CELL THERAPEUTICS INC (Form: 10-Q, Received: 04/29/2014 17:08:46)

Large accelerated filer

Accelerated filer

Non-accelerated filer

¨ (Do not check if a smaller reporting company)

Smaller reporting company

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended: March 31, 2014

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

For the transition period from to

Commission File Number 001-12465

CELL THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


Washington		91-1533912
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

3101 Western Avenue, Suite 600 Seattle, Washington		98121
(Address of principal executive offices)		(Zip Code)

(206) 282-7100

(Registrant’s telephone number, including area code)

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or 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. (Check one):

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

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:


Class		Outstanding at April 23, 2014
Common Stock, no par value		149,830,127

CELL THERAPEUTICS, INC.

TABLE OF CONTENTS


	PAGE
PART I - FINANCIAL INFORMATION

ITEM 1: Financial Statements

Condensed Consolidated Balance Sheets at March 31, 2014 (unaudited) and December 31, 2013		3

Condensed Consolidated Statements of Operations – Three Months Ended March 31, 2014 and 2013 (unaudited)		4

Condensed Consolidated Statements of Comprehensive Loss – Three Months Ended March 31, 2014 and 2013 (unaudited)		5

Condensed Consolidated Statements of Cash Flows – Three Months Ended March 31, 2014 and 2013 (unaudited)		6

Notes to Condensed Consolidated Financial Statements		7

ITEM 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations		14

ITEM 3: Quantitative and Qualitative Disclosures about Market Risk		25

ITEM 4: Controls and Procedures		25

PART II - OTHER INFORMATION

ITEM 1: Legal Proceedings		27

ITEM 1A: Risk Factors		28

ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds		46

ITEM 3: Defaults Upon Senior Securities		46

ITEM 4: Mine Safety Disclosures		46

ITEM 5: Other Information		46

ITEM 6: Exhibits		47

Signatures		52

CELL THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts)


	March 31, 2014			December 31, 2013
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	50,601		$	71,639
Accounts receivable		503			235
Inventory		5,023			5,074
Prepaid expenses and other current assets		3,798			3,567

Total current assets		59,925			80,515
Property and equipment, net		5,148			5,478
Other assets		8,213			7,730

Total assets	$	73,286		$	93,723

LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	4,604		$	5,051
Accrued expenses		9,543			9,469
Warrant liability		—			991
Current portion of deferred revenue		1,043			1,010
Current portion of long-term debt		2,527			3,155
Other current liabilities		393			393

Total current liabilities		18,110			20,069
Deferred revenue, less current portion		1,450			1,626
Long-term debt, less current portion		10,861			10,152
Other liabilities		6,179			5,657

Total liabilities		36,600			37,504
Commitments and contingencies
Common stock purchase warrants		13,461			13,461
Shareholders’ equity:
Common stock, no par value:
Authorized shares – 215,000,000
Issued and outstanding shares – 149,838,981 and 145,508,767 at March 31, 2014 and December 31, 2013, respectively		1,942,989			1,933,305
Accumulated other comprehensive loss		(8,450	)		(8,429	)
Accumulated deficit		(1,908,705	)		(1,879,703	)

Total CTI shareholders’ equity		25,834			45,173
Noncontrolling interest		(2,609	)		(2,415	)

Total shareholders’ equity		23,225			42,758

Total liabilities and shareholders’ equity	$	73,286		$	93,723

See accompanying notes.

CELL THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(unaudited)


	Three Months Ended
	March 31,
	2014			2013
Revenues:
Product sales, net	$	1,268		$	1,126
License and contract revenue		143			—

Total revenues		1,411			1,126


Operating costs and expenses:
Cost of product sold		145			55
Research and development		12,179			8,355
Selling, general and administrative		16,750			11,143
Settlement expense		—			95

Total operating costs and expenses		29,074			19,648

Loss from operations		(27,663	)		(18,522	)
Other income (expense):
Interest expense		(464	)		(48	)
Amortization of debt discount and issuance costs		(178	)		(23	)
Foreign exchange loss		(5	)		(751	)
Other expense		(886	)		(272	)

Total other expense		(1,533	)		(1,094	)


Net loss before noncontrolling interest		(29,196	)		(19,616	)
Noncontrolling interest		194			232

Net loss	$	(29,002	)	$	(19,384	)

Basic and diluted net loss per common share	$	(0.20	)	$	(0.18	)


Shares used in calculation of basic and diluted net loss per common share		142,138			106,697

See accompanying notes.

CELL THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)

(unaudited)


	Three Months Ended
	March 31,
	2014			2013

Net loss before noncontrolling interest	$	(29,196	)	$	(19,616	)


Other comprehensive income (loss):
Foreign currency translation adjustments		(29	)		339
Net unrealized gain on securities available-for-sale		8			34

Other comprehensive income (loss)		(21	)		373


Comprehensive loss		(29,217	)		(19,243	)
Comprehensive loss attributable to noncontrolling interest		194			232

Comprehensive loss attributable to CTI	$	(29,023	)	$	(19,011	)

See accompanying notes.

CELL THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(unaudited)


	Three Months Ended March 31,
	2014			2013

Operating activities
Net loss	$	(29,196	)	$	(19,616	)
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation expense		7,829			2,428
Depreciation and amortization		360			411
Noncash interest expense		178			23
Change in value of warrant liability		886			25
Other		499			251
Changes in operating assets and liabilities:
Accounts receivable		(267	)		(791	)
Inventory		50			(750	)
Prepaid expenses and other current assets		(139	)		3,905
Other assets		(504	)		(388	)
Accounts payable		(410	)		(367	)
Accrued expenses		67			(481	)
Deferred revenue		(143	)		—
Other liabilities		1			2

Total adjustments		8,407			4,268

Net cash used in operating activities		(20,789	)		(15,348	)


Investing activities
Purchases of property and equipment		(35	)		(1,018	)
Proceeds from sales of property and equipment		—			46

Net cash used in investing activities		(35	)		(972	)


Financing activities
Issuance of long-term debt, net		(73	)		9,764
Other		(133	)		(126	)

Net cash provided by (used in) financing activities		(206	)		9,638

Effect of exchange rate changes on cash and cash equivalents		(8	)		560

Net decrease in cash and cash equivalents		(21,038	)		(6,122	)
Cash and cash equivalents at beginning of period		71,639			50,436

Cash and cash equivalents at end of period	$	50,601		$	44,314


Supplemental disclosure of cash flow information
Cash paid during the period for interest	$	439		$	5

Cash paid for taxes	$	—		$	—


Supplemental disclosure of noncash financing and investing activities
Issuance of common stock upon exercise of common stock purchase warrants	$	1,877		$	—

See accompanying notes.

CELL THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

1.	Description of Business and Summary of Significant Accounting Policies

Cell Therapeutics, Inc., also referred to in this Quarterly Report on Form 10-Q as CTI, the Company, we, us or our, is a biopharmaceutical company focused on the acquisition, development and commercialization of less toxic and more effective ways to treat cancer. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with partners. We are currently concentrating our efforts on treatments that target blood-related cancers where there is a high unmet medical need. We are primarily focused on commercializing PIXUVRI® (pixantrone) in the European Union, or the E.U., for adult patients with multiply relapsed or refractory aggressive non-Hodgkin lymphoma, or NHL, and conducting a Phase 3 clinical program of pacritinib for the treatment of myelofibrosis that will support regulatory submission for approval in the United States, or the U.S., and Europe.

We operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products require approval from, and are subject to, ongoing oversight by the Food and Drug Administration, or FDA, in the U.S., by the European Medicines Agency, or EMA, in the E.U. and by comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain and may take many years and may involve expenditure of substantial resources.

Basis of Presentation

The accompanying unaudited financial information of CTI as of March 31, 2014 and for the three months ended March 31, 2014 and 2013 has been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three months ended March 31, 2014 are not necessarily indicative of the results that may be expected for the entire year or for any other subsequent interim period.

Certain information and footnote disclosure normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the rules of the U.S. Securities and Exchange Commission, or the SEC. These unaudited financial statements and related notes should be read in conjunction with our audited annual financial statements for the year ended December 31, 2013 included in our Annual Report on Form 10-K filed with the SEC on March 4, 2014, or the 2013 Form 10-K.

The condensed consolidated balance sheet at December 31, 2013 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles in the U.S. for complete financial statements.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of CTI and its wholly-owned subsidiaries, which include Systems Medicine LLC, or SM, and CTI Life Sciences Limited, or CTILS. CTILS opened a branch in Italy in December 2009. We also retain ownership of our branch, Cell Therapeutics Inc. – Sede Secondaria, or CTI (Europe), however, we ceased operations related to this branch in September 2009. In addition, CTI Commercial LLC, a wholly-owned subsidiary, was included in the consolidated financial statements until dissolution in March 2012.

As of March 31, 2014, we also had a 61% interest in our majority-owned subsidiary, Aequus Biopharma, Inc., or Aequus. The remaining interest in Aequus not held by CTI is reported as noncontrolling interest in the consolidated financial statements.

All intercompany transactions and balances are eliminated in consolidation.

Accounts Receivable

Our accounts receivable balance includes trade receivables related to PIXUVRI sales. We estimate an allowance for doubtful accounts based upon the age of outstanding receivables and our historical experience of collections, which includes adjustments for risk of loss for specific customer accounts. We periodically review the estimation process and make changes to our assumptions as necessary. When it is deemed probable that a customer account is uncollectible, the account balance is written off against the existing allowance. We also consider the customers’ country of origin to determine if an allowance is required based on the uncertainty associated with the recent European financial crisis. As of March 31, 2014 and December 31, 2013, our accounts receivable did not include any balance from a customer in a country that has exhibited financial stress that would have had a material impact on our financial results. We did not record an allowance for doubtful accounts as of March 31, 2014 and December 31, 2013.

Value Added Tax Receivable

Our European operations are subject to a value added tax, or VAT, which is usually applied to all goods and services purchased and sold throughout Europe. The VAT receivable is approximately $5.8 million and $5.7 million as of March 31, 2014 and December 31, 2013, of which $5.6 million and $5.6 million is included in other assets and $0.2 million and $0.1 million is included in prepaid expenses and other current assets as of March 31, 2014 and December 31, 2013, respectively. The collection period of VAT receivable for our European operations ranges from approximately three months to five years. For our Italian VAT receivable, the collection period is approximately three to five years. As of March 31, 2014, the VAT receivable related to operations in Italy is approximately $5.6 million. We review our VAT receivable balance for impairment whenever events or changes in circumstances indicate the carrying amount might not be recoverable.

Inventory

We carry inventory at the lower of cost or market. The cost of finished goods and work in process is determined using the standard-cost method, which approximates actual cost based on a first-in, first-out method. Inventory includes the cost of materials, third-party contract manufacturing and overhead costs, quality control costs and shipping costs from the manufacturers to the final distribution warehouse associated with the production and distribution of PIXUVRI. Production costs for our other product candidates continue to be charged to research and development expense as incurred prior to regulatory approval or until our estimate for regulatory approval becomes probable. We regularly review our inventories for impairment and reserves are established when necessary. Estimates of excess inventory consider our projected sales of the product and the remaining shelf lives of product. In the event we identify excess, obsolete or unsaleable inventory, the value is written down to the net realizable value.

Revenue Recognition

We currently have conditional approval to market PIXUVRI in the E.U. Revenue is recognized when there is persuasive evidence of the existence of an agreement, delivery has occurred, prices are fixed or determinable, and collectability is assured. Where the revenue recognition criteria are not met, we defer the recognition of revenue by recording deferred revenue until such time that all criteria under the provision are met.

Product Sales

We sell PIXUVRI directly to health care providers and through a limited number of distributors. We generally record product sales upon receipt of the product by the health care providers and certain distributors at which time title and risk of loss pass. Product sales are recorded net of distributor discounts, estimated government-mandated rebates, trade discounts, and estimated product returns. Reserves are established for these deductions and actual amounts incurred are offset against the applicable reserves. We reflect these reserves as either a reduction in the related account receivable or as an accrued liability depending on the nature of the sales deduction. These estimates are periodically reviewed and adjusted as necessary.

Government-mandated discounts and rebates

Our products are subject to certain programs with government entities in the E.U. whereby pricing on products is discounted below distributor list price to participating health care providers. These discounts are provided to participating health care providers either at the time of sale or through a claim by the participating health care providers for a rebate. Due to estimates and assumptions inherent in determining the amount of government-mandated discounts and rebates, the actual amount of future claims may be different from our estimates, at which time we would adjust our reserves accordingly.

Product returns and other deductions

At the time of sale, we also record estimates for certain sales deductions such as product returns and distributor discounts and incentives. We offer certain distributors a limited right of return or replacement of product that is damaged in certain instances. When we cannot reasonably estimate the amount of future product returns and/or other sales deductions, we do not recognize revenue until the risk of product return and additional sales deductions have been substantially eliminated. To date, there have been no PIXUVRI product returns.

Cost of Product Sold

Cost of product sold includes third party manufacturing costs, shipping costs, contractual royalties, and other costs of PIXUVRI product sold. Cost of product sold also includes any necessary allowances for excess inventory that may expire and become unsalable. We did not record an allowance for excess inventory as of March 31, 2014 and 2013.

Net Loss Per Share

Basic net income (loss) per share is calculated based on the net income (loss) attributable to common shareholders divided by the weighted average number of shares outstanding for the period excluding any dilutive effects of options, warrants, unvested share awards and convertible securities. Diluted net income (loss) per common share assumes the conversion of all dilutive convertible securities, such as convertible debt and convertible preferred stock using the if-converted method, and assumes the exercise or vesting of other dilutive securities, such as options, warrants and restricted stock using the treasury stock method. As of March 31, 2014 and 2013, options, warrants and unvested share rights aggregating 16.6 million and 11.5 million common share equivalents, respectively, prior to the application of the as-if converted method for convertible securities and the treasury stock method for other dilutive securities, such as options and warrants, are not included in the calculation of diluted net loss per share as they are anti-dilutive.

Fair Value Measurement

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest:

Level 1 – Observable inputs, such as unadjusted quoted prices in active markets for identical assets or liabilities.

Level 2 – Observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, or other inputs that are observable directly or indirectly.

Level 3 – Unobservable inputs that are supported by little or no market activity, requiring an entity to develop its own assumptions.

If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

Concentrations of Credit Risk

Financial instruments which potentially subject us to concentrations of credit risk consist of accounts receivable. The Company has accounts receivable from the sale of PIXUVRI from a small number of distributors and health care providers. Further, the Company does not require collateral on amounts due from its distributors and is therefore subject to credit risk. The Company has not experienced any significant credit losses to date as a result of credit risk concentration and does not consider an allowance for doubtful accounts to be necessary.

Recently Adopted Accounting Standards

In March 2013, the Financial Accounting Standards Board, or FASB, issued guidance to clarify when to release cumulative foreign currency translation adjustments when an entity ceases to have a controlling financial interest in a subsidiary or group of assets within a foreign entity. The amendment is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013 and should be applied prospectively to derecognition events occurring after the effective date, with early adoption permitted. The adoption of this guidance did not have an impact on our consolidated financial statements.

In July 2013, the FASB issued guidance on the presentation of an unrecognized tax benefit when a net operating loss carryforward, similar tax loss or tax carryforward exists. FASB concluded that an unrecognized tax benefit should be presented as a reduction of a deferred tax asset except in certain circumstances the unrecognized tax benefit should be presented as a liability and should not be combined with deferred tax assets. The amendment is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, with early adoption permitted. The adoption of this guidance did not have an impact on our consolidated financial statements.

Reclassifications

Certain prior year items have been reclassified to conform to current year presentation.

2.	Inventory

The components of PIXUVRI inventory consisted of the following as of March 31, 2014 and December 31, 2013 (in thousands):


	March 31, 2014		December 31, 2013
Finished goods	$	565	$	601
Work-in-process		4,458		4,473

Total inventory	$	5,023	$	5,074

3.	Long-term Debt

In March 2014, we entered into a First Amendment, or the Amendment, to Loan and Security Agreement (and as amended by the Amendment, the Loan Agreement) with Hercules Capital Funding Trust 2012-1, or Hercules, which was assigned from the original lender, Hercules Technology Growth Capital, Inc. The Amendment modified certain terms applicable to the presently outstanding loan balance of $15.0 million, or the Original Loan, as described below and provides us with the option to borrow an additional $5.0 million, or the 2014 Term Loan Availability, through October 31, 2014, subject to certain conditions. We paid a facility charge of $72,500 in connection with the Amendment.

Pursuant to the Amendment, the interest-only period of the Original Loan has been extended by six months such that the 24 equal monthly installments of principal and interest (mortgage style) will now commence on November 1, 2014 (rather than May 1, 2014). In addition, the interest rate on the Original Loan (which is currently 12.25% plus the amount by which the prime rate exceeds 3.25%) will, upon Hercules’ receipt of evidence of the achievement of positive Phase III data in connection with our PERSIST-1 clinical trial, be reduced to 11.25% plus the amount by which the prime rate exceeds 3.25%. The modified terms were not considered substantially different pursuant to ASC 470-50, Modification and Extinguishment .

If we elect to borrow the funds under the 2014 Term Loan Availability, interest on such portion would float at a rate per annum equal to 10.00% plus the amount by which the prime rate exceeds 3.25%. Any borrowings under the 2014 Term Loan Availability would be repayable in 24 equal monthly installments of principal and interest (mortgage style) commencing on November 1, 2014. As of the time of this filing, we have not borrowed the funds underlying the 2014 Term Loan Availability.

Subject to certain exceptions, all loan obligations under the Loan Agreement are secured by a first priority security interest on substantially all of our personal property (excluding our intellectual property).

As of December 31, 2013, the fair value of the warrant issued in connection with the consummation of the Loan Agreement in March 2013 was $1.0 million and was classified as a liability since it did not meet the considerations necessary for equity classification. The warrant was categorized as Level 2 in the fair value hierarchy as the significant inputs used in determining fair value were considered observable market data. In January 2014, all of the warrant was exercised into 0.5 million shares of common stock via cashless exercise.

4.	Legal Proceedings

On December 10, 2009, the Commissione Nazionale per le Società e la Borsa (which is the public authority responsible for regulating the Italian securities markets), or CONSOB, sent us a notice claiming, among other things, violation of the provisions of Section 114, paragraph 1 of the Italian Legislative Decree no. 58/98 due to the asserted late disclosure of the contents of the opinion expressed by Stonefield Josephson, Inc., an independent registered public accounting firm, with respect to our 2008 financial statements. The sanctions established by Section 193, paragraph 1 of the Italian Legislative Decree no. 58/98 for such violations could require us to pay a pecuniary administrative sanction amounting to between $7,000 and $684,000 upon conversion from euros as of March 31, 2014. Until CONSOB’s right is barred, CONSOB may, at any time, confirm the occurrence of the asserted violation and apply a pecuniary administrative sanction within the foregoing range. To date, we have not received any such notification.

The Italian Tax Authority, or the ITA, issued notices of assessment to CTI (Europe) based on the ITA’s audit of CTI (Europe)’s VAT returns for the years 2003, 2005, 2006 and 2007, or, collectively, the VAT Assessments. The ITA audits concluded that CTI (Europe) did not collect and remit VAT on certain invoices issued to non-Italian clients for services performed by CTI (Europe). We believe that the services invoiced were non-VAT taxable consultancy services and that the VAT returns are correct as originally filed. We are defending ourselves against the assessments both on procedural grounds and on the merits of the case. We received favorable rulings in 2012, which remain subject to further appeal, and our then remaining deposit for the VAT Assessments was refunded to us in January 2013. Due to the change of the position for the VAT Assessments, we reversed the entire reserve for VAT assessed as of December 31, 2012.

In June 2013, the Regional Tax Court issued decision no. 119/50/13 in regards to the 2003 VAT assessment, which accepted the appeal of the ITA and reversed the previous decision of the Provincial Tax Court. We believe that such decision has not carefully taken into account our arguments and the documentation we filed, and we therefore plan to appeal such decision in front of the Supreme Court both on procedural grounds and on the merits of the case. In January 2014, we were notified that the ITA has requested partial payment of the 2003 VAT assessment in the amount of €430,118. We paid such amount in March 2014.

If the final decisions of the Supreme Court for the VAT Assessments are unfavorable to us, we may incur up to $12.9 million in losses for the VAT amount assessed including penalties, interest and fees upon conversion from euros as of March 31, 2014.

5.	Share-based Compensation Expense

The following table summarizes share-based compensation expense for the three months ended March 31, 2014 and 2013, which was allocated as follows (in thousands):


	Three Months Ended March 31,
	2014		2013
Research and development	$	782	$	403
Selling, general and administrative		7,047		2,025

Total share-based compensation expense	$	7,829	$	2,428

For the three months ended March 31, 2014 and 2013, we incurred share-based compensation expense due to the following types of awards (in thousands):


	Three Months Ended March 31,
	2014		2013
Performance rights	$	503	$	340
Restricted stock		5,969		1,995
Options		1,357		93

Total share-based compensation expense	$	7,829	$	2,428

6.	Other Comprehensive Loss

Total accumulated other comprehensive loss consisted of the following as of March 31, 2014 and December 31, 2013 (in thousands):


	Net Unrealized Gain (Loss) on Securities Available-for- sale			Foreign Currency Translation Adjustments			Accumulated Other Comprehensive Loss
December 31, 2013	$	(422	)	$	(8,007	)	$	(8,429	)
Current period other comprehensive income (loss)		8			(29	)		(21	)

March 31, 2014	$	(414	)	$	(8,036	)	$	(8,450	)

7.	Leases

Our deferred rent balance was $4.7 million as of March 31, 2014, of which $0.4 million was included in other current liabilities and $4.3 million was included in other liabilities . As of December 31, 2013, our deferred rent balance was $4.8 million, of which $0.4 million was included in other current liabilities and $4.4 million was included in other liabilities .

Item 2.

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

This Quarterly Report on Form 10-Q may contain, in addition to historical information, “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and should be read in conjunction with the Condensed Consolidated Financial Statements and the related Notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q. When used in this Quarterly Report on Form 10-Q, terms such as “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of those terms or other comparable terms are intended to identify such forward-looking statements. Such statements, which include statements concerning sufficiency of cash resources and related projections, product sales, research and development expenses, selling, general and administrative expenses, additional financings and additional losses, are subject to known and unknown risks and uncertainties, including, but not limited to, those discussed below and elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K, particularly in “Factors Affecting Our Operating Results and Financial Condition,” that could cause actual results, levels of activity, performance or achievements to differ significantly from those projected. Although we believe that expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We will not update any of the forward-looking statements after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or changes in our expectations. Readers are cautioned not to place undue reliance on these forward-looking statements, which apply only as of the date of this Quarterly Report on Form 10-Q.

OVERVIEW

We are a biopharmaceutical company focused on the acquisition, development and commercialization of less toxic and more effective ways to treat cancer. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with partners. We are currently concentrating our efforts on treatments that target blood-related cancers where there is an unmet medical need. We are primarily focused on commercializing PIXUVRI® (pixantrone), or PIXUVRI, in the European Union, or the E.U., for multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, or NHL, and conducting a Phase 3 clinical trial program of pacritinib for the treatment of myelofibrosis that will support regulatory submission for approval in the United States, or the U.S., and Europe.

PIXUVRI

PIXUVRI is a novel aza-anthracenedione derivative that is structurally related to anthracyclines and anthracenediones, but does not appear to be associated with the same level of cardiotoxic effects. In May 2012, the European Commission granted conditional marketing authorization in the E.U. of PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. PIXUVRI is the first approved treatment in the E.U. for patients with multiply relapsed or refractory aggressive B-cell NHL who have failed two or three prior lines of therapy. In connection with the conditional marketing authorization, we are conducting the required post-approval commitment trial, which compares pixantrone and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL.

As of the date of this filing, PIXUVRI was available in Austria, Denmark, Finland, Germany, Italy, France, Netherlands, Norway, Sweden and the United Kingdom, or the U.K. We have established a commercial organization, including sales, marketing, supply chain management and reimbursement capabilities to commercialize PIXUVRI in the E.U. PIXUVRI is not approved in the U.S. We are pursuing potential partners for commercializing PIXUVRI in other markets, excluding countries in the E.U. where CTI has a commercial presence and the U.S.

