have been granted under the Plan and are outstanding as of June 30, 2015. Additionally, 260,000 shares of restricted common stock have been granted under the Plan.  As of June 30, 2015, there were 4,045,593 options available for issuance under the Plan.

The following table summarizes stock option activity for the Company during the six months ended June 30, 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

1,718,000

 

  

$

0.55

  

  

 

0

  

  

 

0

  

Exercised

0

 

  

$

0

  

  

 

0

  

  

 

0

  

Forfeited or expired

(187,861

)

  

$

(2.19

)  

  

 

0

  

  

 

0

  

Outstanding June 30, 2015

10,844,904

 

  

$

1.19

  

  

 

3.54

  

  

$

10,500

  

Vested at June 30, 2015

8,146,613

 

  

$

1.21

  

  

 

2.07

  

  

$

10,500

  

 

As of June 30, 2015 , the total unrecognized compensation cost related to unvested stock options amounted to $2.8 million, which will be recognized over the weighted-average remaining requisite service period of approximately  16 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 had a five-year term from the date of issuance. As of June 30, 2015, the remaining warrants to purchase 1,290,996 shares of the Company’s common stock at $2.50 expired. (See “Warrant Liability” below.)

14


In connection with the February 2011 common stock private placement, the Company issued to the investors warrants to p urchase 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 equi ty 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 proportiona tely 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 Cont rolled 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, 201 4 , 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 June 30 , 2015 , warrants to purchase 3,666,836 shares of the Company’s c ommon 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 June 30, 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 June 30, 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 June 30, 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 June 30, 2015 , the price per share of Company’s common stock was $0.47 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 contained 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 did not qualify for equity treatment, and therefore were recognized as a liability. The warrant liability was adjusted to fair value each reporting period and any change in value was 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 June 30, 2014, the Company recorded a credit to other income of $73,587 and for the six months ended June 30, 2014 , the Company recorded a charge to other expense of $51,640. For the three and six months ended June 30, 2015, the Company recorded a credit to other income of $7,746.  The remaining warrants expired during the three months ended June 30, 2015.  

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

15


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 mod el. 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 adju sted 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 Februar y 2015 underwritten public offering , the exercise price of the warrants was adjusted to $ 1.44 and the number of warrants was proportionately increased t o 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 o f 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 June 30 , 2014 , the Company recorded a credit to other income of $175,547 and for the six months ended June 30, 2014, the Company recorded a charge to other expense of $ 115,293 .  As of June 30 , 2015 , the Company revalued the warrants using the binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 80 %; (iii) risk free rate of 0. 16 .% and (iv) expected term of . 64 years. For the three and six months ended June 30 , 2015 , the Company recorded a credit to other income of $ 22,001 and $ 656,911, respectively . As of June 30 , 2015 , the carrying value of the warrant liability is $ 22,001 .

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 June 30, 2015, the Company revalued the warrants using the binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 91.0%; (iii) risk free rate of 1.51% and (iv) expected term of 4.61 years.  For the three and six months ended June 30, 2015, the Company recorded a credit to other income of $205,205 and $1,324,505, respectively. As of June 30, 2015, the carrying value of the warrant liability is $2,872,870.

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 June 30, 2015 and 2014 :

 

 

June 30, 2015

 

 

June 30, 2014

 

Balance – January 1

$

597,719

 

 

$

1,064,810

 

Issuance of warrants and effect of repricing

 

4,286,314

 

 

 

24,600

 

Exercise of warrants

 

0

 

 

 

0

 

(Gain) or loss included in earnings

 

(1,989,162

)

 

 

166,933

 

Transfers in and out/or out of Level 3

 

0

 

 

 

0

 

Balance – June 30

$

2,894,871

 

 

$

1,256,343

 

 

Additionally , during the six months ended June 30, 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 or six months ended June 30, 2015 or June 30, 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


A valuation allowance is required if the weight of available evidence suggests it is more likely than not that some portion or all of the deferred tax asset will not be recognized.   Accordingly, a valuation allowance has been established for the full amount of the deferred tax asset s .

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:

 

 

June 30, 2015

 

 

June 30, 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

 

17

%

 

 

-1

%

Change in valuation allowance for deferred tax assets

 

23

%

 

 

41

%

Total

 

0

%

 

 

0

%

 

Deferred taxes consisted of the following:

 

June 30, 2015

 

 

December 31, 2014

 

Net operating loss carryforwards

$

18,757,528

 

 

$

16,302,000

 

Stock-based compensation

 

2,404,882

 

 

 

2,191,000

 

Less valuation allowance

 

(21,162,410

)

 

 

(18,493,000

)

Net deferred tax asset

$

0

 

 

$

0

 

As of June 30, 2015 and December 31, 2014, the Company had federal and California income tax net operating loss carry forwards of approximately $46.9 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 potential future limitations of IRS Section 382, as well as expiration of federal and state net operating loss carryforwards.

 

9. Subsequent Events

 

Subsequent to June 30, 2015, the Company entered an agreement with Novella Clinical to conduct the Phase 3 registration trial of ICT-107.  Novella Clinical is a full-service, global clinical research organization providing clinical trial services to small and mid-sized oncology companies.  Novella will supervise the trial in the United States, Europe and Canada and will recruit approximately 400 patients with newly diagnosed glioblastoma.  The Company anticipates initiating the Phase 3 trial in the fourth quarter of 2015.  The Company may terminate this agreement upon 60 days’ notice.

 

 

 

17


Item 2. Ma nagement’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 immunotherapy product candidates, and has not generated any recurring revenues. The Company’s lead product candidate, ICT-107, completed Phase 2 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 3 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 June 30, 2015, the Company had an accumulated deficit of $65,926,502. 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 six months ended June 30, 2015 and 2014, we recorded an expense of $4,235,436 and $3,159,804, 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, 2010 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 June 30, 2015 and 2014

Net Loss

We incurred a net loss of $3,154,730 and $2,199,140 for the three months ended June 30, 2015 and 2014, respectively. The increase in the net loss is primarily due to an increase in research and development expenses during the most recent quarter.  Additionally, general and administrative and stock based compensation expenses were also higher during the quarter ended June 30, 2015.  

Revenues

We did not have any revenue during the three months ended June 30, 2015 and 2014 and we do not expect to have any revenue in 2015.

Expenses

 

Research and development expenses for the three months ended June 30, 2015 were $2,236,817 compared to $1,460,044 in the same period in 2014.  During the quarter ended June 30, 2015, we incurred expenses related to the start-up and planning of the Company’s ICT-107 Phase 3 trial.  We also increased the number of participating sites in the Company’s ICT-121 program.  Additionally, we incurred expenses related to our stem cell immunotherapies for the treatment of cancer.  These incremental expenses were partially offset by the wind down of expenses related to the Phase 2 trial of ICT-107.  As of December 31, 2014, our ICT-140 trial for ovarian cancer was placed on hold.  As a result, we incurred minimal expense related to this program during the most recent quarter.  We anticipate that this program will remain on hold until we obtain additional financing or finds a partner for this program.

General and administrative expenses for the three months ended June 30, 2015 and 2014 were $926,637 and $838,232, respectively. The increase reflects additional professional fees incurred to support various contract negotiations, patent protection costs and governmental compliance.   

Six months ended June 30, 2015 and 2014

Net Loss

We incurred a net loss of $4,579,576 and $5,361,117 for the six months ended June 30, 2015 and 2014, respectively. The decrease in the net loss reflects a credit of $1,989,162 related to the revaluation of our derivative warrants offset by increases in research and development expenses, stock based compensation and general and administrative expenses.

19


Revenues

We did not have any revenue during the six months ended June 30, 2015 and 2014 and we do not expect to have any revenue in 2015.

Expenses

Research and development expenses for the six months ended June 30, 2015 and 2014 were $4,235,436 and $3,159,804, respectively. During the six months ended June 30, 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.  

 

General and administrative expenses for the six months ended June 30, 2015 and 2014 were $1,823,309 and $1,703,634, respectively. The increase reflects additional professional fees incurred to support various contract negotiations, patent protection costs and governmental compliance.  

Liquidity and Capital Resources

As of June 30, 2015, we had working capital of $31,388,966, 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 immunotherapy 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 June 30, 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 June 30, 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.

20


As of June 30 , 2015 , we had no long-term debt obligations or other similar long-term liabilities. We have various purchase commitments for spon sored 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 June 30, 2015.

 

 

Total

 

 

Less than
1 year

 

 

1-3
years

 

 

3-5
years

 

 

More than
5 years

 

Unconditional purchase obligations

$

104,000

 

 

$

26,000

 

 

$

52,000

 

 

$

26,000

 

 

$

-

 

Operating lease obligation

 

119,507

 

 

 

102,399

 

 

 

17,108

 

 

 

-

 

 

 

-

 

 

$

223,507

 

 

$

128,399

 

 

$

69,108

 

 

$

26,000

 

 

$

-

 

Cash Flows

We used $6,907,527 of cash in our operations for the six months ended June 30, 2015, compared to $5,316,372 for the six months ended June 30, 2014. During the six months ended June 30, 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.   During the six months ended June 30, 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 2 trial. Our general and administrative expenses increased between periods as we incurred additional professional fees.  We recorded a non-cash credit of $1,989,162 related to the revaluation of our warrant derivaties.   We had $532,188 of non-cash expenses for the six months ended June 30, 2015, consisting of $88,939 of financing expense associated with the repricing of warrants resulting from the February 2015 financing, $429,964 of stock based compensation and $13,285 of depreciation expense.  We had $528,100 of non-cash expenses during the six months ended June 30, 2014, consisting of $166,933 related to the increase in our warrant liabilities, $312,650 of stock based compensation and $23,917 of depreciation expense and $24,600 of financing expense associated with the repricing of our warrant derivatives resulting from the issuance of shares of our common stock pursuant to our Sales Agreement with Cantor. 

During the six months ended June 30, 2015, our investing cash flows used $6,443 to acquire certain computer equipment. During the six months ended June 30, 2014, our investing cash flows used $3,600 to acquire certain computer software.  

As described above, we completed an underwritten public offering during the six months ended June 30, 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 six months ended June 30, 2015, we did not receive any proceeds from the exercise of stock options, the exercise of warrants or from our controlled equity offering.  During the six months ended June 30, 2014, we received net proceeds of $1,045,000 from the exercise of stock options and $2,289,316 in net proceeds 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 June 30, 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 a nd 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 June 30, 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. Exh ibits

 

Exhibit
No.

  

Description

 

10.1

 

 

Form of Restricted Stock Unit Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd.

 

10.2

 

 

Amended & Restated Exclusive License Agreement dated May 13, 2015 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.

 

10.3

 

 

Services Agreement dated June 11, 20015 between ImmunoCellular Therapeutics, Ltd  and PCT, LLC, a Caladrius Company

 

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


SIGNA TURES

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: August 7, 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 JUNE 30, 2015

 

Exhibit
No.

  

Description

 

10.1

 

 

Form of Restricted Stock Unit Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd.

 

10.2

 

 

Amended & Restated Exclusive License Agreement dated May 13, 2015 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.

 

10.3

 

 

Services Agreement dated June 11, 20015 between ImmunoCellular Therapeutics, Ltd  and PCT, LLC, a Caladrius Company

 

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 10.1

ImmunoCellular Therapeutics, Ltd.
Restricted Stock Unit Grant Notice
( 2006 Equity Incentive Plan)

ImmunoCellular Therapeutics, Ltd. (the “ Company ”), pursuant to Section 8.1.2 of the Company’s 2006 Equity Incentive Plan (the “ Plan ”), hereby grants to Participant an award of shares of the Company’s Common Stock (“ Restricted Stock Units ”) under the terms set forth below (the “ Award ”). The Award is subject to all of the terms and conditions as set forth in this notice of grant (this “ Restricted Stock Unit Grant Notice ”) and in the Plan and the Restricted Stock Unit Award Agreement (the “ Award Agreement ”), both of which are attached hereto and incorporated herein in their entirety. Capitalized terms not otherwise defined herein shall have the meanings set forth in the Plan or the Award Agreement. In the event of any conflict between the terms in the Award and the Plan, the terms of the Plan shall control.

Participant:

 

Date of Grant:

 

Vesting Commencement Date:

 

Number of Restricted Stock Units/Shares:

 

 

Vesting Schedule:

The shares subject to the Award shall vest as follows: ________________________.

 

 

Issuance Schedule:

Subject to any change on a Capitalization Adjustment, one share of Common Stock will be issued for each Restricted Stock Unit that vests at the time set forth in Section 6 of the Award Agreement.

 

 

Additional Terms/Acknowledgements: Participant acknowledges receipt of, and understands and agrees to, this Restricted Stock Unit Grant Notice, the Award Agreement and the Plan. Participant further acknowledges that as of the Date of Grant, this Restricted Stock Unit Grant Notice, the Award Agreement and the Plan set forth the entire understanding between Participant and the Company regarding the acquisition of the Common Stock pursuant to the Award specified above and supersede all prior oral and written agreements on the terms of this Award with the exception, if applicable, of (i) any compensation recovery policy that is adopted by the Company or is otherwise required by applicable law, and (ii) any written employment or severance arrangement that would provide for vesting acceleration of this Award upon the terms and conditions set forth therein.

 

By accepting this Award, Participant acknowledges having received and read this Restricted Stock Unit Grant Notice, the Award Agreement and the Plan and agrees to all of the terms and conditions set forth in these documents. Participant consents to receive Plan documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

 

 

 

 

 

 

 


 


ImmunoCellular Therapeutics, Ltd . Participant

By:

 

 

 

 

 

Signature

 

 

Signature

Title:

 

 

Date:

 

Date:

 

 

 

 

 

Attachments :

Restricted Stock Unit Award Agreement and 2006 Equity Incentive Plan

 


 

 

 

 

 

 


 

Attachment I

Restricted Stock Unit Award Agreement

 

 

 

 

 

 

 


 

ImmunoCellular Therapeutics, Ltd.

Restricted Stock Unit Award Agreement

(2006 Equity Incentive Plan)

 

Pursuant to the Restricted Stock Unit Grant Notice (the “ Grant Notice ”) and this Restricted Stock Unit Award Agreement (the “ Agreement ”), ImmunoCellular Therapeutics, Ltd. (the “ Company ”) has awarded you (“ Participant ”) a Restricted Stock Unit Award (the “ Award ”) pursuant to Section 8.1.2 of the Company’s 2006 Equity Incentive Plan (the “ Plan ”) for the number of Restricted Stock Units/shares indicated in the Grant Notice. Capitalized terms not explicitly defined in this Agreement or the Grant Notice shall have the same meanings given to them in the Plan. The terms of your Award, in addition to those set forth in the Grant Notice, are as follows.

1. Grant of the Award. This Award represents the right to be issued on a future date one (1) share of Common Stock for each Restricted Stock Unit that vests on the applicable vesting date(s) (subject to any adjustment under Section 3 below) as indicated in the Grant Notice. As of the Date of Grant, the Company will credit to a bookkeeping account maintained by the Company for your benefit (the “ Account ”) the number of Restricted Stock Units/shares of Common Stock subject to the Award. This Award was granted in consideration of your services to the Company.

2. Vesting. Subject to the limitations contained herein, your Award will vest, if at all, in accordance with the vesting schedule provided in the Grant Notice, provided that vesting will cease upon the termination of your Continuous Service. Upon such termination of your Continuous Service, the Restricted Stock Units/shares of Common Stock credited to the Account that were not vested on the date of such termination will be forfeited at no cost to the Company and you will have no further right, title or interest in or to such underlying shares of Common Stock.

3. Number of Shares. The number of Restricted Stock Units/shares subject to your Award may be adjusted from time to time for Capitalization Adjustments, as provided in the Plan. Any additional Restricted Stock Units, shares, cash or other property that becomes subject to the Award pursuant to this Section 3, if any, shall be subject, in a manner determined by the Board, to the same forfeiture restrictions, restrictions on transferability and time and manner of delivery as applicable to the other Restricted Stock Units and shares covered by your Award. Notwithstanding the provisions of this Section 3, no fractional shares or rights for fractional shares of Common Stock shall be created pursuant to this Section 3. Any fraction of a share will be rounded down to the nearest whole share.

4. Securities Law Compliance . You may not be issued any Common Stock under your Award unless the shares of Common Stock underlying the Restricted Stock Units are either (i) then registered under the Securities Act, or (ii) the Company has determined that such issuance would be exempt from the registration requirements of the Securities Act. Your Award must also comply with other applicable laws and regulations governing the Award, and you shall not receive such Common Stock if the Company determines that such receipt would not be in material compliance with such laws and regulations.

5. Transfer Restrictions . Prior to the time that shares of Common Stock have been delivered to you, you may not transfer, pledge, sell or otherwise dispose of this Award or the shares issuable in respect of your Award, except as expressly provided in this Section 5. For example, you may not use shares that may be issued in respect of your Restricted Stock Units as security for a loan. The restrictions on transfer set forth herein will lapse upon delivery to you of shares in respect of your vested Restricted Stock Units.

1.


 

(a) Death . Your Award is transferable by will and by the laws of descent and distribution. At your death, vesting of your Award will cease and your executor or administrator of your estate shall be entitled to receive, on behalf of your estate, any Common Stock or other consideration that vested but was not issued before your death.

(b) Domestic Relations Orders. Upon receiving written permission from the Board or its duly authorized designee, and provided that you and the designated transferee enter into transfer and other agreements required by the Company, you may transfer your right to receive the distribution of Common Stock or other consideration hereunder, pursuant to a domestic relations order or marital settlement agreement that contains the information required by the Company to effectuate the transfer. You are encouraged to discuss the proposed terms of any division of this Award with the Company General Counsel prior to finalizing the domestic relations order or marital settlement agreement to verify that you may make such transfer, and if so, to help ensure the required information is contained within the domestic relations order or marital settlement agreement.

6. Date of Issuance.

(a) The issuance of shares in respect of the Restricted Stock Units is intended to comply with Treasury Regulations Section 1.409A-1(b)(4) and will be construed and administered in such a manner. Subject to the satisfaction of the withholding obligations set forth in this Agreement, in the event one or more Restricted Stock Units vests, the Company shall issue to you one (1) share of Common Stock for each Restricted Stock Unit that vests on the applicable vesting date(s) (subject to any adjustment under Section 3 above). The issuance date determined by this paragraph is referred to as the “ Original Issuance Date ”.

(b) If the Original Issuance Date falls on a date that is not a business day, delivery shall instead occur on the next following business day. In addition, if:

(i) the Original Issuance Date does not occur (1) during an “open window period” applicable to you, as determined by the Company in accordance with the Company’s then-effective policy on trading in Company securities, or (2) on a date when you are otherwise permitted to sell shares of Common Stock on an established stock exchange or stock market, and

(ii) either (1) Withholding Taxes do not apply, or (2) the Company decides, prior to the Original Issuance Date, (A) not to satisfy the Withholding Taxes by withholding shares of Common Stock from the shares otherwise due, on the Original Issuance Date, to you under this Award, and (B) not to permit you to pay your Withholding Taxes in cash,

then the shares that would otherwise be issued to you on the Original Issuance Date will not be delivered on such Original Issuance Date and will instead be delivered on the first business day when you are not prohibited from selling shares of the Company’s Common Stock in the open public market, but in no event later than December 31 of the calendar year in which the Original Issuance Date occurs (that is, the last day of your taxable year in which the Original Issuance Date occurs), or, if and only if permitted in a manner that complies with Treasury Regulations Section 1.409A-1(b)(4), no later than the date that is the 15th day of the third calendar month of the applicable year following the year in which the shares of Common Stock under this Award are no longer subject to a “substantial risk of forfeiture” within the meaning of Treasury Regulations Section 1.409A-1(d).

(c) The form of delivery ( e.g. , a stock certificate or electronic entry evidencing such shares) shall be determined by the Company.

2.


 

7. Dividends. You shall receive no benefit or adjustment to your Award with respect to any cash dividend, stock dividend or other distribution that does not result from a Capitalization Adjustment.

8. Restrictive Legends. The shares of Common Stock issued under your Award shall be endorsed with appropriate legends as determined by the Company.

9. Execution of Documents. You hereby acknowledge and agree that the manner selected by the Company by which you indicate your consent to your Grant Notice is also deemed to be your execution of your Grant Notice and of this Agreement. You further agree that such manner of indicating consent may be relied upon as your signature for establishing your execution of any documents to be executed in the future in connection with your Award.

10. Award not a Service Contract .

(a) Nothing in this Agreement (including, but not limited to, the vesting of your Award or the issuance of the shares subject to your Award), the Plan or any covenant of good faith and fair dealing that may be found implicit in this Agreement or the Plan shall: (i) confer upon you any right to continue in the employ of, or affiliation with, the Company or an Affiliate; (ii) constitute any promise or commitment by the Company or an Affiliate regarding the fact or nature of future positions, future work assignments, future compensation or any other term or condition of employment or affiliation; (iii) confer any right or benefit under this Agreement or the Plan unless such right or benefit has specifically accrued under the terms of this Agreement or Plan; or (iv) deprive the Company of the right to terminate you at will and without regard to any future vesting opportunity that you may have.

(b) The Company has the right to reorganize, sell, spin-out or otherwise restructure one or more of its businesses or Affiliates at any time or from time to time, as it deems appropriate (a “ reorganization ”). Such a reorganization could result in the termination of your Continuous Service, or the termination of Affiliate status of your employer and the loss of benefits available to you under this Agreement, including but not limited to, the termination of the right to continue vesting in the Award. This Agreement, the Plan, the transactions contemplated hereunder and the vesting schedule set forth herein or any covenant of good faith and fair dealing that may be found implicit in any of them do not constitute an express or implied promise of continued engagement as an employee or consultant for the term of this Agreement, for any period, or at all, and shall not interfere in any way with the Company’s right to conduct a reorganization.

11. Withholding Obligations.

(a) On each vesting date, and on or before the time you receive a distribution of the shares underlying your Restricted Stock Units, and at any other time as reasonably requested by the Company in accordance with applicable tax laws, you hereby authorize any required withholding from the Common Stock issuable to you and/or otherwise agree to make adequate provision in cash for any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company or any Affiliate that arise in connection with your Award (the “ Withholding Taxes ”). Additionally, the Company or any Affiliate may, in its sole discretion, satisfy all or any portion of the Withholding Taxes obligation relating to your Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you by the Company; (ii) causing you to tender a cash payment; (iii) permitting or requiring you to enter into a “same day sale” commitment, if applicable, with a broker-dealer that is a member of the Financial Industry Regulatory Authority (a “ FINRA Dealer ”) whereby you irrevocably elect to sell a portion of the shares to be delivered in connection with your Restricted Stock Units to satisfy the Withholding Taxes and whereby the FINRA

3.


 

Dealer irrevocably commits to forward the proceeds necessary to satisfy the Withholding Taxes directly to the Compa ny and/or its Affiliates; or (iv) withholding shares of Common Stock from the shares of Common Stock issued or otherwise issuable to you in connection with the Award with a Fair Market Value (measured as of the date shares of Common Stock are issued to pursuant to Section 6) equal to the amount of such Withholding Taxes; provided , however , that the number of such shares of Common Stock so withheld will not exceed the amount necessary to satisfy the Company’s required tax withholding obligations using the minimum statutory withholding rates for federal, state, local and foreign tax purposes, including payroll taxes, that are applicable to supplemental taxable income; and provided , further, that to the extent necessary to qualify for an exemption from application of Section 16(b) of the Exchange Act, if applicable, such share withholding procedure will be subject to the express prior approval of the Company’s Compensation Committee.

(b) Unless the tax withholding obligations of the Company and/or any Affiliate are satisfied, the Company shall have no obligation to deliver to you any Common Stock.

(c) In the event the Company’s obligation to withhold arises prior to the delivery to you of Common Stock or it is determined after the delivery of Common Stock to you that the amount of the Company’s withholding obligation was greater than the amount withheld by the Company, you agree to indemnify and hold the Company harmless from any failure by the Company to withhold the proper amount.

12. Tax Consequences. The Company has no duty or obligation to minimize the tax consequences to you of this Award and shall not be liable to you for any adverse tax consequences to you arising in connection with this Award. You are hereby advised to consult with your own personal tax, financial and/or legal advisors regarding the tax consequences of this Award and by signing the Grant Notice, you have agreed that you have done so or knowingly and voluntarily declined to do so. You understand that you (and not the Company) shall be responsible for your own tax liability that may arise as a result of this investment or the transactions contemplated by this Agreement.