Decisions by governmental authorities and healthcare providers will impact the price and market acceptance of PIXUVRI, as pricing and availability of prescription pharmaceuticals are subject to governmental control in almost all European markets. Accordingly, any future revenues are dependent on market acceptance of PIXUVRI, the reimbursement decisions made by the governmental authorities and healthcare providers in each country where PIXUVRI is available for sale and other factors. In February 2014, PIXUVRI received final guidance for funding and reimbursement from the National Institute for Health and Care Excellence in England/Wales. Previously, in December 2013, we reached agreement for funding and reimbursement with the National Association of Statutory Health Insurance Funds in Germany, and in the third quarter of 2013, PIXUVRI was granted market access in Italy and France.

In January 2014, we reached an agreement with Novartis International Pharmaceutical Ltd., or Novartis, to reacquire rights to PIXUVRI and paclitaxel poliglumex (Opaxio™), or Opaxio. In exchange for Novartis’ agreement to return such rights to us, which we had previously granted to Novartis in September 2006, we are obligated to make payments to Novartis based on net sales of Opaxio and PIXUVRI. For additional information on this agreement, please see the discussion in Part I, Item 2, “License Agreements and Additional Milestone Activities – Novartis.”

Pacritinib

Our lead development candidate, pacritinib, is an oral inhibitor of both Janus Kinase 2, or JAK2, and FMS-like tyrosine kinase (FLT3), which demonstrated meaningful clinical benefit and good tolerability in myelofibrosis patients in Phase 2 clinical trials. Myelofibrosis is a blood-related cancer caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response, scarring the bone marrow and limiting its ability to produce red blood cells prompting the spleen and liver to take over this function. Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue, itching and pain. We believe pacritinib may offer an advantage over other JAK inhibitors through effective relief of symptoms with less treatment-emergent thrombocytopenia and anemia.

In collaboration with Baxter International, Inc., or Baxter, pursuant to our worldwide license agreement to develop and commercialize pacritinib, or the Baxter Agreement, we are pursuing a broad approach to advancing pacritinib for patients with myelofibrosis by conducting two Phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the PERSIST-1 trial, which was initiated in January 2013; and the other in patients with low platelet counts, the PERSIST-2 trial, which opened for enrollment in March 2014. In October 2013, we reached an agreement with the U.S. Food and Drug Administration, or FDA, on a Special Protocol Assessment for PERSIST-2. The trial, together with PERSIST-1, is intended to support registration in the U.S. and the E.U. For additional information on this agreement, please see the discussion in Part I, Item 2, “License Agreements and Additional Milestone Activities – Baxter.”

Tosedostat

Tosedostat is an oral aminopeptidase inhibitor that has demonstrated significant responses in patients with acute myeloid leukemia, or AML. It is currently being evaluated in several Phase 2 trials, which are being conducted as cooperative group sponsored and investigator-sponsored trials, or ISTs. These trials are evaluating tosedostat in combination with hypomethylating agents in AML and myelodysplastic syndrome, which are cancers of the blood and bone marrow. We anticipate that data from these signal-finding trials may be used to determine the appropriate design for a Phase 3 trial.

Opaxio

Opaxio is our novel biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. Taxanes, including paclitaxel (Taxol®) and docetaxel (Taxotere®), are widely used for the treatment of various solid tumors. Development of Opaxio is currently being conducted through cooperative group trials and ISTs focusing on ovarian cancer, glioblastoma multiforme and head and neck cancers. Opaxio is being evaluated in a Phase 3 trial, GOG-0212, as a potential maintenance therapy for women with advanced stage ovarian cancer who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. This trial is being conducted and managed by the Gynecologic Oncology Group, or the GOG, which is one of the National Cancer Institute’s funded cooperative cancer research groups focused on the study of gynecologic malignancies. For purposes of registration, the primary endpoint of this trial is overall survival of patients treated with Opaxio compared to no maintenance therapy. The statistical analysis plan calls for up to four interim analyses and one final analysis, each with boundaries for early closure for superior efficacy or for futility. The first interim analysis was conducted in January 2013, which passed the futility boundary and continued with no changes. In January 2014, we were informed by the GOG that enrollment in the trial had been completed with 1,150 patients enrolled.

Financial summary

Our product sales are currently generated solely from the sales of PIXUVRI in Europe. We recorded $1.3 million in total net product sales for the three months ended March 31, 2014. Our product sales may vary significantly from period to period as the commercialization and reimbursement negotiations for PIXUVRI progress. Our loss from operations for the three months ended March 31, 2014 was $27.7 million, compared to $18.5 million for the same period in 2013. Our results of operations may vary substantially from year to year and from quarter to quarter and, as a result, you should not rely on them as being indicative of our future performance.

As of March 31, 2014, we had cash and cash equivalents of $50.6 million and outstanding debt under our senior secured term loan agreement of $15.0 million (with an option to borrow an additional $5.0 million through October 31, 2014, subject to certain conditions). Please refer to Note 3, Long-term Debt , under Part I, Item 1 in this Quarterly Report on Form 10-Q, which note is incorporated herein by reference, for further information relating to our senior secured term loan agreement, including the amendment thereto that we entered into in March 2014.

RESULTS OF OPERATIONS

Three months ended March 31, 2014 and 2013

Product sales, net. Net product sales from PIXUVRI for the three months ended March 31, 2014 and 2013 were $1.3 million and $1.1 million, respectively. We sell PIXUVRI directly to health care providers and through a limited number of wholesale distributors in the E.U. Of our product sales during the three months ended March 31, 2014, 94 percent were made to a single customer. All sales of PIXUVRI during the periods presented were made in Europe. We generally record product sales upon receipt of the product by the health care provider or distributor at which time title and risk of loss pass. Product sales are recorded net of distributor discounts, estimated government-mandated discounts and rebates, trade discounts and estimated product returns. Any future revenues are dependent on market acceptance of PIXUVRI, the reimbursement decisions made by governmental authorities in each country where PIXUVRI is available for sale and other factors.

As of March 31, 2014, the balance from activity in returns, discounts and rebates is reflected in accounts receivable and a ccrued expenses . Balances and activity for the components of our gross to net sales adjustments for the three months ended March 31, 2014 are as follows (in thousands):


	Product returns		Rebates and other			Total
Balance at December 31, 2013		39		177			216
Provision for current period sales		3		—			3
Adjustments for prior period sales		—		—			—
Payments/credits for current period sales		—		—			—
Payments/credits for prior period sales		—		(69	)		(69	)

Balance at March 31, 2014	$	42	$	108		$	150

Please refer to Note 1, Description of Business and Summary of Significant Accounting Policies , under Part I, Item 1 in this Quarterly Report on Form 10-Q, which note is incorporated herein by reference, for further information.

License and contract revenue. In connection with the consummation of the Baxter Agreement in 2013, we allocated $2.7 million of the upfront payment we received under the Baxter Agreement and recorded such $2.7 million amount as deferred revenue upon such consummation. We recognize license and contract revenue based on a proportional performance method, by which revenue is recognized in proportion to the development costs incurred. The development services under the Baxter Agreement are expected to be performed through approximately 2018, with the majority of development services expected to be completed by approximately the end of 2015. Of the initial $2.7 million deferred revenue balance recorded upon consummation of the Baxter Agreement, approximately $0.1 million was recognized as revenue during the three months ended March 31, 2014 and included in license and contract revenue . We had no such revenue during the three months ended March 31, 2013. The following table illustrates such balance of deferred revenue under the Baxter Agreement as of March 31, 2014 and December 31, 2013 (in thousands):


	March 31, 2014		December 31, 2013
Current portion of deferred revenue	$	1,043	$	1,010
Deferred revenue, less current portion		1,450		1,626

Total deferred revenue	$	2,493	$	2,636

Cost of product sold. Cost of product sold for the three months ended March 31, 2014 and 2013 was $145,000 and $55,000 for the sales of PIXUVRI, respectively. We began capitalizing costs related to the production of PIXUVRI in February 2012 upon receiving a positive opinion for conditional approval by The Committee for Medicinal Products for Human Use, or the CHMP, which is a committee of the EMA. The manufacturing costs of PIXUVRI product prior to receipt of the CHMP’s positive opinion was expensed as research and development as incurred. While we tracked the quantities of individual PIXUVRI product lots, we did not track manufacturing costs in our inventory system prior to capitalization, and therefore the manufacturing cost of PIXUVRI produced prior to capitalization is not reasonably determinable. Most of this reduced-cost inventory is expected to be available for us to use commercially. The timing of the sales of such reduced-cost inventory and its impact on gross margin is dependent on the level of PIXUVRI sales as well as our ability to utilize this inventory prior to its expiration date. We expect that our cost of product sold as a percentage of product revenue will increase in future periods as PIXUVRI product manufactured and expensed prior to capitalization is sold. At this time, we cannot reasonably estimate the timing or rate of consumption of reduced-cost PIXUVRI product manufactured and expensed prior to capitalization.

Research and development expenses. Our research and development expenses for compounds under development and preclinical development for the three months ended March 31, 2014 and 2013 were as follows (in thousands):


	Three Months Ended March 31,
	2014		2013
Compounds under development:
PIXUVRI	$	1,201	$	1,286
Pacritinib		5,964		1,989
Opaxio		107		548
Tosedostat		160		334
Brostallicin		1		2
Operating expenses		4,647		4,153
Research and preclinical development		99		43

Total research and development expenses	$	12,179	$	8,355

Costs for our compounds include external direct expenses such as principal investigator fees, clinical research organization charges and contract manufacturing fees incurred for preclinical, clinical, manufacturing and regulatory activities associated with preparing the compounds for submissions of New Drug Applications or similar regulatory filings to the FDA, the EMA or other regulatory agencies outside the U.S. and Europe, as well as upfront license fees for acquired technology. Subsequent to receiving a positive opinion for conditional approval of PIXUVRI in the E.U. from the EMA’s CHMP, costs associated with commercial batch production, quality control, stability testing, and certain other manufacturing costs of PIXUVRI were capitalized as inventory. Operating expenses include our personnel and an allocation of occupancy, depreciation and amortization expenses associated with developing these compounds. Research and preclinical development costs primarily include costs associated with external laboratory services associated with other compounds. We are not able to capture the total cost of each compound because we do not allocate operating expenses to all of our compounds. External direct costs incurred by us as of March 31, 2014 were $87.4 million for PIXUVRI (excluding costs prior to our merger with Novuspharma S.p.A in January 2004), $18.7 million for pacritinib (excluding costs for pacritinib prior to our acquisition of certain assets from S*BIO Pte Ltd, or S*BIO, in May 2012 and $29.1 million of in-process research and development expenses associated with such acquisition), $227.1 million for Opaxio, $10.9 million for tosedostat (excluding costs for tosedostat prior to the effectiveness of the Chroma License Agreement (see “License Agreements and Additional Milestone Activities – Chroma Therapeutics, Ltd.” below)) and $9.6 million for brostallicin (excluding costs for brostallicin prior to our acquisition of Systems Medicine, LLC in July 2007).

Research and development expenses increased to $12.2 million for the three months ended March 31, 2014 compared to $8.4 million for the three months ended March 31, 2013. PIXUVRI costs decreased primarily due to a reduction in clinical development costs associated with the PIX306 trial, our on-going confirmatory trial for PIXUVRI in the E.U. This decrease was partially offset by an increase in medical affairs activities in the E.U. Costs for pacritinib increased primarily due to clinical development start-up costs associated with the PERSIST-2 trial, in addition to site initiation, patient enrollment and other clinical development costs associated with the PERSIST-1 trial. Costs associated with pacritinib manufacturing and medical affairs activities also increased between periods. Costs for our Opaxio program decreased primarily due to completion of the required patient enrollment in the GOG-0212 trial during the period ended March 31, 2014, in addition to a reduction in manufacturing costs. Development costs for tosedostat decreased primarily due to a reduction in clinical development activity associated with the Chroma License Agreement. Operating expenses included in research and development expenses increased primarily due to an increase in non-cash share-based compensation and discretionary bonus expense. These increases were partially offset by a decrease in employee termination costs.

Regulatory agencies, including the FDA and EMA, regulate many aspects of a product candidate’s life cycle, including research and development and preclinical and clinical testing. We will need to commit significant time and resources to develop our current and any future product candidates. Our drug candidates pacritinib, tosedostat and Opaxio are currently in clinical development, and our product PIXUVRI, which is currently being commercialized in parts of Europe, is undergoing a post-approval commitment study. Many drugs in human clinical trials fail to demonstrate the desired safety and efficacy characteristics. We are unable to provide the nature, timing and estimated costs of the efforts necessary to complete the development of pacritinib, tosedostat and Opaxio, and to complete the post-approval commitment study of PIXUVRI, because, among other reasons, we cannot predict with any certainty the pace of patient enrollment of our clinical trials, which is a function of many factors, including the availability and proximity of patients with the relevant condition. We rely on third parties to conduct clinical trials, which may result in delays or failure to complete trials if the third parties fail to perform or meet applicable standards. Even after a clinical trial is enrolled, preclinical and clinical data can be interpreted in different ways, which could delay, limit or preclude regulatory approval and advancement of this compound through the development process. We or regulatory authorities may suspend clinical trials at any time on the basis that the participants are being exposed to unacceptable health risks. Even if our drugs progress successfully through initial human testing in clinical trials, they may fail in later stages of development. A number of companies in the pharmaceutical industry, including us, have suffered significant setbacks in advanced clinical trials, even after reporting promising results in earlier trials. For these reasons, among others, we cannot estimate the date on which clinical development of our product candidates will be completed, if ever, or when we will generate material net cash inflows from PIXUVRI or be able to begin commercializing pacritinib, Opaxio or tosedostat to generate material net cash inflows. In order to generate revenue from these products, our product candidates need to be developed to a stage that will enable us to commercialize, sell or license related marketing rights to third parties.

We are also unable to control the amount and timing of resources any of our collaborators devote to product candidates, where applicable, which may result in delays in the development or marketing of products. Because of these risks and uncertainties, we cannot accurately predict when or whether we will successfully complete the development of our product candidates or the ultimate product development cost.

The risks and uncertainties associated with completing development on schedule and the consequences to operations, financial position and liquidity if the project is not timely completed are discussed in more detail in our risk factors, which begin on page 28 of this Quarterly Report on Form 10-Q and, in particular, in the following risk factors: “ If our collaboration with Baxter with respect to pacritinib or any other collaboration for our products or product candidates is not successful, or if we are unable to enter into additional collaborations, we may not be able to effectively develop and/or commercialize the applicable product(s), which could have a material adverse effect on our business .”, “ Product candidates that appear promising in research and development may fail to reach later stages of development for a number of reasons, including, among others, that clinical trials may take longer to complete than expected or may not be completed at all. ”; “ We or our collaboration partners may not obtain or maintain the regulatory approvals required to commercialize some or all of our products. ”; “ Even if our drug candidates are successful in clinical trials and receive regulatory approvals, we or our collaboration partners may not be able to successfully commercialize them. ”; and “ Even if our products receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review by the FDA, the EMA and other foreign regulatory agencies, as applicable, and may be subject to additional post-marketing obligations, all of which may result in significant expense and limit commercialization of our products, including PIXUVRI. ”

Selling, general and administrative expenses. Selling, general and administrative expenses were $16.8 million for the three months ended March 31, 2014 as compared to $11.1 million for the three months ended March 31, 2013. This increase was primarily due to a $5.0 million increase in non-cash share-based compensation, a $0.6 million increase related to our provision for value added tax, or VAT, assessments associated with our Cell Therapeutics Inc. – Sede Secondaria, or CTI (Europe) branch, and a $0.5 million increase in compensation and benefits mainly related to an increase in the average number of personnel between comparable periods. These increases were partially offset by a $0.6 million decrease in advertising and promotional expenses associated with the commercial launch of PIXUVRI in the E.U.

Settlement expense. For the three months ended March 31, 2013, we recorded $0.1 million in settlement expense related to an agreement entered into with one of our former executive officers for severance payments and related benefits upon such officer’s separation from us in the prior year and attorneys’ fees in connection with a shareholder lawsuit. There was no settlement expense for the corresponding period in 2014.

Interest expense . Interest expense increased for the three months ended March 31, 2014 as compared to the three months ended March 31, 2013. This increase was primarily due to interest incurred on our senior secured term loan issued in March 2013 and December 2013.

Amortization of debt discount and issuance costs . Amortization of debt discount and issuance costs for the three months ended March 31, 2014 and 2013 is related to the amortization of debt discount and issuance costs incurred on our senior secured term loan originally issued in 2013.

Foreign exchange loss. The foreign exchange losses for the three months ended March 31, 2014 and 2013 are due to fluctuations in foreign currency exchange rates, primarily related to payables and receivables in our European branches and subsidiaries denominated in foreign currencies.

Other expense. The expense amount for the three months ended March 31, 2014 is primarily related to the change in fair value of the warrant issued to Hercules Technology Growth Capital, Inc. The expense amount for the three months ended March 31, 2013 is primarily related to loss on disposal of property and equipment.

LIQUIDITY AND CAPITAL RESOURCES

Overview

Cash and cash equivalents. As of March 31, 2014, we had $50.6 million in cash and cash equivalents.

Net cash used in operating activities. Net cash used in operating activities increased to $20.8 million during the three months ended March 31, 2014 as compared to $15.3 million for the same period in 2013. The change is primarily due to an increase in research and development activities related to pacritinib in the first quarter of 2014, an increase in interest paid on our long term debt and a refund of a VAT deposit received during the first quarter of 2013.

Net cash used in investing activities. Net cash used in investing activities decreased to $35,000 for the three months ended March 31, 2014 compared to $972,000 for the same period in 2013 due to a decrease in purchases of property and equipment.

Net cash provided by (used in) financing activities. Net cash used in financing activities was $0.2 million for the three months ended March 31, 2014. Net cash provided by financing activities of $9.6 million for the three months ended March 31, 2013 was primarily due to the issuance of long-term debt during the period.

In March 2013, we entered into a Loan and Security Agreement, or the Loan and Security Agreement, with Hercules Technology Growth Capital, Inc. for a senior secured term loan of up to $15.0 million. The first $10.0 million was funded in March 2013, and we exercised our option to borrow an additional $5.0 million in December

2013. In March 2014, we entered into a First Amendment, or the Amendment, to Loan and Security Agreement (and as amended by the Amendment, the Loan Agreement) with Hercules Capital Funding Trust 2012-1, which was assigned from the original lender, Hercules Technology Growth Capital, Inc. The Amendment modifies certain terms of the original loan including the grant of an option to borrow an additional $5.0 million, or the 2014 Term Loan Availability, through October 31, 2014, subject to certain conditions. As of the time of this filing, we have not borrowed the funds underlying the 2014 Term Loan Availability. As used in this Quarterly Report on Form 10-Q, “senior secured term loan agreement” and “senior secured term loan” refer to the Loan Agreement and the term loan provided thereunder, respectively. For additional information on the Loan Agreement, please refer to Note 3, Long-term Debt , under Part I, Item 1 in this Quarterly Report on Form 10-Q.

Capital Resources and Requirements

As of March 31, 2014, our available cash and cash equivalents were $50.6 million, and we had $15.0 million in debt outstanding under our senior secured term loan agreement (with an option to borrow an additional $5.0 million through October 31, 2014, subject to certain conditions). At our currently planned spending rate, we believe that our present financial resources, together with potential pacritinib milestone payments projected to be earned and received over the course of 2014 and 2015 under our collaboration with Baxter, and expected European sales from PIXUVRI, will be sufficient to fund our operations into the third quarter of 2015. However, our future capital requirements will depend on many factors, including:

•

changes in manufacturing;

•

results of, and other developments with respect to, our clinical trials (including changes in clinical trial expenses);

•

acquisitions of compounds or other assets;

•

any expansion of our sales and marketing organization in Europe;

•

activities with respect to regulatory approvals;

•

failure to receive projected milestone payments in connection with our compounds;

•

failure to achieve projected sales of PIXUVRI; and

•

other unplanned business developments.

These and other factors may consume resources earlier than planned, and as a result, our forecast for the period for which we will have sufficient resources to fund our business may fail.

We expect that we will need to raise additional funds to develop our business. We may seek to raise such capital through equity or debt financings, partnerships, collaborations, joint ventures, disposition of assets or other sources. If additional funds are raised by issuing equity securities, substantial dilution to existing shareholders may result. Additional funding may not be available on favorable terms or at all. If we fail to obtain additional capital when needed, we may be required to delay, scale back or eliminate some or all of our research and development programs, reduce our selling, general and administrative expenses and/or refrain from making our contractually required payments when due, which could harm our business, financial condition, operating results and prospects.

The following table includes information relating to our contractual obligations as of March 31, 2014 (in thousands):


Contractual Obligations	Payments Due by Period
	Total		Less than 1 Year		1-3 Years		3-5 Years		More than 5 Years
Operating leases:
Facilities	$	19,524	$	2,516	$	4,671	$	4,656	$	7,681
Long-term debt		15,000		2,831		12,169		—		—
Interest on long-term debt(1)		3,111		1,807		1,304		—		—
Purchase commitments(2)		2,292		2,239		53		—		—
Other obligations(3)		1,335		53		1,282		—		—

	$	41,262	$	9,446	$	19,479	$	4,656	$	7,681

(1)	The interest rate on our long-term debt currently floats at a rate per annum equal to 12.25% plus the amount by which the prime rate exceeds 3.25%. The amounts presented for interest payments in future periods assume a prime rate of 3.25%.

(2)	Purchase commitments include obligations related to manufacturing supply, insurance and other purchase commitments.

(3)	Other obligations do not include $4.7 million deferred rent associated with our operating lease for office space.

Some of our licensing agreements obligate us to pay a royalty on net sales of products utilizing licensed technology. Such royalties are dependent on future product sales and are not provided for in the table above as they are not estimable. For additional information, please see discussion below in “License Agreements and Additional Milestone Activities.”

LICENSE AGREEMENTS AND ADDITIONAL MILESTONE ACTIVITIES

Baxter

In November 2013, we entered into the Baxter Agreement for the development and commercialization of pacritinib for use in oncology and potentially additional therapeutic areas. Under the Baxter Agreement, we granted Baxter an exclusive, worldwide (subject to co-promotion rights discussed below), royalty-bearing, non-transferable license (which is sub-licensable under certain circumstances) to our know-how and patents relating to pacritinib. Licensed products under the Baxter Agreement consist of products in which pacritinib is an ingredient.

Baxter granted to us a non-exclusive license in order for us to perform our rights and obligations under the Baxter Agreement, including our co-promotion rights in the U.S. and manufacturing obligations.

Baxter paid us an upfront payment of $60 million, which included a $30 million investment in our equity. We are also eligible to receive potential payments of up to $302 million upon the successful achievement of certain development and commercialization milestones, comprised of $112 million of potential clinical, regulatory and commercial launch milestone payments, and potential additional sales milestone payments of up to $190 million. Of such milestones, $67 million relates to clinical progress milestones. We and Baxter will jointly commercialize and share profits and losses on sales of pacritinib in the U.S.

We were responsible for all development costs incurred prior to January 1, 2014, and will be responsible for approximately $96 million in U.S. and E.U. development costs incurred on or after January 1, 2014. Of such $96 million

in development costs, we anticipate that up to $67 million will be offset through the potential receipt from Baxter through 2015 of the aforementioned clinical progress milestones. All development costs exceeding the $96 million threshold will generally be shared as follows: (i) costs generally applicable worldwide will be shared 75 percent to Baxter and 25 percent to us, (ii) costs applicable to territories exclusive to Baxter will be 100 percent borne by Baxter and (iii) costs applicable exclusively to co-promotion in the U.S. will be shared equally between the parties, subject to certain exceptions.