13. Non-Compete Agreement . As a further condition to the receipt of Common Stock pursuant to the vesting of your Award, you may be required not to render services for any organization, or engage directly or indirectly in any business, competitive with the Company at any time during which (i) your Award is outstanding and for six (6) months after the receipt of Common Stock pursuant to the vesting and settlement of your Award.  Failure to comply with this condition will cause your Award and the issuance of shares under your Award to be rescinded and the benefit of such issuance or award to be repaid to the Company.

14. Unsecured Obligation. Your Award is unfunded, and as a holder of a vested Award, you shall be considered an unsecured creditor of the Company with respect to the Company’s obligation, if any, to issue shares or other property pursuant to this Agreement. You shall not have voting or any other rights as a stockholder of the Company with respect to the shares to be issued pursuant to this Agreement until such shares are issued to you pursuant to Section 6 of this Agreement. Upon such issuance, you will obtain full voting and other rights as a stockholder of the Company. Nothing contained in this Agreement, and no action taken pursuant to its provisions, shall create or be construed to create a trust of any kind or a fiduciary relationship between you and the Company or any other person.

15. Notices . Any notice or request required or permitted hereunder shall be given in writing to each of the other parties hereto and shall be deemed effectively given on the earlier of (i) the date of personal delivery, including delivery by express courier, or delivery via electronic means, or (ii) the date that is five (5) days after deposit in the United States Post Office (whether or not actually received by the addressee), by registered or certified mail with postage and fees prepaid, addressed at the following

4.


 

addresses or at such other address(es) as a party may designate by ten (10) days’ advance written notice to each of the other parties hereto:

Company: ImmunoCellular Therapeutics, Ltd.
Attn: Stock Administrator
23622 Calabasas Road, Suite 300

Calabasas, CA 91302 USA

Participant: Your address as on file with the Company

at the time notice is given

 

16. Headings . The headings of the Sections in this Agreement are inserted for convenience only and shall not be deemed to constitute a part of this Agreement or to affect the meaning of this Agreement.

17. Miscellaneous.

(a) The rights and obligations of the Company under your Award shall be transferable by the Company to any one or more persons or entities, and all covenants and agreements hereunder shall inure to the benefit of, and be enforceable by, the Company’s successors and assigns.

(b) You agree upon request to execute any further documents or instruments necessary or desirable in the sole determination of the Company to carry out the purposes or intent of your Award .

(c) You agree that if so requested by the Company or any representative of the underwriters in connection with any registration of the offering of any securities of the Company under the Securities Act, you will be required to not sell or otherwise transfer any shares of Common Stock acquired upon vesting of your Award during the applicable lock-up period following the effective date of a registration statement of the Company filed under the Securities Act; provided, however, that such restriction will apply only to a registration statement of the Company which includes securities to be sold on behalf of the Company to the public in an underwritten public offering under the Securities Act and the restriction period will not exceed 180 days after the registration statement becomes effective.

(d) You acknowledge and agree that you have reviewed your Award in its entirety, have had an opportunity to obtain the advice of counsel prior to executing and accepting your Award and fully understand all provisions of your Award .

(e) This Agreement shall be subject to all applicable laws, rules and regulations, and to such approvals by any governmental agencies or national securities exchanges as may be required.

(f) All obligations of the Company under the Plan and this Agreement shall be binding on any successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation or otherwise, of all or substantially all of the business and/or assets of the Company.

18. Governing Plan Document . Your Award is subject to all the provisions of the Plan, the provisions of which are hereby made a part of your Award , and is further subject to all interpretations, amendments, rules and regulations which may from time to time be promulgated and adopted pursuant to the Plan. Your Award (and any compensation paid or shares issued under your Award) is subject to

5.


 

recoupment in accordance with The Dodd–Frank Wall Street Reform and Consumer Protection Act and any implementing regulations thereunder, any clawback policy adopted by the Company and any compensation recovery policy otherwise required by applicable law. No recovery of compensation under such a clawback policy will be an event giving rise to a right to voluntarily terminate employment upon a r esignation for “g ood r eason, or for a “constructive termination” or any similar term under any plan of or agreement with the Company.

19. Effect on Other Employee Benefit Plans. The value of the Award subject to this Agreement shall not be included as compensation, earnings, salaries or other similar terms used when calculating benefits under any employee benefit plan (other than the Plan) sponsored by the Company or any Affiliate except as such plan otherwise expressly provides. The Company expressly reserves its rights to amend, modify or terminate any or all of the employee benefit plans of the Company or any Affiliate.

20. Choice of Law . The interpretation, performance and enforcement of this Agreement shall be governed by the law of the State of Delaware without regard to that state’s conflicts of laws rules.

21. Severability. If all or any part of this Agreement or the Plan is declared by any court or governmental authority to be unlawful or invalid, such unlawfulness or invalidity shall not invalidate any portion of this Agreement or the Plan not declared to be unlawful or invalid. Any Section of this Agreement (or part of such a Section) so declared to be unlawful or invalid shall, if possible, be construed in a manner which will give effect to the terms of such Section or part of a Section to the fullest extent possible while remaining lawful and valid.

22. Other Documents . You acknowledge receipt of and the right to receive a document providing the information required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus. In addition, you acknowledge receipt of the Company’s policy permitting certain individuals to sell shares only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.

23. Amendment. This Agreement may not be modified, amended or terminated except by an instrument in writing, signed by you and by a duly authorized representative of the Company. Notwithstanding the foregoing, this Agreement may be amended solely by the Board by a writing which specifically states that it is amending this Agreement, so long as a copy of such amendment is delivered to you, and provided that, except as otherwise expressly provided in the Plan, no such amendment materially adversely affecting your rights hereunder may be made without your written consent. Without limiting the foregoing, the Board reserves the right to change, by written notice to you, the provisions of this Agreement in any way it may deem necessary or advisable to carry out the purpose of the Award as a result of any change in applicable laws or regulations or any future law, regulation, ruling or judicial decision, provided that any such change shall be applicable only to rights relating to that portion of the Award which is then subject to restrictions as provided herein.

24. Compliance with Section 409A of the Code . This Award is intended to comply with the “short-term deferral” rule set forth in Treasury Regulation Section 1.409A-1(b)(4). Notwithstanding the foregoing, if it is determined that the Award fails to satisfy the requirements of the short-term deferral rule and is otherwise deferred compensation subject to Section 409A, and if you are a “Specified Employee” (within the meaning set forth in Section 409A(a)(2)(B)(i) of the Code) as of the date of your “separation from service” ( within the meaning of Treasury Regulation Section 1.409A-1(h) and without regard to any alternative definition thereunder ), then the issuance of any shares that would otherwise be made upon the date of the separation from service or within the first six (6) months thereafter will not be made on the originally scheduled date(s) and will instead be issued in a lump sum on the date that is six (6) months and one day after the date of the separation from service, with the

6.


 

balance of the shares issued thereafter in accordance with the original vesting and issuance schedule set forth above, but if and only if such delay in the issuance of the shares is necessary to avoid the imposition of adverse taxation on you in respect of the shares under Section 409A of the Code. Each installment of shares that vests is intended to constitute a “separate payment” for purposes of Treasury Regulation Section 1.409A-2(b)(2).

* * * * *

 

This Restricted Stock Unit Award Agreement shall be deemed to be signed by the Company and the Participant upon the signing by the Participant of the Restricted Stock Unit Grant Notice to which it is attached.

7.


 

Attachment II

2006 Equity Incentive Plan

[ * ] = 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

CONFIDENTIAL

AMENDED & RESTATED EXCLUSIVE LICENSE AGREEMENT

THIS AMENDED & RESTATED EXCLUSIVE LICENSE AGREEMENT (“Agreement”) is entered into this 13 th day of May 2015 (“Effective Date”) by and between CEDARS-SINAI MEDICAL CENTER , a California nonprofit public benefit corporation (“CSMC”), with offices at 8700 Beverly Boulevard, Los Angeles, California 90048-1865, and ImmunoCellular Therapeutics, Ltd., a Delaware limited liability company (“Licensee”), with offices at 23622 Calabasas Road, Suite 300, Calabasas, CA 91302.

R E C I T A L S

A. CSMC owns Patent Rights and Technical Information (as defined below) invented or developed in the course of certain research into the diagnosis of diseases and disorders in humans and the prevention and treatment of disorders in humans utilizing cellular therapies, including dendritic cell-based vaccines for brain tumors and other cancers and neurodegenerative disorders at CSMC conducted under the direction of Dr. John Yu (Dr. Yu, hereinafter, “Inventor”; the research, hereinafter, “Research Project”).

B. CSMC and Licensee entered into that certain Exclusive License Agreement dated November 17, 2006, as amended by the First Amendment dated June 16, 2008, the Second Amendment dated August 1, 2009 and the Third Amendment dated March 26, 2010 (as amended, the “Original License Agreement.”)  Pursuant to the Original License Agreement, CSMC granted to Licensee an exclusive, worldwide license to conduct research in the Field of Use, and to develop, manufacture, use and sell Products (as defined below) in the Field of Use, using the Patent Rights and Technical Information.  

C. CSMC and Licensee wish to amend and restate the terms of the Original License Agreement on the terms and subject to the conditions set forth in this Agreement.

D. CSMC and Licensee intend that the execution, delivery and performance of this Agreement by each party, and the consummation of the transactions contemplated hereunder, shall not at any time threaten CSMC’s tax-exempt status under Section 501(c)(3) of the Internal Revenue Code and Section 23701d of the California Revenue and Taxation Code, or cause CSMC to be in default under any of CSMC’s issued and outstanding tax-exempt bonds.

NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

 

 


1.

DEFINITIONS

1.1 Affiliate ” or “ Affiliates ” shall mean any corporation, person or entity, which controls, is controlled by, or is under common control with, a party to this Agreement without regard to stock or other equity ownership.  For purposes hereof, the terms “control” and “controls” mean the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a corporation, person or entity, whether through the ownership of voting securities, by contract or otherwise.

1.2 Confidential Information ” shall mean any confidential or proprietary information furnished by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) in connection with this Agreement, including, without limitation, all specifications, know how, trade secrets, technical information, drawings, software, models, business information and patent applications pertaining to the Patent Rights and Technical Information, and as further provided in Section 10 hereof.  Without limitating the foregoing, Licensee’s Confidential Information includes without limitation any and all progress reports made hereunder, sublicense agreements, any reports or other information regarding Sales and Gross Sales of Products and Royalties (whether from Licensee or its Permitted Sublicensee), Sublicense Income and audits and audit reports of Licensee and its Permitted Sublicensees.

1.3 FDA ” shall mean the United States Food and Drug Administration, or any successor agency thereof.

1.4 Field of Use ” shall mean cellular therapies or diagnostics utilizing cellular therapies, including dendritic cell-based vaccines for cancer.

1.5 Funding Agencies ” shall mean any public or private granting agencies which have provided funding to CSMC or to any of the inventors named on the Patent Rights for the development of any of the Patent Rights or Technical Information prior to the Effective Date.

1.6 “CSMC Improvements” shall mean all improvements or enhancements to the Patent Rights that, after the Effective Date, are conceived and reduced to practice if patentable, or reduced to practice if not patentable, by the Inventor (except in the case of Dr. John Yu working in his capacity as Licensee’s Chief Scientific Officer and without using any facilities, resources or personnel of CSMC).

1.7 Invention ” shall mean all unpatented, patentable and patented inventions, discoveries, designs, apparatuses, systems, machines, methods, processes, uses, devices, models, composition of matter, technical information, trade secrets, know-how, codes, programs or configurations of any kind which are in the Field of Use.

1.8 Licensee Developments ” shall mean any and all processes, uses, designs, applications, methods and compositions-of-matter, indications, improvements, enhancements and modifications in the Field of Use directly based upon or directly created using the Patent Rights and/or Technical Information and which were discovered or developed by or on behalf of Licensee (exclusive of work performed by CSMC or the Inventor, except in the case of Dr. John

- 2 –

[ * ] = 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.

 

 


Yu working in his capacity as Licensee’s Chief Scientific Officer and without using any facilities, resources or personnel of CSMC) during the term of this Agreement.

1.9 Patent Rights ” shall mean the patents and/or patent applications existing on the Effective Date which are described on Schedule A attached hereto, and all patents and/or patent applications (including provisional patent applications) existing as of the Effective Date in any other country corresponding to any of the foregoing, and all divisions, continuations, reissues, reexaminations, supplementary protection certificates and extensions thereof, whether domestic or foreign, all claims of continuations-in-part that are entitled to the benefit of the priority date of any of the foregoing, and any patent that issues thereon, excluding any Licensee Developments or Inventions by Dr. John Yu working in his capacity as Licensee’s Chief Scientific Officer and without using any facilities, resources or personnel of CSMC.  The Patent Rights are all owned by CSMC.

1.10 Product ” or “ Products ” shall mean any products and/or services in the Field of Use utilizing or derived in any manner whatsoever from any of the Patent Rights, Technical Information or Licensee Developments, which Products, except for the license granted hereunder, would infringe a Valid Claim.  As of the Effective Date, Licensee is developing three (3) Products: ICT-107, ICT-121 and ICT-140. All references to “Products” in this Agreement shall be deemed to include the ICT-140 Product, as such term is defined in subsection 1(b) of Schedule F hereto.

1.11 Technical Information ” shall mean, as of the Effective Date, the following information in the Field of Use which is described in the Patent Rights or otherwise provided to Licensee:  Know-how, trade secrets, unpublished patent applications, software, bioinformatics, unpatented technology, technical information, statistical information and analyses, biological materials, chemical reagents, preclinical and clinical information, in each case which has been conceived or reduced to practice prior to the Effective Date, in the conduct of the Research Project at CSMC under the direction of the Inventor.  The Technical Information shall further include information in the Field of Use described in Schedule B hereto which is embodied in the Patent Rights and which has been reduced to practice prior to the Effective Date in the conduct of the aforementioned research programs at CSMC under the direction of the Inventor.  Technical Information is all owned by CSMC.

1.12 Territory ” shall mean the entire world.

1.13 Valid Claim ” shall mean a claim of a pending patent application or an issued patent included within the Patent Rights or CSMC Improvements licensed to Licensee, which claim has not (a) been pending for longer than seven (7) years after the actual filing date of the patent application, (b) lapsed, been canceled or become abandoned, (c) been declared invalid or unenforceable by a non-appealable decision or judgment of a court or other appropriate body or authority of competent jurisdiction, or (d) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.  

- 3 –

[ * ] = 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.

LICENSE

2.1 Grant of Exclusive Rights.   Subject to the terms of this Agreement, CSMC hereby grants to Licensee, and Licensee hereby accepts from CSMC, the exclusive, worldwide license, with the right to grant sublicenses (subject to the terms of Section 2.2 hereof), during the term of this Agreement (as provided in Section 6 hereof) to conduct research in the Field of Use using the Patent Rights and the Technical Information and to develop, use, make, have made, practice, import, carry out, manufacture, have manufactured, offer for sale, sell and/or have sold Products in the Field of Use in the Territory using the Patent Rights and the Technical Information.  The foregoing grant of exclusivity is made expressly subject to the following:

(a) All applicable laws and regulations, including, without limitation, the requirements of federal law as pertains to the manufacture of products within the United States;

(b) All applicable rules of the Funding Agencies which have provided funding to CSMC or to any of its employees (including any of the inventors named on the Patent Rights) for the development of the Patent Rights and Technical Information; and

(c) The following non-exclusive rights to the Patent Rights and Technical Information, which are retained by CSMC within the Field of Use:

(i) Subject to Licensee’s right to prior review to determine the patentability thereof (which shall expire forty-five (45) days after Licensee’s receipt thereof), the right to submit for publication the scientific findings from research conducted by or through CSMC or its investigators (including the Inventor) related to the Patent Rights and the Technical Information; and provided further that if Licensee determines to file a patent application, Licensee shall have a further thirty (30) day period thereafter to do so, and CSMC shall delay any publication with respect thereto for that period.

(ii) the right (A) to use any tangible or intangible information contained in the Patent Rights , the Technical Information or any CSMC Improvements (so long as CSMC shall treat such information as Confidential Information and maintain its confidentiality in accordance with Section 10 hereof), for CSMC’s research, internal teaching and other educationally-related and non-commercial (except for charges to its own patients) clinical purposes, where clinical use does not involve a third party funding grant to commercialize such information, and (B) to obtain research funding for further study and development thereof from governmental and other nonprofit organizations (including grant applications).

(d) Except as provided by Section 2.3 hereof, CSMC shall not, under any circumstances, grant and/or transfer any rights retained by CSMC under Section 2.1(c) to any third party (other than to Licensee or, where required by applicable law, rule, regulation, governmental policy or contract, to any Funding Agency or the United States Government) to commercialize Inventions or information related thereto derived directly from the Patent Rights or the Technical Information in the Field of Use as a result of CSMC’s teaching and internal

- 4 –

[ * ] = 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.

 

 


research and clinical activities with respect to the Patent Rights and Technical Information otherwise permitted by Section 2.1(c)(ii) above.

(e) Notwithstanding any other provision hereof to the contrary, all rights to the Patent Rights, Technical Information and CSMC Improvements outside of the Field of Use are retained by CSMC. Furthermore, this Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of CSMC other than Patent Rights regardless of whether such patents are dominant or subordinate to Patent Rights.

(f) The grant of exclusive rights hereunder is made expressly subject to any non-exclusive license and any option granted by CSMC to the Torrey Pines Institute of Molecular Studies (“TPIMS”) per the specific contractual requirements of the April 4, 2006 Material Transfer Agreement (“TPIMS MTA”) between CSMC and TPIMS.  CSMC has been informed by the Inventor that the individual peptides included in the Materials (as defined in the TPIMS MTA) consist solely of superagonist peptides that are epitopes of gp100 and HER-2 whose sequences are defined in Schedule C .  CSMC and Licensee acknowledge that (a) to date, they have not been able to reacquire the rights of CSMC licensed to TPIMS and any option granted to TPIMS pursuant to the specific contractual requirements of the TPIMS MTA, and (ii) CSMC has re-initiated its efforts to find a reasonable resolution of the issue with TPIMS.

2.2 Right to Sublicense or Assign Rights.   Licensee shall have the right to grant sublicenses or to assign any or all of the rights granted hereunder to (a) an Affiliate; (b) a biopharmaceutical, pharmaceutical or bio-diagnostic company which is generally recognized in such industries and which, at the time of the sublicense, has a market capitalization of at least $100,000,000; and/or (c) a party which has been approved by CSMC in writing, if such party has a market capitalization of less than $100,000,000 at the time of the sublicense,  such approval not to be unreasonably withheld (each, a “Permitted Sublicensee”).  Licensee shall submit a written request for approval to CSMC’s Technology Transfer Office by electronic mail at CSTechTransfer@cshs.org and by courier or overnight mail at the following address: 8727 W. Third Street, Suite #203, Los Angeles, CA 90048, and CSMC shall advise Licensee of its decision and of the reason for its decision within thirty (30) days of receiving the request from Licensee.  Any such Permitted Sublicensee shall be subject in all respects to the provisions contained in this Agreement and Licensee will remain primarily liable to CSMC for, and shall be responsible for monitoring and enforcing, performance of all of Licensee’s obligations hereunder by any such Permitted Sublicensee.  Without limiting the generality of the foregoing, as an express condition of any such sublicense, any such Permitted Sublicensee shall be required to agree in writing to be bound by commercially reasonable reporting and record keeping, indemnification and inspection provisions, and the applicable provisions of this Agreement, including, without limitation, those pertaining to the use of CSMC’s name and marks, indemnification of CSMC and the use of CSMC’s Confidential Information.  Permitted Sublicensees shall have the right to further sublicense only to parties that meet the criteria set forth in the first sentence of this Section 2.2.  Licensee shall promptly forward to CSMC a copy of any and all fully executed sublicense agreements, any subsequent amendments, and all copies of Permitted Sublicensees’ royalty reports, in no event more than thirty (30) days following execution or receipt thereof, as applicable provided that Licensee may redact sensitive

- 5 –

[ * ] = 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.

 

 


confidential information that is not directly related to Licensee’s obligations to CSMC hereunder .   Licensee shall also keep CSMC reasonably informed with respect to the progress of any relations entered into with any Permitted Sublicensees.  If Licensee shall conduct one or more audits of its Permitted Sublicensees hereunder during the term hereof, Licensee shall provide copies of all audit reports to CSMC on a timely basis.  Licensee understands and agrees that none of its permitted sublicenses hereunder shall reduce in any manner any of its obligations set forth in this Agreement.   

2.3 CSMC Improvements.   Subject to the rights and applicable rules of the Funding Agencies, Licensee shall have, for a period of sixty (60) days after receipt by Licensee of written notice from CSMC disclosing a CSMC Improvement, the exclusive first right to negotiate with CSMC to obtain one or more licenses to the CSMC Improvement in the Field of Use upon such terms and conditions as shall be agreed by the parties hereto, which terms and conditions shall include provisions for fair market value consideration for the grant of any such licenses.  If Licensee declines or fails to pursue, or if the parties fail to conclude negotiations for a license to, such CSMC Improvement in the Field of Use during the sixty (60) day period specified above, then CSMC shall have the right to commence discussions with any other party concerning such CSMC Improvement.  Subject to the provisions of this Section 2.3, Licensee acknowledges and agrees that CSMC expressly retains and reserves any and all right, title and interest in and to the CSMC Improvement, whether or not in the Field of Use and, accordingly, no license to any CSMC Improvement is granted to Licensee under this Agreement.  

2.4 Licensee Developments. Licensee hereby grants to CSMC the following nonexclusive, royalty free, fully paid up rights and licenses to the Licensee Developments:

(a) Subject to Licensee’s right to prior review to determine the patentability thereof within forty-five (45) days following receipt by Licensee, the right and license to publish the scientific findings from research conducted by or through Licensee or on its behalf by CSMC or the Inventor related to the Licensee Developments; and provided further that if Licensee determines to file a patent application, Licensee shall have a further thirty (30) day period thereafter to do so and CSMC’s right and license shall be delayed until completion of that period.

(b) Except as provided below in this Section 2.4, the right (A) to use any tangible or intangible information contained in the Licensee Developments (so long as CSMC shall treat such information as Confidential Information and maintain its confidentiality in accordance with Section 10 hereof), for CSMC’s research, internal teaching and other educationally-related and non-commercial (except for charges to its own patients) clinical purposes, where clinical use does not involve a third party funding grant to commercialize such information, and (B) to obtain research funding for further study and development thereof from governmental and other nonprofit organizations (including grant applications).

Except as provided in Section 2.3 hereof, CSMC shall not, under any circumstances, grant and/or transfer any rights granted to CSMC under this Section 2.4 to any third party (other than to Licensee or, where required by applicable law, rule, regulation, governmental policy or contract, to any Funding Agency or the United States Government) to commercialize Inventions in the Field of Use resulting directly from the Licensee Developments as a result of CSMC’s

- 6 –

[ * ] = 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.

 

 


internal research and clinical activities with respect to the Licensee Developments otherwise permitted by Section 2.4(b) above.

2.5 Milestones.   Licensee acknowledges that it is important to CSMC, and a requirement of the United States Government under Title 35, Section 203 of the United States Code, that Licensee pursue the development, commercialization and marketing of Products and otherwise exercise commercially reasonable efforts to maximize the value of this Agreement to CSMC.  CSMC and Licensee have agreed on the Milestones set forth on Schedule D , with each such Milestone being deemed a separate and independent condition.  Licensee represents and warrants to CSMC that as of the Effective Date, Licensee has met all of the Milestones required under the Original License Agreement, other than the Milestones set forth in Schedule D to this Agreement.  Within sixty (60) days after each anniversary of the Effective Date, Licensee shall prepare and deliver to CSMC an annual written report (to be certified by an executive officer of Licensee) that provides an overview of Licensee’s progress towards achieving each Milestone and its other efforts with respect to the ongoing development, commercialization, and marketing of the Products.  If Licensee believes that it is or will be unable to achieve such Milestones despite its diligent efforts, Licensee may request amendments or reasonable extensions to Schedule D in writing for CSMC’s consideration. Licensee agrees to provide any additional information reasonably required by CSMC to evaluate Licensee’s performance under this Agreement.  If Licensee fails to meet any annual Milestone designated in Schedule D hereto, and has not obtained an extension or amendment to such Milestone(s), CSMC may, at its option and as its sole remedy for Licensee’ breach of this Section 2.5, upon written notice to Licensee, convert the exclusive license granted under Section 2.1 hereof to a non-exclusive license or to a co-exclusive license, or terminate the license.

2.6 Rights in Bankruptcy.   All rights and licenses granted under or pursuant to this Agreement by CSMC to Licensee are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code and other similar international laws, licenses of rights to “intellectual property” as defined in Section 101 of the U.S. Bankruptcy Code or such international laws.  CSMC agrees that Licensee, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code and other similar international laws.  CSMC further agrees that, in the event of the commencement of a bankruptcy proceeding by or against CSMC under the U.S. Bankruptcy Code, Licensee shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and the same, if not already in Licensee’s possession, shall be promptly delivered to it (i) upon any such commencement of a bankruptcy proceeding upon its written request therefore, unless CSMC elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under (i) above, upon the rejection of this Agreement by or on behalf of CSMC upon written request therefore by Licensee.

3.

REPRESENTATIONS AND WARRANTIES

3.1 Representations and Warranties of CSMC.   Except for the rights, if any, of the Funding Agencies or the United States Government, CSMC represents and warrants to Licensee

- 7 –

[ * ] = 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.

 

 


that, to the best of its actual, current knowledge (without investigation outside of CSMC as to such representations and warranties) (a) it has the right to grant the licenses in this Agreement, (b) except for the rights granted by CSMC to TPIMS pursuant to the TPIMS MTA and the license described in Section 2.1(f), it has not granted licenses to the Patent Rights or Technical Information to any other party that would restrict the rights granted hereunder except as stated herein, (c) there are no claims, judgments or settlements to be paid by CSMC with respect the Patent Rights or Technical Information or pending claims or litigation relating to the Patent Rights or Technical Information, (d) it is the sole owner of the Patent Rights and Technical Information , other than the P atent Rights described in item VIII on Schedule A hereto, which are jointly owned by CSMC and Licens ee , (e) the patents and patent applications in the Patent Rights have been applied for, and (f) it has not received notice from any third party that the Patent Rights or Technical Information infringes the proprietary rights of any third party.  Except for any potential or actual rights of Funding Agencies or the United States Government and the rights of TPIMS under the TPIMS MTA and the license described in Section 2.1(f), CSMC is not aware that any additional rights or licenses are necessary for Licensee to exercise its licensed rights granted by CSMC under this Agreement.

3.2 Representations and Warranties of Licensee .  Licensee represents and warrants to CSMC that (a) Licensee is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, is qualified to do business in the State of California and has the corporate power and authority to enter into this Agreement and to perform its obligations hereunder; (b) the execution and delivery of this Agreement by Licensee and the performance by Licensee of its obligations hereunder have been duly authorized by all necessary corporate action; (c) this Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms; (d) neither the execution or delivery of this Agreement by Licensee, nor the performance by Licensee of its obligations hereunder, (i) requires the consent or approval of any third party, except the directors of Licensee, which consent has been obtained; (ii) shall constitute a default under any material contract by which Licensee or any of its material assets is bound (or any event which, with notice or lapse of time, or both, would constitute such a default); or (iii) shall constitute a violation of any judgment, order or decree of any court, arbitrator, governmental agency or authority binding upon Licensee; (e) to the best of Licensee’s actual, current knowledge (without investigation outside of Licensee as to such representations and warranties), Licensee has not granted, and will not grant, licenses to the Patent Rights to any third party that would conflict with or otherwise compromise the rights reserved by CSMC hereunder; and (f) as of the Effective Date, ICT-140 does not infringe a Valid Claim of the Patent Rights.

3.3 Limited Warranty; Certain Damages.  

(a) Limited Warranty.   CSMC makes no representation or warranty other than those expressly specified in this Agreement.  Licensee accepts the Patent Rights and the Technical Information on an “AS-IS” basis.  CSMC MAKES NO OTHER WARRANTIES CONCERNING PATENT RIGHTS OR TECHNICAL INFORMATION COVERED BY THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS

- 8 –

[ * ] = 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.

 

 


TO PATENT RIGHTS, TECHNICAL INFORMATION OR ANY PRODUCT.  CSMC MAKES NO WARRANTY OR REPRESENTATION AS TO THE VALIDITY OR SCOPE OF PATENT RIGHTS, OR THAT ANY PRODUCT WILL BE FREE FROM AN INFRINGEMENT ON PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR THAT NO THIRD PARTIES ARE IN ANY WAY INFRINGING PATENT RIGHTS COVERED BY THIS AGREEMENT. LICENSEE HEREBY AGREES THAT LICENSEE WILL NOT GIVE, AND SHALL NOT PERMIT ANY PERMITTED SUBLICENSEES OR AFFILIATES THEREOF TO GIVE, ANY SUCH WARRANTY OR REPRESENTATION TO THIRD PARTIES ON BEHALF OF CSMC.

(b) Certain Damages.   EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 10 OR IN ACCORDANCE WITH THE OBLIGATION TO INDEMNIFY SET FORTH IN SECTION 8, IN NO EVENT SHALL CSMC BE LIABLE FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER CSMC KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES.  EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 10 OR IN ACCORDANCE WITH THE OBLIGATION TO INDEMNIFY SET FORTH IN SECTION 8, CSMC’S AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT PAID BY LICENSEE TO CSMC UNDER THIS AGREEMENT.  THE FOREGOING EXCLUSIONS AND LIMITATIONS SHALL APPLY TO ALL CLAIMS AND ACTIONS OF ANY KIND, WHETHER BASED ON CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO NEGLIGENCE), OR ANY OTHER GROUNDS.

3.4 Rights Retained by Funding Agencies.   Licensee acknowledges that to the extent that the Patent Rights and Technical Information have been developed in part under one or more funding agreements (“Funding Agreements”) with one or more Funding Agencies, such Funding Agencies have certain statutory, non-exclusive rights relative thereto for use for government purposes as well as regulatory or statutory “march-in rights” (collectively, “Statutory Rights”).  Licensee also acknowledges that to the extent that the CSMC Improvements may be developed in part under one or more Funding Agreements with one or more Funding Agencies, such Funding Agencies may have certain Statutory Rights relative thereto.  This Agreement is explicitly made subject to such Statutory Rights and, to the extent of any conflict between any such Statutory Rights and this Agreement, such Statutory Rights shall prevail.

4.

CONSIDERATION

In consideration of the execution and delivery by CSMC of this Agreement, Licensee agrees as follows:

- 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.

 

 


4.1 Issuance of Stock ; License Fee .   The parties acknowledge and agree that in accordance with the Original License Agreement, Licensee (a) issued and sold to CSMC shares of the voting common stock of Licensee (the “Shares”) described in the Stock Purchase Agreement dated November 17, 2006 between Licensee and CSMC, a copy of which is attached as Schedule E hereto ; and (b) paid to CSMC a non-refundable license fee in the amount of Sixty Two Thousand Dollars ($62,000).  

4.2 Milestone Payments.   Licensee agrees to pay and shall pay to CSMC the following one time only non-creditable, non-refundable milestone payments (each, a “Milestone Payment”):

(a) Within thirty (30) days of the first patient dosing in a Phase III clinical trial for the ICT-107 Product, Licensee shall pay CSMC a Milestone Payment in the amount of [*] .  

(b) Within thirty (30) days of the first commercial sale of the ICT-107 Product, Licensee shall pay CSMC a Milestone Payment of [*] .

(c) Within thirty (30) days of Licensee’s confirmation that total, aggregate Gross Sales of all Products have exceeded [*] , Licensee shall pay CSMC a Milestone Payment of [*] .

(d) Within thirty (30) days of Licensee’s confirmation that total, aggregate Gross Sales of ICT-107 Products have exceeded [*] , Licensee shall pay CSMC a Milestone Payment of [*] .

(e) Within thirty (30) days of receiving the first FDA marketing approval or foreign equivalent for the ICT-121 Product, Licensee shall pay CSMC a Milestone Payment in the amount of [*] .  

(f) Within thirty (30) days of receiving the first FDA marketing approval or foreign equivalent for the ICT-140 Product, Licensee shall pay CSMC a Milestone Payment in the amount of [*] .  

4.3 Payment of Royalties.   Licensee shall pay to CSMC certain royalties, which shall be determined and paid in accordance with Schedule F hereto.

4.4 Value of License Consideration.   CSMC acknowledges and agrees that the royalties and other obligations of Licensee under this Agreement constitute fair market value for the rights granted to Licensee under this Agreement based on arms’-length negotiations with Licensee and an independent evaluation made by CSMC’s outside expert(s).

4.5 Licensee Challenge of Patent Rights.   Should Licensee bring, directly or through a third party indirectly, an action challenging the validity, scope or enforceability of any Patent Rights, Licensee will first provide CSMC with at least ninety (90) days’ prior written notice that it intends to do so before filing such a challenge.  Following the giving of such notice,

- 10 –

[ * ] = 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.

 

 


Licensee will pay to CSMC the Royalties and Sublicense Fees due hereunder during the pendency of such action.   Additionally, Licensee agrees to reimburse CSMC for all costs actually incurred by CSMC in connection with the applicable legal proceedings. Should the outcome of such action determine that any claim of a patent challenged by Licensee is valid , infringed and enforceable, Licensee will thereafter pay to CSMC the Royalties and Sublicense Fees due hereunder at the rate of two (2) times the applicable rate for all Products sold that would infringe such claim.  Such increased royalty reflects the increased value of the Patent Rights upheld in such action.  In the event that a challenge of Licensed Patents brought by Licensee is partially or entirely successful, Licensee will have no right to recoup any Royalties or other amounts paid before or during the period of the challenge.    

5.

PATENT RIGHTS

5.1 Prosecution.   The parties acknowledge and agree that in accordance with the Original License Agreement, Licensee has assumed full responsibility for the application, maintenance, reexamination, reissue, opposition and prosecution of any kind (collectively “Prosecution”) relating to the Patent Rights in the Territory.  Licensee shall continue to diligently pursue the Prosecution of the Patent Rights for the benefit of CSMC, using counsel approved by CSMC, at Licensee’s sole expense.  For all purposes of the patent Prosecution, CSMC shall be named the “client” of such patent counsel.  Each party shall provide the other with copies of any and all material or communications with the United States Patent and Trademark Office, or any foreign patent office, and CSMC shall be afforded the opportunity of prior review and comment on such action or paper.

5.2 Abandonment, Disclaimers, etc.   Licensee shall obtain the prior written consent of CSMC (which consent shall not be unreasonably withheld), prior to abandoning, disclaiming, withdrawing, seeking reissue, seeking reexamination or allowing to lapse any patent or patent application within the Patent Rights.  In the event that Licensee shall elect to abandon the Prosecution (including the payment of maintenance fees or annuities) of any patent or patent application included in the Patent Rights, Licensee shall notify CSMC of such election at least forty-five (45) days before a final due date which would result in abandonment or bar of patentability of the patent or patent application.  In such event, CSMC may, at its sole option and expense, continue Prosecution of the patent application or patent.  Licensee further agrees that it shall not file any continuation-in-part application relating to the Patent Rights unless the additional disclosure or material to be included in the continuation-in-part application is necessary or appropriate to support the patentability of a claim recited in a parent application on which the continuation-in-part application is based.  Prior to filing any continuation-in-part application, Licensee shall consult with CSMC to discuss the need for filing such an application.  If CSMC shall disagree with Licensee’s conclusion that such a continuation-in-part application is either necessary or appropriate to support the patentability of a claim recited or capable of being recited in a patent application, then the matter shall be submitted for resolution to independent patent counsel mutually agreed upon by the parties, who will determine whether a continuation-in-part application is necessary or appropriate in accordance with this Section 5.2.  Any decision made by such independent patent counsel shall be conclusive and binding on the parties hereto.

- 11 –

[ * ] = 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.

 

 


5.3 Expenses.   Licensee shall pay all expenses resulting from its obligations in Section 5.1 hereof.  CSMC shall exercise reasonabl e efforts to cause the Inventor (to the extent he is available and on CSMC’s staff as an employee ) to cooperate fully with Licensee with respect to the Prosecution of the Patent Rights, and CSMC shall be reimbursed for all reasonable out ‑of ‑pocket expenses as such expenses are incurred.

5.4 CREATE Act.   Licensee shall not invoke the Cooperative Research and Technology Enhancement Act of 2004, as set forth under Title 35, Section 102(c) of the United States Code (the “CREATE Act”), with respect to the Patent Rights without first obtaining the prior written consent of CSMC.  

6.

TERM AND TERMINATION

6.1 Term.   Unless earlier terminated as provided in Section 2.5 or 6.2 hereof, the term of this Agreement shall commence on the Effective Date and shall expire, on a country-by-country basis, on the date upon which the last to expire of a Valid Claim within the Patent Rights in each such country shall expire.  

6.2 Termination.   Except as provided by Section 6.3 hereof, and in addition to the termination provisions of Section 2.5, this Agreement shall terminate upon the earliest to occur of the following:

(a) Automatically if Licensee shall enter into a liquidating bankruptcy, be adjudged insolvent, liquidate, dissolve and/or if the business of Licensee shall be placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of Licensee or otherwise; provided, however, that if any such action is involuntary, termination shall not take place unless the action is not reversed within thirty (30) days.  Further, Licensee shall give CSMC at least forty-five (45) days’ prior written notice before Licensee initiates any bankruptcy proceeding, and CSMC shall have the right to terminate this Agreement immediately upon receipt of such notice;

(b) Automatically if the performance by either party to this Agreement of any term, covenant, condition or provision hereof (i) shall jeopardize (A) the licensure of CSMC, (B) CSMC’s participation in the Medicare, Medi-Cal or other reimbursement or payment programs, (C) the full accreditation of CSMC by the Joint Commission of Accreditation of Healthcare Organizations or any other state or nationally recognized accreditation organization, or (D) CSMC’s tax-exempt status; or (ii) is deemed illegal or unethical by any recognized governmental agency or body.  Upon the occurrence of any of the items set forth in this subparagraph (b), CSMC shall provide written notice to Licensee setting forth the reason for such proposed termination and the parties shall work in good faith to attempt to revise the terms of this Agreement to mitigate the issues described in (i) and (ii) of the preceding sentence while protecting Licensee’s interest in the Patent Rights and Technical Information.  If CSMC and Licensee cannot within thirty (30) days from the foregoing notice by CSMC resolve the issues described in (i) and (ii) above through a revision to the terms of this Agreement reasonably satisfactory to CSMC, CSMC may immediately terminate this Agreement upon written notice to Licensee;

- 12 –

[ * ] = 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.

 

 


(c) Upon thirty (30) days’ written notice from CSMC that a required payment by Licensee is delinquent if, within such thirty (30) day period, Licensee shall fail to pay fully any royalty payment required by Section 4. 3 hereof or Schedule F hereto;

(d) Upon sixty (60) days’ written notice from CSMC if, within such sixty (60) day period following notice from CSMC that it is in breach or default, Licensee shall fail to cure fully any breach or default of any material obligation under this Agreement as described in such written notice detailing the facts of such breach with reasonable specificity; provided, however, that Licensee may avoid such termination if, before the end of such 60-day period, such breach or default has been cured by Licensee to the reasonable satisfaction of CSMC;

(e) Upon sixty (60) days’ written notice from Licensee if, within such sixty (60) day period, CSMC shall fail to cure fully any breach or default of any material obligation under this Agreement as described in such written notice detailing the facts of such breach with reasonable specificity; provided, however, that CSMC may avoid such termination if, before the end of such 60 day period, such breach or default has been cured by CSMC to the reasonable satisfaction of Licensee;

(f) Upon the mutual written agreement of the parties hereto (such termination to be effective as of the date mutually agreed upon in such written agreement); or

(g) Upon sixty (60) days’ written notice from Licensee if Licensee voluntarily elects to terminate this Agreement.

6.3 Obligations Upon Termination.   Upon any termination of this Agreement pursuant to Section 2.5 or 6.2 hereof, nothing herein shall be construed to release any party from any liability for any obligation incurred through the effective date of termination (e.g., confidentiality, reimbursement of patent expenses incurred prior to such date, etc.) or for any breach of this Agreement prior to the effective date of such termination.  Licensee may, for a period of one (1) year after the effective date of such termination, sell all tangible Products customarily classified as “inventory” that it has on hand at the date of termination, subject to payment by Licensee to CSMC of the applicable Royalty and Sublicense Fee, as set forth in Schedule F ; provided, that any such action by Licensee does not subject CSMC to any of the occurrences set forth in Section 6.2(b) hereof.

6.4 Effect of Termination.   In the event of any termination of this Agreement pursuant to Section 6.2 hereof, where such termination has not been caused by any action or inaction on the part of any Permitted Sublicensee of Licensee or by any breach by such Permitted Sublicensee of its obligations under its sublicense from Licensee, such termination of this Agreement shall be without prejudice to the rights of each non-breaching Permitted Sublicensee of Licensee and each non-breaching Permitted Sublicensee shall be deemed to be a licensee of CSMC thereunder, and CSMC shall be entitled to all rights, but shall not be subject to any obligations (other than the grant of license and appurtenant obligations under this Agreement to the extent provided for in such Permitted Sublicense) of Licensee thereunder.  This Section 6.4, however, shall not be applicable if this Agreement has been terminated under Section 6.2(b)

- 13 –

[ * ] = 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 circumstances where the application of this Section 6.4 would subject CSMC to any of the occurrences set forth in Section 6.2(b).

6.5 Right to Institute Legal Actions.   Notwithstanding the provisions of Section 6.2 hereof, but subject to Section 2.5 hereof, CSMC, on the one hand, and Licensee, on the other hand, may institute any other legal action or pursue any other remedy against the other party permitted by applicable law if the other party does not substantially cure any breach or default of any material obligation as provided herein.

6.6 Reversion of Rights.   Notwithstanding anything to the contrary set forth herein (including, but not limited to, Section 5 hereof), full responsibility for Prosecution of the Patent Rights shall, at the option of CSMC (exercisable in its sole and absolute discretion), and at its sole expense from the date of reversion, revert to CSMC upon any termination of this Agreement.

7.

INFRINGEMENT BY THIRD PARTIES

7.1 Enforcement.   Licensee shall have the first right and obligation to enforce, at its sole expense, any Patent Rights to the extent licensed hereunder against infringement by third parties and shall notify CSMC in writing in advance of all such enforcement efforts; provided, that Licensee shall be obligated to enforce the Patent Rights only if Licensee determines that it is commercially reasonable to do so in light of all relevant business and economic factors. Upon Licensee’s undertaking to pay all expenditures reasonably incurred by CSMC, CSMC shall reasonably cooperate in any such enforcement and, as necessary, join as a party therein.  Licensee shall reimburse CSMC for all expenses, including reasonable attorneys’ fees, incurred in connection with any such enforcement.  In the event that Licensee does not file suit against or commence and conclude settlement negotiations with a substantial infringer of Patent Rights within ninety (90) days of receipt of a written demand from CSMC that Licensee bring suit, then CSMC shall have the right, at its own expense, to enforce any Patent Rights, and such Patent Rights shall no longer be subject to this Agreement.  Any damages or other recovery from an infringement action undertaken by Licensee shall first be used to reimburse the parties, on a pro rata pari passu basis, for the costs and expenses incurred in such action, and shall thereafter be treated as Sublicense Income in accordance with Schedule F .  If Licensee fails to prosecute any such action to completion, then any damages or other recovery net of the parties’ costs and expenses incurred in such infringement action shall be the sole property of CSMC.  

7.2 Defense Of Patent Rights.   In the event that any Patent Rights are the subject of a legal action seeking declaratory relief or of any reexamination or opposition proceeding instituted by a third party, the parties agree to promptly consult with each other concerning the defense of such actions or proceedings.  If the parties agree that such defense should be undertaken, then Licensee shall bear the expenses, including attorneys’ fees, associated with such defense and in any recoupment of expenses.  If the parties disagree, then the party desiring to defend the action or proceeding may proceed with such defense and will bear its own expenses, and be entitled to all sums recovered.  Any damages or other recovery from any such defense undertaken by Licensee shall first be used to reimburse the parties, on a pro rata pari

- 14 –

[ * ] = 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.

 

 


passu basis, for the costs and expenses incurred in such defense, and shall thereafter be treated as Sublicense Income in accordance with Schedule F .

8.

INDEMNIFICATION

8.1 Indemnification by Licensee.   Subject to Section 8.2 hereof, Licensee shall hold harmless, defend and indemnify CSMC and each of its officers, directors, employees (including the Inventor), agents and sponsors of the research (except Licensee) (each, an “Indemnified Party”, and collectively, the “Indemnified Parties”) from and against any and all claims, damages, losses, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses and costs of investigation, whether or not suit is filed) suffered or incurred by any of the Indemnified Parties in any third party action, suit, litigation, arbitration or dispute of any kind (“Action”) to the extent arising or resulting from any negligence or willful acts or omissions on the part of Licensee, its Affiliates or Permitted Sublicensees in connection with (a) their use of the Patent Rights or Technical Information and/or (b) the exercise of their rights hereunder or under any sublicense, including, but not limited to (i) the preclinical development and clinical testing of Products, and (ii) the manufacture, sale, use, marketing, or other disposition of Products developed, manufactured, sold, marketed, used or otherwise disposed of under this Agreement.  The foregoing indemnification shall not apply to any claim, damage, loss, liability, cost or expense to the extent attributable to the acts or omissions of any licensee of CSMC other than Licensee or a Permitted Sublicensee, or the negligent activities or intentional misconduct of any of the Indemnified Parties.  As part of its obligations hereunder, Licensee shall defend any Action brought against any of the Indemnified Parties with counsel of its own choosing and reasonably acceptable to CSMC, and neither CSMC nor any other Indemnified Party shall enter into any settlement of any such Action without first obtaining prior approval of Licensee.  Licensee shall pay all costs, including attorneys’ fees, incurred in enforcing this indemnification action.  Should CSMC or any other Indemnified Party not afford Licensee the right to defend any such Action, or should CSMC or any other Indemnified Party not obtain the approval of Licensee to any such settlement, Licensee shall have no obligation to indemnify CSMC or any other Indemnified Party hereunder.  Should Licensee fail to provide a defense for the Indemnified Parties as required hereunder, then Licensee shall reimburse CSMC for its out-of-pocket expenses (including reasonable attorneys’ fees and expenses and costs of investigation) which are incurred as a result of any investigation, defense or settlement relating to the foregoing, which reimbursement shall be made to CSMC upon receipt by Licensee of invoices reflecting in reasonable detail such expenses incurred by CSMC.  Licensee shall obtain and maintain insurance policies (including products liability and general liability policies at such time as is appropriate) which are reasonable and necessary to cover its activities and to comply with the indemnification obligations set forth above.  Such insurance policies shall name CSMC as an additional insured party, and shall provide a minimum of Three Million Dollars ($3,000,000) in coverage per occurrence.  Upon initiation of any human clinical studies using a therapeutic molecule covered by the Patent Rights, Licensee shall have first increased its insurance coverage to an aggregate amount that is commercially reasonable and consistent with prevailing business practice for the risks involved.  Licensee shall provide CSMC with Certificates of Insurance within thirty (30) days of the Effective Date (subject to extension if reasonably required) and annually thereafter, evidencing the policies required in accordance with

- 15 –

[ * ] = 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 Section 8.1 , together with copies of the endorsement which specifies CSMC as an additional insured and the declarations page for each such insurance policy . Licensee shall provide CSMC with prompt written notice of any material change in coverage under such policies.   The certificate of insurance, endorsements and declarations pages (and any renewals or replacements thereof), if required, shall be sent to CSMC ’s Technology Transfer Office by electronic mail at CSTechTransfer@cshs.org and by prepaid, first class, certified mail, return receipt requested, at the following address: 8727 W. Third Street, Suite #203, Los Angeles, CA 90048.

8.2 Notice of Claim.   CSMC shall promptly notify Licensee in writing of any claim or Action or material threat thereof brought against any Indemnified Party in respect of which indemnification may be sought and, to the extent allowed by law, shall reasonably cooperate with Licensee in defending or settling any such claim or Action.  No settlement of any claim, Action or threat thereof received by CSMC and for which CSMC intends to seek indemnification (for itself or on behalf of any other Indemnified Party) shall be made without the prior joint written approval of Licensee and CSMC.