Outside the U.S., we are eligible to receive tiered high single-digit to mid-teen percentage royalty payments based on net sales for myelofibrosis, and higher double digit royalties for other indications, subject to reduction by up to 50 percent if (i) Baxter is required to obtain additional third party licenses, on which it is obligated to pay royalties, to fulfill its obligations under the Baxter Agreement and (ii) in any jurisdiction where there is no longer either regulatory exclusivity or patent protection.

The Baxter Agreement will expire when there is no longer any obligation for Baxter to pay royalties to us in any jurisdiction, at which time the licenses granted to Baxter will become perpetual and royalty-free. We or Baxter may terminate the Baxter Agreement prior to its expiration in certain circumstances. Following the one year anniversary of receipt of regulatory approval in Australia, Canada, China, France, Germany, Italy, Japan, Spain, the U.K. or the U.S., we may terminate the Baxter Agreement as to one or more particular countries if Baxter has not undertaken requisite regulatory or commercialization efforts in the applicable country and certain other conditions are met. Baxter may terminate the Baxter Agreement earlier than its expiration in certain circumstances including (i) in the event development costs for myelofibrosis for the period commencing January 1, 2014 are reasonably projected to exceed a specified threshold, (ii) as to some or all countries in the event of commercial failure of the licensed product or (iii) without cause following the one-year anniversary of the effective date of the Baxter Agreement, provided that such termination will have a lead-in period of six months before it becomes effective. Additionally, either party may terminate the Baxter Agreement prior to its expiration in events of force majeure, or the other party’s uncured material breach or insolvency. In the event of a termination prior to the expiration date, rights in pacritinib will revert to us.

The Baxter Agreement also requires Baxter and us to negotiate and enter into a Manufacturing and Supply Agreement, which will provide for the manufacture of the licensed products, with an option for Baxter to finish and package encapsulated bulk product, within 180 days of the effective date of the Baxter Agreement.

University of Vermont

We entered into an agreement with the University of Vermont, or UVM, in March 1995, as amended, or the UVM Agreement, which grants us an exclusive license, with the right to sublicense, for the rights to PIXUVRI. Pursuant to the UVM Agreement, we acquired the rights to make, have made, sell and use PIXUVRI, and we are obligated to make royalty payments to UVM ranging from low single-digits to mid single-digits as a percentage of net sales. The higher royalty rate is payable for net sales in countries where specified UVM licensed patents exist, or where we have obtained orphan drug protection, until such UVM patents or such protection no longer exists. For a period of ten years after first commercialization of PIXUVRI, the lower royalty rate is payable for net sales in such countries after expiration of the designated UVM patents or loss of orphan drug protection, and in all other countries without such specified UVM patents or orphan drug protection. Unless otherwise terminated, the term of the UVM Agreement continues for the life of the licensed patents in those countries in which a licensed patent exists, and continues for ten years after the first sale of PIXUVRI in those countries where no such patents exist. We may terminate the UVM Agreement, on a country-by-country basis or on a patent-by-patent basis, at any time upon advance written notice. UVM may terminate the UVM Agreement upon advance written notice in the event royalty payments are not made. In addition, either party may terminate the UVM Agreement in the event of an uncured material breach of the UVM Agreement by the other party or in the event of bankruptcy of the other party.

S*BIO

We acquired the compounds SB1518 (which is referred to as “pacritinib”) and SB1578, which inhibit JAK2, from S*BIO in May 2012. Under our agreement with S*BIO, we are required to make milestone payments to S*BIO up to an aggregate amount of $132.5 million if certain U.S., E.U. and Japanese regulatory approvals are

obtained or if certain worldwide net sales thresholds are met in connection with any pharmaceutical product containing or comprising any compound that we acquired from S*BIO for use for specific diseases, infections or other conditions. At our election, we may pay up to 50 percent of any milestone payments to S*BIO through the issuance of shares of our common stock or shares of our preferred stock convertible into our common stock. In addition, S*BIO will also be entitled to receive royalty payments from us at incremental rates in the low single-digits based on certain worldwide net sales thresholds on a product-by-product and country-by-country basis.

Chroma Therapeutics, Ltd.

We entered into an agreement, or the Chroma License Agreement, with Chroma Therapeutics, Ltd., or Chroma, in March 2011 under which we have an exclusive license to certain technology and intellectual property controlled by Chroma to develop and commercialize the drug candidate, tosedostat, in North, Central and South America, or collectively, the Licensed Territory. Pursuant to the terms of the Chroma License Agreement, we are required to make a milestone payment to Chroma of $5.0 million upon the initiation of the first pivotal trial. The Chroma License Agreement also includes additional development- and sales-based milestone payments related to AML and certain other indications, up to a maximum amount of $209.0 million payable by us to Chroma if all development and sales milestones are achieved.

Under the Chroma License Agreement, we are required to pay Chroma royalties on net sales of tosedostat in any country within the Licensed Territory. Royalties commence on the first commercial sale of tosedostat in any country in the Licensed Territory and continue with respect to that country until the latest of the expiration date of the last patent claim, the expiration of all regulatory exclusivity periods for tosedostat in that country or ten years after the first commercial sale in that country. Royalty payments to Chroma are based on net sales volumes in any country within the Licensed Territory and range from the low- to mid-teens as a percentage of net sales.

Under the Chroma License Agreement, we are required to oversee and are responsible for performing the development operations and commercialization activities in the Licensed Territory, and Chroma will oversee and is responsible for performing the development operations and commercialization activities worldwide except for the Licensed Territory. We will be responsible for 75 percent of all development costs, while Chroma will be responsible for 25 percent of all development costs, subject to certain exceptions. Chroma is responsible for the manufacturing of tosedostat for development purposes in accordance with the terms of our supply agreement with Chroma. We have the option of obtaining a commercial supply of tosedostat from Chroma or from another manufacturer at our sole discretion in the Licensed Territory. The Chroma License Agreement may be terminated by us at our convenience upon 120 days’ written notice to Chroma. The Chroma License Agreement may also be terminated by either party following a material breach by the other party subject to notice and cure periods. As discussed in Part II, Item 1, “Legal Proceedings,” the parties have certain disputes arising under the Chroma License Agreement, although no court proceedings have commenced as of the time of this filing.

Gynecologic Oncology Group

We entered into an agreement with the GOG in March 2004, as amended, related to the GOG-0212 trial of Opaxio in patients with ovarian cancer, which the GOG is conducting. We recorded a $0.9 million obligation due to the GOG based on the 1,100 patient enrollment milestone achieved in the third quarter of 2013, of which $0.4 million remained in accounts payable as of March 31, 2014 (and was subsequently paid in April 2014). In the first quarter of 2014, we also recorded a $0.3 million obligation to the GOG as required under the agreement based on the additional 50 patients enrolled, with such amount being included in accounts payable as of March 31, 2014 (and subsequently paid in April 2014).We may be required to pay up to an additional $1.0 million upon the attainment of certain other milestones, of which $0.5 million has been recorded in accrued expenses as of March 31, 2014.

PG-TXL

In November 1998, we entered into an agreement, or the PG-TXL Agreement, with PG-TXL Company, L.P., or PG-TXL, as amended, which grants us an exclusive worldwide license for the rights to Opaxio and to all potential uses of PG-TXL’s polymer technology. Pursuant to the PG-TXL Agreement, we acquired the rights to research, develop, manufacture, market and sell anti-cancer drugs developed using this polymer technology. Pursuant to the PG-TXL Agreement, we are obligated to make payments to PG-TXL upon the achievement of certain development

and regulatory milestones of up to $14.4 million. The timing of the remaining milestone payments under the PG-TXL Agreement is based on trial commencements and completions for compounds protected by PG-TXL license rights, and regulatory and marketing approval of those compounds by the FDA and the EMA. Additionally, we are required to make royalty payments to PG-TXL based on net sales. Our royalty payments range from low to mid single-digits as a percentage of net sales. Unless otherwise terminated, the term of the PG-TXL Agreement continues until no royalties are payable to PG-TXL. We may terminate the PG-TXL Agreement upon advance written notice to PG-TXL in the event issues regarding the safety of the products licensed pursuant to the PG-TXL Agreement arise during development or clinical data obtained reveal a materially adverse tolerability profile for the licensed product in humans, or for any reason upon advance written notice. In addition, either party may terminate the PG-TXL Agreement upon advance written notice in the event certain license fee payments are not made; in the event of an uncured material breach of the respective material obligations and conditions of the PG-TXL Agreement; or in the event of liquidation or bankruptcy of a party.

Novartis

In January 2014, we entered into a termination agreement, or the Termination Agreement, with Novartis to reacquire the rights to PIXUVRI and Opaxio, or collectively, the Compounds, previously granted to Novartis under our License and Co-Development Agreement with Novartis entered into in September 2006, as amended, or the Original Agreement. Pursuant to the Termination Agreement, the Original Agreement was terminated in its entirety, except for certain customary provisions, including those pertaining to confidentiality and indemnification, which survive termination.

Under the Termination Agreement, we agreed not to transfer, license, sublicense or otherwise grant rights with respect to intellectual property of the Compounds unless the recipient thereof agrees to be bound by the terms of the Termination Agreement. We also agreed to provide potential payments to Novartis, including a percentage ranging from the low double-digits to the mid-teens, of any consideration received by us or our affiliates in connection with any transfer, license, sublicense or other grant of rights with respect to intellectual property of PIXUVRI or Opaxio, respectively; provided that such payments will not exceed certain prescribed ceilings in the low single-digit millions. Novartis is entitled to receive potential payments of up to $16.6 million upon the successful achievement of certain sales milestones of the Compounds. We are also obligated to pay to Novartis tiered low single-digit percentage royalty payments for the first several hundred million in annual net sales, and ten percent royalty payments thereafter based on annual net sales of each Compound, subject to reduction in the event generic drugs are introduced and sold by a third party, causing the sale of PIXUVRI or Opaxio to fall by a percentage in the high double-digits. To the extent we are required to pay royalties on net sales of Opaxio pursuant to the PG-TXL Agreement, we may credit a percentage of the amount of such royalties paid to those payable to Novartis, subject to certain exceptions. Notwithstanding the foregoing, royalty payments for both PIXUVRI and Opaxio are subject to certain minimum floor percentages in the low single-digits.

Nerviano Medical Sciences

Our license agreement with Nerviano Medical Sciences, S.r.l. for brostallicin, dated October 6, 2006, provides for the potential payment by us of up to $80 million in milestone payments based on the achievement of certain product development results. Due to the early stage of development of brostallicin, we cannot make a determination that the milestone payments are reasonably likely to occur at this time.

Cephalon

In June 2005, we entered into an acquisition agreement with Cephalon, Inc., or Cephalon. Cephalon was subsequently acquired by Teva Pharmaceutical Industries Ltd., or Teva. Under this agreement, we have the right to receive up to $100 million in payments upon achievement by Teva of specified sales and development milestones related to TRISENOX. In November 2013, we received a $5.0 million payment related to achievement of a sales milestone.

Critical Accounting Estimates

We make certain judgments and use certain estimates and assumptions when applying accounting principles generally accepted in the U.S. in the preparation of our condensed consolidated financial statements. We evaluate our estimates and judgments on an on-going basis and base our estimates on historical experience and on assumptions that we believe to be reasonable under the circumstances. Our experience and assumptions form the basis for our judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may vary materially from what we anticipate and different assumptions or estimates about the future could change our reported results. There have been no material changes to our critical accounting estimates discussed in our 2013 Form 10-K. For a discussion of our critical accounting estimates, please see Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2013 Form 10-K.

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

Foreign Exchange Market Risk

We are exposed to risks associated with the translation of euro-denominated financial results and accounts into U.S. dollars for financial reporting purposes. Changes in the value of the U.S. dollar as compared to the euro might have an adverse effect on our reported results of operations and financial condition. As the net positions of our unhedged foreign currency transactions fluctuate, our earnings might be negatively affected. In addition, the reported carrying value of our euro denominated assets and liabilities held in our European branches and subsidiaries will be affected by fluctuations in the value of the U.S. dollar compared to the euro. As of March 31, 2014, we had a net asset balance, excluding intercompany payables and receivables, in our European branches and subsidiaries denominated in euros. If the euro were to weaken 20 percent against the dollar, our net asset balance would decrease by approximately $2.4 million as of this date.

Interest Rate Risk

As of March 31, 2014, we had an outstanding balance under our senior secured term loan of $15.0 million, and we have the option to borrow an additional $5.0 million through October 31, 2014, subject to certain conditions. The senior secured term loan bears interest at variable rates. Based on the outstanding amount under such loan at March 31, 2014 of $15.0 million (which remains outstanding as of the time of this filing) a 1.0 percent increase in interest rates would result in additional annualized interest expense of $0.1 million. For a detailed discussion of our senior secured term loan, including a discussion of the applicable interest rate, please refer to Note 3, Long-term Debt under Part I, Item 1 in this Quarterly Report on Form 10-Q.

Item 4.

Controls and Procedures

(a) Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, or the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the U.S. Securities and Exchange Commission, or the SEC, and that such information is accumulated and communicated to our management to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.

Our management, under the supervision and with the participation of our President and Chief Executive Officer and Executive Vice President, Finance and Administration, or EVP of Finance, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this Quarterly Report on Form 10-Q. Based upon that evaluation, our President and Chief Executive Officer and EVP of Finance have concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective.

(b) Changes in Internal Control over Financial Reporting

There have been no changes to our internal control over financial reporting that occurred during the first fiscal quarter ended March 31, 2014 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

Item 1.

Legal Proceedings

On December 10, 2009, the Commissione Nazionale per le Società e la Borsa (which is the public authority responsible for regulating the Italian securities markets), or CONSOB, sent us a notice claiming, among other things, violation of the provisions of Section 114, paragraph 1 of the Italian Legislative Decree no. 58/98 due to the asserted late disclosure of the contents of the opinion expressed by Stonefield Josephson, Inc., an independent registered public accounting firm, with respect to our 2008 financial statements. The sanction established by Section 193, paragraph 1 of the Italian Legislative Decree no. 58/98 for such violation could require us to pay a pecuniary administrative sanction amounting to between $7,000 and $684,000 upon conversion from euros as of March 31, 2014. Until CONSOB’s right is barred, CONSOB may, at any time, confirm the occurrence of the asserted violation and apply a pecuniary administrative sanction within the foregoing range. To date, we have not received any such notification.

In April 2009, December 2009 and June 2010, the Italian Tax Authority, or the ITA, issued notices of assessment to CTI (Europe) based on the ITA’s audit of CTI (Europe)’s VAT returns for the years 2003, 2005, 2006 and 2007. The ITA audits concluded that CTI (Europe) did not collect and remit VAT on certain invoices issued to non-Italian clients for services performed by CTI (Europe). The assessments, including interest and penalties, for the years 2003, 2005, 2006 and 2007 are €0.5 million, €5.5 million, €2.5 million and €0.8 million. We believe that the services invoiced were non-VAT taxable consultancy services and that the VAT returns are correct as originally filed. We are defending ourselves against the assessments both on procedural grounds and on the merits of the case, although we can make no assurances regarding the ultimate outcome of these cases. If the final decision of the Supreme Court is unfavorable to us, or if, in the interim, the ITA were to make a demand for payment and we were to be unsuccessful in suspending collection efforts, we may be requested to pay the ITA an amount up to €9.4 million, or approximately $12.9 million converted using the currency exchange rate as of March 31, 2014, plus collection fees, notification expenses and additional interest for the period lapsed between the date in which the assessments were issued and the date of effective payment.

2003 VAT. In September 2011, the Provincial Tax Court issued decision no. 229/3/2011, which (i) fully accepted the merits of our appeal, (ii) declared that no penalties can be imposed against us and (iii) found the ITA liable to pay us €10,000, as partial refund of the legal expenses we incurred for our appeal. In October 2012, the ITA appealed this decision. In June 2013, the Regional Tax Court issued decision no. 119/50/13, which accepted the appeal of the ITA and reversed the previous decision of the Provincial Tax Court. We plan to appeal such decision to the Supreme Court both on procedural grounds and on the merits of the case. In March 2014, we paid a deposit in respect of the 2003 VAT matter of €0.4 million, or approximately $0.6 million upon conversion from euros as of the date of payment following the ITA’s request for such payment.

2005 VAT. In January 2011, the Provincial Tax Court issued decision No. 4/2010 which (i) partially accepted our appeal and declared that no penalties can be imposed against us, (ii) confirmed the right of the ITA to reassess the VAT (plus interest) in relation to the transactions identified in the 2005 notice of assessment and (iii) repealed the suspension of the notice of deposit payment. Both the ITA and CTI appealed to the higher court against the decision. In October 2012, the Regional Tax Court issued a decision no. 127/31/2012, which (i) fully accepted the merits of our appeal and (ii) confirmed that no penalties can be imposed against us. On April 15, 2013, the ITA appealed the decision to the Italian Supreme Court.

2006 VAT. In October 2011, the Provincial Tax Court issued decision no. 276/21/2011 (jointly with the 2007 VAT case) in which it (i) fully accepted the merits of our appeal, (ii) declared that no penalties can be imposed against us and (iii) found that for the 2006 and 2007 VAT cases the ITA was liable to pay us €10,000 as partial refund of the legal expenses incurred for the appeal. In December 2011, the ITA appealed this decision to the Regional Tax Court. On April 16, 2013, the Regional Tax Court issued decision no. 57/35/13 (jointly with the 2007 VAT case) in which it fully rejected the merits of the ITA’s appeal, declared that no penalties can be imposed against us and found the ITA liable to pay us €12,000, as partial refund of the legal expenses we incurred for this appeal. The ITA appealed such decision in November 2013.

2007 VAT. In October 2011, the Provincial Tax Court issued decision no. 276/21/2011 (jointly with the 2006 VAT case described above) in which the Provincial Tax Court (i) fully accepted the merits of our appeal, (ii) declared that no penalties can be imposed against us, and (iii) found that for 2006 and 2007 VAT cases the ITA was liable to pay us €10,000 as partial refund of the legal expenses incurred for the appeal. In December 2011, the ITA appealed this decision to the Regional Tax Court. On April 10, 2013, the ITA refunded the VAT deposit including interest and collection fees of €0.1 million. On April 16, 2013, the Regional Tax Court issued decision no. 57/35/13 (jointly with the 2006 VAT case) in which it fully rejected the merits of the ITA’s appeal, declared that no penalties can be imposed against us and found the ITA liable to pay us €12,000 as partial refund of the legal expenses we incurred for this appeal. The ITA appealed such decision in November 2013.

In July 2012, Chroma sent us a letter claiming that we breached the Chroma License Agreement by allegedly making decisions as to the development of tosedostat without requisite approval, failing to hold certain meetings and not using diligent efforts to develop tosedostat. We dispute the allegations on numerous grounds; in particular, we believe Chroma failed to comply with certain of its antecedent obligations and failed to demonstrate an ability to manufacture tosedostat to requisite standards. A party may terminate the Chroma License Agreement for a material breach only after arbitration. Court proceedings have not been initiated as of the time of this filing.

In addition to the items discussed above, we are from time to time subject to legal proceedings and claims arising in the ordinary course of business.

Item 1A.

Risk Factors

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. The occurrence of any of the following risks described below and elsewhere in this document, including the risk that our actual results may differ materially from those anticipated in these forward-looking statements, could materially adversely affect our business, financial condition, operating results or prospects and the trading price of our common stock. Additional risks and uncertainties that we do not presently know or that we currently deem immaterial may also impair our business, financial condition, operating results and prospects and the trading price of our common stock.

Factors Affecting Our Operating Results and Financial Condition

We expect that we will need to raise additional financing to develop our business, but additional funds may not be available on acceptable terms, or at all. Any inability to raise required capital when needed could impair our ability to make our contractually obligated payments and harm our liquidity, financial condition, business, operating results and prospects.

We have substantial operating expenses associated with the development of our product candidates and the commercialization of PIXUVRI, and we have significant contractual payment obligations. Our available cash and cash equivalents were $50.6 million as of March 31, 2014. At our currently planned spending rate, we believe that our present financial resources, together with potential pacritinib milestone payments projected to be earned and received over the course of 2014 and 2015 under our collaboration with Baxter and expected European sales from PIXUVRI, will be sufficient to fund our operations into the third quarter of 2015. Cash forecasts and capital requirements are subject to change as a result of a variety of risks and uncertainties. Changes in manufacturing, clinical trial expenses, acquisitions of compounds or other assets, any expansion of our sales and marketing organization in Europe, activities with respect to regulatory approvals and other unplanned business developments may consume capital resources earlier than planned. Additionally, we may not receive the anticipated pacritinib milestone payments or sales from PIXUVRI. Due to these and other factors, our forecast for the period for which we will have sufficient resources to fund our operations, as well as any other operational or business projection we have disclosed, or may, from time to time, disclose, may fail.

We have $15.0 million outstanding under our senior secured term loan agreement and have an option to borrow an additional $5.0 million through October 31, 2014, subject to certain conditions. Based on the current outstanding balance, we are required to make monthly interest payments of approximately $158,000, and commencing November 1, 2014 through October 1, 2016, we will be required to make monthly interest plus principal payments in the aggregate amount of approximately $709,000. The senior secured term loan agreement

also requires us to comply with restrictive covenants, including those that limit our operating flexibility and ability to borrow additional funds. A failure to make a required loan payment or an uncured covenant breach could lead to an event of default, and in such case, all amounts then outstanding may become due and payable immediately.

We expect that we will need to acquire additional funds in order to develop our business, including in the event our costs are greater than anticipated or our cash inflow projections fail, or in the event we seek to expand our operations. We may seek to raise such capital through equity or debt financings, partnerships, collaborations, joint ventures, disposition of assets or other sources, but our ability to do so is subject to a number of risks and uncertainties, including:

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our ability to raise capital through the issuance of additional shares of our common stock or convertible securities is restricted by the limited number of our residual authorized shares, the difficulty of obtaining shareholder approval to increase authorized shares, and the restrictive covenants of our senior secured term loan agreement;

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issuance of equity securities or convertible securities will dilute the proportionate ownership of existing shareholders;

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our ability to raise debt capital is limited by our existing senior secured term loan agreement;

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some of such arrangements may require us to relinquish rights to certain assets; and

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we may be required to meet additional regulatory requirements, and we may be subject to certain contractual limitations, which may increase our costs and harm our ability to obtain funding.

For these and other reasons, additional funding may not be available on favorable terms or at all. If we fail to obtain additional capital when needed, we may be required to delay, scale back or eliminate some or all of our research and development programs, reduce our selling, general and administrative expenses and/or refrain from making our contractually required payments when due, which could harm our business, financial condition, operating results and prospects.

We may continue to incur net losses, and we may never achieve profitability.

We were incorporated in 1991 and have incurred a net operating loss every year since our formation. As of March 31, 2014, we had an accumulated deficit of $1.9 billion. We are pursuing regulatory approvals for PIXUVRI, pacritinib, tosedostat and Opaxio. We will need to continue to conduct research, development, testing and regulatory compliance activities and procure manufacturing and drug supply services, the costs of which, together with projected general and administrative expenses, may result in operating losses for the foreseeable future. There can be no assurances that we will ever achieve profitability.

If our collaboration with Baxter with respect to pacritinib or any other collaboration for our products or product candidates is not successful, or if we are unable to enter into additional collaborations, we may not be able to effectively develop and/or commercialize the applicable product(s), which could have a material adverse effect on our business.

Under the Baxter Agreement, we rely heavily on Baxter to collaborate with us in respect of the development and global commercialization of our lead product candidate, pacritinib. As a result of our dependence on our relationship with Baxter, the eventual success or commercial viability of pacritinib is, to a certain extent, beyond our control. We are subject to a number of specific risks associated with our dependence on our collaborative relationship with Baxter, including: possible disagreements between Baxter and us as to the timing, nature and extent of our development plans, including clinical trials or regulatory approval strategy; changes in personnel at Baxter who are key to the collaboration efforts; any changes in Baxter’s business strategy adverse to our interests; and possible disagreements with Baxter regarding ownership of proprietary rights. Furthermore, the contingent financial returns under our collaboration with Baxter depend in large part on the achievement of development and commercialization milestones, plus a share of revenues from any sales. Therefore, our success, and any associated future financial returns to us and our investors, will depend in large in part on the performance of both Baxter and us under the Baxter Agreement.