9.

USE OF NAMES

Licensee shall not, unless as required by any law or governmental regulation, use the name of CSMC, and/or any of its trademarks, service marks, trade names or fictitious business names without express prior written consent of the Vice President for Public Relations and Marketing of CSMC.  Further, prior to any reference by Licensee to the names or marks of CSMC in any manner, Licensee shall provide CSMC with a writing reflecting the proposed reference so that CSMC can review the reference within a reasonable period of time prior to the proposed use thereof by Licensee.  This limitation includes, but is not limited to, use by Licensee in any regulatory filing, advertising, offering circular, prospectus, sales presentation, news release or trade publication.  Subject to compliance by Licensee with the foregoing, which shall be deemed conditions precedent to any use of CSMC’s name or marks by Licensee, Licensee shall ensure that the name of CSMC is used as scientifically or academically appropriate in the “byline” of any article, abstract, manuscript or any other publication related to the subject matter hereof.

10.

CONFIDENTIALITY

10.1 Non-Disclosure.   Except to the extent Licensee’s counsel determines that disclosure of the terms of this Agreement is required by law, the parties hereto shall keep the terms of this Agreement and all business and scientific discussions relating to the business of the parties strictly confidential.  All patient information to which a party is given access by the other party shall be subject to the provisions of the Confidentiality of Medical Information Act (Cal. Civ. Code §§56, et seq.) and the Health Insurance Portability and Accountability Act of 1996, and all regulations promulgated thereunder.  It may, from time to time, be necessary for the parties, in connection with performance under this Agreement, to disclose Confidential Information (including know-how) to each other.  The Receiving Party (as defined in Section 1.2 hereof) shall keep in strictest confidence the Confidential Information of the Disclosing Party (as defined in Section 1.2 hereof), using the standard of care it normally uses for information of like character, and shall not disclose the Confidential Information to any third party or use it except

- 16 –

[ * ] = 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.

 

 


as expressly authorized by the prior written consent of the Disclosing Party or as otherwise permitted by this Agreement; provided, however, that Licensee may disclose the Confidential Information received from CSMC to its Permitted Sublicensee s as shall be reasonably necessary to carry out the intent of this Agreement or any sublicense granted by Licensee as contemplated by this Agreement if, but only if, such Permitted Sublicensee s each execute a confidentiality agreement containing confidentiality provisions no less restrictive than those confidentiality provisions contained in this Section 10.  The Receiving Party’s obligation hereunder shall not apply to Confidential Information that the Receiving Party can show:

(a) Is or later becomes part of the public domain through no fault or neglect of the Receiving Party;

(b) Is received in good faith from a third party having no obligations of confidentiality to the Disclosing Party, provided that the Receiving Party complies with any restrictions imposed by the third party;

(c) Is independently developed by the Receiving Party without use of the Disclosing Party’s Confidential Information; or

(d) Is required by law or regulation to be disclosed (including, without limitation, in connection with FDA filings, filings with another government agency or as required under the California Public Records Act), provided that the Receiving Party uses reasonable efforts to restrict disclosure and to obtain confidential treatment.

10.2 Limits on Permitted Disclosures.   Each party agrees that any disclosure or distribution of the other party’s Confidential Information within its own organization shall be made only as is reasonably necessary to carry out the intent of this Agreement.  The parties further agree that all of their respective officers, employees, agents, representatives or Permitted Sublicensees to whom any Confidential Information is disclosed or distributed shall have agreed to maintain its confidentiality.  In such event, the Receiving Party shall identify with reasonable particularity, upon request by the Disclosing Party, each person within the Receiving Party’s organization to whom the Receiving Party has disclosed or distributed Confidential Information.

10.3 Legally Required Disclosures.   If a subpoena or other legal process concerning Confidential Information is served upon any party hereto pertaining to the subject matter hereof, the party served shall notify the other party immediately, the other party shall cooperate with the party served, at the other party’s expense, in any effort to contest the validity of such subpoena or other legal process.  This Section 10.3 shall not be construed in any way to limit any party’s ability to satisfy any disclosure of its relationship with the other party required by any governmental authority.

10.4 Patent Rights as Confidential Information.   The Patent Rights are understood by Licensee to be the Confidential Information of CSMC to the extent “unpublished” as such term is construed under the United States Patent Laws.  As such, Licensee’s confidentiality obligations hereunder automatically extend to any and all Technical Information and to any and all patent applications of CSMC relating to any Patent Rights, Technical Information and CSMC

- 17 –

[ * ] = 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.

 

 


Improvements and to any and all communications with the United States Patent Office, and any foreign patent office relating to any Paten t Rights, Technical Information or CSMC Improvements .

10.5 Return of Confidential Information.   In the event of any termination of this Agreement, the Receiving Party shall promptly return all Confidential Information and any copies made thereof previously made available to the Receiving Party by the Disclosing Party, except that the Receiving Party may retain one copy of the Confidential Information in the custody of its chief legal officer solely for the purpose of monitoring compliance with this Agreement.

10.6 Remedies.   Both parties acknowledge and agree that it would be difficult to measure damages for breach by either party of the covenants set forth in this Section 10, and that injury from any such breach would be incalculable, and that money damages would therefore be an inadequate remedy for any such breach.  Accordingly, either party shall be entitled, in addition to all other remedies available hereunder or under law or equity, to injunctive or such other equitable relief as a court may deem appropriate to restrain or remedy any breach of such covenants.

11.

INFORMATION EXCHANGE

In addition to the Patent Rights and Technical Information, the parties shall cooperate to exchange such non-confidential information as may be appropriate and necessary to facilitate Licensee’s development and commercialization of Products incorporating any Patent Rights or Technical Information.

12.

PATENT MARKING

In the event any Product is the subject of a patent under the Patent Rights, Licensee shall actually or virtually mark all Products made, sold or otherwise disposed of by or on behalf of it or any of its Permitted Sublicensees as set forth under Title 35, Section 287(a) of the United States Code and shall respond to any request or disclosure under Title 35, Section 287(b)(4)(B) of the United States Code by only notifying CSMC of the request for disclosure.

13.

MISCELLANEOUS

13.1 Notices.   Any notice, request, instruction or other document required by this Agreement shall be in writing and shall be deemed to have been given (a) if mailed with the United States Postal Service by prepaid, first class, certified mail, return receipt requested, at the time of receipt by the intended recipient, (b) if sent by Federal Express®, Airborne®, or other overnight carrier, signature of delivery required, at the time of receipt by the intended recipient, or (c) if sent by facsimile transmission, when so sent and when receipt has been acknowledged by appropriate telephone or facsimile receipt, addressed as follows:

- 18 –

[ * ] = 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.

 

 


I n the case of CSMC to:

Cedars-Sinai Medical Center

8700 Beverly Boulevard
Los Angeles, California 90048-1865

Attn: Senior Vice President for Finance & CFO

Fax: 310-423-0120

With a copy to: Vice President for Legal & Technology Affairs

or in the case of the Licensee to:

ImmunoCellular Therapeutics, Ltd.
23622 Calabasas Road, Suite 300

Calabasas, CA 91302

Fax:  (818) 224-5287

or to such other address or to such other person(s) as may be given from time to time under the terms of this Section 13.1.

13.2 Compliance with Laws.   Each party shall comply with all applicable federal, state and local laws and regulations in connection with its activities pursuant to this Agreement.

13.3 Governing Law; Venue.   For any dispute between the parties to this Agreement which arises from or relates to this Agreement, the Agreement shall be construed and enforced in accordance with the laws of the United States of America and of the State of California, irrespective of choice of laws provisions.  The parties agree that Los Angeles County, California shall be the situs of any legal proceeding arising out of or relating to this Agreement.  Each party hereby waives any right it may have to assert the doctrine of forum non conveniens or similar doctrine or to object to venue with respect to any proceeding brought in accordance with this Section, and stipulates that the state and federal courts located in Los Angeles, California shall have in personam jurisdiction and venue over each of them for the purpose of litigating any dispute, controversy, or proceeding arising out of or related to this Agreement.  Each party hereby authorizes and accepts service of process sufficient for personal jurisdiction in any action against it as contemplated by this Section by registered or certified mail, return receipt requested, postage prepaid, to its address for the giving of notices as set forth in this Agreement.

13.4 Waiver.   Failure of any party to enforce a right under this Agreement shall not act as a waiver of that right or the ability to assert that right relative to the particular situation involved.

- 19 –

[ * ] = 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.

 

 


13.5 Enforceability.   If any provision of this Agreement shall be found by a court of competent jurisdiction to be void, invalid or unenforceable, the same shall be reformed to comply with applicable law or stricken if not so conformable, so as not to affect the validity or enforceability of the remainder of this Agreement.

13.6 Modification.   No change, modification, or addition or amendment to this Agreement, or waiver of any term or condition of this Agreement, is valid or enforceable unless in writing and signed and dated by the authorized officers of the parties to this Agreement.

13.7 Entire Agreement.   This Agreement, the Schedules hereto (which are incorporated herein by this reference as if fully set forth herein) and the Stock Purchase Agreement constitute the entire agreements among the parties with respect to the subject matter hereof and thereof, and replace and supersede as of the date hereof and thereof any and all prior agreements and understandings, whether oral or written, between the parties with respect to the subject matter of such agreements.

13.8 Successors.   Except as otherwise expressly provided in this Agreement, this Agreement shall be binding upon, inures to the benefit of, and is enforceable by, the parties and their respective heirs, legal representatives, successors and permitted assigns.

13.9 Construction.   This Agreement has been prepared, examined, negotiated and revised by each party and their respective attorneys, and no implication shall be drawn and no provision shall be construed against any party to this Agreement by virtue of the purported identity of the drafter of this Agreement or any portion thereof.

13.10 Counterparts.   This Agreement may be executed simultaneously in one or more counterparts, each of which shall constitute one and the same instrument.  This Agreement may be executed by facsimile.

13.11 Attorneys’ Fees.   In the event of any action at law or in equity between the parties hereto to enforce any of the provisions hereof, the unsuccessful party to such litigation shall pay to the successful party all reasonable costs and expenses, including reasonable attorneys’ fees, incurred therein by such successful party; and if such successful party shall recover a judgment in any such action or proceeding, such reasonable costs, expenses and attorneys’ fees may be included in and as part of such judgment.

13.12 Assignment.

(a) This Agreement is personal to Licensee and only assignable by Licensee in accordance with Section 2.2 or as part of a sale, regardless of whether such a sale occurs through an asset sale, stock sale, merger or other combination, or any other transfer of Licensee’s entire business, or that part of Licensee’s business that exercises all rights granted under this Agreement, subject to Section 13.12(b).  Any other attempt to assign this Agreement by Licensee is null and void.  In the event of a bankruptcy, assignment is permitted only to a party that can provide adequate assurance of future performance, including diligent development and sales, of Products.

- 20 –

[ * ] = 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.

 

 


(b) Prior to any assignment, the following conditions must be met: (i) Licensee must give CSMC thirty (30) days prior written notice of the assignment, including the new assignee’s contact information, and (ii) the new assignee must agree in writing to CSMC to be bound by this Agreement.   It is understood and agreed that if Licensee is unable or is advised by its legal counsel not to give CSMC prior written notice of any such assignment, then Licensee shall give written notice of such assignment as promptly as possible thereafter and in any event within thirty (30) days of the assignment.  

(c) Subject to the limitations on assignment herein, this Agreement shall be binding upon and inure to the benefit of any successors in interest and assigns of CSMC and Licensee.  CSMC shall have the right to assign its rights hereunder as part of any reorganization or bond financing.

13.13 Further Assurances.   At any time and from time to time after the Effective Date, each party shall do, execute, acknowledge and deliver, and cause to be done, executed, acknowledged or delivered, all such further acts, transfers, conveyances, assignments or assurances as may be reasonably required to consummate the transactions contemplated by this Agreement.

13.14 Survival.   The following sections shall survive any expiration or earlier termination of this Agreement:  6.3, 8, 9, 10, 12 and 13.  The provisions set forth in Schedule F also shall survive any expiration or earlier termination of this Agreement, to the extent set forth therein.

13.15 Force Majeure.   Neither party will be responsible for delays resulting from causes beyond its reasonable control, including without limitation fire, earthquake, acts of terrorism, war or riot, provided that the nonperforming party uses commercially reasonable efforts to avoid or remove these causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever the delaying causes are removed.

- 21 –

[ * ] = 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.

 

 


IN WITNESS WHEREOF, the parties have caused their duly authorized representatives to execute this Agreement as of the date first above written.

Date:  May 13, 2015

“LICENSEE”:

 

IMMUNOCELLULAR THERAPEUTICS, LTD., A DELAWARE LIMITED LIABILITY COMPANY

 

 

By: /s/ Andrew Gengos

Name:  Andrew Gengos

Title:  President & CEO

 

Date:  May 13, 2015

“CSMC”:

 

CEDARS SINAI MEDICAL CENTER,
A CALIFORNIA NONPROFIT PUBLIC BENEFIT CORPORATION

 

 

By: /s/ James D. Laur

James D. Laur, Esq.

Vice President, Legal & Technology Affairs

 

Date:  May 14, 2015

By: /s/ Edward M. Prunchunas

Edward M. Prunchunas

Senior Vice President for Finance and CFO

 

 

 

 


- 22 –

[ * ] = 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 LISTING

Schedule A Patent Rights

Schedule B Technical Information

Schedule C Peptide Sequences

Schedule D Milestones

Schedule E Stock Purchase Agreement dated November 17, 2006

Schedule F Royalty Provisions

Schedule G Royalty Reporting Form

 

 

 

- 23 –

[ * ] = 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 A

Patent Rights

 

[*]

A - 1

[ * ] = 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 B

TECHNICAL INFORMATION

[*]

B - 1

[ * ] = 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 C

PEPTIDE SEQUENCES

[*]

C - 1

[ * ] = 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 D

MILESTONES

[*]

D - 1

[ * ] = 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 E

STOCK PURCHASE AGREEMENT DATED NOVEMBER 17, 2006

 

Previously filed by us on November 22, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

E - 1

[ * ] = 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 F

ROYALTY PROVISIONS

All capitalized terms not otherwise defined in this Schedule F shall have the meanings ascribed to them in the Exclusive License Agreement to which this Schedule F is attached (the “Agreement”).

1. Royalties.   

(a) Royalty Rates .  Licensee shall pay, or cause to be paid, to CSMC a running royalty equal to the applicable percentage of the Gross Sales Price received by Licensee or its Permitted Sublicensees from the Sale of Products, the manufacture, use, sale or distribution of which infringes a Valid Claim within the Patent Rights (or, in the case of ICT-140 Products, a Valid Claim within the ICT-140 Patent Rights, as such terms are defined in subsection 1(b) of this Schedule F below) in the country in which such Product is sold or distributed, and which have been sold or otherwise distributed by Licensee or its Permitted Sublicensees hereunder to a third party (other than a wholly-owned subsidiary of Licensee) in such country (each, a “Royalty”) in the applicable amount set forth in the following chart:

 

Product

Royalty Rate

ICT-107

[*] of Gross Sales of ICT-107 Products* until the gross amount of all revenues received by Licensee or its Permitted Sublicensees from Sales of ICT-107, ICT-121 and ICT-140 Products* in any year have reached [*] ; thereafter, [*] of Gross Sales of ICT-107 Products* for the remainder of such year

ICT-121

[*] of Gross Sales of ICT-121 Products* until the gross amount of all revenues received by Licensee or its Permitted Sublicensees from of ICT-107, ICT-121 and ICT-140 Products* in any year have reached [*] ; thereafter, [*] of Gross Sales of ICT-121 Products* for the remainder of such year

ICT-140

[*] of Gross Sales of ICT-140 Products* subject to subsection 1(b) of this Schedule F below

*the manufacture, use, sale or distribution of which infringes a Valid Claim within the Patent Rights (or, in the case of ICT-140 Products, a Valid Claim within the ICT-140 Patent Rights, as such terms are defined in subsection 1(b) of this Schedule F below) in the country in which such Product is sold or distributed, and which have been sold or otherwise distributed by Licensee or any Permitted Sublicensee hereunder to a third party (other than a wholly-owned subsidiary of Licensee) in such country.

On Sales of Products which are made in other than an arms’-length transaction, the value of the Gross Sales attributed under this Section 1 to such a transaction shall be that which would

F - 1

[ * ] = 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.

 

 


have been received in an arms’-length transaction, based on sales of like quality and quantity products on or about the time of such transaction.

For the avoidance of doubt, the Royalty Rates provided for above for Gross Sales of ICT-107 and ICT-121 Products shall be re-set at the beginning of each year, such that at the beginning of each year during which Royalties are due and payable under this Agreement, the Royalty Rate for each of ICT-107 and ICT-121 Products shall be [*] of Gross Sales until the gross amount of all revenues received by Licensee or its Permitted Sublicensees from Sales of ICT-107, ICT-121 and ICT-140 Products in such year have reached [*] and, thereafter for the remainder of such year, the Royalty Rate shall be [*] of Gross Sales of ICT-107 and ICT-121 Products.  

(b) Royalties Payable on ICT-140 Products .  Notwithstanding anything to the contrary set forth in this Agreement, the parties agree that Licensee shall be obligated to pay (or cause to be paid) Royalties on Gross Sales of ICT-140 Products at the royalty rate set forth in the table in Paragraph 1(a) above in the event that the ICT-140 Product infringes a Valid Claim in the country of sale, of either (i) the jointly-owned Patent Rights described in item VIII on Schedule A hereto; or (ii) United States Patent Application No. 61/764,789 filed on February 14, 2013 and United States Patent Application No. 14/181,417 filed on February 14, 2014, each of which covers the invention titled “Cancer Vaccines and Vaccination Methods” and each of which names James Bender and John Yu as inventors, and all patents and/or patent applications (including provisional patent applications) existing as of the Effective Date in any other country corresponding to any of the foregoing, and all divisions, continuations, reissues, reexaminations, supplementary protection certificates and extensions thereof, whether domestic or foreign, all claims of continuations-in-part that are entitled to the benefit of the priority date of any of the foregoing, and any patent that issues thereon, excluding any Licensee Developments or Inventions by Dr. John Yu working in his capacity as Licensee’s Chief Scientific Officer and without using any facilities, resources or personnel of CSMC (collectively, the patent rights described in subsections (i) and (ii) of this sentence shall be referred to as the “ ICT-140 Patent Rights ”; any product which infringes a Valid Claim in the country of sale of the ICT-140 Patent Rights shall be referred to as an “ ICT-140 Product ”).  Licensee’s royalty obligations as to the ICT-140 Product shall terminate on a country-by-country basis concurrently with the expiration of the last to expire of a Valid Claim within any of the ICT-140 Patent Rights in each such country, including any term extensions thereof.  For purposes of this Paragraph only, the term “ Valid Claim ” shall mean a claim of any of the ICT-140 Patent Rights, which claim has not, if it is a pending patent application, been pending for longer than seven (7) years after the actual filing date of the patent application, or, if it is a pending patent application or a patent that has issued from the ICT-140 Patent Rights, has not (a)  lapsed, been canceled or become abandoned, (b) been declared invalid or unenforceable by a non-appealable decision or judgment of a court or other appropriate body or authority of competent jurisdiction, or (c) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.  

2. Sublicense Fee.   Licensee shall pay CSMC the following sublicense fees on any Sublicense Income received from any Permitted Sublicensee (“Sublicense Fee”):

F - 2

[ * ] = 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.

 


Product

Effective Date of

Sublicense Agreement

Percent of Non-Royalty Sublicense Revenues Payable to CSMC

ICT-107

Prior to receipt of FDA approval (or foreign equivalent) for ICT-107 Product

[*]

ICT-107

After receipt of FDA approval (or foreign equivalent) for ICT-107 Product

[*]

ICT-121

Prior to receipt of FDA approval (or foreign equivalent) for ICT-121 Product

[*]

ICT-121

After receipt of FDA approval (or foreign equivalent) for ICT-121 Product

[*]

ICT-140

At any time during the term

[*]

 

Any non-cash consideration received by Licensee from Permitted Sublicensees as Sublicense Income shall be valued at its fair market value as of the date of receipt and the Sublicense Fee reflecting such amount shall be paid in cash to CSMC.  In the event that the Patent Rights are sublicensed in combination with one or more patented technologies that are not covered under this Agreement, Sublicense Income for the purposes of this Section 2 shall be calculated on a pro-rata basis in a manner to be mutually agreed in good faith by CSMC and Licensee (which agreement may be a condition of approval under Section 2.2).

3. No Duplicative Royalties.   Subject to the provisions of Paragraph 1 above, in those circumstances in which a Royalty is payable to CSMC from the sale of a Product by an Affiliate of Licensee which is a Permitted Sublicensee, and in which a royalty is also payable to Licensee from the Sale of the same Product by the same Affiliate, then Licensee shall not be required to pay a Royalty to CSMC with respect to the royalties so received by Licensee on the same Product, if and to the extent the required royalty is received by CSMC from the Affiliate.  Only one Royalty shall be paid with respect to each unit of Product sold, regardless of how many Patent Rights or Valid Claims cover such Product.  This exclusion is intended to avoid the payment of duplicative royalties, shall be strictly construed, and shall not apply to other forms of compensation paid to Licensee by its Affiliates.

4. Suspension of Obligations.   In the event that Licensee is legally prevented from commercializing one or more Products as a result of patent infringement issues relating to the Patent Rights, all of Licensee’s obligations with respect to such Products, including, without limitation, Royalty and other payment obligations under this Schedule F , milestone and diligence obligations related to that particular Product in that jurisdiction, shall be suspended unless and

F - 3

[ * ] = 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.

 


until such patent infringement issues are resolved.  In the event that any such issues are not resolved during the term of the Agreement, or in the event that such issues are resolved in a manner that would continue to prevent Licensee from commercializing such Products, then Licensee shall have no further obligations hereunder with respect to such Products.

5. Duration of Royalty Obligations. The royalty obligations of Licensee as to each Product shall terminate on a country-by-country basis concurrently with the expiration of the last to expire of a Valid Claim within the Patent Rights that covers such Product in each such country, including any term extensions thereof; provided, that notwithstanding the foregoing, Licensee’s royalty obligations as to the ICT-140 Product shall terminate as set forth in subsection 1(b) of this Schedule F.

6.

Payment and Accounting.

(i) Reports. Each payment of Royalties shall be accompanied by a report in the form attached as Schedule G hereto, which sets forth in reasonable detail the number and each type of Product sold and the calculation of Gross Sales applicable thereto, and such additional details as may be reasonably requested by CSMC for the determination of Royalties payable hereunder.  Products shall be considered as being sold for the purpose of the calculation of Royalties under this Agreement when revenues have been received from Sales of the Products.  Each payment of Sublicense Fees shall be accompanied by a report in the form attached as Schedule G hereto setting forth in reasonable detail the basis for the calculation of such amounts, and such additional details as may be reasonably requested by CSMC for the determination of Sublicense Fees payable hereunder.  Hard copies of such reports shall be sent to CSMC’s address set forth in Section 13.1 of the Agreement, while an electronic copy shall be sent by electronic mail to CSTechTransfer@cshs.org .  Except as otherwise provided herein, all amounts due hereunder shall be paid in United States dollars and shall be made without set off and free and clear of (and without any deduction or withholding for) any taxes, duties, levies, imposts or similar fees or charges.  Royalties shall be payable by Licensee quarterly, within forty-five (45) days after the end of each calendar quarter, based upon revenues accrued during the immediately preceding calendar quarter.  Licensee agrees to pay and shall pay to CSMC, or cause its Permitted Sublicensees to pay to CSMC, all Royalties resulting from the activities of its Permitted Sublicensees, within forty-five (45) days after the end of each calendar quarter.  

(ii) Notice of Payment.   Licensee shall provide prompt written notice to CSMC that it has paid any Milestone Payment required by Section 4.2 by electronic mail to CSTechTransfer@cshs.org .  

(iii) Wire Transfer Instructions.   All payments due hereunder shall be made by Licensee to CSMC in accordance with the following wire transfer instructions:

[*]

(iv) Records and Audits.   Licensee shall create and maintain complete and accurate records and documentation concerning all Sales of Products by Licensee and its Permitted Sublicensees as well as transactions based upon which Sublicense Fees are due, in sufficient detail to enable the Royalties and Sublicense Fees, respectively, that is payable hereunder to be determined.  Licensee shall retain such records and documentation for not less

F - 4

[ * ] = 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.