The continued development of our other compounds also depends on our ability to enter into and/or maintain collaborations. We have entered into a third-party service provider agreement with Quintiles Commercial Europe Limited, which provides a variety of services related to the commercialization of PIXUVRI in Europe. We are also pursuing potential partners for commercializing PIXUVRI in other markets, excluding countries in the E.U. where CTI has a commercial presence and the U.S. Because we rely on third parties to manufacture, distribute, and market and sell PIXUVRI, we have limited control over the efforts of these third parties, and we may receive less revenue than if we commercialized PIXUVRI ourselves. We are also a party to other agreements with third parties for our product candidates, including an agreement with the GOG, to perform a Phase 3 trial of Opaxio in patients with ovarian cancer.

If we fail to enter into additional collaborative arrangements or to maintain existing or future arrangements and service provider relationships, we may be unable to further develop and commercialize product candidates, generate revenues to grow, sustain our business or achieve profitability, which would harm our business, financial condition, operating results and prospects.

Product candidates that appear promising in research and development may fail to reach later stages of development for a number of reasons, including, among others, that clinical trials may take longer to complete than expected or may not be completed at all.

Successful development of anti-cancer and other pharmaceutical products is highly uncertain, and obtaining regulatory approval to market drugs to treat cancer is expensive, difficult and speculative. Product candidates that appear promising in research and development may fail to reach later stages of development for several reasons, including, but not limited to:

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delay or failure in obtaining necessary U.S. and international regulatory approvals, or the imposition of a partial or full regulatory hold on a clinical trial;

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difficulties in formulating a product candidate, scaling the manufacturing process and obtaining manufacturing approval, pricing, reimbursement issues or other factors that may make the product uneconomical to commercialize;

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production problems, such as the inability to obtain raw materials or supplies satisfying acceptable standards for the manufacture of our products, equipment obsolescence, malfunctions or failures, product quality/contamination problems or changes in regulations requiring manufacturing modifications;

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inefficient cost structure of a product candidate compared to alternative treatments;

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obstacles resulting from proprietary rights held by others with respect to a product candidate, such as patent rights;

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lower than anticipated rates of patient enrollment as a result of factors, such as the number of patients with the relevant conditions, the proximity of patients to clinical testing centers, eligibility criteria for tests and competition with other clinical testing programs;

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preclinical or clinical testing requiring significantly more time than expected, resources or expertise than originally expected and inadequate financing, which could cause clinical trials to be delayed or terminated;

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failure of clinical testing to show potential products to be safe and efficacious, and failure to demonstrate desired safety and efficacy characteristics in human clinical trials;

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suspension of a clinical trial at any time by us, a collaboration partner or a regulatory authority on the basis that the participants are being exposed to unacceptable health risks or for other reasons; or

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failure of third parties, such as contract research organizations, academic institutions, collaborators, cooperative groups and/or investigator sponsors, to conduct, oversee and monitor clinical trials and results.

If the development of our product candidates is delayed or fails, our development costs may increase and the ability to commercialize our product candidates may be harmed, which could harm our business, financial condition, operating results or prospects.

We or our collaboration partners may not obtain or maintain the regulatory approvals required to commercialize some or all of our products.

We are subject to rigorous and extensive regulation by the FDA in the U.S. and by comparable agencies in other states and countries, including the EMA in the E.U. Pacritinib and our other product candidates are currently in research or development and, other than conditional marketing authorization for PIXUVRI in the E.U., we have not received marketing approval for our compounds (and we are not currently pursuing FDA marketing approval of PIXUVRI). Information about the status of regulatory approvals of our compounds can be found in Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and is incorporated by reference herein. Our products may not be marketed in the U.S. until they have been approved by the FDA and may not be marketed in other countries until they have received approval from the appropriate agencies. Each product candidate requires significant research, development and preclinical testing and extensive clinical investigation before submission of any regulatory application for marketing approval. Obtaining regulatory approval requires substantial time, effort and financial resources, and we may not be able to obtain approval of any of our products on a timely basis, or at all. The number and focus of preclinical and clinical trials that will be required for approval by the FDA, the EMA or any other foreign regulatory agency varies depending on the drug candidate, the disease or condition that the drug candidate is designed to address and the regulations applicable to any particular drug candidate. Preclinical and clinical data can be interpreted in different ways, which could delay, limit or preclude regulatory approval. The FDA, the EMA and other foreign regulatory agencies can delay, limit or deny approval of a drug candidate for many reasons, including, but not limited to:

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a drug candidate may not be shown to be safe or effective;

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a clinical trial results in negative or inconclusive results or adverse medical events occur during a clinical trial;

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they may not approve the manufacturing process of a drug candidate;

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they may interpret data from pre-clinical and clinical trials in different ways than we do;

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a drug candidate may fail to comply with regulatory requirements; or

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they might change their approval policies or adopt new regulations.

Any delay or failure by us to obtain regulatory approvals of our products could adversely affect the marketing of our products. If our products are not approved quickly enough to provide net revenues to defray our operating expenses, our business, financial condition and operating results will be harmed.

Even if our drug candidates are successful in clinical trials and receive regulatory approvals, we or our collaboration partners may not be able to successfully commercialize them.

Pacritinib, Opaxio and tosedostat are currently in clinical trials; the development and clinical trials of these products may not be successful and, even if they are, such products may never be successfully developed into commercial products. Even if our products are successful in clinical trials or in obtaining other regulatory approvals, our products (even those that have been granted conditional marketing authorization, such as PIXUVRI) may not reach the market for a number of reasons including:

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they may be found ineffective or cause harmful side effects;

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they may be difficult to manufacture on a scale necessary for commercialization;

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they may be uneconomical to produce;

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we may fail to obtain reimbursement amount approvals or pricing that is cost effective for patients as compared to other available forms of treatment;

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they may not compete effectively with existing or future alternatives to our products;

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we are unable to sell marketing rights or develop commercial operations;

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they may fail to achieve market acceptance; or

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we may be precluded from commercialization of our products by proprietary rights of third parties.

In particular, with respect to the future potential commercialization of pacritinib, we will be heavily dependent on our collaboration partner, Baxter. Under the terms of our agreement, Baxter has exclusive commercialization rights for all indications for pacritinib outside the U.S., while we share commercialization rights with Baxter in the U.S.

The failure of Baxter (or any other applicable collaboration partner) to fulfill its commercialization obligations with respect to a product, or the occurrence of any of the events itemized in the foregoing list, could adversely affect the commercialization of our products. If we fail to commercialize products or if our future products do not achieve significant market acceptance, we will not likely generate significant revenues or become profitable.

If users of our products are unable to obtain adequate reimbursement from third-party payors, market acceptance of our products may be limited and we may not achieve anticipated revenues.

To the extent our products are successfully introduced to market, they may not be considered cost-effective and third-party or government reimbursement might not be available or sufficient. Governmental and other third-party payors continue to attempt to contain healthcare costs by strictly controlling, directly or indirectly, pricing and reimbursement, and we expect pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S. to continue. In almost all European markets, pricing and choice of prescription pharmaceuticals are subject to governmental control. Therefore, the price of our products and their reimbursement in Europe is and will be determined by national regulatory authorities. A variety of factors are considered in making reimbursement decisions, including whether there is sufficient evidence to show that treatment with the product is more effective than current treatments, that the product represents good value for money for the health service it provides and that treatment with the product works at least as well as currently available treatments. Reimbursement decisions from any of the European markets may impact reimbursement decisions in other European markets. The continuing efforts of government and insurance companies, health maintenance organizations and other payors of healthcare costs to contain or reduce costs of health care may affect our future revenues and profitability, and the future revenues and profitability of our potential customers, suppliers and collaborative partners and the availability of capital.

We may never be able to generate significant product revenues from the sale of PIXUVRI.

We anticipate that, for at least the next several years, our ability to generate revenues and become profitable will depend on the commercial success in Europe of our only marketed product candidate, PIXUVRI. PIXUVRI is not approved for marketing in the U.S. PIXUVRI is available to healthcare providers in certain countries in Europe. See Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a discussion of the reimbursement status in applicable European countries. However, our ability to continue to commercialize PIXUVRI in the E.U. will depend on our ability to obtain an annual renewal of our conditional marketing authorization for PIXUVRI and to timely complete the post-marketing study of PIXUVRI aimed at confirming the clinical benefit previously observed in PIXUVRI. A failure of such study could result in a cessation of commercialization of PIXUVRI in the E.U.

In addition, the successful commercialization of PIXUVRI in Europe depends heavily on our ability to obtain and maintain favorable reimbursement rates for users of PIXUVRI, as well as on various additional factors, including, without limitation, our ability to:

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increase and maintain demand for and sales of PIXUVRI in Europe and obtain greater acceptance of PIXUVRI by physicians and patients;

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establish and maintain agreements with wholesalers and distributors on reasonable terms;

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maintain, and enter into additional, commercial manufacturing arrangements with third-parties, cost-effectively manufacture necessary quantities and build distribution, managerial and other capabilities; and

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further develop and maintain a commercial organization to market PIXUVRI.

If we are unable to successfully commercialize PIXUVRI in Europe as planned, our business, financial condition, operating results and prospects could be harmed.

We have in the past received and may in the future receive audit reports with an explanatory paragraph on our consolidated financial statements.

Our independent registered public accounting firm included an explanatory paragraph in its reports on our consolidated financial statements for each of the years ended December 31, 2007 through December 31, 2011 regarding their substantial doubt as to our ability to continue as a going concern. Although our independent registered public accounting firm removed this going concern explanatory paragraph in its report on our December 31, 2012 consolidated financial statements, we expect to continue to need to raise additional financing to develop our business and satisfy obligations as they become due. The inclusion of a going concern explanatory paragraph in future years may negatively impact the trading price of our common stock and make it more difficult, time consuming or expensive to obtain necessary financing, and we cannot guarantee that we will not receive such an explanatory paragraph in the future.

We may not be able to maintain our listings on The NASDAQ Capital Market and the MTA in Italy, or trading on these exchanges may otherwise be halted or suspended, which may make it more difficult for investors to sell shares of our common stock.

Maintaining the listing of our common stock on The NASDAQ Capital Market requires that we comply with certain listing requirements. We have in the past and may in the future fail to continue to meet one or more listing requirements. For example, in June 2012, we received a notification from The NASDAQ Stock Market LLC, or NASDAQ, indicating non-compliance with the requirement to maintain a minimum closing bid price of $1.00 per share and that we would be delisted if we did not timely regain compliance. We regained compliance through a reverse stock split in September 2012, but we could fail to meet the continued listing requirements as a result of a decrease in our stock price or otherwise.

If our common stock ceases to be listed for trading on The NASDAQ Capital Market for any reason, it may harm our stock price, increase the volatility of our stock price, decrease the level of trading activity and make it more difficult for investors to buy or sell shares of our common stock. Our failure to maintain a listing on The NASDAQ Capital Market may constitute an event of default under our senior secured term loan and any future indebtedness, which would accelerate the maturity date of such debt or trigger other obligations. In addition, certain institutional investors that are not permitted to own securities of non-listed companies may be required to sell their shares adversely affecting the trading price of our common stock. If we are not listed on The NASDAQ Capital Market or if our public float falls below $75 million, we will be limited in our ability to file new shelf registration statements on SEC Form S-3 and/or to fully use one or more registration statements on SEC Form S-3. We have relied significantly on shelf registration statements on SEC Form S-3 for most of our financings in recent years, so

any such limitations may harm our ability to raise the capital we need. Delisting from The NASDAQ Capital Market could also affect our ability to maintain our listing or trading on the MTA. Trading in our common stock has been halted or suspended on both The NASDAQ Capital Market and MTA in the past and may also be halted or suspended in the future due to market or trading conditions at the discretion of The NASDAQ Stock Market LLC, CONSOB or the Borsa Italiana (which ensures the development of the managed markets in Italy). Any halt or suspension in the trading in our common stock may negatively impact the trading price of our common stock.

We may be unable to obtain a quorum for meetings of our shareholders or obtain necessary shareholder approvals and therefore be unable to take certain corporate actions.

Our articles of incorporation require that a quorum, generally consisting of one-third of the outstanding shares of voting stock, be represented in person, by telephone or by proxy in order to transact business at a meeting of our shareholders. In addition, amendments to our articles of incorporation, such as an amendment to increase our authorized capital stock, generally require the approval of a majority of our outstanding shares. Failure to meet a quorum or obtain shareholder approval can prevent us from raising capital through equity financing or otherwise taking certain actions that may be in the best interest of the company and shareholders.

A substantial majority of our common shares are held by Italian institutions and, under Italian laws and regulations, it is difficult to communicate with the beneficial holders of those shares to obtain votes. In 2006, we were unable to obtain a quorum at two scheduled annual meetings. Following that failure to obtain a quorum, we contacted certain depository banks in Italy where significant numbers of shares of our common stock were held and asked them to cooperate by making a book-entry transfer of their share positions at Monte Titoli to their U.S. correspondent bank, who would then transfer the shares to an account of the Italian bank at a U.S. broker-dealer that is an affiliate of that bank. Certain of the banks contacted agreed to make the share transfer pursuant to these arrangements as of the record date of the meeting, subject to the relevant beneficial owner being given notice before such record date and taking no action to direct the voting of such shares. Obtaining a quorum and necessary shareholder approvals at shareholder meetings will depend in part upon the willingness of the Italian depository banks to continue participating in the custody transfer arrangements, and we cannot be assured that those banks that have participated in the past will continue to participate in custody transfer arrangements in the future.

As a result of the foregoing, we may be unable to obtain a quorum or shareholder approval of proposals, when needed, at annual or special meetings of shareholders. Even if we are able to obtain a quorum at our shareholder meetings, we may not obtain enough votes to approve matters to be resolved upon at those meetings. For example, a proposal to approve a reverse stock split failed to receive sufficient votes to pass at the March 2009 shareholders meeting. Any failure to obtain a quorum or the requisite vote on a proposal in question could harm us.

We could fail in financing efforts if we fail to receive shareholder approval when needed.

We are required under the NASDAQ Marketplace Rules to obtain shareholder approval for any issuance of additional equity securities that would comprise more than 20 percent of the total shares of our common stock outstanding before the issuance of such securities sold at a discount to the greater of book or market value in an offering that is not deemed to be a “public offering” by the NASDAQ Marketplace Rules or NASDAQ as well as under certain other circumstances. We have in the past and may in the future issue additional equity securities that would comprise more than 20 percent of the total shares of our common stock outstanding in order to fund our operations. However, we might not be successful in obtaining the required shareholder approval for any future issuance that requires shareholder approval pursuant to the NASDAQ Marketplace Rules, particularly in light of the difficulties we have experienced in obtaining a quorum and holding shareholder meetings discussed above. If we are unable to obtain financing due to shareholder approval difficulties, such failure may harm our ability to continue operations.

We are subject to limitations on our ability to issue additional shares of our common stock or undertake other business initiatives due to Italian regulatory requirements.

Compliance with Italian regulatory requirements may delay additional issuances of our common stock or other business initiatives. Under Italian law, we must publish a registration document, securities note and summary that have to be approved by CONSOB prior to issuing common stock that exceeds, in any twelve-month period, 10

percent of the number of shares of our common stock outstanding at the beginning of that period, subject to certain exceptions. If we are unable to obtain and maintain a registration document, securities note or summary to cover general financing efforts under Italian law, we may be required to raise money using alternative forms of securities. For example, we have in the past issued convertible preferred stock and may in the future issue convertible securities because the common stock resulting from the conversion of such securities, subject to current provisions of European Directive No. 71/2003 and, according to the current interpretations of the Committee of European Securities Regulators, is not subject to the 10 percent limitation imposed by E.U. and Italian law. However, any changes to Italian regulatory requirements, exemptions or interpretations may increase compliance costs or limit our ability to issue securities.

We are subject to Italian regulatory requirements, which could result in administrative and other challenges and additional expenses.

Because our common stock is traded on the MTA in Italy, we are required to also comply with the rules and regulations of CONSOB and the Borsa Italiana, which regulate companies listed on Italy’s public markets. Compliance with these regulations and responding to periodic information requests from Borsa Italiana and CONSOB requires us to devote additional time and resources to regulatory compliance matters and to incur additional expenses of engaging additional outside counsel, accountants and other professional advisors. Actual or alleged failure to comply with Italian regulators can also subject us to regulatory investigations. For more information on current investigations, see the regulatory investigations that are discussed in more detail in Part II, Item 1, “Legal Proceedings.”

We will incur a variety of costs for and may never realize the anticipated benefits of acquisitions.

We evaluate and acquire assets and technologies from time to time. If appropriate opportunities become available, we may attempt to acquire other businesses and assets that we believe are a strategic fit with our business. The process of negotiating an acquisition and integrating an acquired business and assets may result in operating difficulties and expenditures. In addition, our acquisitions may require significant management attention that would otherwise be available for ongoing development of our business, whether or not any such transaction is ever consummated. Moreover, we may never realize the anticipated benefits of any acquisition. Any acquisitions could result in potentially dilutive issuances of equity securities, including common stock and preferred stock, the incurrence of debt, contingent liabilities and/or amortization expenses related to intangible assets, which could harm our business, financial condition, operating results or prospects. In addition, following any acquisition our results of operations and the market price of our common stock may be affected by factors different from those that affected our results of operations and the market price of our common stock prior to such acquisition.

We may owe additional amounts for value added taxes related to our operations in Europe.

Our European operations are subject to the VAT, which is usually applied to all goods and services purchased and sold throughout Europe. The VAT receivable was $5.8 million and $5.7 million as of March 31, 2014 and December 31, 2013, respectively. On April 14, 2009, December 21, 2009 and June 25, 2010, the ITA issued notices of assessment to CTI (Europe) based on the ITA’s audit of CTI (Europe)’s VAT returns for the years 2003, 2005, 2006 and 2007. The ITA audits concluded that CTI (Europe) did not collect and remit VAT on certain invoices issued to non-Italian clients for services performed by CTI (Europe). The assessments, including interest and penalties, for the years 2003, 2005, 2006 and 2007 are €0.5 million, €5.5 million, €2.5 million and €0.8 million. While we are defending ourselves against the assessments both on procedural grounds and on the merits of the case, there can be no assurances that we will be successful in such defense. Further information pertaining to these cases can be found in Part II, Item 1, “Legal Proceedings” and is incorporated by reference herein. If the final decision of the Supreme Court is unfavorable to us, or if, in the interim, the ITA were to make a demand for payment and we were to be unsuccessful in suspending collection efforts, we may be requested to pay to the ITA an amount up to €9.4 million (or approximately $12.9 million converted using the currency exchange rate as of March 31, 2014) plus collection fees, notification expenses and additional interest for the period lapsed between the date in which the assessments were issued and the date of effective payment.

Even if our products receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review by the FDA, the EMA and other foreign regulatory agencies, as applicable, and may be subject to additional post-marketing obligations, all of which may result in significant expense and limit commercialization of our products, including PIXUVRI.

Even if our other products receive regulatory approvals, we will be subject to numerous regulations and statutes regulating the manner of selling and obtaining reimbursement for those products. Regulatory approvals that we receive for our products may be subject to limitations on the indicated uses for which the product may be marketed or require potentially costly post-marketing follow-up studies. Even if a product receives regulatory approval, we may not be able to maintain compliance with regulatory requirements, which could result in the product being withdrawn from the market, product seizures, injunctions, regulatory restrictions on our business and sales activities, monetary penalties or criminal prosecution. In addition, PIXUVRI is subject to extensive regulatory requirements regarding its labeling, packaging, adverse event reporting, storage, advertising, promotion and record-keeping. If the FDA, the EMA or other foreign regulatory agency approves any of our other products, they will also be subject to similar extensive regulatory requirements. The subsequent discovery of previously unknown problems with PIXUVRI or any of our other products, including adverse events of unanticipated severity or frequency, or the discovery that adverse effects or unknown toxicities observed in preclinical research or clinical trials that were believed to be minor actually constitute more serious problems, may result in restrictions on the marketing of the product or withdrawal of the drug from the market. If we are not granted full approval of PIXUVRI in the E.U. or we are unable to renew our conditional marketing authorization for PIXUVRI in the E.U., our business, financial condition, operating results and prospects would be harmed.

We cannot predict the outcome of our post-approval commitment trial for PIXUVRI, and any failure thereof, as well as any additional clinical trials or actions we may need to pursue to obtain approval in the E.U. or otherwise, may negatively affect our business, financial condition, operating results or prospects.

In March 2011, we initiated a randomized pivotal trial of PIXUVRI for the treatment of relapsed or refractory aggressive B-cell NHL. This post-approval commitment trial, referred to as PIX-R, or PIX306, compares a combination of PIXUVRI plus rituximab to a combination of gemcitabine plus rituximab in patients who have relapsed after one to three prior regimens for aggressive B-cell NHL and who are not eligible for autologous stem cell transplant. We cannot predict the outcome of PIX306. We may not be able to demonstrate the clinical benefit of PIXUVRI in patients who had previously received rituximab or that PIXUVRI is more clinically effective than treatments currently used in clinical practice. We may not be able to complete the PIX306 clinical trial by June 2015 or at all. If we are unable to submit the trial data from PIX306 by June 2015, it may result in the withdrawal of the conditional marketing authorization for PIXUVRI by the E.U. We may also need to take additional steps to obtain regulatory approval of PIXUVRI. The expense to design and conduct clinical trials are substantial, and any failure of PIX306, as well as any additional clinical trials or actions we may need to pursue to obtain approval of PIXUVRI in the E.U. or otherwise, may negatively affect our business, financial condition, operating results or prospects.

We may be subject to fines, penalties, injunctions and other sanctions if we are deemed to be promoting the use of our products for non-FDA-approved, or off-label, uses.

Our business and future growth depend on the development, use and ultimate sale of products that are subject to FDA, EMA and or other regulatory agencies regulation, clearance and approval. Under the U.S. Federal Food, Drug, and Cosmetic Act and other laws, we are prohibited from promoting our products for off-label uses. This means that in the U.S., we may not make claims about the safety or effectiveness of our products and may not proactively discuss or provide information on the use of our products, except as allowed by the FDA.

Government investigations concerning the promotion of off-label uses and related issues are typically expensive, disruptive and burdensome, generate negative publicity and may result in fines or payments of settlement awards. For example, in April 2007, we paid a civil penalty of $10.6 million and entered into a settlement agreement with the USAO for the Western District of Washington arising out of their investigation into certain of our prior marketing practices relating to TRISENOX, which was divested to Cephalon in July 2005. As part of that settlement agreement and in connection with the acquisition of Zevalin, we also entered into a corporate integrity agreement with the Office of the Inspector General, Health and Human Services, which required us to establish a compliance committee and compliance program and adopt a formal code of conduct. If our promotional activities are found to be in violation of applicable law or if we agree to a settlement in connection with an enforcement action, we would likely face significant fines and penalties and would likely be required to substantially change our sales, promotion, grant and educational activities.

A failure to comply with laws and regulations that govern our cross-border conduct, as well as with healthcare fraud and abuse and false claims laws and regulations, could result in substantial penalties and prosecution.

We are subject to risks associated with doing business outside of the U.S., which exposes us to complex foreign and U.S. regulations. For example, we are subject to regulations imposed by the Foreign Corrupt Practices Act, or FCPA, and other anti-corruption laws that generally prohibit U.S. companies and their intermediaries from offering, promising, authorizing or making improper payments to foreign government officials for the purpose of obtaining or retaining business. The SEC and U.S. Department of Justice have increased their enforcement activities with respect to the FCPA. Internal control policies and procedures and employee training and compliance programs that we have implemented to deter prohibited practices may not be effective in prohibiting our employees, contractors or agents from violating or circumventing our policies and the law.

In addition, we are subject to various state and federal fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and federal False Claims Act. There are similar laws in other countries. These laws may impact, among other things, the sales, marketing and education programs for our drugs. The federal Anti-Kickback Statute prohibits persons from knowingly and willingly soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a federal healthcare program. The federal False Claims Act prohibits persons from knowingly filing, or causing to be filed, a false claim to, or the knowing use of false statements to obtain payment from the federal government. Suits filed under the False Claims Act can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. Many states have also adopted laws similar to the federal Anti-Kickback Statute and False Claims Act.

We are unable to predict whether we could be subject to actions under any of the foregoing or similar laws and regulations, or the impact of such actions. If we were to be found to be in violation of these laws or regulations, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from government healthcare reimbursement programs and the curtailment or restructuring of our operations, all of which could have a material adverse effect on our business and results of operations.

We are dependent on third-parties for a number of significant activities including, in particular, for the manufacture, testing and distribution of products and product candidates and associated activities. Any failure or delay in these undertakings by third-parties could harm our business.

Our business is dependent on the performance by third parties of their responsibilities under contractual relationships, including, in particular, for the manufacture, testing and distribution of products and product candidates and associated activities. We do not have internal analytical laboratory or manufacturing facilities to allow the testing or production of drug products in compliance with current Good Manufacturing Practices, or cGMPs. As a result, we rely on third party vendors for manufacturing services, as well as for certain warehousing, transportation, order processing and cash collection services. In particular, we are dependent on a single vendor for the manufacturing of each of PIXUVRI, pacritinib and tosedostat. With respect to Opaxio, we are relying on stored inventory of the drug, as we do not presently have a manufacturing agreement in place for this product candidate. Because we do not have a manufacturing infrastructure, we are dependent upon our vendors to supply us in a timely manner with products manufactured in compliance with cGMPs or similar manufacturing standards imposed by the U.S. and/or applicable foreign regulatory authorities, including the FDA and EMA. Any of such regulatory authorities may take action against a contract manufacturer who violates cGMPs. Failure of our manufacturers to comply with FDA, EMA or other applicable regulations may cause us to curtail or stop the manufacture of such products until we obtain regulatory compliance.

If the third parties on which we depend were to default on the performance of their contractual obligations to us or otherwise fail in properly executing their activities on our behalf, including, but not limited to, those relating to the manufacture, testing, distribution and related undertakings of a product or product candidate, our business could be harmed.

We face direct and intense competition from our competitors in the biotechnology and pharmaceutical industries, and we may not compete successfully against them.

Competition in the oncology market is intense and is accentuated by the rapid pace of technological and product development. We anticipate that we will face increased competition in the future as new companies enter the market. Our competitors in the U.S. and elsewhere are numerous and include, among others, major multinational pharmaceutical companies, specialized biotechnology companies and universities and other research institutions. Specifically:

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In Europe, PIXUVRI faces competition from existing treatments for adults with multiply relapsed or refractory aggressive B-cell NHL. For example, patients are currently being treated with bendamustine, oxaliplatin and gemcitabine, although these particular agents do not have regulatory approval in Europe for the foregoing indication. If we were to pursue bringing PIXUVRI to market in the U.S. (which is not currently part of our near-term plan), PIXUVRI would face similar competition. In addition, PIXUVRI may face competition in the E.U. (and, if applicable in the future, the U.S.) if new anti-cancer drugs with reduced toxicity and/or increased efficacy are developed and marketed in the E.U. and/or the U.S.

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If we are successful in bringing pacritinib to market, pacritinib will face competition from ruxolitinib (Jakafi ^® ) and new drugs targeting similar diseases that may be developed and marketed.

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If we are successful in bringing Opaxio to market, we will face direct competition from oncology-focused multinational corporations. Opaxio will compete with other taxanes. Many oncology-focused multinational corporations currently market or are developing taxanes, epothilones, and other cytotoxic agents, which inhibit cancer cells by a mechanism similar to taxanes, or similar products. Such corporations include, among others, Bristol-Myers Squibb Co., which market paclitaxel and generic forms of paclitaxel; Sanofi-Aventis U.S. LLC, which markets docetaxel; Genentech, Inc., Hoffmann-La Roche Inc. and Astellas Pharma US, Inc., which market Tarceva™; Genentech, Inc. and Hoffmann-La Roche Inc., which market Avastin™; Eli Lilly & Company, which markets Alimta ^® ; and Celgene Corporation, which markets Abraxane™. In addition, other companies such as Telik, Inc. are also developing products, which could compete with Opaxio.

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If we are successful in bringing tosedostat to market, tosedostat will face competition from currently marketed products, such as cytarabine, Dacogen ^® , Vidaza ^® , Clolar ^® , Revlimid ^® , Thalomid ^® and new anti-cancer drugs that may be developed and marketed.

Many of our competitors, particularly the multinational pharmaceutical companies, either alone or together with their collaborators, have substantially greater financial and technical resources and substantially larger development and marketing teams than us, as well as significantly greater experience than we do in developing, manufacturing and marketing products. As a result, products of our competitors might come to market sooner or might prove to be more effective, less expensive, have fewer side effects or be easier to administer than ours. In any such case, sales of our current or future products would likely suffer and we might never recoup the significant investments we are making to develop these product candidates.

The pharmaceutical business is subject to increasing government price controls and other restrictions on pricing, reimbursement, and access to drugs, which could affect our future revenues and profitability if new restrictive legislation is adopted.

Legislation and regulations affecting the pricing of pharmaceuticals may change in ways adverse to us before or after any of our proposed products are approved for marketing. In the U.S., we are subject to substantial pricing, reimbursement and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit managers, and implementation of U.S. health care reform legislation is increasing these pricing pressures. The Patient Protection and Affordable Care Act (HR 3590) instituted comprehensive health care reform in 2010 and includes provisions that, among other things, reduce and/or limit Medicare reimbursement, require all individuals to have health insurance (with limited exceptions) and impose new and/or increased taxes. These measures could significantly influence the purchase of healthcare services and products, resulting in lower prices and reducing demand for our products. In addition, many state legislative proposals could further negatively affect our pricing and reimbursement for, or access to, our products.

Globally, governments are becoming increasingly aggressive in imposing health care cost-containment measures such as:

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adopting more restrictive price controls;

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limiting and reducing both coverage and the amount of reimbursement for new therapeutic products;

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denying or limiting coverage for products that are approved by the FDA or the EMA, but are considered experimental or investigational by third-party payors;

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restricting access to human pharmaceuticals based on the payors’ assessments of comparative effectiveness and value;

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refusing in some cases to provide coverage when an approved product is used for disease indications in a way that has not received FDA or EMA marketing approval; and

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denying coverage altogether.

If adequate third-party or government coverage is not available, market acceptance of our products may be limited and we may not be able to maintain price levels sufficient to realize an appropriate return on our investment in research and product development or achieve anticipated revenues.

If any of our license agreements for intellectual property underlying our compounds are terminated, we may lose the right to develop or market that product.

We have acquired or licensed intellectual property from third parties, including patent applications and patents relating to intellectual property for PIXUVRI, pacritinib and tosedostat. We have also licensed the intellectual property for our drug delivery technology relating to Opaxio, which uses polymers that are linked to drugs known as polymer-drug conjugates. Some of our product development programs depend on our ability to maintain rights under these licenses. Each licensor has the power to terminate its agreement with us if we fail to meet our obligations under these licenses. We may not be able to meet our obligations under these licenses. If we default under any license agreement, we may lose our right to market and sell any products based on the licensed technology and may be forced to cease operations, liquidate our assets and possibly seek bankruptcy protection. Bankruptcy may result in the termination of agreements pursuant to which we license certain intellectual property rights.

If we are unable to acquire additional product candidates, our future product portfolio and potential profitability could be harmed.

One component of our business strategy is the in-licensing and acquisition of drug compounds developed by other pharmaceutical and biotechnology companies or academic research laboratories. PIXUVRI, pacritinib, tosedostat and Opaxio have all been in-licensed or acquired from third-parties. Competition for new promising compounds and commercial products can be intense. If we are not able to identify future in-licensing or acquisition opportunities and enter into arrangements on acceptable terms, our future product portfolio and potential profitability could be harmed.

We hold rights under numerous patents that we have acquired or licensed or that protect inventions originating from our research and development, and the expiration of any one or more of these patents may allow our competitors to copy the inventions that are currently protected.

We dedicate significant resources to protecting our intellectual property, which is important to our business. We have filed numerous patent applications in the U.S. and various other countries seeking protection of inventions originating from our research

and development, and we have also obtained rights to various patents and patent applications under licenses with third parties and through acquisitions. Patents have been issued on many of these applications. We have pending patent applications or issued patents in the U.S. and foreign countries directed to PIXUVRI, pacritinib, tosedostat, Opaxio and other product candidates. However, the lives of these patents are limited. Patents for the individual products extend for varying periods according to the date of the patent filing or grant and the legal term of patents in the various countries where patent protection is obtained. The patent status of our compounds follows:

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Our PIXUVRI-directed patents currently in force in Europe expire from 2015 through 2023. Certain of such European patents are also subject to Supplementary Protection Certificates that extend the life of the applicable patents such that they will instead expire from 2020 to 2027. In addition, we are seeking to obtain Supplementary Protection Certificates for certain other of our PIXUVRI-directed European patents that, if obtained, could provide extensions of the applicable patents through 2027. However, no assurances can be made that such extensions will be granted. Our PIXUVRI-directed U.S. patents expired in 2014, and although we have a pending PIXUVRI-directed U.S. patent application (which, if granted, would expire in 2023), we have to date been unable to obtain issuance of a patent for such application (and no assurances can be made that we will ever receive such patent). Our PIXUVRI-directed patents outside of Europe and the U.S. expire from 2015 to 2023.

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Our U.S. and various foreign pacritinib-directed patents expire from 2026 through 2029.

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Our tosedostat-directed U.S. and Canadian patents expire from 2017 to 2018, while our tosedostat-directed patents in Mexico expire in 2020.

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Our U.S. and various foreign Opaxio-directed patents expire on various dates ranging from 2017 through 2018.

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Our U.S. and various foreign brostallicin-directed patents expire on various dates ranging between 2017 through 2021.

In the absence of a patent, as in the case of PIXUVRI in the U.S., we will, to the extent possible, need to rely on unpatented technology, know-how and confidential information. Ultimately, the lack or expiration at any given time of a patent to protect our compounds may allow our competitors to copy the underlying inventions and better compete with us.

If we fail to adequately protect our intellectual property, our competitive position could be harmed.

Development and protection of our intellectual property are critical to our business. If we do not adequately protect our intellectual property, competitors may be able to practice our technologies. Our success depends in part on our ability to:

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obtain and maintain patent protection for our products or processes both in the U.S. and other countries;

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protect trade secrets; and

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prevent others from infringing on our proprietary rights.

The patent position of biopharmaceutical firms generally is highly uncertain and involves complex legal and factual questions. The U.S. Patent and Trademark Office has not established a consistent policy regarding the breadth of claims that it will allow in biotechnology patents. If it allows broad claims, the number and cost of patent interference proceedings in the U.S. and the risk of infringement litigation may increase. If it allows narrow claims, the risk of infringement may decrease, but the value of our rights under our patents, licenses and patent applications may also decrease. Patent applications in which we have rights may never issue as patents, and the claims of any

issued patents may not afford meaningful protection for our technologies or products. In addition, patents issued to us or our licensors may be challenged and subsequently narrowed, invalidated or circumvented. Litigation, interference proceedings or other governmental proceedings that we may become involved in with respect to our proprietary technologies or the proprietary technology of others could result in substantial cost to us.

We also rely upon trade secrets, proprietary know-how and continuing technological innovation to remain competitive. Third parties may independently develop such know-how or otherwise obtain access to our technology. While we require our employees, consultants and corporate partners with access to proprietary information to enter into confidentiality agreements, these agreements may not be honored.

Patent litigation is widespread in the biotechnology industry, and any patent litigation could harm our business.

Costly litigation might be necessary to protect a patent position or to determine the scope and validity of third-party proprietary rights, and we may not have the required resources to pursue any such litigation or to protect our patent rights. Any adverse outcome in litigation with respect to the infringement or validity of any patents owned by third parties could subject us to significant liabilities to third parties, require disputed rights to be licensed from third parties or require us to cease using a product or technology. With respect to our in-licensed patents, if we attempt to initiate a patent infringement suit against an alleged infringer, it is possible that our applicable licensor will not participate in or assist us with the suit and as a result we may not be able to effectively enforce the applicable patents against the alleged infringers.

We may be unable to obtain or protect our intellectual property rights and we may be liable for infringing upon the intellectual property rights of others, which may cause us to engage in costly litigation and, if unsuccessful, could cause us to pay substantial damages and prohibit us from selling our products.

At times, we may monitor patent filings for patents that might be relevant to some of our products and product candidates in an effort to guide the design and development of our products to avoid infringement, but may not have conducted an exhaustive search. We may not be able to successfully challenge the validity of third-party patents and could be required to pay substantial damages, possibly including treble damages, for past infringement and attorneys’ fees if it is ultimately determined that our products infringe such patents. Further, we may be prohibited from selling our products before we obtain a license, which, if available at all, may require us to pay substantial royalties.

Moreover, third parties may challenge the patents that have been issued or licensed to us. We do not believe that PIXUVRI, pacritinib or any of the other compounds we are currently developing infringe upon the rights of any third parties nor are they infringed upon by third parties; however, there can be no assurance that our technology will not be found in the future to infringe upon the rights of others or be infringed upon by others. In such a case, others may assert infringement claims against us, and should we be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’ patent rights. In addition to any damages we might have to pay, we may be required to obtain licenses from the holders of this intellectual property, enter into royalty agreements or redesign our drug candidates so as not to utilize this intellectual property, each of which may prove to be uneconomical or otherwise impossible. Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology and the technology exclusively licensed from any third parties. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors.

Even if infringement claims against us are without merit, or if we challenge the validity of issued patents, lawsuits take significant time, may, even if resolved in our favor, be expensive and divert management attention from other business concerns . Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations.

We are currently and may in the future be subject to litigation proceedings that could harm our financial condition and operating results.

We may be subject to legal claims or regulatory matters involving shareholder, consumer, regulatory and other issues. As described in Part II, Item 1, “Legal Proceedings,” we are currently engaged in a number of pending legal matters. Litigation is subject to inherent uncertainties, and unfavorable rulings could occur. Adverse outcomes in some or all of such pending cases may result in significant monetary damages or injunctive relief against us. It is possible that our financial condition and operating results could be harmed in any period in which the effect of an unfavorable final outcome becomes probable and reasonably estimable, and if an unfavorable ruling were to occur in any of the legal proceedings we are or may be subject to, our business, financial condition, operating results and prospects could be harmed. We are subject to a variety of claims and lawsuits from time to time, some of which arise in the ordinary course of our business. The ultimate outcome of litigation and other claims is subject to inherent uncertainties, and our view of these matters may change in the future.

Securities class action and shareholder derivative lawsuits are often instituted against issuers, and we have been subjected to such actions. For example, on May 31, 2013, we settled a shareholder derivative lawsuit pursuant to which we agreed to implement certain corporate governance measures and were required to pay $1.4 million in plaintiffs’ attorneys’ fees and reimbursement of expenses, all of which amount was covered by our insurance.

We cannot predict with certainty the eventual outcome of pending litigation. Furthermore, we may have to incur substantial expenses in connection with such lawsuits and management’s attention and resources could be diverted from operating our business as we respond to the litigation. Our insurance is subject to high deductibles and there is no guarantee that the insurance will cover any specific claim that we currently face or may face in the future, or that it will be adequate to cover all potential liabilities and damages. In the event of an adverse outcome under any currently pending or future lawsuit, our business could be materially harmed.

Our net operating losses may not be available to reduce future income tax liability.

We have substantial tax loss carryforwards for U.S. federal income tax purposes, but our ability to use such carryforwards to offset future income or tax liability is limited under section 382 of the Internal Revenue Code of 1986, as amended, as a result of prior changes in the stock ownership of the company. Moreover, future changes in the ownership of our stock, including those resulting from issuance of shares of our common stock upon exercise of outstanding warrants, may further limit our ability to use our net operating losses.

Our operations in our European branches and subsidiaries make us subject to increased risk regarding currency exchange rate fluctuations.

We are exposed to risks associated with the translation of euro-denominated financial results and accounts into U.S. dollars for financial reporting purposes. The carrying value of the assets and liabilities, as well as the reported amounts of revenues and expenses, in our European branches and subsidiaries will be affected by fluctuations in the value of the U.S. dollar as compared to the euro. Changes in the value of the U.S. dollar as compared to the euro might have an adverse effect on our reported operating results and financial condition.

We may be unable to obtain the raw materials necessary to produce a particular product or product candidate.

We may not be able to purchase the materials necessary to produce a particular product or product candidate in adequate volume and quality. For example, paclitaxel, a material used to produce Opaxio, is derived from certain varieties of yew trees and the supply of paclitaxel is controlled by a limited number of companies. If any raw material required to produce a product or product candidate is insufficient in quantity or quality, if a supplier fails to deliver in a timely fashion or at all or if these relationships terminate, we may not be able to qualify and obtain a sufficient supply from alternate sources on acceptable terms, or at all.

Because there is a risk of product liability associated with our products, we face potential difficulties in obtaining insurance, and if product liability lawsuits were to be successfully brought against us, our business may be harmed.

Our business exposes us to potential product liability risks inherent in the testing, manufacturing and marketing of human pharmaceutical products. In particular, as a result of the commercialization of PIXUVRI, our

risk with respect to potential product liability has increased. If our insurance covering a product or product candidate is not maintained on acceptable terms or at all, we might not have adequate coverage against potential liabilities. Our inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could prevent or limit the commercialization of any products we develop. A successful product liability claim could also exceed our insurance coverage and could harm our financial condition and operating results.

Since we use hazardous materials in our business, we may be subject to claims relating to improper handling, storage or disposal of these materials.

Our research and development activities involve the controlled use of hazardous materials, chemicals and various radioactive compounds. We are subject to international, federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of such materials and certain waste products. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by the regulations, the risk of accidental contamination or injury from these materials cannot be eliminated completely. In the event of such an accident, we could be held liable for any damages that result and any such liability not covered by insurance could exceed our resources. Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development or production efforts.

We depend on sophisticated information technology systems to operate our business and a cyber-attack or other breach of these systems could have a material adverse effect on our business.

We rely on information technology systems to process, transmit and store electronic information in our day-to-day operations. The size and complexity of our information technology systems makes them vulnerable to a cyber-attack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any such successful attacks could result in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our operations. Cyber-attacks are becoming more sophisticated and frequent. We have invested in our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current or potential threats. There can be no assurance that these measures and efforts will prevent future interruptions or breakdowns. If we fail to maintain or protect our information technology systems and data integrity effectively or fail to anticipate, plan for or manage significant disruptions to these systems, we could have difficulty preventing, detecting and controlling fraud, have disputes with customers, physicians and other health care professionals, have regulatory sanctions or penalties imposed, have increases in operating expenses, incur expenses or lose revenues as a result of a data privacy breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results of operations, financial condition and cash flows.

Risks Related To the Securities Markets

The market price of shares of our common stock is extremely volatile, which may affect our ability to raise capital in the future and may subject the value of your investment in our securities to sudden decreases.

The market price for securities of biopharmaceutical and biotechnology companies, including ours, historically has been highly volatile, and the market from time to time has experienced significant price and volume fluctuations that are unrelated to the operating performance of such companies. For example, during the 12-month period ended April 23, 2014, our stock price has ranged from a low of $0.97 to a high of $4.25. Fluctuations in the trading price or liquidity of our common stock may harm the value of your investment in our common stock.

Factors that may have an impact, which, depending on the circumstances, could be significant, on the market price and marketability of our securities include:

•

announcements by us or others of results of clinical trials and regulatory actions;

•

announcements by us or others of serious adverse events that have occurred during administration of our products to patients;

•

announcements of technological innovations or new commercial therapeutic products by us, our collaborative partners or our present or potential competitors;

•

our issuance of debt, equity or other securities, which we need to pursue to generate additional funds to cover our operating expenses;

•

our quarterly operating results;

•

developments or disputes concerning patent or other proprietary rights;

•

developments in relationships with collaborative partners;

•

acquisitions or divestitures;

•

our ability to realize the anticipated benefits of pacritinib;

•

litigation and government proceedings;

•

adverse legislation, including changes in governmental regulation;

•

third-party reimbursement policies;

•

changes in securities analysts’ recommendations;

•

short selling of our securities;

•

changes in health care policies and practices;

•

a failure to achieve previously announced goals and objectives as or when projected;

•

halting or suspension of trading in our common stock on The NASDAQ Capital Market by NASDAQ or on the MTA by CONSOB, or the Borsa Italiana; and

•

general economic and market conditions.

Shares of common stock are equity securities and are subordinate to any preferred stock we may issue and to any existing or future indebtedness.

Shares of our common stock rank junior to any shares of our preferred stock that we may issue in the future and to our existing indebtedness, including our senior secured term loan agreement, or future indebtedness we may incur and to all creditor claims and other non-equity claims against us and our assets available to satisfy claims on us, including claims in a bankruptcy or similar proceeding. Our senior secured term loan agreement restricts, and any future indebtedness and preferred stock may restrict, payment of dividends on our common stock.

Additionally, unlike indebtedness, where principal and interest customarily are payable on specified due dates, in the case of our common stock, dividends are payable only when and if declared by our Board of Directors or a duly authorized committee of our Board of Directors, and as a corporation, we are restricted to making dividend payments and redemption payments out of legally available assets. We have never paid a dividend on our common stock and have no current intention to pay dividends in the future. Furthermore, our common stock places no restrictions on our business or operations or on our ability to incur indebtedness or engage in any transactions, subject only to the voting rights available to shareholders generally.

Future sales or other dilution of our equity may harm the market price of shares of our common stock.

We expect to issue additional equity securities to fund our operating expenses as well as for other purposes, including in connection with acquisitions we may make from time to time. The market price of our shares of common stock or preferred stock could decline as a result of sales of a large number of shares of our common stock or preferred stock or similar securities in the market, or the perception that such sales could occur in the future.

Anti-takeover provisions in our charter documents, in our shareholder rights plan, or rights plan, and under Washington law could make removal of incumbent management or an acquisition of us, which may be beneficial to our shareholders, more difficult.

Provisions of our amended and restated articles of incorporation and bylaws may have the effect of deterring or delaying attempts by our shareholders to remove or replace management, to commence proxy contests or to effect changes in control. These provisions include:

•

a classified board of directors so that only approximately one-third of our Board of Directors is elected each year;

•

elimination of cumulative voting in the election of directors;

•

procedures for advance notification of shareholder nominations and proposals;

•

the ability of our Board of Directors to amend our bylaws without shareholder approval; and

•

the ability of our Board of Directors to issue shares of preferred stock without shareholder approval upon the terms and conditions and with the rights, privileges and preferences as the Board of Directors may determine.

Pursuant to our rights plan, an acquisition of 20 percent or more of our common stock by a person or group, subject to certain exceptions, could result in the exercisability of the preferred stock purchase right accompanying each share of our common stock (except those held by a 20 percent shareholder, which become null and void), thereby entitling the holder to receive upon exercise, in lieu of a number of units of preferred stock, that number of shares of our common stock having a market value of two times the exercise price of the right. The existence of our rights plan could have the effect of delaying, deterring or preventing a third party from making an acquisition proposal for us and may inhibit a change in control that some, or a majority, of our shareholders might believe to be in their best interest or that could give our shareholders the opportunity to realize a premium over the then-prevailing market prices for their shares. In addition, as a Washington corporation, we are subject to Washington’s anti-takeover statute, which imposes restrictions on some transactions between a corporation and certain significant shareholders. These provisions, alone or together, could have the effect of deterring or delaying changes in incumbent management, proxy contests or changes in control.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

Stock Repurchases in the First Quarter

The following table sets forth information with respect to purchases of our common stock during the three months ended March 31, 2014:


Period	Total Number of Shares Purchased (1)		Average Price Paid per Share		Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs		Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs
January 1 – January 31, 2014		500	$	2.20		—		—
February 1 – February 28, 2014		8,489	$	3.31		—		—
March 1 – March 31, 2014		19,685	$	3.88		—		—

Total		28,674	$	3.68		—		—

(1)	Represents purchases of shares in connection with satisfying tax withholding obligations on the vesting of restricted stock awards to employees granted under our 2007 Equity Incentive Plan, as amended and restated.