 


than seven (7) years from the date of their creation.  During the term of this Agreement and for a period of three (3) years thereafter, CSMC and its representatives shall have the right to audit such records and documentation as shall pertain to the determination and payment of Royalties and Sublicense Fees .  Such examiners shall have reasonable access during regular business hours to Licensee’s offices and the relevant records, files and books of account, and shall have the right to examine any other records reasonably necessary to determine the accuracy of the calculations provided by Licensee.  The costs of any such audit shall be borne by CSMC, unless as a result of such inspection it is determined that the amounts payable by Licensee for any period are in error by greater than five percent (5%), in which case the costs of such audit shall be borne by Licensee.  CSMC shall report the results of any such audit to Licensee within forty ‑five (45) days of completion.  Thereafter, Licensee shall promptly pay to CSMC the amount of any underpayment discovered in such audit, or CSMC shall credit to Licensee against future Royalty payments the amount of any overpayment discovered in such audit, as the case may be.  In addition, Licensee shall pay interest on any underpayment at the rate that is the lower of (i) two percent (2%) over the rate of interest announced by Bank of America in Los Angeles, California (or any successor in interest thereto or any commercially equivalent financial institution if no such successor exists) to be its “prime rate”, or (ii) the highest rate permitted by applicable law, from the date such amount was underpaid to the date payment is actually received.

(v) Currency Transfer Restrictions. If any restrictions on the transfer of currency exist in any country or other jurisdiction so as to prevent Licensee from making payments to CSMC, Licensee shall take all commercially reasonable steps to obtain a waiver of such restrictions or to otherwise enable Licensee to make such payments.  If Licensee is unable to do so, Licensee shall make such payments to CSMC in a bank account or other depository designated by CSMC in such country or jurisdiction, which payments shall be in the local currency of such country or jurisdiction, unless payment in United States dollars is permitted.  Any payment by Licensee to CSMC in currencies other than United States dollars shall be calculated using the appropriate foreign exchange rate for such currency quoted in the California edition of The Wall Street Journal for the close of business of the last banking day of the calendar quarter in which such payment is being made.

(vi) Late Charges. A service charge of two percent (2%) per month, not to exceed the maximum rate allowed by applicable law, shall be payable by Licensee on any portion of Licensee’s outstanding Royalty or Sublicense Fee balance or any other amount payable by Licensee hereunder (including, without limitation, reimbursement for Prosecution costs as set forth in Section 4.1 hereof) that is not paid to CSMC within thirty (30) days past the due date.

(vii) Taxes.   Licensee shall pay, or cause to be paid, any and all taxes required to be paid or withheld on any sales or other transfers for value of Products or Patent Rights (other than taxes imposed on the income or revenues of CSMC); provided, however, that under no circumstances shall the amounts of such taxes be deducted from the total amount of payments otherwise due to CSMC hereunder.  Upon CSMC’s request, Licensee shall secure and send to CSMC proof of any such taxes withheld and paid by Licensee or its Permitted Sublicensees.

F - 5

[ * ] = 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.

 


(viii) No Escrow.   Licensee shall pay all Royalties and Sublicense Fees directly to CSMC and shall not pay royalties into any escrow or other similar account, including in the event of a validity or non-infringement challenge to the Patent Rights.

7. Certain Definitions.

(a) “Gross Sales Price” means the gross amount of all revenues (whether in the form of cash, property or otherwise) received by Licensee or its Permitted Sublicensees from the Sale of Products less (but only to the extent separately itemized as a part of the gross price charged):  (i) transportation, handling, insurance and sales taxes, (ii) rebates and other allowances actually paid or allowed and which are standard and customary in the industry, and (iii) sales commissions to third party distributors actually paid; provided, however, that no other deduction shall be made for royalties, commissions, costs of collection or similar items payable with respect to the Royalty Bearing Products.  For the purposes of the definition of “Gross Sales Price”, it is acknowledged and agreed by the parties that Sales to wholly-owned subsidiaries of Licensee shall not be included.  In the event that Product is sold in the form of a Combination Product (a fixed-dose combination product containing two or more separate drug components in a single dosage form) then the Gross Sales Price for such Combination Product will be calculated by multiplying the actual Gross Sales Price of such Combination Product by the fraction A/(A+B+C) where:  A is the average sales price of the Product contained in the Combination Product if sold separately by Licensee or its Permitted Sublicensee, B is the average sales price of any other active ingredients in the Combination Product if sold separately by Licensee, its Permitted Sublicensee or a third party, and C is the cost of combining Product with the other active ingredient(s).  In the event that the Product is sold in the form of a Combination Product containing one or more active ingredients other than the Product and one or more such active ingredients of the Combination Product are not sold separately, then the parties shall jointly select an individual pricing expert who shall set the formula for determining the Gross Sales Price for such Combination Product and such expert’s determination shall be binding.  The cost of retaining the expert shall be shared equally between the parties.

(b) “Sales” means the sale or other transfer for value.  Sales do not include the sale of Products at or below the fully burdened cost of manufacturing solely for research or clinical testing or for indigent or similar public support or compassionate use programs.

(c) “Sublicense Income” means payments that Licensee received from a Permitted Sublicensee  in consideration for any rights granted to Patent Rights under a sublicense agreement, including without limitation upfront fees, license maintenance fees, milestone payments or other payments, including the fair market value of any non-cash consideration, but excluding the following payments: (i) payments made in consideration for the issuance of equity or debt securities of Licensee or other securities convertible into capital stock of Licensee, (ii) payments specifically committed under the terms of Licensee’s agreement with the Permitted Sublicensee for the research or development by Licensee of Products, including reimbursement for past research or development activities, (iii) payments received by Licensee from third parties for actual direct and indirect costs incurred by Licensee (including reimbursement of actual, identifiable past costs incurred by Licensee) related to product

F - 6

[ * ] = 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.

 


development and manufacturing activities, general and administrative expenses, and co-development activities, including any amounts received by Licensee for the manufacture and supply of Products or components thereof for any use , (iv) milestone payments based on achievement of milestones for which Licensee is required to make payments to CSMC pursuant to Section 4. 2 of the Agreement, (v) payments made to Licensee for the license or sublicense by Licensee of any intellectual property other than the Patent Rights and the Technical Information, (vi) payments made to Licensee to fund or reimburse the actual, identifiable costs, expenses and fees incurred by Licensee for the filing, prosecution and maintenance of patents or other intellectual property, (vii) payments made to Licensee for sales of products other than Products , and (viii) sublicense royalty payments made in connection with the sale of Products, so long as Licensee pays or causes to be paid to CSMC Royalties on amounts received by Licensee’s Permitted Sublicensees under Paragraph 1 hereof .  For clarity, research or development activities include without limitation the design and conduct of non-clinical and pre-clinical studies and clinical trials (including in the conduct of any Phase IV trials or other post-marketing studies).  Licensee shall provide written notice to CSMC in the event that Licensee is required, under the terms of Licensee’s agreement with the Permitted Sublicensee , to refund any Sublicense Income received to the Permitted Sublicensee (the “Refunded Sublicense Income”); thereafter, CSMC shall provide a credit to Licensee in an amount equal to the Sublicense Fee paid by Licensee to CSMC under Paragraph 1 hereof with respect to such Refunded Sublicense Income, which shall be creditable against Royalties otherwise payable under this Agreement.

 

F - 7

[ * ] = 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 G

 

ROYALTY REPORTING FORM

 

Licensee name:

Reporting period:

Date of report:

Date of first commercial sale:

 

Royalty Report

Product (list products by name)

No. units sold

Invoiced price per unit

Gross sales

Allowable deductions (attached itemized detail)

Country of sale/foreign currency/ conversion rate

Net sales

Product name

 

 

 

 

 

 

Product name

 

 

 

 

 

 

Product name

 

 

 

 

 

 

Total

 

 

 

 

 

 

 

Total net sales

$

Royalty rate

 

Royalty due

$

 

Total royalty due: $___________________________

 

Sublicense Revenue Report

Total Sublicense Income received

$

Date received

 

Applicable percentage payable to CSMC

 

Total Sublicense Fees payable to CSMC

$

 

Report prepared by:

Title:

Date:

 

G - 1

[ * ] = 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.

 

 


Please send report to:

Cedars-Sinai Medical Center
8700 Beverly Boulevard
Los Angeles, California  90048-1865
Attention:  Senior Vice President for Academic Affairs

with a copy to Senior Vice President for Legal Affairs & General Counsel

 

Please send electronic copy to CSTechTransfer@cshs.org .

 

G - 2

[ * ] = 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.

 

 

[ * ] = 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 10.3

CONFIDENTIAL

SERVICES AGREEMENT

This Services Agreement ( the “ Agreement ”) dated as of June 11, 2015 (the “ Effective Date ”) is between IMMUNOCELLULAR THERAPEUTICS, LTD. , a Delaware limited liability company having its principal office at 23622 Calabasas Road, Suite 300, Calabasas, CA 91302 (the “ Client ”) and P CT, LLC, A CALADRIUS COMPANY , a Delaware limited liability company having its principal office at 4 Pearl Court, Suite C, Allendale, New Jersey 07401 (“ PCT ”), each a “ Party ” and collectively the “ Parties ”.  This Agreement incorporates by reference the terms and conditions set forth in Attachment A (“ Attachment A ”) and Attachment B (“ Attachment B ”) each attached hereto and made a part hereof.  Capitalized terms not otherwise defined herein will have the meaning set forth in Attachment A or Attachment B, as applicable.  In consideration of the premises and mutual covenants herein contained, the Parties hereby agree as follows:

DESCRIPTION AND Scope of Work

(A)

The Parties have previously executed a Services Agreement dated September 9, 2011 as amended by Program Amendment Order #1 with an effective date of February 17, 2012, Program Amendment Order #2 with an effective date of July 6, 2012, Program Amendment Order #3 with an effective date of August 27, 2012, Program Amendment #4 (“ ICT -107 PAO #4 ”) with an effective date of October 11, 2012 and Program Amendment Order # 5 (“ ICT-107 PAO #5 ”) with an effective date of May 1, 2013 (collectively, the “ 2011 ICT-107 Services Agreement ”) pursuant to which PCT provides Services (as defined in the 2011 ICT-107 Services Agreement) in connection with Client’s Phase III ICT-107 autologous cell therapy product (the “ ICT-107 Product ”) and cell manufacturing platform defined as the manufacturing process for making dendritic cells without targeted antigens (the “ ICT Platform ”).

(B)

The Parties also previously executed a Services Agreement dated May 10, 2013, as amended by Program Amendment Order No. 1 (“ ICT-121 PAO #1 ”) with an effective as of July 23, 2013 (collectively, the “ ICT-121 Services Agreement ”) pursuant to which PCT provides Services (as defined in the ICT-121 Services Agreement) in connection with Client’s ICT-121 autologous cell therapy product (the “ ICT-121 Product ”). ICT-107 Product and ICT-121 Product are individually and collectively, referred to as “ Product ”, and the 2011 ICT-107 Services Agreement and the ICT-121 Services Agreement are individually and collectively, referred to as the “ Services Agreement ”.

(C)

The ICT Platform may also serve as a basis for future development and manufacture of Client’s other ICT Platform-based products (collectively, “ Other ICT Products ”).

Version 7 Page 1

[ * ] = 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.

 


 

(D)

Client and PCT agree that the ICT Platform as currently implemente d at PCT’s facility located at 291 North Bernardo Avenue, Mountain View California (the “ MV Facility ”) as of the Room Start Date (as defined in Paragraph (1) under heading “Services” below) will serve as the basis for Phase III and potential commercial manufacture of ICT-107 Pro duct and manufacture of ICT-121 for applicable phase trial (s) for ICT-121 Product.  The manufacturing process (the “ Manufacturing Proces s”) for Product includes any and all processes and activities (or any step in any process of activity) used by PCT to manufacture Product (including the manufacturing, processing, packaging, labeling, quality control testing, release , shipping and storage of the same) as evidenced in batch documentation relating to such Product, as applicable.  Within the Manufacturing Process are the processes and activities for the ICT Platform as well as additional manufacturing activities requisite for the manufacture, testing and release of a single (1) lot of the Product, as applicable (the “ICT Platform activities” ).

(E)

This Agreement is entered into by PCT and Client in order to provide for PCT to expand its current manufacturing capacity at the MV Facility for Client’s ICT-107 Product in support of Client’s Phase III clinical trials and to manufacture ICT-121 Product as provided herein. Commencing on the Room Start Date Client desires that PCT provide the Services (as defined below) which Services are in lieu of similar services that are set forth in either Services Agreement.

SERVICES

Client requires the services (the “ Services ”) described below:

(1)

Effective as of the date (the “ Room Start Date ”) which is the earlier of (a) the date PCT’s designated point of contact receives from Client a written notice (the “ Room Start Notice ”) stating that the training of PCT Team Members (as defined in Paragraph 1(B)(i) below) and the requalification of the ICT-107 Product’s Manufacturing Process (the “ ICT-107 Process Requalification ”) in the Room (as defined in Paragraph 1(A) below) is to commence and (b) August 1, 2015, through the Termination Date (as defined in Paragraph 1(C)(iii) below):

(A)

[*] Room .  PCT will provide a controlled environment room (the “ Room ”) on a [*] basis for Client’s Runs as determined below, including Paragraphs 1(B)(vii) and (viii) below, in the MV Facility and promptly commence identifying and subsequently training PCT Team Members as well as promptly commence the ICT-107 Process Requalification.  Client shall have the right, ahead of PCT and all other PCT customers and clients, to schedule up to the agreed upon number of monthly Runs (as defined in Paragraph 1(B)(xii) below) in such Room [*] and thereafter, based on such scheduling, PCT shall carry out such scheduled Runs as provided herein, including Paragraphs 1(B)(vii) and (viii) below.

(i)

For purposes hereof, [*] basis means that through the Termination Date, Client shall be able to obtain Services as described in this Agreement (including having the Room and PCT Team Members available to perform Services on Client’s behalf as provided for herein) except to the limited extent that PCT may perform Other Services for itself or for other clients pursuant to this Paragraph. At any time, PCT may perform other services (“ Other Services ”) either on its own behalf or for the benefit of any other

Version 7 Page 2

[ * ] = 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.

 


 

client of PCT in the Room subject at all times to Client’s ability to obtain Services as described in this Agreement . PCT wil l source and receive materials and maintain in the Room mutually agreed upon equipment as the Parties a gree is necessary for the Services [* ] (exc ept for Client Equipment as defined in Paragraph 1(D)(i) below) . PCT will notify Client in advance in writing of its commencing the pe rformance of Other Services when viral vector material (without any detail as to the type of such material) will be in the Room.  Further, whenever incubators are in use in connection with a Client Manufacturing Process and contain any component material in connection with a Run, PCT will not simultaneously or concurrently place any other material or item associated with Other Services in such incubator while Client material is within such incubator.

(ii)

PCT will maintain, validate, clean, monitor and provide calibration services of the Room and the equipment within the Room in accordance with current PCT Standard Operating Procedures (“ SOPs ”) and all other requirements as set forth in Attachment B hereto including Section 2 thereof and the Quality Agreement.

(iii)

The ICT-107 Process Requalification will occur under GMP conditions in the Room. The ICT-107 Process Requalification will commence on the Room Start Date and be completed within one hundred and twenty (120) days of the Room Start Date subject to the provisions of this Agreement.  The ICT-107 Process Requalification will include the scheduling of engineering runs (“ Engineering Runs ”) and process qualification runs (“ PQ Runs ”) for the ICT-107 Requalified Process as the Parties mutually agree in writing and schedule. The manufacturing of Product utilizing the requalified ICT-107 Product Manufacturing Process will be interlinked with appropriate testing that will attempt to meet pre-determined mutually agreed upon written specifications.  In addition, if applicable and in connection with the ICT-107 Requalification Process, the qualification of critical manufacturing equipment, aseptic processes and Room qualification will be executed according to qualification protocols which will be jointly reviewed and approved by PCT and the Client in writing.  Engineering Runs and PQ Runs will be conducted (a) pursuant to the most current versions of the ICT-107 Product Manufacturing Process documentation (SOPs and MBR) and (b) pursuant to an ICT-107 process qualification protocol mutually agreed to by the Parties in writing, if necessary.

(iv)

Commencing on the Room Start Date, in lieu of the manufacture of ICT-121 Product under the ICT-121 Services Agreement, Client may schedule and PCT shall commence the manufacture of ICT-121 Product in the Room in the manner provided in this Agreement. Providing Runs for ICT-121 Product is subject to the Parties agreeing in writing to the number of Runs that will be provided in Slots during each applicable month as provided in Paragraphs 1(B)(vii) and (viii), identification and training, if any, of PCT Team Members as provided herein and payment of the applicable Room Fee (as defined in Paragraph 1(E)(i)(a) below) and all PCT Team Member Fees (as defined in Paragraph 1(E)(ii) below) for such month.

(v)

As provided below, Client can request and have PCT perform the agreed upon number of monthly Runs at the times and manner provided below.

Version 7 Page 3

[ * ] = 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.

 


 

(B)

PCT Team Members .

(i)

PCT [*] will, throughout the period ending on the Termination Date, identify and establish a PCT staff team (the “ PCT Team ”) to perform Services. PCT [*] will identify existing PCT staff personnel and PCT will hire, at PCT’s cost and expense, additional PCT staff personnel (collectively, “ PCT Team Members ”) for the PCT Team. Notwithstanding either Services Agreement to the contrary and regardless of the existence and/or identification of PCT staff personnel performing services as described in the applicable Services Agreement prior to the Room Start Date, Client and PCT agree that a new PCT Team will be identified and created for the Services as provided herein. The new PCT Team may include personnel who are involved in the manufacture of ICT-121 Product. [*] PCT through the period ending with the Termination Date will periodically (a) determine the number of PCT Team Members necessary for providing the Services [*] and the monthly number of Runs that the Parties agree can be scheduled and commenced in a particular month by trained PCT Team Members (provided the ICT-107 Process Requalification has been completed to PCT’s reasonable satisfaction) and (b) mutually agree upon the make-up of the PCT Team Members for all such Services.  Unless the Parties otherwise agree in writing the number of PCT Team Members will [*] as more particularly described in Paragraph 1(B)(vii) below.   [*] The Parties agree that (a) each PCT Team Member may require up to four (4) months of training in order to be capable of performing all of the Services to be provided by PCT that the Parties mutually agree are to be provided in a particular month through the Termination Date and (b) the ICT-107 Product Manufacturing Process in existence as of the Room Start Date may require up to four (4) months to be requalified and that, collectively, these training/requalification requirements (which, as applicable, may take place concurrently) and may have an effect on PCT’s ability to provide Services, including Runs at the monthly capacity set forth in Paragraph 1(B)(vii) below within the time frames that the Parties desire and initially determine pursuant to this Paragraph.

(ii)

Based upon the determination regarding the number and responsibility of PCT Team Members for the Services through the Termination Date, on an on-going basis, PCT’s designated point of contact for the various Services shall notify Client’s designated point of contact, in writing (with email being an acceptable writing), the identity and responsibility of the various individuals that PCT assigns to the PCT Team.  The date that PCT notifies Client that a PCT staff member has been assigned to the PCT Team shall be such PCT Team Member’s start date (the “ PCT Team Member Start Date ”) in the PCT Team and be deemed a PCT Team Member. PCT shall only assign and hire persons to the PCT Team that PCT has a reasonable belief will have sufficient experience and expertise to adequately perform such person’s respective role on the PCT Team. [*]

(iii)

The make-up of the PCT Team may include (without limitation) manufacturing specialists, quality assurance/documentation specialists, and quality control analysts. [*] The Parties agree that identity testing as agreed upon by the Parties of agreed upon critical materials will require third party vendor testing (“ Third Party Testing ”) and will be sent out by PCT as provided in the Manufacturing Process for the Product and

Version 7 Page 4

[ * ] = 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.

 


 

PCT will manage the performance of the Third Party Testing at no additional cost to the Client.

(iv)

[*]

(v)

PCT will provide training activities to each PCT Team Member requiring training pursuant to a training plan agreed to by the Parties in writing (the “ Training Plan ”), which Training Plan will outline the requirements/activities regarding applicable manufacturing, quality control and quality assurance training.  PCT [*] will reasonably determine the number and make-up of PCT Team Members required in order for PCT to be able to perform Services for each month factoring in to such determination the monthly number of Runs that the Parties mutually agree in writing are to be provided during applicable monthly periods, the need for training PCT Team Members in order to perform the desired number of Runs and the completion of the ICT-107 Process Requalification to PCT’s reasonable satisfaction.  Such training of and subsequent performance of Services by PCT Team Members shall occur pursuant to a schedule mutually determined by the Parties in writing [*] . PCT shall notify Client in writing when PCT determines that the particular PCT Team Member’s training has been completed to the reasonable satisfaction of PCT.

(vi)

Client will have first priority to PCT Team Members for training as well as the performance of Services by such PCT Team Members in accordance with Paragraphs 1(A) and 1(A)(i) above.

(vii)

Subject to (a) [*] the appropriate number and make-up of the PCT Team to provide Services and up to the number of Runs described in this Paragraph 1(B)(vii), (b) [*] and (c) PCT having reasonably determined that designated PCT Team Members have been satisfactorily trained to perform the applicable Services, including Runs and that the ICT-107 Process Requalification is complete, PCT, subject to the receipt of Request Notices (as defined in Paragraph 1(C)(iii) below) will schedule, as the Parties agree in writing, up to a maximum of [*] Runs per month. The Parties further agree, notwithstanding the preceding, that no more than [*] Runs may be scheduled and commenced during any week (with a week commencing on Monday and ending on Sunday) and no more than [*] Run may be scheduled and commenced on any day, unless otherwise agreed to, in writing between the Parties’ respective points of contact, in advance.   [*] . For purposes of clarity PCT shall not be responsible to provide any Services or the mutually agreed upon number of monthly Runs, as mutually scheduled or a particular scheduled Run, if there are insufficient PCT Team Members at the time of the commencement of the scheduled Service or Run or anytime during such Service or Run due to (I) the removal of PCT Team Members at Client’s written request, (II) [*] , (III) the fact that a necessary PCT Team Member required for the Services or Runs is ill, injured, fails to arrive at the PCT Facility without notification to PCT or is no longer employed by PCT or (IV) Force Majeure, and PCT reasonably determines that as a result of any such occurrence the then existing/remaining PCT Team Member complement cannot support the applicable Services, the mutually agreed upon monthly number of Runs or the particular Services or Run.

Version 7 Page 5

[ * ] = 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.

 


 

(viii)

Commencing with the month in which the Room Start Date occurs, at the beginning of each month (or in the case of the month in which the Room Start Date occurs promptly after the Room Start Date), PCT will make available to Client [* ] to enable the Client, during the applicable month to schedule and have PCT commence and carry out at least such month’s number of Runs as agreed to by the Parties pursuant Paragraph 1 (B)(vii) above.   [* ]

(ix)

If during any calendar month and pursuant to a Request Notice, Client requests PCT to schedule Runs in excess of the mutually agreed upon monthly or weekly limitations/maximums for Runs as provided in Paragraphs 1(B)(vii) and (viii) above (“ Additional Runs ”), PCT [*] however, PCT’s decision not to accommodate a request for an Additional Run [*] will not be a breach of PCT’s obligations to Client hereunder.  Within [*] Business Days of PCT’s receipt of a Request Notice for an Additional Run, PCT will provide Client with a written response notice regarding PCT’s accommodating such requested Additional Run, provided, however, if PCT fails to respond within such [*] Business Day period, then PCT will be deemed to have rejected Client’s request to schedule such Additional Run.

(x)

A condition to PCT’s ability to provide the agreed upon Services or Runs is the training of PCT Team Members in accordance with the Training Plan and the completion of the ICT-107 Process Requalification.

(xi)

PCT shall use commercially reasonable efforts to provide adequate supply chain and other support services in connection with all Services.

(xii)

As agreed by the Parties, in writing, PCT Team Members may perform [*] Runs ”.

(xiii)

PCT shall reasonably determine when a PCT Team Member has completed training and is available for the performance of all Services.