Item 3.

Defaults Upon Senior Securities

None.

Item 4.

Mine Safety Disclosures

Not applicable.

Item 5.

Other Information

Not applicable.

Item 6.

Exhibits


Exhibit Number	Exhibit Description	Location

2.1	Agreement and Plan of Merger by and between Cell Therapeutics, Inc. and Novuspharma, S.p.A., dated as of June 16, 2003.	Incorporated by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K, filed on June 17, 2003.

2.2	Acquisition Agreement by and among Cell Therapeutics, Inc., Cell Technologies, Inc. and Cephalon, Inc., dated June 10, 2005.	Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on June 14, 2005.

2.3	Acquisition Agreement among Cell Therapeutics, Inc., Cactus Acquisition Corp., Saguaro Acquisition Company LLC, Systems Medicine, Inc. and Tom Hornaday and Lon Smith dated July 24, 2007.	Incorporated by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K, filed on July 27, 2007.

2.4	Second Amendment to the Acquisition Agreement, dated as of August 6, 2009, by and among Cell Therapeutics, Inc. and each of Tom Hornaday and Lon Smith, in their capacities as Stockholder Representatives.	Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on August 7, 2009.

3.1	Amended and Restated Articles of Incorporation.	Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-3 (File No. 333-153358), filed on September 5, 2008.

3.2	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series F Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on February 9, 2009.

3.3	Amendment to Amended and Restated Articles of Incorporation.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on March 27, 2009.

3.4	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 1 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on April 13, 2009.

3.5	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 2 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on August 21, 2009.

3.6	Articles of Amendment to Amended and Restated Articles of Incorporation; Certificate of Designation, Preferences and Rights of Series ZZ Junior Participating Cumulative Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Registration Statement on Form 8-A, filed on December 28, 2009.

3.7	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 3 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on January 19, 2010.



3.8	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 4 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on April 5, 2010.

3.9	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 5 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on May 27, 2010.

3.10	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 6 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on July 27, 2010.

3.11	Amendment to Amended and Restated Articles of Incorporation.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on September 17, 2010.

3.12	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 7 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on October 22, 2010.

3.13	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 8 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on January 18, 2011.

3.14	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 9 Preferred Stock.	Incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed on January 18, 2011.

3.15	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 10 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on February 24, 2011.

3.16	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 11 Preferred Stock.	Incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed on February 24, 2011.

3.17	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 12 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on May 2, 2011.

3.18	Articles of Amendment to Amended and Restated Articles of Incorporation.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on May 18, 2011.

3.19	Amendment to Amended and Restated Articles of Incorporation.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on June 17, 2011.


3.20	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 13 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on July 6, 2011.

3.21	Amendment to Amended and Restated Articles of Incorporation.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on November 15, 2011.

3.22	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 14 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on December 14, 2011.

3.23	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 15-1 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on May 31, 2012.

3.24	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 16 Preferred Stock.	Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed on June 5, 2012.

3.25	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 15-2 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on August 1, 2012.

3.26	Amendment to Amended and Restated Articles of Incorporation.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on August 31, 2012.

3.27	Amendment to Amended and Restated Articles of Incorporation.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on September 4, 2012.

3.28	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 17 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on October 11, 2012.

3.29	Amendment to Amended and Restated Articles of Incorporation of Cell Therapeutics, Inc.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on June 26, 2013.

3.30	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 18 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on September 18, 2013.

3.31	Articles of Amendment to Amended and Restated Articles of Incorporation; Designation of Preferences, Rights and Limitations of Series 19 Preferred Stock.	Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on November 15, 2013.


3.32	Second Amended and Restated Bylaws.	Incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed on February 22, 2010.

4.1	Shareholder Rights Agreement, dated December 28, 2009, between Cell Therapeutics, Inc. and Computershare Trust Company, N.A.	Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form 8-A, filed on December 28, 2009.

4.2	First Amendment to Shareholder Rights Agreement, dated as of August 31, 2012, between Cell Therapeutics, Inc. and Computershare Trust Company, N.A., as Rights Agent.	Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on September 4, 2012.

4.3	Second Amendment to Shareholder Rights Agreement, dated as of December 6, 2012, between Cell Therapeutics, Inc. and Computershare Trust Company, N.A., as Rights Agent.	Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed on December 7, 2012.

4.4	Class B Common Stock Purchase Warrant, dated April 13, 2009.	Incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K, filed on April 13, 2009.

4.5	Common Stock Purchase Warrant, dated April 13, 2009.	Incorporated by reference to Exhibit 4.2 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 6, 2009.

4.6	Common Stock Purchase Warrant, dated May 11, 2009.	Incorporated by reference to Exhibit 4.3 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 6, 2009.

4.7	Form of Common Stock Purchase Warrant, dated April 6, 2010.	Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed on April 5, 2010.

4.8	Form of Common Stock Purchase Warrant, dated May 27, 2010.	Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed on May 27, 2010.

4.9	Form of Common Stock Purchase Warrant, dated July 27, 2010.	Incorporated by reference to Exhibit 4.6 to the Registrant’s Quarterly Report on Form 10-Q, filed on August 6, 2010.

4.10	Form of Common Stock Purchase Warrant, dated October 22, 2010.	Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed on October 22, 2010.

4.11	Form of Common Stock Purchase Warrant, dated May 3, 2011.	Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed on May 2, 2011.



4.12	Form of Common Stock Purchase Warrant, dated July 5, 2011.	Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed on July 6, 2011.

4.13	Form of Common Stock Purchase Warrant, dated December 13, 2011.	Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed on December 14, 2011.

4.14	Form of Warrant to Purchase Common Stock, dated May 29, 2012.	Incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K, filed on May 31, 2012.

4.15	Form of Warrant to Purchase Common Stock, dated July 30, 2012.	Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on August 1, 2012.

4.16	Warrant Agreement, dated March 26, 2013, by and between Cell Therapeutics, Inc. and Hercules Technology Growth Capital, Inc.	Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on March 28, 2013.

10.1	First Amendment to Loan and Security Agreement, dated as of March 25, 2014, by and among Cell Therapeutics, Inc., Systems Medicine LLC and Hercules Capital Funding Trust 2012-1.	Filed herewith.

10.2†	Termination Agreement, effective as of January 3, 2014, by and between Novartis International Pharmaceutical Ltd. and Cell Therapeutics, Inc.	Filed herewith.

10.3†	Amendment No. 4 to Wholesale Distribution Agreement, effective January 1, 2014, by and between CTI Life Sciences Limited and Max Pharma GmbH.	Filed herewith.

31.1	Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	Filed herewith.

31.2	Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	Filed herewith.

32	Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	Filed herewith.

101. INS	XBRL Instance	Filed herewith.

101. SCH	XBRL Taxonomy Extension Schema	Filed herewith.

101. CAL	XBRL Taxonomy Extension Calculation	Filed herewith.

101. DEF	XBRL Taxonomy Extension Definition	Filed herewith.

101. LAB	XBRL Taxonomy Extension Labels	Filed herewith.

101. PRE	XBRL Taxonomy Extension Presentation	Filed herewith.

†	Portions of these exhibits have been omitted pursuant to a request for confidential treatment.

SIGNATURES

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


	CELL THERAPEUTICS, INC.
	(Registrant)

Dated: April 29, 2014	By:	/s/ James A. Bianco, M.D.
		James A. Bianco, M.D.
		President and Chief Executive Officer

Dated: April 29, 2014	By:	/s/ Louis A. Bianco
		Louis A. Bianco
		Executive Vice President,
		Finance and Administration

Exhibit 10.1

FIRST AMENDMENT TO LOAN AND SECURITY AGREEMENT

This FIRST AMENDMENT TO LOAN AND SECURITY AGREEMENT (this “ Amendment ”), dated as of March 25, 2014 (the “ First Amendment Date ”), is by and among CELL THERAPEUTICS, INC., a Washington corporation (“ Cell Therapeutics ”), and SYSTEMS MEDICINE LLC, a Delaware limited liability company (“ Systems Medicine ”; Cell Therapeutics and Systems Medicine are hereinafter referred to individually and collectively, jointly and severally, as “ Borrower ”), and HERCULES CAPITAL FUNDING TRUST 2012-1 (“ Lender ”), assignee of HERCULES CAPITAL FUNDING 2012-1 LLC, assignee of HERCULES TECHNOLOGY GROWTH CAPITAL, INC., a Maryland corporation.

WHEREAS , Borrower and Lender are parties to a certain Loan and Security Agreement, dated as of March 26, 2013 (as the same may from time to time be amended, modified or supplemented in accordance with its terms, the “ Loan Agreement ”); and

WHEREAS , in accordance with Section 11.3 of the Loan Agreement, Borrower and Lender desire to amend the Loan Agreement as provided herein.

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

1. Defined Terms . Terms not otherwise defined herein which are defined in the Loan Agreement shall have the same respective meanings herein as therein.

2. Amendments to Loan Agreement . Subject to the satisfaction of the conditions set forth in Section 3 of this Amendment, as of the First Amendment Date, the Loan Agreement is hereby amended as follows:

(a) The Loan Agreement shall be amended by inserting the following new definitions to appear alphabetically in Section 1.1 thereof:

“ 2014 Closing Date ” March 25, 2014.

“ 2014 Draw Period ” means the period commencing upon the 2014 Closing Date and ending on the earlier to occur of (i) October 31, 2014, and (ii) an Event of Default.

“ 2014 Term Loan Advance ” is defined in Recital B hereof.

“ 2014 Term Loan Interest Rate ” means for any day, a floating rate per annum rate equal to the greater of either (i) ten percent (10.00%), or (ii) the sum of (A) ten percent (10.00%), plus (B) the Prime Rate minus three and one quarter of one percent (3.25%).

“ 2014 Term Loan Maturity Date ” is October 1, 2016.

“ Bank of America Cash Collateral Account ” means, collectively, one or more Deposit Accounts or accounts holding Investment Property in an aggregate amount not to exceed $250,000 for the purpose of cash collateralizing obligations in respect of credit card services and other cash management obligations owing by Cell Therapeutics to Bank of America, N.A. and its affiliates.

“ Maximum 2014 Term Loan Amount ” is defined in Recital B hereof.

“ Milestone Event ” means receipt by Lender of evidence satisfactory to Lender in its sole and absolute discretion, that Borrower has achieved positive phase III data in connection with its PERSIST-1 clinical trials.

“ Non-Renewal Facility Fee ” means Seventy-Two Thousand Five Hundred Dollars ($72,500.00); provided that if the Borrower unconditionally and irrevocably requests the 2014 Term Loan Advance in an amount of Five Million Dollars ($5,000,000.00) prior to the expiration of the 2014 Draw Period, Lender shall refund Thirty-Five Thousand Dollars ($35,000.00) of such Non-Renewal Facility Fee to the Borrower on the Advance Date of the 2014 Term Loan Advance.

(b) The following terms and their respective definitions set forth in Section 1.1 are amended in their entirety and replaced with the following:

“ Advances(s) ” means a Term Loan Advance and/or 2014 Term Loan Advance.

“ Amortization Date ” means November 1, 2014.

“ Term Loan Interest Rate ” means for any day, a floating rate per annum rate equal to the greater of either (i) twelve and one-quarter of one percent (12.25%), or (ii) the sum of (A) twelve and one-quarter of one percent (12.25%), plus (B) the Prime Rate minus three and one quarter of one percent (3.25%) (which interest rate shall be reduced to greater of either (i) eleven and one-quarter of one percent (11.25%), or (ii) the sum of (A) eleven and one-quarter of one percent (11.25%), plus (B) the Prime Rate minus three and one quarter of one percent (3.25%) upon the occurrence of the Milestone Event). The Term Loan Interest Rate will change from time to time on the day the Prime Rate changes.

(c) The Loan Agreement shall be amended by deleting subsection (ix)(d) of the definition of “ Permitted Investments ” in Section 1.1 thereof in its entirety and replaced with the following:

(d) any Borrower in Aequus Biopharma not to exceed (i) Three Million Dollars ($3,000,000.00) in the aggregate for Borrower’s 2014 fiscal year, and (ii) Two Million Dollars ($2,000,000.00) in the aggregate for each fiscal year of Borrower thereafter, provided that, in each case, no Event of Default has occurred and is continuing or would exist after giving effect to such Investment;

(d) The recitals to the Loan Agreement are hereby amended in their entirety and replaced with the following:

A. Borrower has requested Lender to make available to Borrower, and Lender is willing to make, two (2) term loans (each a “ Term Loan Advance ” and collectively, the “ Term Loan Advances ”) in an aggregate principal amount of up to Fifteen Million Dollars ($15,000,000) (the “ Maximum Term Loan Amount” ) on the terms and conditions set forth in this Agreement; and

B. Borrower has requested Lender to make available to Borrower, and Lender is willing to make, term loans (each a “ 2014 Term Loan Advance ” and collectively, the “ 2014 Term Loan Advances ”) in an aggregate principal amount of up to Five Million Dollars ($5,000,000.00) (the “ Maximum 2014 Term Loan Amount ”) on the terms and conditions set forth in this Agreement.

(e) Section 2.1(d) of the Loan Agreement (Payment) is hereby amended by deleting the text “30” therein and inserting the text “24” in lieu thereof.

(f) The Loan Agreement is amended by inserting the following new provision to appear as Section 2.1.1 (2014 Term Loan) thereof:

2.1.1 2014 Term Loan .

(a) Advances . Subject to the terms and conditions of this Agreement, during the 2014 Draw Period, Borrower may request 2014 Term Loan Advances in an amount of up to Five Million Dollars ($5,000,000). The aggregate outstanding 2014 Term Loan Advances shall not exceed the Maximum 2014 Term Loan Amount. Proceeds of any Advance shall be deposited into an account that is subject to a perfected security interest in favor of Lender.

(b) Advance Request . To obtain a 2014 Term Loan Advance, Borrower shall complete, sign and deliver to Lender an Advance Request (in the case of any Advance made after the Closing Date, at least five (5) Business Days before the Advance Date). Lender shall fund the 2014 Term Loan Advance in the manner requested by the Advance Request provided that each of the conditions precedent to such 2014 Term Loan Advance is satisfied as of the requested Advance Date.

(c) Interest . The principal balance of each 2014 Term Loan Advance shall bear interest thereon from such Advance Date at the 2014 Term Loan Interest Rate based on a year consisting of 360 days, with interest computed daily based on the actual number of days elapsed. The 2014 Term Loan Interest Rate will float and change on the day the Prime Rate changes from time to time.

(d) Payment . Borrower will pay interest on each 2014 Term Loan Advance on the first business day of each month, beginning the month after the Advance Date. Commencing on the Amortization Date, and continuing on the first business day of each month thereafter, Borrower shall repay the aggregate principal balance of 2014 Term Loan Advances that are outstanding on the Amortization Date in 24 equal monthly installments of principal and interest (mortgage style). The entire principal balance of the 2014 Term Loan Advances and all accrued but unpaid interest hereunder, and all other Secured Obligations then outstanding with respect to the 2014 Term Loan Advances, shall be due and payable on 2014 Term Loan Maturity Date. Borrower shall make all payments under this Agreement without setoff, recoupment or deduction and regardless of any counterclaim or defense. Lender will initiate debit entries to the Borrower’s account as authorized on the ACH Authorization on each payment date of all periodic obligations payable to Lender under each 2014 Term Loan Advance. Once repaid, a 2014 Term Loan Advance or any portion thereof may not be reborrowed.

(g) The last sentence of Section 2.2 of the Loan Agreement (Maximum Interest Rate) is hereby amended by deleting the text “Term Loan Advances” therein and inserting the text “Term Loan Advances and/or 2014 Term Loan Advances” in lieu thereof.

(h) Section 2.5 of the Loan and Security Agreement (End of Term Charge) is hereby amended in its entirety and replaced with the following:

2.5 End of Term Charge . On the earliest to occur of (i) the Term Loan Maturity Date, (ii) the date that Borrower prepays the outstanding Secured Obligations relating to the Term Loan Advances in full, or (iii) the date that the Secured Obligations relating to the Term Loan Advances become due and payable in full, Borrower shall pay Lender a charge of One Million Two Hundred Seventy-Five Thousand Dollars ($1,275,000). Notwithstanding the required payment date of such charge, it shall be deemed earned by Lender as of the Closing Date.

(i) The preamble of Section 4 of the Loan Agreement (Conditions Precedent to Loan) is hereby amended by deleting the text “Term Loan Advances” therein and inserting the text “Term Loan Advances and/or 2014 Term Loan Advances” in lieu thereof.

(j) Section 4.2 of the Loan Agreement (All Advances) shall be amended by inserting the following new provision to appear as subsection (e) thereof:

(e) for 2014 Term Loan Advances, Lender shall have received a legal opinion (authority/enforceability) from Borrower’s counsel dated as of the 2014 Closing Date.

(k) The first sentence of Section 7.12 of the Loan Agreement (Deposit Accounts) is hereby amended by inserting (i) “the Bank of America Cash Collateral Account,” immediately after “trust accounts,” and (ii) “(other than the Bank of America Cash Collateral Account)” immediately after “Investment Property”.

(l) The first sentence of Section 11.17 of the Loan Agreement (Borrower Liability) is hereby amended in its entirety and replaced with the following:

Each Borrower hereunder shall be jointly and severally obligated to repay all Term Loan Advances and/or 2014 Term Loan Advances made hereunder, regardless of which Borrower actually receives said Term Loan Advance and/or 2014 Term Loan Advances, as if each Borrower hereunder directly received all Term Loan Advances and/or 2014 Term Loan Advances.

3. Conditions to Effectiveness . Lender and Borrower agree that this Amendment shall become effective upon the satisfaction of the following conditions precedent, each in form and substance satisfactory to Lender:

(a) Lender shall have received a fully-executed counterpart of this Amendment signed by Borrower;

(b) Lender shall have received certified resolutions of Borrower’s board of directors evidencing approval of this Amendment;

(c) Borrower shall have paid to Lender, for the account of Lender, the Non-Renewal Facility Fee which shall be deemed earned on the effective date of this Amendment; and

(d) Lender shall have received payment for all reasonable and documented out-of-pocket fees and expenses incurred by Lender in connection with this Amendment, including, but not limited to, all legal fees and expenses, payable pursuant to Section 11.11 of the Loan Agreement.

4. Post-Closing Condition . Borrower shall provide Lender within sixty (60) days after the First Amendment Date with a copy of the termination of the claim of lien filed by GLY Construction, Inc. (Claim of Lien Recorded No. 20120724000882).

5. Representations and Warranties . The Borrower hereby represents and warrants to Lender as follows:

(a) Representations and Warranties in the Agreement . The representations and warranties of Borrower set forth in Section 5 of the Loan Agreement are true and correct in all material respects on and as of the Effective Date with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date.

(b) Authority, Etc . The execution and delivery by Borrower of this Amendment and the performance by Borrower of all of its agreements and obligations under the Loan Agreement and the other Loan Documents, as amended hereby, are within the corporate or limited liability company authority, as applicable, of Borrower and have been duly authorized by all necessary corporate action on the part of Borrower. With respect to Borrower, the execution and delivery by Borrower of this Amendment does not and will not require any registration with, consent or approval of, or notice to any Person (including any governmental authority).

(c) Enforceability of Obligations . This Amendment, the Loan Agreement and the other Loan Documents, as amended hereby, constitute the legal, valid and binding obligations of Borrower enforceable against Borrower in accordance with their terms, except as enforceability is limited by bankruptcy, insolvency, reorganization, moratorium, general equitable principles or other laws relating to or affecting generally the enforcement of, creditors’ rights and except to the extent that availability of the remedy of specific performance or injunctive relief is subject to the discretion of the court before which any proceeding therefor may be brought.

(d) No Default . Immediately after giving effect to this Amendment (i) no fact or condition exists that would (or would, with the passage of time, the giving of notice, or both) constitute an Event of Default, and (ii) no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing.

(e) Event of Default . By its signature below, Borrower hereby agrees that it shall constitute an Event of Default if any representation or warranty made herein should be false or misleading in any material respect when made.

6. Reaffirmations . Except as expressly provided in this Amendment, all of the terms and conditions of the Loan Agreement and the other Loan Documents remain in full force and effect. Nothing contained in this Amendment shall in any way prejudice, impair or effect any rights or remedies of Lender under the Loan Agreement and the other Loan Documents. Except as specifically amended hereby, Borrower hereby ratifies, confirms, and reaffirms all covenants contained in the Loan Agreement and the other Loan Documents. The Loan Agreement, together with this Amendment, shall be read and construed as a single agreement. All references in the Loan Documents to the Loan Agreement or any other Loan Document shall hereafter refer to the Loan Agreement or such other Loan Document as amended hereby.

7. Execution in Counterparts . This Amendment may be executed in any number of counterparts, each of which shall be deemed an original, but which together shall constitute one instrument.

8. Miscellaneous .

(a) THIS AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF CALIFORNIA, EXCLUDING CONFLICT OF LAWS PRINCIPLES THAT WOULD CAUSE THE APPLICATION OF LAWS OF ANY OTHER JURISDICTION.

(b) The captions in this Amendment are for convenience of reference only and shall not define or limit the provisions hereof.

(c) This Amendment expresses the entire understanding of the parties with respect to the transactions contemplated hereby. No prior negotiations or discussions shall limit, modify, or otherwise affect the provisions hereof.

(d) Any determination that any provision of this Amendment or any application hereof is invalid, illegal or unenforceable in any respect and in any instance shall not affect the validity, legality, or enforceability of such provision in any other instance, or the validity, legality or enforceability of any other provisions of this Amendment.

[ Remainder of this page intentionally left blank ]

IN WITNESS WHEREOF , Borrower and Lender have duly executed and delivered this Amendment as of the day and year first above written.


BORROWER:

CELL THERAPEUTICS, INC.

By:		/s/ Louis A. Bianco



Print Name:		Louis A. Bianco



Title:		E.V.P. Finance & Administration


SYSTEMS MEDICINE LLC

By: Cell Therapeutics, Inc., as Sole Member

By:		/s/ Louis A. Bianco



Print Name:		Louis A. Bianco



Title:		E.V.P. Finance & Administration

Accepted in Palo Alto, California:


LENDER:

HERCULES CAPITAL FUNDING TRUST 2012-1

By: Hercules Technology Growth Capital, Inc., its authorized servicer

By:		/s/ Ben Barry



Print Name:		Ben Barry



Title:		Senior Counsel

Exhibit 10.2

EXECUTION VERSION

**	Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

TERMINATION AGREEMENT

This Termination Agreement (this “ Agreement ”), effective as of January 3, 2014 (the “ Effective Date ”), is made by and between Novartis International Pharmaceutical Ltd., a limited company organized and existing under the laws of Bermuda (“ Novartis ”), and Cell Therapeutics, Inc., a corporation organized and existing under the laws of the State of Washington (“ Cell Therapeutics ”). Novartis and Cell Therapeutics are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

WHEREAS, Novartis, Cell Therapeutics, and Cell Therapeutics Europe S.r.l. are parties to the License and Co-Development Agreement, dated September 15, 2006, as amended by an Amendment to License and Co-Development Agreement effective as of May 22, 2007, a Second Amendment to License and Co-Development Agreement effective as of August 1, 2007, a Third Amendment to the License and Co-Development Agreement effective as of November 19, 2007 and a Fourth Amendment to License and Co-Development Agreement effective as of January 12, 2009 (the “ Original Agreement ”);

WHEREAS, Cell Therapeutics Europe S.r.l. was merged into Cell Therapeutics and as a result no longer exists as an entity;

WHEREAS, Novartis has not exercised either (i) the Development Rights or (ii) the Pixantrone Option;

WHEREAS, the Parties desire to terminate the Original Agreement as set forth in this Agreement; and

WHEREAS, in consideration for Novartis relinquishing its rights under the Original Agreement and assigning certain rights and intellectual property to Cell Therapeutics, Cell Therapeutics is willing to grant Novartis certain rights and make certain payments to Novartis, all as provided herein.

NOW, THEREFORE, for and in consideration of the covenants, conditions and undertakings hereinafter set forth, it is agreed by and between the Parties as follows:

ARTICLE 1

DEFINITIONS

Capitalized terms not defined herein shall have the meanings ascribed to them in the Original Agreement, a copy of which is attached hereto as Schedule I. As used herein, the following terms have the meanings set forth below:

“ Accounting Firm ” has the meaning set forth in Section 3.4.3 .

“ Agreement ” has the meaning set forth in the preamble.

“ Annual Net Sales ” shall mean, with respect to Opaxio or Pixantrone, the Net Sales of Opaxio or Pixantrone during a Calendar Year.

“ Assigned Trademarks ” has the meaning set forth in Section 2.4.2 .

“ Auditor ” has the meaning set forth in Section 3.6.2 .

“ Calendar Year ” shall mean each calendar year starting on January 1 ^st and ending on December 31st.

“ Cell Therapeutics ” has the meaning set forth in the preamble.

“ Cell Therapeutics Entities ” shall mean (i) Cell Therapeutics, its Affiliates, and their respective licensees and sublicensees, and (ii) Transferees, Affiliates of such Transferees, and their respective licensees and sublicensees. Each of the foregoing is referred to as a “ Cell Therapeutics Entity ”.

“ Dispute Notice ” has the meaning set forth in Section 3.4.2 .

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

“ Existing Third Party License Agreement ” means the PG-TXL License Agreement.

“ Final Allocation ” has the meaning set forth in Section 3.4.3 .

“ Indemnified Party ” has the meaning set forth in Section 8.3.1 .

“ Indemnifying Party ” has the meaning set forth in Section 8.3.1 .

“ Milestone Notice ” has the meaning set forth in Section 3.3.3 .

“ Net Sales ” shall mean the gross amount invoiced for the supply or sale of Opaxio or Pixantrone by Cell Therapeutics Entities to Third Parties, less the following amounts to the extent deducted from or on such invoice or absorbed or accrued or reserved by Cell Therapeutics Entities in accordance with U.S. GAAP: (i) customary quantity, trade and/or cash discounts (including coupons and/or indigent patient programs or discounts), chargebacks, defects, rejections, recalls, field destroys, returns (including anticipated returns), allowances, wholesaler inventory management fees, rebates (including any and all federal, state, or local government, regulatory or agency rebates) and price adjustments allowed or given; (ii) tariffs, sales and other excise taxes (including value added taxes) and duties directly related to the sale, to the extent such items are included in the gross invoice price, (iv) deduction of actual distribution and warehouse related expenses, not to exceed **, (v) amounts repaid or credited or uncollectible amounts on previously sold products, and (vi) any other specifically identifiable amounts included in gross amounts invoiced for Pixantrone or Opaxio products, to the extent such amounts are customary exclusions from net sales calculations in the pharmaceutical industry for reasons substantially equivalent to those listed above.

With respect to the calculation of Net Sales:

(i) Net Sales include only the value charged or invoiced on the first arm’s-length sale to an Other Party and sales between or among Cell Therapeutics Entities shall be disregarded for purposes of calculating Net Sales;

(ii) If Opaxio or Pixantrone is delivered to the Other Party before being invoiced (or is not invoiced), Net Sales will be calculated at the time all the revenue recognition criteria of the applicable Cell Therapeutics Entity under its Accounting Standards are met; and

(iii) In the event that a product is sold in a finished dosage form containing Opaxio or Pixantrone in combination with one or more other active ingredients (a “Combination Product”), the Net Sales will be calculated by multiplying the Net Sales of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in the relevant country of the product containing Opaxio or Pixantrone as the sole active ingredient(s) in finished form, and B is the weighted average sale price (by sales volume) in that country of the product(s) containing the other component(s) as the sole active ingredient(s) in finished form. Regarding prices comprised in the weighted average price when sold separately referred to above, if these are available for different dosages from the dosages of Opaxio, Pixantrone and other active ingredient components that are included in the Combination Product, then Cell Therapeutics shall be entitled to make a proportional adjustment to such prices in calculating the royalty-bearing Net Sales of the Combination Product. If the weighted average sale price cannot be determined for the product(s) containing Opaxio or Pixantrone as the sole active ingredient(s) in finished form or other product(s) containing the single component(s), the calculation of Net Sales for Combination Products will be agreed by the Parties based on the relative value contributed by each component (each Party’s agreement not to be unreasonably withheld or delayed).

“ Novartis ” has the meaning set forth in the preamble.

“ Opaxio ” means the (i) Compound and (ii) any product which incorporates or comprises the Compound in finished dosage form.

“ Opaxio Assets ” means all Patent Rights, Know-How, trademarks and other intellectual property owned or Controlled at any time by Cell Therapeutics or its Affiliates relating to Opaxio.

“ Original Agreement ” has the meaning set forth in the recitals.

“ Other Party ” means a Third Party not constituting a Cell Therapeutics Entity.

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

“ Partnering Agreement ” has the meaning set forth in Section 3.3.1 .

“ Pixantrone ” means (i) the Pixantrone Compound and (ii) any product which incorporates or comprises the Pixantrone Compound in finished dosage form.

“ Pixantrone Assets ” means all Patent Rights, Know-How, trademarks and other intellectual property owned or Controlled at any time by Cell Therapeutics or its Affiliates relating to Pixantrone.

“ Proposed Allocation ” has he meaning set forth in Section 3.4.1 .

“ Quarterly Report ” means a written report or reports showing each of: (a) the Net Sales and quantity of each of Opaxio and Pixantrone sold in each country in the Territory during the reporting period by applicable Cell Therapeutics Entities, including (i) each Cell Therapeutics Entity realizing Net Sales, (ii) gross sales and all deductions taken to calculate Net Sales, and (iii) Net Sales in local currency and the exchange rates used to calculate Net Sales in USD, (b) the royalties, payable in USD, which shall have accrued under Section 3.1.4 with respect to such Net Sales and the basis of calculating those royalties, and (c) a summary of any other payments that have become payable to Novartis under Section 3.1 in such Calendar Quarter.

“ Surviving Provisions ” has the meaning set forth in Section 2.2 .

“ Third Party Claim ” has the meaning set forth in Section 8.3.1 .

“ Transaction Notice ” has the meaning set forth in Section 3.3.1 .

“ Transaction Payment ” has the meaning set forth in Section 3.3.2 .

“ Transaction Payment Notice ” has the meaning set forth in Section 3.3.2 .

“ Transfer ” means, directly or indirectly, to sell, transfer, assign, convey or similarly dispose of, either voluntarily or involuntarily, or to enter into any contract, option or other arrangement or understanding with respect to the direct or indirect sale, transfer, assignment, conveyance or similar disposition of, any of the Opaxio Assets or the Pixantrone Assets.

“ Transferee ” means any Third Party to whom any of the Opaxio Assets or Pixantrone Assets are Transferred.

ARTICLE 2

TERMINATION OF TERMINATED AGREEMENTS

AND ASSIGNMENT OF RIGHTS

2.1 Termination of the Original Agreement . Subject to Section 2.2 , as of the Effective Date, (a) the Original Agreement is hereby terminated immediately and in its entirety (including, unless otherwise specified in Section 2.2 , those provisions stated in the Original Agreement to survive termination), (b) the Original Agreement shall have no further force or effect, and (c) all rights and obligations of Cell Therapeutics and Novartis under the Original Agreement shall cease and terminate immediately. For the avoidance of doubt, the Original Agreement is not being terminated pursuant to Section 13 thereof and, therefore, the provisions of Section 13 and 14 of the Original Agreement are not applicable to the termination of the Original Agreement pursuant to this Agreement.

2.2 Survival of Certain Provisions of the Original Agreement . Notwithstanding the foregoing Section 2.1 , (a) the following provisions of the Original Agreement (collectively, the “ Surviving Provisions ”) shall survive termination pursuant to this Agreement indefinitely: (i) Section 1.1 (Definitions), to the extent such defined terms are used in this Agreement; (ii) Section 10.1 (Ownership of Inventions); (iii) with respect to actions, omissions, events or occurrences prior to the Effective Date, Section 16 (Indemnification; Liability) and (iv) Section 18 (General Provisions), other than Section 18.15 (HSR Filing) and except to the extent that the provisions thereof conflict with the corresponding provisions of this Agreement, in which case the provisions of this Agreement shall control; and (b) with respect to Confidential Information disclosed by a Party or its Affiliates prior to the Effective Date, the provisions of Section 12 (Confidentiality) of the Original Agreement shall survive termination pursuant to this Agreement for a period of ** years following the Effective Date.

2.3 Letter of Authorization . The Parties acknowledge that that certain Letter of Authorization, dated as of September 15, 2006, from Cell Therapeutics to Novartis, is terminated in accordance with its terms as of the Effective Date.

2.4 Assignment of Rights .

2.4.1 Novartis hereby assigns to Cell Therapeutics all of its rights under Sections 14.01(b), (c) and (d) and 14.02 of the PG-TXL License Agreement.

2.4.2 Simultaneously herewith, as of the Effective Date, Novartis is assigning certain trademarks (the “ Assigned Trademarks ”) to Cell Therapeutics pursuant to the Trademark Assignment in the form of Exhibit A .

2.4.3 All costs or expenses associated with the assignments under this Section 2.4 shall be borne by Cell Therapeutics, including any and all fees and costs associated with the preparation of local assignment deeds, powers of attorney, legalization, notarization, apostille and translation services, as necessary, for Novartis to facilitate the global recordation of the assignments.

2.4.4 NOVARTIS MAKES NO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE ASSIGNED TRADEMARKS, INCLUDING WITH RESPECT TO THE VALIDITY, SUBSISTENCE OR ENFORCEABILITY THEREOF.

2.5 Return of Materials . Promptly after the Effective Date Novartis shall return all Confidential Information in its possession, including but not limited to electronic copies of trademark files and original trademark certificates, or, at the option of Novartis, shall use commercially reasonable efforts to destroy all documents containing any Confidential Information and certify to Cell Therapeutics as to having taken such efforts. Notwithstanding the foregoing, Novartis may retain one (1) copy of the Confidential Information in its files solely to allow it to monitor its continued obligations hereunder.

ARTICLE 3

PAYMENTS

3.1 Payments by Cell Therapeutics . In consideration of the termination of Novartis’ licenses, options and other rights under the Original Agreement, Cell Therapeutics shall pay to Novartis the amounts set forth in this Section 3.1 .

3.1.1 Opaxio Payments . Cell Therapeutics shall pay to Novartis ** of any and all payments (including the fair market value of any non-monetary consideration) received from time to time by Cell Therapeutics or its Affiliates in consideration for or in connection with any Transfer, license, sublicense or other grant of rights (including rights to research, Develop, Commercialize or manufacture Opaxio) with respect to any of the Opaxio Assets by any Cell Therapeutics Entity to any Third Party (including any up-front payments, option payments, milestone payments, royalties, the portion of any equity purchase payments in excess of the fair market value of such equity (without attributing any value to the Opaxio Assets for purposes of determining such fair market value), the portion of any service fees in excess of fair market value and any other such compensation); provided , that the amounts payable under this Section 3.1.1 shall not exceed ** in the aggregate. Notwithstanding the foregoing, to the extent any such payments to Cell Therapeutics or its Affiliates from a Third Party represent reimbursement without premium or other mark-up for bona fide out-of-pocket research and development expenses with respect to Opaxio actually incurred by Cell Therapeutics or its Affiliates after entry into such Transfer, license, sublicense or other grant of rights, Novartis shall not be entitled to a portion of any such payments under this Section 3.1.1 .

3.1.2 Pixantrone Payments . Cell Therapeutics shall pay to Novartis ** of any and all payments (including the fair market value of any non-monetary consideration) received from time to time by Cell Therapeutics or its Affiliates in consideration for or in connection with any Transfer, license, sublicense or other grant of rights (including rights to research, Develop, Commercialize or manufacture Pixantrone) with respect to any of the Pixantrone Assets by any Cell Therapeutics Entity to any Third Party (including any up-front payments, option payments, milestone payments, royalties, the portion of any equity purchase payments in excess of the fair market value of such equity (without attributing any value to the Pixantrone Assets for purposes of determining such fair market value), the portion of any service fees in excess of fair market value and any other such compensation); provided , that the amounts payable under this Section 3.1.2 shall not exceed ** in the aggregate. Notwithstanding the foregoing, to the extent any such payments to Cell Therapeutics or its Affiliates from a Third Party represent reimbursement without premium or other mark-up for bona fide out-of-pocket research and development expenses with respect to Pixantrone actually incurred by Cell Therapeutics or its Affiliates after entry into such Transfer, license, sublicense or other grant of rights, Novartis shall not be entitled to a portion of any such payments under this Section 3.1.2 .

3.1.3 Milestones . Cell Therapeutics shall pay to Novartis the following milestone payments upon the achievement of the milestone events set forth below:


Milestone Event:	If Achieved for Pixantrone:	If Achieved for Opaxio:
**	**	**
**	**	**

The amounts payable pursuant to this Section 3.1.3 shall be cumulative, each such amount to be payable one time upon achievement of the milestone event applicable to such payment. Total potential payments under this Section are $16,600,000.

3.1.4 Royalties . Royalties will be payable on Annual Net Sales of Opaxio and Pixantrone on a product-by–product and country-by-country basis from the First Commercial Sale of the applicable product in such country following the Effective Date of this Agreement until the later of (a) the expiration of the last to expire Valid Claim of the Patent Rights owned or Controlled by Cell Therapeutics or its Affiliates as of the Effective Date claiming the composition of matter of the applicable product or the use of the applicable product, or (b) ** from the First Commercial Sale of the applicable product in such country (“Royalty Term”). During the applicable Royalty Term, Cell Therapeutics shall pay to Novartis the following royalties on Annual Net Sales of Opaxio and Pixantrone, as provided below:


Aggregate Annual Net Sales of Opaxio Worldwide in any Calendar Year:				Royalty Rate:
**				**
**				10%


Aggregate Annual Net Sales of Pixantrone Worldwide in any Calendar Year:				Royalty Rate:
**				**
**				10%

3.1.5 Reduction in Royalty Rate . Subject to Section 3.1.7 , with respect to Opaxio or Pixantrone in any country, in the event of a Loss of Market Exclusivity with respect to Opaxio or Pixantrone, as applicable, during the Royalty Term in such country, the royalty rates applicable in accordance with Section 3.1.4 to Net Sales of Opaxio or Pixantrone, as applicable, in such country, shall be reduced by ** for so long as such Loss of Market Exclusivity persists in such country. For purposes hereof:

“ Loss of Market Exclusivity ” with respect to Opaxio or Pixantrone in any country shall be deemed to have occurred only if: (i) one or more Generic Equivalent(s) of such product are being marketed by a Third Party (other than any Cell Therapeutics Entity) in such country; and (ii) Net Sales of such product in that country during any Calendar Quarter following introduction of the Generic Equivalent(s) have fallen by ** in that country from the average quarterly Net Sales of such product in such country over the last ** Calendar Quarters ending prior to the introduction of such Generic Equivalent(s) and such decline in sales is attributable to the marketing or sale in such country of a Generic Equivalent of such product by a Third Party (other than any Cell Therapeutics Entity).

“ Generic Equivalent ” means, with respect to Opaxio or Pixantrone in a given country, any true generic product (i.e., a non-proprietary product) with the same active ingredient(s) and administration route as such product.

3.1.6 Third Party Obligations with Respect to Opaxio . To the extent Cell Therapeutics is required to pay royalties on net sales of Opaxio pursuant to the Existing Third Party License Agreement, ** of the amount of such royalties actually paid in any Calendar Year may be credited against the royalties payable hereunder in such Calendar Year, provided, that, with respect to Aggregate Annual Net Sales of Opaxio in excess of **, in no event shall the effective royalty rate applicable to such Aggregate Annual Net Sales be reduced by more than ** as a result of all such credits in such Calendar Year. By way of illustration of the foregoing, assuming the Aggregate Annual Net Sales of Opaxio were ** and the effective royalty rate paid under the Existing Third Party License Agreement in the applicable Calendar Year were **, the royalty that may be credited against the applicable portion of the royalty payable to Novartis would be ** (i.e., ** of **), but reduced to ** by operation of the limitation set forth in the preceding sentence; accordingly, the royalty payment to Novartis would be computed as follows: ** multiplied by ** plus ** multiplied by ** (i.e., ** minus the **), for a total royalty payment due to Novartis of **.

3.1.7 Royalty Floor . Notwithstanding any other provision of this Agreement, including Sections 3.1.5 and 3.1.6 , in no event shall the royalty rate applicable to any Net Sales of Opaxio be reduced below ** and in no event shall the royalty rate applicable to any Net Sales of Pixantrone be reduced below **.

3.2 Transfers; Licenses . Notwithstanding anything to the contrary in this Agreement, Cell Therapeutics shall not, and shall cause the other Cell Therapeutics Entities not to, Transfer, license, sublicense or otherwise grant rights (including rights to research, Develop, Commercialize or manufacture Opaxio or Pixantrone, as applicable) with respect to any of the Opaxio Assets or Pixantrone Assets to any other Person unless such Person has agreed in writing to be bound by the terms and conditions of this Agreement applicable to Cell Therapeutics Entities. Cell Therapeutics shall be responsible for the failure of any such Cell Therapeutics Entities to comply with this Agreement.

3.3 Notices and Payments .

3.3.1 Transaction Notice . In the event that Cell Therapeutics or another Cell Therapeutics Entity enters into any contract, agreement or other arrangement with respect to any transaction described in Section 3.1.1 or 3.1.2 (a “ Partnering Agreement ”), Cell Therapeutics shall provide Novartis with written notice of such transaction (each, a “ Transaction Notice ”), which notice shall include (i) a true and complete copy of such Partnering Agreement, except that such copy may be redacted to delete such Confidential Information as Cell Therapeutics shall reasonably determine to be unnecessary to enable Novartis to review for purposes of compliance with this Agreement, but which copy shall otherwise be true and complete, and (ii) if applicable, the allocation and certification required pursuant to Section 3.4.1 . The Transaction Notice shall be delivered to Novartis (i) within ** days after entering into the applicable Partnering Agreement if Cell Therapeutics or an Affiliate thereof is a party to such Partnering Agreement or (ii) within ** days after entering into the applicable Partnering Agreement if Cell Therapeutics or an Affiliate thereof is not a party such Partnering Agreement. Notwithstanding the foregoing, if a redacted form of any Partnering Agreement is provided as contemplated above, at the request of Novartis, an unredacted copy of such Partnering Agreement shall promptly be provided by Cell Therapeutics to outside counsel or an independent accounting firm designated by Novartis and which is bound by confidentiality obligations at least equivalent to those provided herein in order to confirm compliance with this Agreement and such counsel or firm shall be entitled to disclose solely those portions of the redacted copy to Novartis that it reasonably determines are relevant to determining compliance with this Agreement.

3.3.2 Transaction Payment Notice . Upon receipt by Cell Therapeutics or an Affiliate thereof of any payment or other consideration described in Section 3.1.1 or 3.1.2 (each, a “ Transaction Payment ”), Cell Therapeutics shall provide Novartis with written notice of such Transaction Payment, including the amount thereof and the type of payment (e.g., up-front, milestone, royalty, etc.) (each, a “ Transaction Payment Notice ”) within ** days after such receipt, and shall make all payments due to Novartis pursuant to Section 3.1.1 or 3.1.2 in connection with such Transaction Payment within ** days after such receipt.

3.3.3 Milestone Notice . Within ** days after the achievement of any milestone set forth in Section 3.1.3 , Cell Therapeutics shall provide Novartis with written notice of such milestone achievement (each, a “ Milestone Notice ”), together with payment of the corresponding milestone payment.

3.3.4 Royalty Notice . Within ** days after the end of each Calendar Quarter, Cell Therapeutics shall provide Novartis with a Quarterly Report, together with payment of the royalties due pursuant to Section 3.1.4 with respect to such Calendar Quarter, provided such report and payment may be extended by ** days with respect to information being supplied by a Cell Therapeutics Entity other than Cell Therapeutics or one of its Affiliates.

3.4 Payment Allocation .

3.4.1 Notice and Proposed Allocation . If a Transfer, license, sublicense or other grant of rights (including rights to research, Develop, Commercialize or manufacture Opaxio or Pixantrone) by any Cell Therapeutics Entity to any Third Party includes (i) both

Opaxio Assets and Pixantrone Assets or (ii) Opaxio Assets and/or Pixantrone Assets and any other assets not constituting Opaxio Assets or Pixantrone Assets, then all consideration paid for or in connection with such transaction shall be allocated among the applicable assets based on the fair market value thereof for purposes of determining payments due to Novartis hereunder arising out of such transaction. Cell Therapeutics shall include such allocation and an explanation in reasonable detail as to the basis therefor (the “ Proposed Allocation ”) in the Transaction Notice with respect to such transaction together with a certification from its chief executive officer or chief financial officer that such allocation has been determined in good faith and in accordance with this Section 3.4.1 .

3.4.2 Dispute Notice . Cell Therapeutics shall permit Novartis and its representatives to review documents and other information of Cell Therapeutics or its Affiliates relating to the Proposed Allocations which documents and other information may be redacted to delete such Confidential Information as Cell Therapeutics shall reasonably determine to be unnecessary to enable Novartis to review for purposes thereof, and, at Novartis’ written request, shall provide Novartis and its representatives with copies of any such documents or other information, as so redacted, for such purpose. Unless Novartis disputes the calculations or amounts with respect to the Proposed Allocation in writing (a “ Dispute Notice ”) within sixty (60) days following receipt of the applicable Transaction Notice, subject to Cell Therapeutics having complied with its obligations pursuant to this Section 3.4.2 , the Proposed Allocation shall become final and binding. Notwithstanding the foregoing, if any of such documents or other information is redacted as provided above, at the request of Novartis, an unredacted copy of such documents and other information shall promptly be provided by Cell Therapeutics to outside counsel or an independent accounting firm designated by Novartis and which is bound by confidentiality obligations at least equivalent to those provided herein in order to confirm compliance with this Agreement and such counsel or firm shall be entitled to disclose solely those portions of the redacted documents and other information to Novartis that it reasonably determines are relevant to determining compliance with this Agreement.

3.4.3 Dispute Resolution . If Novartis provides a Dispute Notice within sixty (60) days following receipt of the applicable Transaction Notice, Cell Therapeutics and Novartis shall attempt in good faith to resolve such dispute promptly, but in any event within thirty (30) days after delivery of the Dispute Notice. If Cell Therapeutics and Novartis are unable to resolve the dispute within such thirty (30)- day period, Novartis shall select an internationally recognized public accounting firm (the “ Accounting Firm ”), subject to the consent of Cell Therapeutics (such consent not to be unreasonably withheld), to promptly resolve any remaining disagreements and determine the allocation in accordance with Section 3.4.1 . The Accounting Firm shall be instructed to investigate only those items which are in dispute. Novartis and Cell Therapeutics will each furnish to the Accounting Firm such work papers and other documents and information relating to the disputed items and amounts and answer questions, as the Accounting Firm may reasonably request. Neither Novartis nor Cell Therapeutics shall have any ex parte communications or meetings with the Accounting Firm without the prior written consent of the other. Novartis and Cell Therapeutics shall instruct the Accounting Firm to render its determination as to the proper allocation of value (the “ Final Allocation ”) within thirty (30) days following the referral of such matter thereto, and the determination of the Accounting Firm shall be final and binding upon the Parties. In the event that the Final Allocation results in any adjustment to the amount of any payment previously made pursuant to Section 3.1.1 or 3.1.2 , a payment necessary to reflect such adjustment shall be made by the applicable Party to the other Party within ten (10) days of the determination of the Final Allocation.

3.4.4 Fees and Expenses . The fees and expenses of the Accounting Firm shall be borne by Novartis; provided , however , that if any amount payable to Novartis pursuant to Section 3.1.1 or 3.1.2 increases by more than ** based on the Final Allocation from the amount that would have been payable based on the Proposed Allocation, Cell Therapeutics shall pay **.

3.5 Payment Terms . Payments to Novartis hereunder shall be made by electronic wire transfer of immediately available funds to an account of Novartis or one of its Affiliates, as designated in writing by Novartis to Cell Therapeutics.