(xiv)

[*]

(C)

Runs . As of the Room Start Date, the 2011 ICT-107 Services Agreement and the ICT-121 Services Agreement are terminated and of no further force and effect except for those terms and provisions therein that expressly survive termination thereof.  Notwithstanding the preceding sentence, the terms and provisions of ICT-107 PAO #4, ICT-107 PAO #5 and ICT-121 PAO #1 that, as provided in each of ICT-107 PAO #4, ICT-107 PAO #5 and ICT-121 PAO #1, are to be performed from and after the Room Start Date, shall continue to survive and PCT and Client shall each perform their respective obligations thereunder until the services to be provided by PCT are completed or terminated as provided in each such Program Amendment Order.

(i)

PCT will perform Runs as described herein.

(ii)

A condition to PCT’s ability to commence any Run on the scheduled date, as applicable, is PCT’s receipt by [*] am on the applicable day of Client sourced Client Materials, Raw Materials or other appropriate biological material in sufficient quantity and quality and satisfying mutually agreed upon Product Specifications and acceptance criteria.  If PCT believes that any received Client sourced Client Materials

Version 7 Page 6

[ * ] = 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.

 


 

or other appropriate biological material are deficient, then the Parties immediately shall cooperate to determine the reason therefor, and shall address any deficiency.

(iii)

Definitions.

Business Day ” means any day at the MV Facility other than a Saturday, Sunday, the Friday after Thanksgiving or state and federal holidays.

Business Hours ” are 8:30 a.m. – 5:00 p.m. on any Business Day.

GMP means current Good Manufacturing Practices as promulgated by the United States Food and Drug Administration or any successor agency thereto (the “ FDA ”), including the regulations within the meaning of 21 CFR Parts 210, 211 [*] .

Request Notice ” means a written notice received by PCT’s designated point of contact for a Run (or Additional Run that is provided pursuant to Paragraph 1(B)(ix) above) not less than [*] Business Days prior to a day [*] is available as provided to Client pursuant to Paragraph 1(B)(viii) above specifying the type of Run (or Additional Run) that is to be scheduled.  Request Notices may be sent by email to PCT’s designated point of contact.  To the extent a Request Notice is received by PCT at any time other than during Business Hours, such Request Notice shall be deemed to have been delivered to PCT during Business Hours on the next succeeding Business Day and the [*] Business Day period commences on such next succeeding Business Day.

Termination Date ” means the earlier of:

(a)

The date the Parties mutually agree, in writing that the scheduling and performance of Services and Runs ends (which shall be the last day of a month);

(b)

The last day of the month following PCT’s designated point of contact’s receipt of no less than [*] days written notice that Client will no longer require Services, provided, however , such written notice shall not be effective prior to the last day of the month following the [*] anniversary of the Room Start Date; and

(c)

[*]

(iv)

Services.

(a)

Upon PCT’s receipt of a Request Notice indicating [*] that a Run (or Additional Run) is to be scheduled to commence, PCT will schedule the Run (and if agreed to as provided in Paragraph 1(B)(ix) above, the Additional Run) and, subject to all other terms and conditions of this Agreement, commence the Run/Additional Run on the scheduled date.

(b)

If (a) Client cancels the scheduled Slot activity or (b) PCT does not receive the necessary Client sourced Client Materials/Raw Materials/ appropriate biological material for the scheduled Slot activity by [*] am on the date of the commencement of [*] activity, then, unless the Parties otherwise mutually agree in writing, PCT shall be relieved of the obligation to commence the scheduled [*] activity [*] .

Version 7 Page 7

[ * ] = 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.

 


 

(c)

Testing of Product by PCT (or a third party service provider subcontracted by PCT) will be performed , for the ICT-107 Product, according to the methods qualified in the ICT-107 Requalification Process and , for the ICT-121 Product, in accordance with the methods that were qualified for the ICT-121 Product under the ICT-121 Services Agreement.

(d)

Product will be stored in quarantine at the MV Facility until release and after release maintained at the MV Facility until shipment of such Product is requested by Client or Client’s designated clinical site in accordance with Paragraph 1(D) below.

(e)

Manufacturing inventories, production schedules and shipments of Product will be coordinated with the Client through PCT’s point of contact, as designated in writing by PCT to Client.

(f)

PCT shall maintain the GMP compliance of the Room as of the Room Start Date , as well as the utilities, systems and equipment used in connection with the Services and provide environmental monitoring, cleaning and Quality Control testing services detailed herein and as specified in the Quality Agreement.

(g)

PCT shall retain and store samples of Product pursuant to GMP, applicable SOPs and other appropriate protocols relating to the Services.  At Client’s written election, retains shall be returned to Client or its designee or destroyed at Client’s cost and expense.

(h)

Regardless of whether Client requests PCT to schedule Runs in a particular calendar month, after the Room Start Date, PCT has fully earned the fees provided in Paragraph 1(E) below for such calendar month.

(D)

Client Equipment, Storage and Shipping .

(i)

Client has purchased the equipment as described in Exhibit 1 to Attachment A (which together with the Freezer (defined in Paragraph 1(D)(ii) immediately below is collectively, the “ Client Equipment ”), which has been delivered to, and installed at, the MV Facility where it shall be used by PCT solely to perform Services for Client either as described in this Agreement or in any other agreement between Client and PCT and for no other purpose.  If additional equipment is required in order for PCT to perform the Services or other activities under this Agreement, then such items shall be added to Exhibit 1 by mutual written agreement of the Parties.

(ii)

Within [*] days of the Effective Date, Client and PCT will coordinate the necessary resources and logistics required to receive and install, at Client’s cost and expense, at the MV Facility one (1) Client owned Liquid Nitrogen Freezer (the “ Freezer ”), including PCT confirming with Client that PCT has the most current list and User Requirement Specifications for the Freezer.

(iii)

Terms and conditions governing Client Equipment are set forth in Attachment A attached hereto and made a part hereof.

Version 7 Page 8

[ * ] = 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.

 


 

(iv)

Prior to the date that Client transfers the Freezer to the MV Facility , PCT will prepare space and , at Client’s cost and expense, the necessary liquid nitrogen supply line to support the installation of the Freezer.

(v)

PCT will, at Client’s cost as provided in Paragraph 1(E) below, receive and install the Freezer, assign a PCT MEF#, perform, as the Parties agree, perform an installation qualification followed by an operation qualification on the Freezer, and connect the Freezer to PCT’s equipment monitoring system.

(vi)

For a period ending no later than [*] after the Termination Date, Product and samples will be maintained in the Freezer until shipment of such Product is requested by Client or Client’s designated clinical site.

(vii)

PCT will coordinate with Client (or Client designated clinical sites) as Client requires and at Client’s cost and expense, upon written notice to PCT, the extraction of any item from the Freezer and the subsequent shipment of such item within the United States as Client specifies in its written notification to PCT.  Client shall pay PCT for maintaining the Freezer at the MV Facility as well as an extraction fee for each extraction of an item from the Freezer as well as the reasonable, documented costs associated with packing and shipping any such item as directed by the Client.

(viii)

Provided a particular item of Client Equipment is no longer required for the performance by PCT of Services pursuant to this Agreement, on (1) Client’s written request for the return of Client Equipment other than the Freezer and (2) the earlier of (x) Client’s written request for the return of the Freezer and (y) [*] after the Termination Date, as applicable, PCT shall coordinate with Client and arrange, at Client’s cost and expense, the de-installation and return of the applicable Client Equipment as instructed by Client in writing. In the alternative, at Client’s election, PCT and Client will arrange for the sale of the Freezer from Client to PCT at the Freezer’s then fair market value reflecting the condition and age of the Freezer at such time.  If the Parties are unable to determine the then fair market value of the Freezer, the Parties will each obtain and provide to the other at least two quotes from reputable third party sources for a Freezer of substantially the same as the Freezer with similar age and condition characteristics.  The fair market value of the Freezer will then be the average of such quotes.

(E)

Compensation . As consideration for PCT’s performance of the Services set forth in this Agreement and in addition to the reimbursable amounts payable by Client to PCT pursuant to Section 4(b) of Attachment B and subject to the terms of this Agreement (including Attachment B), Client will pay to PCT fees (the “ Fees ”) for the performance of the various Services as provided below:

(i)

Room Fee/Freezer Installation/Storage Fee/Shipping Fee .

(a)

Room Fee.  Client will pay PCT a monthly Room fee (the “ Room Fee ”) in the amount of [*] as follows:

Version 7 Page 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.

 


 

(1)

T he monthly Room Fee for the month in which the Room Start Date occurs [* ] the Effective Date .   If the Room Start Date occurs on a day other than the first day of a month, PCT will , at its option [* ] credit a portion of such Room Fee to Client in an amount that is equal to the number of days in such month before the Room Start Date multiplied by [* ] . For purposes of clarity, if the Room Start Date is June [* ] , 2015, PCT will either [* ] provide a credit for the July Room Fee payable by Client in an amount equal to [* ] ( [* ] times [* ] days) .

(2)

Commencing on the first day of each month after the Room Start Date through and including the month in which the Termination Date occurs, Client will pay PCT a monthly Room Fee.

(3)

Except for the first Room Fee payable as provided for in Paragraph 1(E)(i)(a)(1) above, the monthly Room Fees are payable prior to the first day of each month following the Room Start Notice.  PCT has no obligation to schedule or commence a Run or perform any other Services unless PCT has received the monthly Room Fee prior thereto.

(4)

[*] , invoices for the monthly Room Fee may be issued by PCT in advance of the first date of the applicable month following the Room Start Notice and be payable as provided in accordance with Sections 4(a) and (e) of Attachment B.

(b)

Freezer Installation.  In connection with PCT receiving and installing the Freezer and performing the other Services as provided in Paragraphs 1(D) above, PCT will, in addition to invoicing for agreed upon documented reimbursable expenses, invoice for such Services based upon the actual time incurred by PCT staff in performing them at the hourly rates set forth in the table (the “ Additional Services Table ”) contained in Section 17(l) of Attachment B which hourly rates will be dependent on the PCT staff providing the applicable Additional Services.  PCT will determine the appropriate PCT staff to perform the applicable Additional Services. Hourly charges are applied to the total time devoted to the performance of the Additional Services. Such invoice will be payable by Client as provided in accordance with Sections 4(a) and (e) of Attachment B.

(c)

Storage and Extraction Fees.  On and after the Termination Date, and on the first day of each month thereafter through and including the month in which the Freezer is either (1) removed from the MV Facility at Client’s cost and expense (but no later than the month that is [*] from the date that the Termination Date occurs) or (2) purchased by PCT pursuant to Paragraph 1(D)(viii) above, Client will pay PCT a fee equal to [*] per month which monthly fee will cover the cost of liquid nitrogen replenishment and maintenance and environmental monitoring of the Freezer.  Client agrees that the monthly storage fees for the Freezer are payable monthly in advance by Client and that invoices for the monthly storage fee may be issued by PCT in advance of the monthly storage fee due date.  In addition to the storage fee as provided above, on and after the Termination Date Client will be invoiced an extraction fee equal to [*] for each item that PCT is

Version 7 Page 10

[ * ] = 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.

 


 

instructed by Client to extract from the Freezer.  In the instance where multiple items are extracted and shipped to one location at one time, PCT will instead invoice Client based on actual time incurred by PCT staff to provide such services using the hourly rates in the Additional Services Table.   At all times, Client will reimburse PCT for the reasonable, documented out of pocket third party costs of packaging and shipping any such item within the United States as instructed by Client in writing as a reimbursable Expense. In addition, Client shall pay for shipping the shipper back to PCT. All invoices will be payable by Client as provided in accordance with Secti ons 4(a) and (e) of Attachment B .

(1)

In the event at the end of the period provided in Paragraph 1(E)(i)(c) above, after receipt of PCT’s written request for instructions on the disposition of Product or samples remaining in the Freezer and/or disposition of the Freezer, Client fails to instruct PCT on where to return or relocate the same and/or Client fails to pay PCT any outstanding storage and/or extraction fees, on no less than [*] days’ additional written notice to Client, at PCT’s election PCT may (1) return such items to Client at Customer’s address set forth at the beginning of this Agreement, (2) destroy any Product and samples then remaining at the MV Facility, (3) deem that such Product and/or samples have been abandoned by Client and PCT shall have the right, and Client expressly authorizes PCT to dispose of such Product and/or samples for value or otherwise without any compensation or further notice to Client, in each instance, at Client’s cost, expense and responsibility and/or (4) deem the Freezer abandoned and sold and conveyed to PCT at no additional cost to PCT. If PCT, notwithstanding the above, continues to store Product and samples beyond period provided above, Client shall pay immediately upon its receipt of an invoice PCT’s then applicable storage fees.

(ii)

PCT Team Member Fees .  For each PCT Team Member, commencing on the PCT Team Member Start Date for such PCT Team Member and each month thereafter through and including the month in which the Termination Date occurs, as long as such PCT Team Member remains in the PCT Team, Client will pay a monthly fee (the “ PCT Team Member Fee ”) for each PCT Team Member in the amount of [*] .

(a)

If the applicable PCT Team Member Start Date is not the first day of the month, the monthly PCT Team Member Fee for the month in which the PCT Team Member Start Date occurs will be prorated and reduced by [*] for each day prior to the PCT Team Member Start Date.  For purposes of clarity, if one PCT Team Member has a PCT Team Member Start Date of July 1, 2015 and a second PCT Team Member has a PCT Team Member Start Date of July 6, 2015, then for the month of July, PCT will invoice and Client will pay PCT a PCT Team Member Fee for the first PCT Team Member in the amount of [*] and a PCT Team Member Fee for the second PCT Team Member in the amount of [*] ( [*] minus [*] times five (5) days).

(b)

Subject to Paragraph (E)(ii)(a) above and this Paragraph, PCT is entitled to the full PCT Team Member Fee for all PCT Team Members for the applicable month

Version 7 Page 11

[ * ] = 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 , except as provided in this Paragraph 1(B)(ii)(b) no credit [* ] will be provided if, during a particular month, a PCT Team Member is removed from the PCT Team at Client’s request at any time other than the last day of such month as more particularly described in Paragraph 1(B)(xiv) above . [* ] In either situation described in the preceding sentence , Client will receive a credit (presuming Client has paid the applicable monthly PCT Team Member Fee for such individual), to be applied to the next applicable monthly PCT Team Member Fees payable by Client in an amount equal to [* ] for each day from and after the date such PCT Team Member is no longer a part of the PCT Team though the end of such month.

(c)

Except for the month in which the PCT Team Member Start Date occurs, for each PCT Team Member, Client will pay in advance the monthly PCT Team Member Fee for each PCT Team Member.   PCT Team Member Fees will be paid by Client in accordance with Sections 4(a) and (e) of Attachment B.

(iii)

Fees Earned .  Client agrees that regardless of whether Client in a calendar month requests PCT to perform Services, including any Run, PCT shall have fully earned, as applicable, the Room Fee AND the applicable PCT Team Member Fees for such calendar month, provided a Room Start Notice has been given except for the first monthly Room Fee which is non-refundable regardless of whether Client provides a Room Start Notice.  Other than as provided for in this Section (E), no credits will be provided to Client based on or regardless of the Services requested or the number of Runs Client requests PCT to schedule during such calendar month.

(iv)

Fee for PCT Technology Transfer Services/Close-Out Fee .  The close-out activities described in Paragraph 2 below performed during the Close-Out Period (defined in Paragraph 2 below) [*] will be performed by PCT on a time and materials basis at the hourly rates (subject to the adjustments in Section 17 of Attachment B) set forth in the Additional Services Table and will be dependent on the PCT staff providing the various close-out activities [*] .  PCT shall invoice Client for the close-out activities [*] on a periodic basis for PCT close-out activities [*] performed, as applicable.  Each such invoice shall set forth the number of hours spent per PCT staff level member (as set forth in the Additional Services Table) and, as applicable, include receipts and other documentation evidencing the out of pocket costs (without markup except as provided for in Section 4(b) of Attachment B) incurred by PCT, in performing such Services, including as provided in Section 4(b) and (c) of Attachment B.  Client shall pay each invoice as provided in Attachment B.

(v)

Take or Pay Fees/ Additional Product Fees/Surcharges/ Production Fees/Additional Production Fees .  Commencing on the Room Start Date, Client will not pay any Take or Pay Fee, Additional Product Fee or Surcharges (as provided in the 2011 ICT-107 Services Agreement) or any Production Fees or Additional Production Fees (as provided in the ICT-121 Services Agreement).

(vi)

Reimbursable Expenses . Client will pay for all reasonable, documented expenses as set forth in Section 4(b) and Section 4(c) of Attachment B to this Agreement.

Version 7 Page 12

[ * ] = 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)

During the [* ] period (the “ Close-Out Period ”) commencing on the date that PCT initiates services relating to PCT’s close out of this Agreement, PCT will cooperate with Client and collect and transfer all mate rial s , reagents, supplies and equipment, including Client E quipment , Client Materials (defined in Section 2(f) of Attachment B ) and Raw Materials (defined in Section 10(c) of Attachment B ) , Product, data, reports and Records (defined in Section 2(l) of Attachment B ) , and other deliverables, in each instance, for which Client has reimbursed or paid PCT pursuant to this Agreement and arrange to d eliver the same to Client or a third party as requested by the Client, in writing.   The Close-Out Period will commence on the day immediately following the Termination Date [* ] .

(3)

[*] .

(4)

Upon the occurrence of the Termination Date, should Client elect to engage PCT as its development and manufacturing partner for additional services not covered by this Agreement, services which would have been performed during the Close-Out Period (along with its associated cost) will be deferred until the completion of all such services.

General Provisions Applicable To Services

(A)

If in the course of performing Services, any relevant PCT GMP documents in the PCT document control system need to be updated and/or revised with any Client requested changes, such updates and/or revisions will be performed at the cost and expense of Client and provided by PCT to Client and reviewed, approved and executed by Client prior to use in the GMP manufacturing activities. PCT agrees that all Client-specific documents created in order to perform the Services described in this Agreement will be used by PCT only for Product as described in this Agreement and only at the MV Facility unless (i) transferred to Client and/or a third party as part of a Transferred Technology provided by PCT and Client and/or third party uses such PCT created documents for reference only for Client and/or a third party to create and develop its own documents or (ii) otherwise agreed to by the Parties pursuant to an executed Program Amendment Order or other writing between the Parties.  Notwithstanding the foregoing it is agreed that such documents may be used by Client’s other contract manufacturing organizations (CMOs) for Product and/or other ICT Platform products provided, further all references to PCT’s name and/or logo/address or other information that indicates PCT in any manner are redacted/deleted prior to such use.

(B)

The Parties agree that PCT performance of Services is based on (a) the assumptions set forth in this Agreement [*] and (b) the Client reasonably cooperating with PCT in connection with PCT’s performance of the Services set forth in this Agreement, including but not limited to, Client being reasonably responsive to PCT, providing responses in a reasonably expeditious manner and Client providing, as necessary, Client staff and resources and starting material as provided in this Agreement.  The Parties acknowledge that if such assumptions are not correct or Client is either non-responsive or if responsive is not responsive in a reasonably expeditious manner, the Services may be affected and delayed and, therefore, adversely affect the conduct of Client’s trial plans.  PCT will promptly advise Client in writing if it becomes aware that an assumption is not correct and/or if Client has not been reasonably responsive and/or is not responsive in a reasonably timely manner to PCT requests and any of the preceding has the potential of affecting the Services.  If PCT so advises, then changes

Version 7 Page 13

[ * ] = 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.

 


 

may be handled in accordance with the terms regarding Program Amendment Orde rs set forth in the Agreement.

Expense Prepayment:

(A)

In anticipation of the costs and expenses to be incurred by PCT in performing the Services hereunder, on the Effective Date, Client will pay the sum of [*] (“ Expense Prepayment ”) as an advance for [*] costs and expenses.  The Parties agree that the expense prepayments paid by Client pursuant to the Services Agreement in an amount equal to the Expense Prepayment shall be retained by PCT in satisfaction of the Expense Prepayment obligation hereunder. PCT will use the Expense Prepayment solely for [*] costs and expenses of the separately invoiced items set forth in Sections 4(b) and 4(c) of Attachment B. (the “ Expenses ”).  PCT will provide Client with a monthly invoice documenting in reasonable detail such Expenses, including such Expenses that may have been paid by PCT utilizing the Expense Prepayment.  Client shall reimburse PCT the amount set forth in the invoice(s) upon receipt of such invoice(s) which when paid by the Client, to the extent applicable, will replenish the Expense Prepayment (but only to the extent all other Expenses which were not paid with Expense Prepayment funds have been paid in full).

(B)

The Parties intend that the amount of the Expense Prepayment at all times be at least equal to the monthly Expenses incurred by PCT in performing the Services.  In the event either Party reasonably determines that the monthly invoiced costs for such reimbursements are not matched by the Expense Prepayment, either Party shall notify the other Party, in writing, of such determination and the amount by which the Expense Prepayment needs to be altered and provide documentation supporting such determination.  If the Expense Prepayment is to be altered, the Party receiving the notice will upon receipt of such determination seeking a change in the Expense Prepayment, promptly discuss with the notifying Party the amount by which the Expense Prepayment needs to be changed.   [*] Expense Prepayment shall mean the adjusted Expense Prepayment amount applicable from time to time pursuant to this Section (B).

(C)

Upon the expiration or termination of this Agreement, PCT will promptly return to Client the Expense Prepayment paid less any [*] amounts owed by Client to PCT for Services provided by PCT pursuant to any agreement between the Parties and Expenses that remain unpaid as of expiration or termination of this Agreement.

MISCELLANEOUS:

(A)

The Points of Contact at Client for PCT are Andrew Gengos, Chief Executive Officer and President and Marta Schilling, Vice President, Cell Therapy Manufacturing, or any other individual designated in writing from Client to PCT.  PCT may communicate with and/or provide notices and other contact with either or both of Client’s Points of Contact.   All invoices shall be sent to David Fractor, Chief Financial Officer . Vice President and Principal Accounting Officer

(B)

Unless otherwise provided in this Agreement, the Point of Contact at PCT for Client is set forth in Section 2(d) of Attachment B.

Version 7 Page 14

[ * ] = 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.

 


 

(C)

The terms and conditions set forth in Attachment A and Attachment B attached hereto are incorporated herein by reference in their entirety, shall be deemed to be a part hereof to the same extent as if such terms and conditions had been set forth in full herein and by executing this Agreement . Client acknowledges that it has read Attachment A and Attachment B and that the terms and provisions of Attachment A and Attachment B are an integral part of this Agreement.

NO FURTHER TEXT ON THIS PAGE – SIGNATURE PAGE FOLLOWS

 

 

Version 7 Page 15

[ * ] = 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 duly executed by the Parties as of the Effective Date.

PCT, LLC, A CALADRIUS COMPANY

By: /s/ George S. Goldberger

Name: George S. Goldberger

Title: VP Business Development

IMMUNOCELLULAR THERAPEUTICS, LTD.

By: /s/ Andrew Gengos                                   

Name:Andrew Gengos

Title:Chief Executive Officer and President

 

 

Version 7 Page 16

[ * ] = 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.

 


 

ATTACHMENT A

CLIENT EQUIPMENT

1.

Ownership .

(a)

Title.  Title to, and ownership of, the Client Equipment is and shall remain at all times exclusively in Client.

(b)

PCT acknowledges that it does not and will not have any property or other interest in the Client Equipment other than as may be provided in the Agreement [*] .

(c)

[*] .

(d)

PCT shall keep the Client Equipment free of all claims, demands, liens, levies, security interests and other encumbrances arising by, under or through PCT and shall take such action necessary to discharge any such claim, demand, lien, levy, security interest or encumbrance at its own cost and expense.

(e)

PCT shall, at Client’s cost and expense, mark the Client Equipment in the manner requested by Client in writing with a label provided by Client or by another manner of identification agreed to by PCT indicating that the Client Equipment is owned by and the property of Client.

(f)

[*] .

2.

PCT Obligations and Restrictions .

(a)

PCT will:

(i)

Operate the Client Equipment in the same manner as PCT operates PCT owned equipment of a similar nature.  PCT will perform and schedule routine maintenance, repair and calibration activities on Client Equipment, as applicable (including at Client’s cost and expense utilizing third party vendors to perform such services) per PCT’s standard operating procedures relating to the routine maintenance, repair and calibration of PCT owned equipment similar to the Client Equipment. As available, the documented costs of such maintenance, repair and calibration services will be at Client’s cost and expense.   [*] .

(ii)

At its cost and expense, secure and insure the Client Equipment in the same manner as PCT provides for PCT owned equipment similar to the Client Equipment [*] .

(iii)

Maintain accurate and complete and records regarding the servicing, maintenance and repair of the Client Equipment that are required by Applicable Laws.  All such records associated with the Client Equipment shall be [*] treated as the Confidential Information of Client.

(iv)

Keep and use the Client Equipment at the MV Facility and shall not move them from the MV Facility without the prior written consent of Client, except to be returned to Client or its designee as may be provided in the Agreement or in section 3 below.

(v)

[*] .

Version 7 Page 17

[ * ] = 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.

 


 

(vi)

U se the Client Equipment in a careful and proper manner and in compliance with Applicable Laws .

(vii)

At Client’s cost and expense, perform installation and validation activities necessary to operate the Client Equipment and any MV Facility improvements associated solely with such Client Equipment installation/validation in accordance with Applicable Laws.  Client will reimburse PCT for such activities as provided in Section 4 of Attachment B.   [*]

(b)

PCT will not:

(i)

Sell, lease, pledge or otherwise encumber the Client Equipment, or otherwise part with possession of the Client Equipment, except as provided in the Agreement or with the express prior written consent of Client.

(ii)

Represent to any person that PCT has any property or other interest in the Client Equipment, or make any entry in its books and records or in any financial statement or tax return that is inconsistent with Client’s retention of all right, title, and interest in and to the Client Equipment.

(iii)

Use the Client Equipment in any manner that could reasonably be expected to impair the applicability of suppliers’ or manufacturers’ warranties or render the Client Equipment unfit for its originally intended use nor will it permit any person other than authorized, trained and competent personnel to operate the Client Equipment.

(iv)

Allow access to and use of the Client Equipment other than to those of its employees, agents and contractors for whom such access and use is required in order for PCT to perform under the Agreement.

3.

Return of Client Equipment on Expiration or Termination .   Upon the expiration or termination of the Agreement, or at Client’s earlier written request [*] during the Close-Out Period, PCT shall return the Client Equipment to Client or its designee at Client’s written request, at Client’s cost and expense pursuant to Client’s written instructions as agreed to by PCT.  In the alternative, at Client’s election, PCT and Client will arrange for the sale of the Freezer as provided in Paragraph 1(D)(viii) of the Agreement.

(a)


Version 7 Page 18

[ * ] = 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 1 To Attachment A

CLIENT EQUIPMENT

EQUIPMENT DESCRIPTION

MANUFACTURER

MODEL NO.

SERIAL NO.

Elutra (CS-19

TerumoBCT

71800

1E00116

Ultrasonic Bath (UB-01

Branson

M1800

BGA061480500

 

 

 

 

 

 

 

 

 

 

Version 7 Page 19

[ * ] = 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.

 


ATTACHMENT B

TERMS AND CONDITIONS

 

Terms not defined herein have the meaning in the Agreement

1.

Services . Client has approved the Services set forth in the Agreement. Timelines and cost figures are good faith estimates made by PCT based upon information provided by Client to PCT and are not guarantees that the Services can be performed within such estimates; however, PCT will use commercially reasonable efforts to perform the Services within the timelines and cost figures set forth in the Agreement. Services, time durations and fees may need to be adjusted pursuant to a document executed by the Parties (a “ Program Amendment Order ”) to reflect unforeseen time requirements, fee changes or services not originally contemplated.

2.

Conduct of Services to be Performed .

a.

PCT will comply (i) with the Federal Food, Drug and Cosmetic Act as amended, the regulations promulgated thereunder and implementing guidances (the “ Act ”) and (ii) in all material respects with all other applicable United States laws, rules and regulations of any state, federal or local government or regulatory agency (“ Regulatory Agency ”) (except that with respect to the manufacture of Product, PCT will comply in all respects with GMP) in each instance, that governs the Services (the “ Applicable Laws ”) and in effect as of the Effective Date. If Applicable Laws change, PCT will, subject to Prospective Illegality, make commercially reasonable efforts to satisfy the new requirements.

b.

Unless otherwise provided in the Agreement, PCT shall perform the Services at one or more of PCT’s facilities located in the United States, as determined by PCT and agreed to by Client (each a “ Facility ”); provided, however, that if the Agreement provides that Services will be performed at a specific Facility, then Services will only be provided at such Facility.  If Client desires Services, including but not limited to manufacturing Services, to be performed at another PCT Facility, provided the MV Facility where Services were to be performed has not been changed so as to preclude the performance of such Services, Client agrees that performance of Services of such Client initiated services at such additional PCT Facility, if provided by PCT, will be for additional fees and at Client’s costs and expenses pursuant to a Program Amendment Order or other writing between the Parties or as an Additional Service as defined below.  Such fees, costs and expenses at such additional Facility may include, without limitation, those associated with (i) technology transfer to the additional Facility, (ii) training of PCT staff, (iii) validation and qualification of equipment, people, space resources, Services related processes, methods and procedures and (iv) other

activities associated with providing the desired services at the additional PCT Facility.

c.

Within thirty (30) days after PCT’s or Client’s request, the Parties will negotiate [*] and execute a document (a “ Quality Agreement ”) setting forth the (i) responsibilities of each Party’s personnel in relation to quality assurance matters and (ii) responsibilities for material compliance with Applicable Laws, including GMP as appropriate. PCT is responsible for such compliance while Product is in the possession of PCT or third party vendors performing Third Party Testing and Client is responsible for compliance at all other times. Failure to execute a Quality Agreement will not be a default nor be the basis of a termination of the Agreement. If there is a discrepancy between the Quality Agreement and Agreement, the Agreement shall control except that with respect solely to quality assurance/quality control, the terms of the Quality Agreement shall control.

d.

Unless otherwise provided in the Agreement, PCT’s designated point of contact (the “ Point of Contact ”) at PCT for Client is George S. Goldberger, Vice President Business Development, or any other individual designated in writing from PCT to Client.

e.

The Points of Contact will coordinate performance of Services with one another. Communications regarding the conduct of Services shall be addressed to or routed through each Party’s Point of Contact.

f.

Client will provide PCT with sufficient amounts of materials with which to perform Services, as well as all documentation and other data as may be available to apprise PCT of the stability of such materials, describe process characteristics, processing, and proper storage and safety requirements.  With respect to any materials that Client may provide to PCT under the Agreement, including but not necessarily limited to reagents, and any Product manufactured hereunder (collectively, “Client Materials” ), the following shall apply: (i) Client shall at all times retain title to Client Materials, (ii) PCT shall retain exclusive control over Client Materials while such Client Materials are at PCT Facilities and shall not transfer any Client Materials to any third party without the prior written consent of Client except as otherwise provided in this Agreement, the Quality Agreement or SOPs and procedures relating to the Manufacturing Process of Product, (iii) [*] and (iv) PCT shall not take any action inconsistent with Client’s ownership interest in Client Materials, including but not limited to, PCT keeping Client Materials free and clear of any claims, liens, encumbrances, or security interests, and promptly removing the same at PCT’s sole cost and expense.

CONFIDENTIAL

Version 7 – Terms and Conditions Page 1

[ * ] = 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.


 

g.

[*]

h.

No breach of the Agreement exists if a Party, despite using commercially reasonable efforts, fails to fulfill its obligation due to the action or inaction by the other Party or any person or entity (other than the failing Party’s employees). PCT may utilize suppliers and subcontractors for testing services provided that PCT qualifies such suppliers and subcontractors and utilizes such suppliers and subcontractors in accordance with PCT’s standard quality requirements and SOPs.  PCT will identify the suppliers and subcontractors of such testing services.  Each such supplier and subcontractor shall meet all of the applicable requirements of the Agreement and Quality Agreement. If requested by Client, PCT will solicit quotations from additional third party testing servicers selected by Client and reasonably acceptable to PCT and if Client requires PCT to use any such additional third party testing servicers, Client shall be responsible for PCT’s documented costs and expenses which PCT may reasonably incur in qualifying such additional third party testing servicers. Client and/or its representative may, at Client’s cost and expense, conduct quality assurance audits of PCT’s suppliers and subcontractors.

i.

Other than as necessary in order for PCT to perform the Services under the Agreement, PCT shall not analyze, characterize, modify or reverse engineer any Client Materials or take any action to determine the structure or composition of any Client Materials.

j.

The generation, collection, storage, handling, transportation, movement and release of hazardous materials and waste generated in connection with the Services will be the responsibility of PCT at [*] s cost and expense, unless a separate charge for specialized waste disposal is identified in this Agreement.   [*]

k.

INTENTIONALLY OMITTED.

l.

PCT shall maintain complete and accurate records relating to the Services in accordance with GMP and PCT’s quality assurance SOPs (the “ Records ”).  PCT shall maintain and retain all Records, which shall include without limitation quality assurance records, batch record documentation, Deviation Reports, Raw Materials data, analytical assays and data, SOPs and other process documents and records related to the Services as required under Applicable Laws including GMP and (A) if not included in the deliverables previously provided to Client pursuant to this Agreement or not provided to Client in connection with any close-out [*] activities as provided in this Agreement, PCT will at, the direction and written request of Client and at Client’s cost and expense (which will include the reasonable time incurred by PCT personnel at its then current and standard hourly rates required to provide and deliver Records) provide such

Records to Client and (B) be retained by PCT for at least [*] years after termination of this Agreement.  Subject to the need to retain Records pursuant to Applicable Laws PCT, at Client’s direction and written instruction and at Client’s cost and expense, will dispose of the Records, provided, further that PCT may retain one (1) copy of such Records as evidence of PCT’s obligations under this Agreement [*] .

3.

Investigation of Deviations and Corrective Action; Defective Product .

a.

If Client in connection with the Manufacturing Process (which includes the manufacture, processing, packaging, labeling, quality control testing, release, shipping and storage) of Product either (i) instructs PCT to take actions/steps resulting from PCT notifying Client of a deviation in such Manufacturing Process and such actions/steps result in PCT preparing reports documenting such deviations and/or taking corrective actions to address such deviations or (ii) requests PCT to take additional steps and/or actions to address any deviation and/or corrective action above those that PCT reasonably determines are necessary to address the same, in each instance, PCT, at its option, may treat the time required to address either of the above as Additional Services (as defined in Section 17((l) below) which will be invoiced to Client as provided in Section 17(l) unless Client and PCT have otherwise agreed to in writing.

b.

Client shall accept or reject Product based [*] Client’s receipt and review of batch records documentation including release testing results, against the agreed upon written specifications (“ Product Specifications ”) for Product.  “Product Specifications” means the list of tests, references to any analytical procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria to which Product at any stage of the Manufacturing Process for such Product should conform to be considered acceptable for its intended use that are provided by or approved by Client and approved by PCT, as such Product Specifications are amended or supplemented from time to time by mutual agreement of the Parties, in writing.  If Product is not rejected as provided below, such Product shall be deemed accepted. Client shall notify PCT in writing of, as applicable, any Product which has not been manufactured, tested, packaged, labeled, quality control tested, released, stored or shipped in compliance with GMP, the Product Specifications and the associated batch records documentation (“ Defective Product ”) within thirty (30) days of the date of Client’s receipt of the [*] associated batch records documentation. If a dispute exists as to whether Product is a Defective Product, either Party may request (by notice in writing to the other Party) an

CONFIDENTIAL

Version 7 – Terms and Conditions Page 2

[ * ] = 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.

 


 

investigation to determine whether a Product is a Defective Product. Either Party, as provided in the Quality Agreement, will bear the upfront costs of the investigation. If a Quality Agreement does not exist, Client is responsible for the upfront costs. Following the investigation’s completion, the Parties will retrospectively share the costs of such investigation equal to the share of responsibility the Parties agree should be assigned to each Party for the Defective Product. [*]

c.

If a Defective Product exists and PCT, at Client’s written request, manufactures additional product to replace the Defective Product, unless expressly agreed to by PCT, the costs of any materials and/or reagents incurred in connection with manufacturing such replacement product shall be an expense reimbursable by Client to PCT. Unless set forth to the contrary in writing by the Parties, the costs for processing such replacement product shall be (i) borne by PCT if responsibility for the Defective Product lies solely with PCT, (ii) borne by Client if responsibility for the Defective Product lies solely with Client and (iii) apportioned between them if both Parties are responsible for the Defective Product in an amount equal to such Party’s share of responsibility for the Defective Product.

4.

Payment for Services, Other Costs .

a.

The amount and timing of payments are set forth in the Agreement and all amounts are payable in United States Dollars.

b.

Client shall pay and PCT will separately invoice Client for all reasonable [*] costs and expenses [*] incurred by PCT in performing the Services, including, but not limited to:

(i)

Costs of reagents, materials and Raw Materials.

(ii)

[*] costs of travel, accommodations and meals incurred in connection with the Services with such costs to be at the business class level.

(iii)

Costs associated with outsourced or outside testing/analytical services, including, but not limited to, sterility testing, mycoplasma testing, karyotype testing, viral/adventitious agent testing, γ-irradiation services and other assays not performed by PCT.

(iv)

Costs associated with any animal testing.

(v)

Packaging and shipping costs (including test samples and product) to or from PCT or Client or to or from any third party, including but not limited to contract laboratories or testing facilities and Client designated clinical and/or storage sites.

(vi)

Costs of providing or receiving in-process or final product quality control test methods beyond those detailed in the Agreement.

c.

Except to the extent expressly provided in this Agreement, in addition to the above, unless the Parties otherwise agree in writing to the contrary, Client shall pay and PCT will separately invoice Client for the following services, costs and expenses which will be provided by PCT either pursuant to a Program Amendment Order or other writing, with such writing to include email or other written, electronic communication or as an Additional Service as provided in Section 17 below:

(i)

Costs associated with providing, developing and/or validating/qualifying test methods, including assay services or assay methods and the costs of process and assay test method validation to a level required for submission to the FDA beyond those detailed in the Agreement.

(ii)

Costs of any equipment purchased, installed, validated and required solely for a Service provided in this Agreement.

(iii)

Costs associated with storage of any product or specific materials past the duration of the Agreement unless otherwise provided in this Agreement.

(iv)

Costs associated with any stability assessment or trial for the product requested by Client beyond those detailed in the Agreement.

(v)

Environmental monitoring or facility cleaning costs beyond those which are currently incurred by PCT and are due to PCT providing the Services under the Agreement.

(vi)

Costs of the preparation and submission of documentation provided to Regulatory Agencies beyond those detailed in the Agreement.

(vii)

Costs of regulatory services beyond those detailed in the Agreement.

(viii)

Costs related to regulatory and quality services and interactions, including, but not limited to, costs of any additional qualification and/or validation activities to address specific requests received from any Regulatory Agency.

(ix)

Extension of services for a clinical trial beyond the estimated durations set forth in the Agreement.

(x)

Costs of the technology transfer of Services or any part thereof to any GMP manufacturing facility/organization as requested by Client.

d.

In connection with the above Section 4(b)(i) and Section 4(b)(v) costs only, a [*] percent ( [*] %) handling fee will be added by PCT to any invoice.   [*]

e.

Except as provided in the Agreement, undisputed payments are due no later than the scheduled date for payment or if no such scheduled date, no later than thirty (30) days after the invoice date, provided, however, notwithstanding the preceding, undisputed invoices for the reimbursement of expenses as set forth in Section 4(b) of this Attachment B are payable upon receipt of such

CONFIDENTIAL

Version 7 – Terms and Conditions Page 3

[ * ] = 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.

 


 

invoice. Client agrees to advise PCT, in writing within ten (10) days of its receipt of an invoice if it has a good faith dispute as to some or all of the charges (the “Disputed Charges”) set forth in such invoice (with such written notice to state, with specificity, Client’s reason for the Disputed Charges).  As to the Disputed Charges only, the Parties agree that until such Disputed Charge is resolved, such invoice is not payable, provided, however, Client agrees that to the extent expressly provided in this Agreement, if payment is required for the commencement of the performance of particular Services and such payment is a Disputed Charge, PCT upon written notice to Client may refuse to perform such services until the resolution of the particular Disputed Charge occurs and payment is made thereon.  Upon resolution of the dispute associated with each Disputed Charge, the payment of the particular Disputed Charge will again be payable if resolution of such Disputed Charge is in favor of PCT’s position.  If the resolution of such Disputed Charge is in favor of Client’s position, such Disputed Charge, will not be payable until such time as PCT issues a new invoice with a new due date reflecting the Disputed Charge’s resolution.  Undisputed amounts and amounts which are no longer in dispute (after either resolution thereof or the issuance of a new invoice with a new due date) which remain unpaid after the due date accrue interest at the rate of the lesser of [*] percent ( [*] %) per annum or the maximum rate allowed by law, from the date such payment is due until paid in full.

f.

If a Quality Agreement does not exist or does not address the disposal of product, Client is responsible for such costs.

g.

Payments and Fees are subject to a cost of living adjustment (“ COLA ”) effective January 1, 2016 and on January 1 of each successive year (each a “ Determination Date ”). For the twelve (12) month period following the applicable Determination Date, payments and fees may be increased by COLA.  PCT will notify Client in writing of any COLA increase and the changes, if any, in the various payments and fees payable by Client to PCT which increases will be based upon the percentage increase in the U.S. Bureau of Labor Statistics Consumer Price Index For All Urban Consumers (CPI-U) in the state in which the majority of the Services have been provided during the twelve (12) month period ending in the month preceding the month in which PCT notifies Client of the applicable COLA adjustment. Such increases will become effective on the Determination Date set forth in such COLA notification and such COLA notification will be binding and enforceable against Client absent manifest error.

5.

Confidential Information .

a.

“Confidential Information ” is information received by one Party (the “ Receiving Party ”) from or on behalf of the other Party (the “ Disclosing Party ”) that is identified as being confidential (and includes the terms and provisions of this Agreement) or which might permit the Receiving Party to obtain a competitive advantage over those who do not have the information. Confidential Information includes without limitation, any and all non-public scientific, technical, financial, regulatory or business information, or data or trade secrets in whatever form (written, oral or visual) that is furnished or made available by or on behalf of the Disclosing Party to the Receiving Party or developed by either Party under the Agreement.  Confidential Information of Client includes without limitation, the ICT Platform, Manufacturing Process, the Master Batch Record (“ MBR ”) for the manufacture of Product, Product Specifications, Client Materials, Raw Materials, Client Background Intellectual Property and New Intellectual Property, and any and all copies and derivations of and improvements on Client Confidential Information.  Each Party solely owns its Confidential Information.   [*] Confidential Information does not include information which (i) is or becomes a part of the public domain through no act or omission of the Receiving Party or anyone to whom the Receiving Party disclosed Confidential Information, (ii) is or was in the Receiving Party’s lawful possession prior to the disclosure by or on behalf of the Disclosing Party as shown by the Receiving Party’s written records, (iii) is disclosed to the Receiving Party by a third party entitled to disclose such Confidential Information or (iv) was independently developed by the Receiving Party without use of or access or reference to the Confidential Information of the Disclosing Party as shown by the Receiving Party’s written records.

b.

Receiving Party may disclose Confidential Information to an affiliate, employee or agent or contractor (including consultants) under similar written obligations not to use or disclose and to keep the Confidential Information confidential. If disclosure is requested by law or regulation or a valid court order or other governmental body having jurisdiction (including the Securities and Exchange Commission), the Receiving Party will make reasonable efforts to notify the Disclosing Party prior to disclosure to permit Disclosing Party to oppose such disclosure or obtain a protective order or confidential treatment thereof, at Disclosing Party’s cost by appropriate legal action.  If Receiving Party becomes obligated to disclose such Confidential Information in any legal or administrative proceeding, then Disclosing Party shall reimburse Receiving Party all of Receiving Party’s reasonable documented costs and expenses related thereto, including the time Receiving Party’s personnel spend in complying with such disclosure obligations.

CONFIDENTIAL

Version 7 – Terms and Conditions Page 4

[ * ] = 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.

 


 

c.

Except as expressly set forth in this Agreement, Receiving Party shall not use or disclose Disclosing Party’s Confidential Information except to perform obligations, exercise rights or as otherwise expressly permitted under the Agreement. [*] Notwithstanding the preceding, nothing shall prohibit the Receiving Party from summarizing the terms of this Agreement, or from filing the Agreement as an exhibit, in documents the Receiving Party is required to file with any Regulatory Agency, including, but not limited to, the Securities and Exchange Commission; provided that such disclosure shall be only to the extent required to comply with Applicable Laws and the Receiving Party provides the Disclosing Party with a copy of the proposed disclosure prior to such filing.   [*]

d.

Upon termination of the Agreement, Receiving Party shall (i) immediately cease using the Confidential Information and (ii) at the written request of Disclosing Party, promptly, at the Disclosing Party’s cost, destroy or return the tangible embodiments of such Confidential Information. Receiving Party may retain a copy of Confidential Information for the purpose of determining its obligations under the Agreement and for legal and regulatory compliance purposes. The confidentiality, non-disclosure and non-use obligations shall continue for a period of [*] years after the termination of the Agreement.

e.

Money damages would not be a sufficient remedy for any breach of the confidentiality obligations set forth herein and, in addition to all other remedies, the Disclosing Party is entitled to seek injunctive or other equitable relief as a remedy for such breach without posting a bond.

6.

Disclosure; Intellectual Property .

a.

PCT shall disclose and provide to Client documentation of all methods, procedures and processes utilized by PCT in connection with the Services provided pursuant to the Agreement.  Other than documentation relating to the Manufacturing Process for a Product, Other ICT Products or the ICT Platform, which is Confidential Information solely owned by Client, all such documentation and disclosure will constitute Confidential Information within the meaning of section 5(a) of these Terms and Conditions.

b.

As applicable, PCT, its parent or affiliates shall retain ownership of all PCT know-how, processes and procedures that existed and that PCT owned or controlled by, as applicable PCT, its parent or affiliates prior to the Effective Date (the “PCT Background Intellectual Property” ).  PCT will not use or implement or incorporate any PCT Background Intellectual Property into either the Product, the Manufacturing Process and/or ICT Platform or ICT Platform activities. Client shall

retain sole ownership of all know-how, processes and procedures that existed and that Client owned or controlled before PCT commenced providing Services to Client under the Agreement, including without limitation the Manufacturing Process for a Product, Other ICT Product and the ICT Platform (the “Client Background Intellectual Property” ).  For purposes hereof, “controlled” means, with respect to a Party’s Background Intellectual Property, the right, not subject to consent and without violating any legal rights of a third party, to grant a license or sublicense.

c.

Client owns and shall own all right, title and interest in and to the Manufacturing Process (which includes the ICT Platform and ICT Platform activities) and any Product, Client Equipment, Client Materials, Raw Materials (which if provided by PCT have been paid for by Client), deliverable, product and/or process change, improvement, development, invention or discovery, including new uses for the Manufacturing Process, ICT Platform, Product or improvements to the Client Background Intellectual Property or the PCT manufacturing know-how, process and procedures, that result from the Services provided by PCT pursuant to the Agreement, and all intellectual property rights (including enforcement rights) and know-how therein, whether or not patentable, made, conceived or reduced to practice by or on behalf of PCT alone or with others resulting from the Services (collectively, “ New Intellectual Property ”).  PCT shall notify Client in writing of any and all New Intellectual Property promptly after its conception, development or reduction to practice. Without additional consideration, PCT hereby assigns and transfers to Client all of its right, title and interest in and to the New Intellectual Property and agrees to take, and to cause its employees, agents, contractors and consultants to take, all further acts reasonably required to evidence such assignment and transfer to Client, at Client’s cost and expense.

d.

Work output will be prepared on PCT’s standard format and, except as provided above, Client will have exclusive title to all Products delivered pursuant to this Agreement including related data, documentation including batch records documentation and testing results, records, specimens and other reports generated pursuant to the Agreement, all of which shall be Confidential Information of Client. PCT and its subcontractors shall keep complete and accurate records pertaining to any New Intellectual Property and shall record, to the extent practical, all data and information relating to the Services in standard laboratory notebooks, which shall be signed, dated, or kept electronically.  Such documentation shall be kept for a period of five (5) years following the year in which any such efforts were made hereunder.  Without limiting the foregoing, all of the data, results, studies, analyses, evaluations and reports generated by or on behalf of PCT

CONFIDENTIAL

Version 7 – Terms and Conditions Page 5

[ * ] = 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 the Agreement shall be in a form suitable for filing with Regulatory Agencies as part of or in support of (directly or indirectly) any regulatory filings or submissions.

7.

Relationship of Parties . The Agreement does not create an employer-employee relationship between Client and PCT. Neither Party shall hold itself out as an agent or representative of the other. PCT shall perform the Services as an independent contractor of Client and has complete and exclusive control over its Facilities, equipment, employees and agents. Nothing in the Agreement shall constitute PCT, or anyone furnished or used by PCT in the performance of the Services, as an employee, joint venturer, partner, or servant of Client.

8.

Representations, Warranties and Covenants .

a.

General Representations, Warranties and Covenants. Each Party has the necessary right and authority to enter into the Agreement. Neither Party makes any representation, warranty or covenant except as specified in the Agreement or Quality Agreement.

b.

Representations, Warranties and Covenants of PCT. PCT hereby represents, warrants and covenants (and with respect to subsection (iv) certifies) to Client that:

(i)

PCT’s employees and agents have expertise in the relevant subject matter and will perform the Services with due care.

(ii)

PCT and its Facilities shall operate, manufacture and deliver Product in compliance with Applicable Laws.

(iii)

[*]

(iv)

[*]

(v)

[*]

(vi)

[*]

(vii)

[*]

(viii)

[*]

c.

Representations, Warranties and Covenants of Client. Client hereby represents, warrants and covenants to PCT that:

(i)

Client has and will maintain during the term hereof, all necessary permits, licenses approvals, registrations, certifications and authorizations with respect to the use, distribution and/or transfer or sale of Product which is the subject of the Agreement.

(ii)

Client is under no restriction or limitation that would interfere with or hinder, impair or prevent (1) PCT’s performance of the Services or (2) Client’s performance of its obligations under this Agreement.

(iii)

Client (a) shall not knowingly infringe upon any U.S. or foreign copyright, patent, trademark, trade secret or other proprietary or intellectual property right, or misappropriate any trade secret of any third party in any manner that would cause any liability, loss or damage

to PCT (it being understood and agreed that if PCT complies with the requirements of the Agreement and the Quality Agreement in performing the Services, it shall not be an act of infringement for PCT to manufacture Product and the use of Product that is manufactured by PCT hereunder shall not be an act of infringement); and (b) has neither assigned nor entered into any agreement assigning or transferring any right, title or interest to any technology or Intellectual Property that would conflict with its obligations under the Agreement.

(iv)

Client has the unlimited and unrestricted right to deliver to PCT all documentation, including SOPs, development/ qualification/audit reports, MBR and Part Number Specifications or has obtained the necessary permission to make such transfer and/or delivery to PCT.

(v)

All products, materials and reagents required for the Services can be sourced possessing the specifications for such items which will enable PCT to perform the Services.

d.

PCT DOES NOT WARRANT THAT PRODUCT RESULTING FROM THE AGREEMENT IS SAFE OR EFFICACIOUS OR SUCCESSFUL. PCT EXPRESSLY MAKES NO WARRANTY OR GUARANTY WHATSOEVER THAT ANY FDA SUBMISSION PREPARED AS A RESULT OF PERFORMING SERVICES WILL SATISFY THE REQUIREMENTS OF ANY REGULATORY AGENCY AT THE TIME OF SUBMISSION.

e.

EXCEPT AS EXPRESSLY PROVIDED FOR IN THIS SECTION 8, THE PARTIES SPECIFICALLY DISCLAIM ALL EXPRESS OR IMPLIED REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE SERVICES, PRODUCT, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR ANY IMPLIED WARRANTY ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE.

9.

Duration, Default and Termination .

a.

Duration . The Agreement and the performance by Services by PCT hereunder shall terminate on the earlier to occur of (i) December 31, 20018 (unless extended in writing by the Parties), (ii) the expiration of the Close-Out Period and (iii) termination of the Agreement pursuant to this Section 9 of Attachment B. The obligations in Sections 2(f), 2(i), 2(j)), 2(l), 5, 6, 8, 9, 10, 12, 13, 14, 16 and 17 of this Attachment B shall survive expiration or termination of the Agreement.

CONFIDENTIAL

Version 7 – Terms and Conditions Page 6

[ * ] = 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.

 


 

b.

PCT’s default . If PCT defaults with respect to material obligations under the Agreement, Client will promptly notify PCT’s Point of Contact by certified mail, return receipt requested or by overnight courier (“ Written Notice ”) of such material default. PCT has thirty (30) days from receipt of such Written Notice within which to cure such default. If PCT fails to cure such default as identified in the Written Notice, then the Agreement and Quality Agreement may, at Client's option, terminate upon delivery to PCT of a Written Notice terminating the Agreement and applicable Quality Agreement. Upon receipt of such Written Notice of termination, PCT shall terminate the Services.

c.

Client’s default . If Client defaults with respect to material obligations under the Agreement, PCT will promptly provide Client’s Point of Contact with Written Notice of such material default. Client has thirty (30) days from receipt of such Written Notice within which to cure such default. If Client fails to cure such default as identified in the Written Notice, then, at PCT’s option, the Agreement, Quality Agreement and all other agreement(s) then in existence between the parties may be terminated upon delivery to Client of a Written Notice terminating the same and/or PCT may immediately cease performing Services under the Agreement.

d.

INTENTIONALLY OMITTED .

e.

Payments Upon Termination . No later than the date of termination of the Agreement, after application of any Expense Prepayment, Client will pay PCT (i) all amounts to be paid through the date of termination plus [*] reimbursable costs and expenses incurred by PCT prior to the date of termination for which Client is liable to reimburse PCT, (ii) fees for Close-Out activities, if any, if not previously paid [*] , and (iii) reasonable [*] costs and expenses which PCT is irrevocably obligated to pay after the termination of the Agreement (provided such irrevocable obligations were incurred prior to PCT’s receipt of Written Notice of termination and provided PCT uses commercially reasonable efforts to reduce such irrevocable obligations).

f.

No default caused by Force Majeure (as defined in Section 15 below) shall constitute a default under this Agreement.

g.

The Agreement may be automatically and immediately terminated by either Party, upon providing Written Notice to the other Party that such termination is the result of the other Party having a liquidator, receiver, manager, or administrator appointed in bankruptcy.

h.

UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE ENTITLED TO OR LIABLE TO THE OTHER PARTY FOR, PUNITIVE, EXEMPLARY, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR

SPECIAL DAMAGES ARISING IN CONNECTION WITH THE DEFAULT OF ANY OBLIGATION UNDER THE AGREEMENT, EVEN IF A PARTY KNEW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.

i.

Other than as expressly provided for in the Agreement, termination shall not be an exclusive remedy and a Party’s rights and remedies described in the Agreement are not exclusive and are in addition to those rights and remedies available to it at law or in equity.

10.

Indemnification and Limitation of Liability .

a.

PCT shall defend and indemnify Client and Client’s agents, trustees, directors, officers and employees (“ Client’s Agents ”) from all third party claims of any nature, including reasonable attorney’s fees and disbursements (collectively, “ Claims ”) to the extent arising out of or in connection with any negligence or willful act or omission by PCT or PCT’s directors, officers, members and/or employees (“ PCT’s Agents ”) related to the performance of the Services, except to the extent any Claim was incurred or occasioned by the negligent or willful acts or omissions of Client and/or Client’s Agents.

b.

PCT shall not indemnify Client or Client’s Agents for any bodily injury (including death) caused by any Product resulting from the Services or Defective Product unless such bodily injury was caused by PCT’s or a PCT Agent’s negligence or willful and intentional act or omission.

c.

Except to the extent, in the case of each of the following, of any Claim that arose in connection with any negligence or willful and intentional acts or omissions of PCT and/or PCT’s Agents, Client shall defend and indemnify PCT and PCT’s Agents from all third party Claims to the extent arising out of or resulting from: (i) the Services and any Products and Defective Product resulting therefrom; (ii) personal injury to a participant in any clinical trial using any product, including Product or Defective Product, (iii) PCT’s use of Client Background Intellectual Property or New Intellectual Property and/or the Client’s Manufacturing Process in connection with the Services violating or infringing on the patents, trademarks, trade names, service marks or copyrights of any third party and (iv) the harmful or otherwise unsafe or unknown effect of any product, including Product, materials, reagents and/or product required for or derived from the Services performed and/or provided by or on behalf of Client to be used in connection with the Services, including any apheresis and blood collections as well as cellular blood products (collectively, “ Raw Materials ”) or the Product or Defective Product to any person, including without limitation, a third party Claim based upon Client’s or any other person’s or entity’s use, consumption, contact, sale,

CONFIDENTIAL

Version 7 – Terms and Conditions Page 7

[ * ] = 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.

 


 

distribution or marketing of any Raw Material, Defective Product or Product.

d.

Upon receipt of notice of any Claim, the Party seeking indemnification (the “ Indemnified Party ”) shall give written notice thereof to the other Party (the “ Indemnifying Party ”). The Indemnifying Party, at its expense shall promptly assume the complete defense and settlement of such Claim, provided that; (i) the Indemnified Party has the right to participate in the defense of such Claim at its own cost; and (ii) the Indemnifying Party, prior to making any settlement, notifies the Indemnified Party, in writing, of such settlement offer and subsequently consults with the Indemnified Party as to the terms of such settlement. The Indemnifying Party will not, except with the prior written consent of the Indemnified Party, consent to the entry of any judgment or enter into any settlement which does not include, as an unconditional term thereof, the giving by the claimant or plaintiff to the Indemnified Party of a release from all liability in respect thereof. The Indemnified Party will fully cooperate, at the Indemnifying Party’s cost and expense, with Indemnifying Party’s defense and possible settlement of such Claim and Indemnified Party will not, except with the prior written consent of the Indemnifying Party, consent to the entry of any judgment, agree to the disposition of or enter into any settlement with respect to such Claim.

e.

The indemnification obligations shall survive for a period of [*] years following the expiration or termination of the Agreement.

f.

PCT’s liability shall not, under any circumstances, exceed the coverage amounts of the insurance that PCT is required to maintain pursuant to Section 14 below as of the Effective Date (regardless of whether PCT, in fact, maintains such insurance, or maintains such insurance in the amounts specified in Section 14, and whether or not a particular liability is covered by such insurance).

g.

AS TO A CLAIM, NEITHER PARTY IS ENTITLED TO PUNITIVE, EXEMPLARY, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES.

11.

Prospective Events .

a.

“Prospective Cost Increase ” means either the (i) occurrence of an event outside the control of PCT, including, any Force Majeure event after the Effective Date and which PCT did not contemplate before the Effective Date or (ii) enactment or modification of a foreign, state or federal statute or regulation thereof, including Applicable Laws after the Effective Date and which PCT did not contemplate before the Effective Date, in either the case of (i) or (ii) above, (y) has an impact on

manufacture of Product and (z) as to which compliance by PCT with the terms and provisions of the Agreement would impose an unanticipated financial expense upon PCT. “ Prospective Illegality means any foreign, state or federal statute or regulation now existing or enacted or promulgated or re-interpreted after the Effective Date, including Applicable Laws, that is enacted, interpreted by judicial decision, a Regulatory Agency or legal counsel in such manner as to result in the conclusion that any service required of PCT or Client under the Agreement is in violation of such law, rule, guidance or directive.

b.

If a Prospective Illegality or Prospective Cost Increase occurs, Client and PCT shall promptly negotiate in good faith a Program Amendment Order as necessary to address such occurrence.  To the maximum extent possible, any such Program Amendment Order shall preserve the primary benefits sought to be achieved by this Agreement and the underlying economic and financial arrangements between the Parties [*] .  To the extent that a Prospective Cost Increase has occurred, subject to the immediately preceding sentence, pending agreement thereof reflecting the Prospective Cost Increase, PCT on [*] months written notice to the Client, may cease to perform a Service which is the subject of a Prospective Cost Increase [*] . If an agreement cannot be reached, then, unless an earlier date is agreed to by the Parties, the Agreement will automatically terminate on the last day of the month which first occurs after thirty (30) days written notice terminating the Agreement as a result of the existence of the Prospective Illegality.

12.

Regulatory Assistance. PCT and Client shall permit Regulatory Agencies to conduct audits and inspections of the Facility(ies) where Services are performed as may reasonably be requested during normal business hours and PCT shall cooperate, at Client’s cost [*] , with such Regulatory Agencies. Each Party shall give the other as much prior written notice as reasonably possible of such audits or inspections and keep the other Party informed about the results and conclusions of each regulatory inspection. If prior notice (or other communication to Client) advising Client of an inspection/audit is not reasonably possible, PCT shall, within two (2) Business Days of the commencement of said inspection/audit, inform Client of a regulatory inspection that affects Product or Services under this Agreement.   [*] In the event that an inspection/audit by a Regulatory Agency of a Facility where Services are being performed [*] relate to the Product or Services provided to Client in this Agreement, [*] then Client agrees that PCT may charge Client the standard hourly rates for the PCT staff involved (in accordance with the table of hourly rates set forth in Section 17(l) below, as such rates may be adjusted from time to time) with such audit/inspection.   [*]

CONFIDENTIAL

Version 7 – Terms and Conditions Page 8

[ * ] = 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.

Facility Obligations; On-Site Consultations .

a.

[*] once during each twelve (12) month period, Client and/or its representatives may conduct a GMP compliance audit (a “ GMP Audit ”) at each Facility where Services are performed at a time agreed to by the Parties.  During a GMP Audit, Client and/or its representatives may observe, inspect, and audit the manner in which PCT conducts the Manufacturing Process; and (ii) inspect PCT’s Facility, procedures (including SOPs) and records (including Records) relating to the Services, including PCT’s quality and other controls related to the Manufacturing Process.  Client’s costs associated with attending and conducting each GMP Audit shall be at Client’s cost.  Client may schedule a GMP Audit upon providing PCT with a minimum of thirty (30) days prior written notice of the requested GMP Audit. [*] Additional Audits in excess of one (1) GMP Audit per twelve (12) month period (an “ Additional Audit ”) may be requested at any Facility where Services are provided if PCT receives a minimum of thirty (30) days prior written notice of the Additional Audit and Client pays PCT a Ten Thousand Dollar ($10,000) fee [*] .

b.

[*] PCT, upon no less than [*] Business Days’ written notice from Client to PCT’s Point of Contact, will permit Client during Business Hours, to observe and/or consult with PCT at the Facility including during the Manufacturing of any Product (“ On-Site Consultations ”) with PCT, regarding the performance of Services under this Agreement.  In the event that PCT reasonably determines that as a result of repeated On-Site Consultations within a particular period of time that PCT personnel and/or resources need to be compensated for PCT to continue to provide On-Site Consultations, such determination will be communicated to Client, the Parties shall mutually agree in writing on when PCT shall be compensated for any additional On-Site Consultations and until such agreement no additional On-Site Consultations will be provided by PCT.  PCT will not charge Client more than its hourly rates for the conduct for such additional On-Site Consultations as provided in the table below in Section 17(l), as such rates may be adjusted from time to time.

14.

Insurance .

a.

During the Agreement and for [*] years after the expiration or termination of the Agreement, each Party shall, at all times maintain, at its own expense fully paid insurance coverage, in the amounts set forth below, for:

(i)

Comprehensive General Liability (including coverage for bodily injury and property damage) with limits no less than Five Million Dollars ($5,000,000) per occurrence/ Six Million Dollars ($6,000,000) in the aggregate; and

(ii)

Workers Compensation with limits no less than the minimum statutory amounts under Applicable Laws.

b.

PCT shall maintain Professional Liability and Product insurance coverage with limits no less than Five Million Dollars ($5,000,000) per occurrence/ Five Million Dollars ($5,000,000) in the aggregate.

c.

Immediately prior to the initiation of any human clinical trials using product, including product resulting from the Agreement, and for a period of ten (10) years following the termination of the Agreement, Client shall maintain, at its own expense, product and Professional Liability insurance coverage each with limits no less than Five Million Dollars ($5,000,000) per occurrence/ Five Million Dollars ($5,000,000) in the aggregate.

d.

As requested, each Party shall furnish the other a certificate of insurance evidencing the required insurance set forth above, which certificate shall provide that should the policies be cancelled or materially changed before the expiration date thereof, notice of such cancellation or material change will be delivered to each Party.

15.

Force Majeure . Either Party shall be excused from performing its obligations under the Agreement if performance or performance by a person or entity under the control of such Party is delayed or prevented by Force Majeure, provided that such performance shall be excused only to the extent of and during such disability. “ Force Majeure ” means any cause beyond the reasonable control of the Party (or the person or entity under the control of such Party) in question, including, without limitation, governmental actions, wars, riots, terrorism, criminal acts of third parties, civil commotions, fires, floods, earthquakes, epidemics, pandemics, labor disputes (excluding labor disputes involving the work force or any part thereof of the Party in question), embargoes, trade restrictions, restraints or delays affecting shipping or carriers, acts of God or nature, shortages in supplies as a result of vendor/supplier delays in shipping supplies (provided such shortages are not the result of such Party’s non-payment for such supplies and is otherwise beyond the reasonable control of such Party) and prolonged losses of one or more utilities to the applicable Facility(ies). If any part of the Services is invalid as a result of such disability, PCT will, upon written request from Client, but at Client's expense, repeat that part of the Services affected by the disability. If the Party suffering a Force Majeure is unable to perform for a period in excess of [*] days, then the Parties agree to negotiate in good faith a mutually satisfactory approach to resolve the delay resulting from the Force Majeure. If no agreement is reached, then either Party may terminate the Agreement upon providing the other Party with no less than [*] days written notice of termination of the Agreement as a result of the continuing Force Majeure event [*] .

CONFIDENTIAL

Version 7 – Terms and Conditions Page 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.

 


 

16.

Governing Law: Jurisdiction; Service of Process . This Agreement is governed by the laws of New York, without reference to choice of law principles. Any legal action may be brought in any State or Federal court located in the County and State of New York. Each Party submits to the jurisdiction of the aforesaid courts. Each Party irrevocably consents to service of process in any such action by the mailing of copies thereof by registered or certified mail, postage prepaid, to the Party at its address set forth in the Agreement.  Each Party irrevocably waives (a) any objection it may now or hereafter have to the laying of venue of any action and (b) any claim that New York is not a convenient forum for such action.

17.

Miscellaneous .

a.

Conflicting Terms . To the extent the terms or provisions of the Agreement conflict with the terms and provisions of Attachment B, the terms and provisions of the Agreement control.

b.

Return of Materials . Except as otherwise provided for in the Agreement, materials, equipment or supplies for which Client has reimbursed PCT and/or provided to PCT by Client will be delivered to Client upon termination or expiration of the Agreement at Client’s cost and expense if requested by Client in writing.

c.

Notices . Except for Written Notices, notices shall be in writing and be sent (i) by registered or certified mail, postage prepaid with a return receipt requested, or (ii) by an overnight express delivery service, addressed to the other Party at the address provided in the Agreement or at such other address for which such Party gives notice herein. Notice shall be effective upon the date received.

d.

Assignment . [*] The Agreement shall be binding upon the successors and assigns of the Parties.

e.

Expenses . Each party agrees to pay or reimburse the other party for all reasonable [*] costs and expenses incurred in connection with the enforcement, attempted enforcement, or preservation of any rights or remedies under this Agreement, including all costs and expenses of such Party’s counsel.

f.

Publicity . The Parties shall treat the existence and terms of this Agreement as confidential and shall not disclose such information to third parties without the prior written consent of the other Party or except as provided in Section 5 of the Terms and Conditions or this Section.  The Parties agree they may in press releases, marketing materials or other internal or external written communication disclose the fact (using logo and/or name) that PCT and Client have entered into an agreement for services and/or that PCT provides services to the Client.  Except as permitted in the preceding sentences or otherwise required by applicable law or applicable stock

exchange requirements, and in accordance with Section 5, neither Party shall issue or cause the publication of any other press release or public announcement with respect to the subject matter of this Agreement without the express prior approval of the other Party.

g.

Non-Disparagement . Neither Party will, at any time, disparage the business reputation of the other Party or its affiliates or any of the other Party’s (or affiliates) employees, officers, directors, agents and/or clients.

h.

Non-Solicitation . As long as the Agreement remains in effect and for a period of one (1) year after the expiration or termination of this Agreement, neither Party will, directly or indirectly, alone (including through any affiliate, officer, employee, director or agent) or in concert with others, solicit or encourage any employee or consultant of the other Party or the other Party’s affiliates to leave his or her employment or terminate his or her consultancy with such Party. [*]

i.

Entire Agreement . Except as otherwise provided for in the Agreement, this Agreement constitutes the entire agreement between the Parties with respect to the subject matter thereof and supersedes all prior or contemporaneous negotiations, promises or agreements (including, but not limited to any proposal submitted by PCT to Client relating to Services to be provided by PCT) of every nature with respect thereto, all of which have become merged and integrated into or be deemed to be merged into the Agreement. No modification to the Agreement shall be effective unless it is in writing signed by each Party.

j.

Waiver and Construction . No waiver of any provision of the Agreement, in any one or more instances, shall be deemed to be or be construed as a further or continuing waiver of any such provision. No waiver shall be effective unless made in writing and signed by the waiving Party. If any provision of the Agreement is declared void or unenforceable, such provision will be severed and the balance of the Agreement will remain in full force and effect.

k.

Signatures and Counterparts . The Agreement may be executed by an original, facsimile or electronic signature from a duly authorized person of the respective Parties, and be in two or more counterparts, with such counterparts constituting one instrument.

l.

Additional Fees : If Client requests PCT to perform Services of any kind which are not expressly covered by the Agreement or which PCT reasonably determines are beyond the scope of the Services of the Agreement (collectively, “ Additional Services ”), such Additional Services will be provided pursuant to Program Amendment Order to the Agreement executed by the Parties or other writing. If Additional Services are requested and the Parties either elect not to execute or fail

CONFIDENTIAL

Version 7 – Terms and Conditions Page 10

[ * ] = 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.

 


 

to execute a Program Amendment Order or other writing reflecting the Additional Services and payment thereof, Client agrees that, in addition to reimbursing PCT for amounts provided in Section 4 of Attachment B, Client will pay the actual time incurred by PCT in providing such Additional Services which will be based upon PCT’s hourly rates set forth in the table below which hourly rates will be dependent on the PCT staff providing the applicable Additional Services. PCT will in good faith determine the appropriate PCT staff to provide such Additional Services. Upon written notice to Client, PCT may notify Client of changes in the below hourly rates, which revisions to the hourly rates will be effective immediately upon Client’s receipt of such written notification and will apply to the requested Additional Services rendered after the effective date thereof. Hourly charges are applied to the total time devoted to the performance of such Additional Services, including any related travel.

PCT Staff

Rates

Executive Management

[*]

All Other PCT Staff

[*]

In addition, if in connection with the performance of Additional Services, PCT requires the use (“ Asset Use ”) of a Facility, equipment or other tangible PCT assets in order to perform such Additional Services, Client will pay PCT, on an invoice basis, such Asset Use on an as used basis, at PCT’s then current rates offered by PCT to other clients when services to them requires an Asset Use. PCT will invoice Client for Additional Services and Asset Use (plus all reasonable, documented out of pocket and pass through costs and expenses) incurred by PCT.

m.

No Implied Licenses .  Except as expressly set forth in the Agreement, nothing in the Agreement shall be deemed to grant to either Party any right or license, express or implied, under any patents, patent applications, know-how, technology, inventions or other intellectual property of the other Party.

n.

WAIVER OF JURY TRIAL . PCT AND CLIENT WAIVE ANY RIGHTS THEY MAY HAVE TO A TRIAL BY JURY OF ANY DISPUTE ARISING UNDER OR RELATING TO THE AGREEMENT. PCT AND CLIENT AGREE THAT ANY SUCH DISPUTE SHALL BE TRIED BEFORE A JUDGE SITTING WITHOUT A JURY.

CONFIDENTIAL

Version 7 – Terms and Conditions Page 11

[ * ] = 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: August 7, 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: August 7, 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 June 30, 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:  August 7, 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 June 30, 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: August 7, 2015

By:

/s/ David Fractor  

 

 

Name:

David Fractor

 

 

Title:

Principal Financial and Accounting Officer