3.6 Audits .

3.6.1 Cell Therapeutics shall, and shall cause the Cell Therapeutics Entities to keep complete, true and accurate books and records in accordance with Cell Therapeutics’ Accounting Standards, in sufficient detail for Novartis to determine the payments due under this Agreement, for at least three (3) years following the end of the fiscal year to which they pertain.

3.6.2 Novartis shall have the right to appoint an independent, internationally recognized accounting firm (“ Auditor ”) to audit the relevant records of the Cell Therapeutics Entities to confirm any amounts payable pursuant to Section 3.1 , Net Sales, royalties, and any other amounts payable hereunder for a period covering not more than the preceding two (2) fiscal years; provided, however , that the Auditor is reasonably acceptable to Cell Therapeutics and before beginning its audit, executes an undertaking reasonably acceptable to Cell Therapeutics by which the Auditor shall keep confidential all information reviewed during such audit.

3.6.3 Cell Therapeutics shall make its relevant records (and those of the Cell Therapeutics Entities, as applicable) available for inspection by Novartis during regular business hours at the facility(ies) of the Cell Therapeutics Entities where such records are customarily kept, upon reasonable notice from Novartis solely to verify the accuracy of the reports given and payments due hereunder. Such audit right may only be exercised once per Calendar Year by Novartis and only once with respect to records covering any specific fiscal year.

3.6.4 Novartis shall bear the full cost of such audit, unless it discloses an underpayment of the payments audited of more than ** of the amounts due over the audited period, in which case, **. Cell Therapeutics shall promptly remit to Novartis the amount of any underpayment of milestones, royalties, and any other payments due hereunder, including reimbursement, if applicable pursuant to this Section 3.6.4 , of the cost of the audit.

3.7 Tax Matters . The Parties shall use all reasonable and legal efforts to eliminate or minimize tax withholding, to the extent permitted by applicable law, on payments made pursuant to this Agreement. Each Party agrees to cooperate in good faith to provide the other Party with such documents and certifications as are reasonably necessary to enable such other Party to minimize any withholding tax obligations and/or liabilities. The Parties will reasonably cooperate in providing one another with documentation of the payment of any withholding taxes paid pursuant to this Section 3.7 and in completing and filing documents required under the

provisions of any applicable tax laws or under any other applicable law in connection with the making of any required tax payment or withholding payment, or in connection with any claim to a refund of or credit for any such payment. If Cell Therapeutics is required to make any deduction or withholding from payments due to Novartis, Cell Therapeutics will (i) promptly notify Novartis of such requirement, (ii) pay to the relevant authorities on Novartis’s behalf the full amount required to be deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against Novartis, and (iii) promptly forward to Novartis an official receipt (or certified copy) or other documentation reasonably acceptable to Novartis evidencing such payment to such authorities. In the event that Novartis instructs Cell Therapeutics not to withhold tax for any payment, Novartis shall indemnify Cell Therapeutics if the Internal Revenue Service or other relevant authority takes the position that the withholding tax is required.

3.8 United States Dollars . All dollar ($) amounts specified in this Agreement are USD amounts. All payments shall be made in USD.

3.9 Currency Exchange . When conversion of payments from any foreign currency is required to be undertaken by Cell Therapeutics, the USD equivalent shall be calculated using Cell Therapeutics’ then-current standard exchange rate methodology applied in its external reporting for the conversion of foreign currency sales into USD, which methodology shall be in accordance with the Accounting Standards.

3.10 Certain Payment Procedures . Either Party may designate an Affiliate thereof as the recipient of any amounts payable hereunder to such Party. If at any time legal restrictions in any country prevent the prompt remittance of any payments due pursuant to this Agreement, the paying Party shall have the right and option to make such payments by depositing the amount thereof in local currency to the receiving Party’s account in a bank or depository in such country designated by the receiving Party, or, if none is designated by the receiving Party within thirty (30) days, in a recognized banking institution selected by the paying Party, its Affiliates, licensees or sublicensees, as the case may be, and identified in a written notice given to the receiving Party.

3.11 Late Payments . Cell Therapeutics shall pay interest to Novartis on the aggregate amount of any payments that are not paid on or before the date such payments are due under this Agreement at a rate per annum equal to the lesser of ** per month or the highest rate permitted by applicable law, compounded monthly, calculated on the number of days such payments are paid after the date such payments are due.

3.12 No Set-Off . No Person shall have the right to set off any amount to which Novartis is entitled under this Agreement against any payment such Person is required to make under this Agreement or under any other agreement.

ARTICLE 4

Intentionally Omitted.

ARTICLE 5

REPRESENTATIONS AND WARRANTIES

5.1 Representations and Warranties by Each Party . Each Party represents and warrants to the other as of the Effective Date that:

5.1.1 it is a corporation duly organized, validly existing, and in good standing under the laws of its jurisdiction of formation;

5.1.2 it has full corporate power and authority to execute, deliver, and perform this Agreement, and has taken all corporate action required by law and its organizational documents to authorize the execution and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement;

5.1.3 this Agreement constitutes a valid and binding agreement enforceable against it in accordance with its terms (except as the enforceability thereof may be limited by Bankruptcy, bank moratorium or similar laws affecting creditors’ rights generally and laws restricting the availability of equitable remedies and may be subject to general principles of equity whether or not such enforceability is considered in a proceeding at law or in equity);

5.1.4 all consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained; and

5.1.5 the execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement, and the consummation of the transactions contemplated hereby do not and shall not (i) conflict with or result in a breach of any provision of its organizational documents, (ii) result in a breach of any agreement to which it is a party; or (iii) violate any law.

5.2 Disclaimer of Representations and Warranties . EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN SECTION 5.1 , NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY, INCLUDING ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

ARTICLE 6

CONFIDENTIALITY

6.1 Duty of Confidence . Subject to the other provisions of this Section 6 , all Confidential Information disclosed by a Party or its Affiliates under this Agreement will be maintained in confidence and otherwise safeguarded by the recipient Party. The recipient Party may only use the Confidential Information for the purposes of this Agreement and pursuant to the rights granted to the recipient Party under this Agreement. Subject to the other provisions of this Section 7 , each Party shall hold as confidential such Confidential Information of the other Party or its Affiliates in the same manner and with the same protection as such recipient Party maintains its own confidential information.

6.2 Subject to the other provisions of this Section 6 , a recipient Party may only disclose Confidential Information of the other Party to employees, agents, contractors, consultants and advisers of the Party and its Affiliates and sublicensees and to Third Parties to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement; provided , that such Persons are bound to maintain the confidentiality of the Confidential Information in a manner consistent with the confidentiality provisions of this Agreement.

6.3 Exceptions . The obligations under this Section shall not apply to any information to the extent the recipient Party can demonstrate by competent evidence that such information:

6.3.1 is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Agreement by the recipient Party or its Affiliates;

6.3.2 was known to, or was otherwise in the possession of, the recipient Party or its Affiliates prior to the time of disclosure by the disclosing Party or its Affiliate;

6.3.3 is disclosed to the recipient Party or an Affiliate on a non-confidential basis by a Person who is entitled to disclose it without breaching any confidentiality obligation to the disclosing Party or any of its Affiliates; or

6.3.4 is independently developed by or on behalf of the recipient Party or its Affiliates, as evidenced by its written records, without reference to the Confidential Information disclosed by the disclosing Party or its Affiliates under this Agreement.

6.4 Authorized Disclosures .

6.4.1 In addition to disclosures allowed under Section 6.2 , the recipient Party may disclose Confidential Information belonging to the disclosing Party to the extent such disclosure is necessary in the following instances: (i) prosecuting or defending litigation as permitted by this Agreement or the Surviving Provisions, (ii) complying with applicable court orders or governmental regulations; or (iii) to the extent otherwise necessary or appropriate in connection with exercising the rights granted to it hereunder.

6.4.2 In the event the recipient Party is required to disclose Confidential Information of the disclosing Party by law or in connection with bona fide legal process, such disclosure shall not be a breach of this Agreement; provided , that the recipient Party (i) informs the disclosing Party as soon as reasonably practicable of the required disclosure, (ii) limits the disclosure to the required purpose, and (iii) at the disclosing Party’s request and expense, assists in an attempt to object to or limit the required disclosure.

ARTICLE 7

PUBLICITY

7.1 Publicity .

7.1.1 Each Party agrees not to issue any press release or other public statement, whether oral or written, disclosing the existence or terms and conditions of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld, provided however, that neither Party will be prevented from complying with any duty of disclosure it may have pursuant to law or governmental regulation or pursuant to the rules of any recognized stock exchange or quotation system. Notwithstanding the foregoing, following execution of this Agreement the Parties hereby agree that Cell Therapeutics may issue the press release attached hereto as Exhibit B .

7.1.2 In the event of a disclosure required by law, governmental regulation or the rules of any recognized stock exchange or quotation system disclosing terms or conditions of this Agreement beyond that which is contained in the press release attached hereto as Exhibit B , the Parties shall coordinate with each other with respect to the timing, form and content of such required disclosure to the extent practicable under the circumstances, and, if so requested by the other Party, the Party subject to such obligation shall use commercially reasonable efforts to obtain an order protecting to the maximum extent possible the confidentiality of such provisions of this Agreement as reasonably requested by the other Party. If the Parties are unable to agree on the form or content of any required disclosure, such disclosure shall be limited to the minimum required, as determined by the disclosing Party in consultation with its legal counsel. Without limiting the foregoing, each Party shall consult with the other Party on the provisions of this Agreement, together with exhibits or other attachments attached hereto, to be redacted in any filings made by Cell Therapeutics and/or Novartis with the Securities and Exchange Commission or as otherwise required by law.

ARTICLE 8

INDEMNIFICATION

8.1 Indemnification by Cell Therapeutics . Cell Therapeutics shall (and shall cause each Cell Therapeutics Entity to) indemnify and hold Novartis and its Affiliates, and their respective officers, directors, employees, contractors, agents and assigns, harmless from and against any Claims against Novartis or any of the foregoing persons arising or resulting from:

8.1.1 Cell Therapeutics Entities’ Development, manufacture or Commercialization of Opaxio or Pixantrone; or

8.1.2 the breach of any of the covenants, warranties and representations made by Cell Therapeutics to Novartis under this Agreement.

Cell Therapeutics shall only be obliged to so indemnify and hold Novartis harmless to the extent that such Claims do not arise from the breach of this Agreement, negligence or willful misconduct of Novartis.

8.2 Indemnification by Novartis . Novartis shall indemnify and hold Cell Therapeutics and its Affiliates, and their respective officers, directors, employees, contractors, agents and assigns, harmless from and against any Claims against Cell Therapeutics or any of the foregoing persons arising or resulting from:

8.2.1 the breach of any of the covenants, warranties and representations made by Novartis to Cell Therapeutics under this Agreement.

Novartis shall only be obliged to so indemnify and hold Cell Therapeutics harmless to the extent that such Claims do not arise from the breach of this Agreement, negligence or willful misconduct of Cell Therapeutics.

8.3 Indemnification Procedure .

8.3.1 A Party hereto or any of its Affiliates seeking indemnification hereunder (“ Indemnified Party ”) shall notify the other Party (“ Indemnifying Party ”) in writing reasonably promptly after the assertion against the Indemnified Party of any claim or allegation by a Third Party (“ Third Party Claim ”) in respect of which the Indemnified Party intends to base a claim for indemnification hereunder, but the failure or delay so to notify the Indemnifying Party shall not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party except to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve such Third Party Claim is adversely affected thereby.

8.3.2 Subject to the provisions of Sections 8.3.4 and 8.3.5 below, the Indemnifying Party shall have the right, upon written notice given to the Indemnified Party within thirty (30) days after receipt of the notice from the Indemnified Party of any Third Party Claim to assume the defense and handling of such Third Party Claim, at the Indemnifying Party’s sole expense, in which case the provisions of Section 8.3.3 below shall govern.

8.3.3 The Indemnifying Party shall select counsel reasonably acceptable to the Indemnified Party in connection with conducting the defense and handling of such Third Party Claim, and the Indemnifying Party shall defend or handle the same in consultation with the Indemnified Party, and shall keep the Indemnified Party timely apprised of the status of such Third Party Claim. The Indemnifying Party shall not, without the prior written consent of the Indemnified Party, agree to a settlement of any Third Party Claim which could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder, or would involve any admission of wrongdoing on the part of the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party, at the request and expense of the Indemnifying Party, and shall be entitled to participate in the defense and handling of such Third Party Claim with its own counsel and at its own expense. Notwithstanding the foregoing, in the event the Indemnifying Party fails to conduct the defense and handling of any Third Party Claim in good faith after having assumed such, then the provisions of Section 8.3.5 below shall govern.

8.3.4 If the Indemnifying Party does not give written notice to the Indemnified Party, within thirty (30) days after receipt of the notice from the Indemnified Party of any Third Party Claim, of the Indemnifying Party’s election to assume the defense and handling of such Third Party Claim, the provisions of Section 8.3.5 below shall govern.

8.3.5 The Indemnified Party may, at the Indemnifying Party’s expense, select counsel reasonably acceptable to the Indemnifying Party in connection with conducting the defense and handling of such Third Party Claim and defend or handle such Third Party Claim in

such manner as it may deem appropriate, provided, however, that the Indemnified Party shall keep the Indemnifying Party timely apprised of the status of such Third Party Claim and shall not settle such Third Party Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld. If the Indemnified Party defends or handles such Third Party Claim, the Indemnifying Party shall cooperate with the Indemnified Party, at the Indemnified Party’s request but at no expense to the Indemnified Party, and shall be entitled to participate in the defense and handling of such Third Party Claim with its own counsel and at its own expense.

8.4 Special, Indirect and Other Losses . IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS AFFILIATES BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR FOR ANY ECONOMIC LOSS OR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A THIRD PARTY CLAIM.

8.5 No Exclusion . Neither Party excludes any liability for death or personal injury caused by its negligence or that of its employees, agents or sub-contractors.

ARTICLE 9

MISCELLANEOUS

9.1 Entire Agreement of the Parties . This Agreement, together with its Exhibits and the documents to be delivered in connection with this Agreement, and the Surviving Provisions set forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersede all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter. In the event of any conflict between a substantive provision of this Agreement and any Exhibit hereto, the substantive provision of this Agreement shall prevail.

9.2 Governing Law and Jurisdiction . This Agreement shall be governed by and construed under the laws of New York, without giving effect to the conflicts of laws provision thereof. The United Nations Convention on Contracts for the International Sale of Goods (1980) shall not apply to the interpretation of this Agreement. Each Party irrevocably submits to the exclusive jurisdiction of the United States District Court for the Southern District of New York, for the purposes of any suit, action or other proceeding arising out of this Agreement. Each Party agrees to commence any such action, suit or proceeding in the United States District Court for the Southern District of New York or, if such suit, action or other proceeding may not be brought in such court for jurisdictional reasons, in the Supreme Court of the State of New York, New York County. Each Party further agrees that service of any process, summons, notice or document by U.S. registered mail to such Party’s respective address set forth in Section 9.4 shall be effective service of process for any action, suit or proceeding in New York with respect to any matters to which it has submitted to jurisdiction in this Section 9.2 . Each Party irrevocably and unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement in the United States District Court for the Southern District of New York, and hereby and thereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.

9.3 Successors and Assigns; Assignment . The terms and provisions of this Agreement shall inure to the benefit of, and be binding upon, Novartis, Cell Therapeutics and their respective successors and permitted assigns; provided, however , that neither Party may transfer or assign any of its rights and obligations hereunder without the prior written consent of the other, such consent not to be unreasonably withheld. Notwithstanding the foregoing, either Party may assign in writing its rights and obligations, in whole or in part, to (i) one or more of its Affiliates upon notice to the other Party, (ii) the successor to or assignee of all or substantially all of the relevant business to which this Agreement relates (or in the case of Cell Therapeutics, to the respective successors or assignees of the Opaxio Assets and the Pixantrone Assets, subject to the other terms, including the payment terms, hereof), or (iii) in the case of Novartis any of its rights to receive payments hereunder, in whole or in part, to any Person. No permitted assignment shall relieve the assignor of liability hereunder. Any attempted assignment in contravention of the foregoing shall be void.

9.4 Notices . All notices, consents, waivers, and other communications under this Agreement must be in writing and will be deemed to have been duly given when (a) delivered by hand (with written confirmation of receipt), (b) sent by fax or email (with written or comparable confirmation of receipt), provided that a copy is sent by an internationally recognized overnight delivery service (receipt requested), or (c) when received by the addressee, if sent by an internationally recognized overnight delivery service (receipt requested), in each case to the appropriate addresses and fax numbers set forth below (or to such other addresses and fax numbers as a Party may designate by notice):


	If to Cell Therapeutics:

		Cell Therapeutics, Inc.
		3101 Western Ave.
		Suite 600
		Seattle, Washington 98121
		Attention: Legal Affairs
		Fax: **

	with a copy to:	O’Melveny & Myers, LLP
		Two Embarcadero Center, 28th Floor
		San Francisco, CA 94111
		Attention: C. Brophy Christensen
		Fax: **

If to Novartis:

		Novartis International Pharmaceutical Ltd.
		131 Front Street
		Hamilton HM 12, Bermuda
		Attn: Board of Directors

Mailing:

P.O. Box HM 2899

Hamilton HM LX, Bermuda

Fax **

with a copy to:

Novartis Pharma AG

Lichtstrasse 35

Post Office Box 4002

Basel, Switzerland

Attn: Legal Department

Fax: **

and

Novartis Pharma AG

Lichtstrasse 35

Post Office Box 4002

Basel, Switzerland

Attn: Head, Business Development and Licensing

Fax: **

9.5 Severability . Should one or more of the provisions of this Agreement become void or unenforceable as a matter of law, then this Agreement shall be construed as if such provision were not contained herein and the remainder of this Agreement shall be in full force and effect, and the Parties will use their commercially reasonable efforts to substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible with the original intent of the Parties.

9.6 Waivers and Amendments . The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. No waiver shall be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.

9.7 Interpretation . Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation.” The word “will” shall be construed to have the same meaning and effect as the word “shall.” The word “or” shall be construed to have the same meaning and effect as “and/or.” Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any

laws herein shall be construed as referring to such laws as from time to time enacted, repealed or amended, (c) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (d) the words “herein”, “hereof’ and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, and (e) all references herein to Articles, Sections, Exhibits or Schedules shall be construed to refer to Articles, Sections, Exhibits and Schedules of this Agreement unless otherwise expressly stated in this Agreement. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

9.8 Execution in Counterparts; Electronic Signatures . This Agreement may be executed in counterparts, each of which counterparts, when so executed and delivered, shall be deemed to be an original, and all of which counterparts, taken together, shall constitute one and the same instrument even if both Parties have not executed the same counterpart. Signatures provided by facsimile transmission or by electronic delivery in . pdf format shall be deemed to be original signatures.

9.9 Relationship of the Parties . Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of any type between Cell Therapeutics and Novartis, or to constitute one as the agent of the other. Moreover, each Party agrees not to construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give any Party the power or authority to act for, bind, or commit the other.

9.10 Further Assurances . Novartis and Cell Therapeutics hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary to carry out the intent and purposes of this Agreement.

9.11 No Third Party Beneficiary Rights . This Agreement is not intended to and shall not be construed to give any Third Party any interest or rights (including any third party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby.

9.12 Cumulative Remedies . No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

9.13 Waiver of Rule of Construction . Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, any rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

[Signature page follows]

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.


NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD.		CELL THERAPEUTICS, INC.

By:	/s/ H.S. Zivi	By:	/s/ James Bianco

Name:	H.S. Zivi	Name:	James Bianco

Title:	Director	Title:	CEO

By:	/s/ Alison Dyer-Fagundo

Name:	Alison Dyer-Fagundo

Title:	Alternate Director

[Signature Page to Termination Agreement]

Confidential Treatment Requested

Exhibit A

Trademark Assignment

This T RADEMARK A SSIGNMENT dated as of January , 2014 between Novartis AG (“ Assignor ”) and Cell Therapeutics, Inc., a corporation organized and existing under the laws of the State of Washington (“ Assignee ”).

A.	Assignor desires to transfer the trademarks, including registrations and applications therefor, identified in Annex A attached hereto (the “ Assigned Trademarks ”);

B.	Assignee, desires to acquire Assignor’s interest in and to the Assigned Trademarks; and

Assignor makes this assignment pursuant to that certain Termination Agreement (the “ Termination Agreement ”), dated as of January , 2014, by and between Novartis International Pharmaceutical Ltd., a limited company organized and existing under the laws of Bermuda and an affiliate of Assignor, and Assignee.

N OW , T HEREFORE , for good and valuable consideration stated in the Termination Agreement the receipt and adequacy of which is hereby acknowledged, the parties agree as follows:

Assignor does hereby sell, transfer, convey and assign unto Assignee Assignor’s entire right, title and interest in and to the Assigned Trademarks, including without limitation the right to apply for trademark registration and the right to renew the trademark registrations and any trademark registrations which shall issue from the applications included in the Assigned Trademarks anywhere in the world, and all convention and treaty rights based on the Assigned Trademarks, to be held and enjoyed by Assignee for its own use and benefit and for the use and benefit of its successors, assigns and legal representatives, to be used fully and entirely as said rights would have been held and enjoyed by Assignor had this assignment and sale not been made, together with any claims for damages by reason of past infringement of said Assigned Trademarks with the right to sue and collect the same for its own use or for the use of its successors, assigns or other legal representatives.

In the event a transfer of trademark rights is not possible or suitable, Assignor will upon request of Assignee take any reasonable action necessary to allow Assignee to file for Assigned Trademarks in its or its affiliates’ own name; provided, that such filing shall be at Assignee’s sole cost and expense.

Assignor hereby authorizes empowered officials of the United States Patent and Trademark Office and similar trademark offices all over the world to transfer all registrations and applications for said Assigned Trademarks to Assignee as assignee of the entire right, title and interest therein or otherwise as Assignee may direct, in accordance with this instrument of assignment, and to issue to Assignee all registrations which may issue with respect to any applications for said Assigned Trademarks.

4.	NOVARTIS MAKES NO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE ASSIGNED TRADEMARKS, INCLUDING WITH RESPECT TO THE VALIDITY, SUBSISTENCE OR ENFORCEABILITY THEREOF.

I N W ITNESS W HEREOF , each party has caused its proper officer to execute this T RADEMARK A SSIGNMENT .

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NOVARTIS AG

By:

Name:

Title:


Sworn to me this day of 2013


Notary Public


By:

Name:

Title:


Sworn to me this day of 2013


Notary Public


CELL THERAPEUTICS, INC.

By:

Name:

Title:


Sworn to me this day of 2013


Notary Public

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Annex A


Trademark	Country	Application / Registration Number	Next Renewal Due	Current Status
OPAXIO	Argentina	2292593	04 Jun 2019	Registered
OPAXIO	Australia	1244231	06 Mar 2018	Registered
OPAXIO	Bolivia	119832C	29 Jul 2019	Registered
OPAXIO	Brazil	829752455	21 Aug 2022	Registered
OPAXIO	Canada	1397784		Filed
OPAXIO	Chile	844252	17 Mar 2019	Registered
OPAXIO	China	6764728	20 May 2020	Registered
OPAXIO	Colombia	374201	27 Feb 2019	Registered
OPAXIO	European Union	6518617	14 Dec 2017	Registered
OPAXIO	Hong Kong	301130660	02 Jun 2018	Registered
OPAXIO	Iceland	793/2008	01 Aug 2018	Registered
OPAXIO	Israel	212159	03 Jun 2018	Registered
OPAXIO	Japan	5206058	20-Feb-2019	Registered
OPAXIO	Mexico	1058522	03 Jun 2018	Registered
OPAXIO	Norway	247807	25 Sep 2018	Registered
OPAXIO	Paraguay	320479/2009	30 Apr 2019	Registered
OPAXIO	Peru	145596	28 Nov 2018	Registered
OPAXIO	South Africa	2008/12595	03 Jun 2018	Filed
OPAXIO	South Korea / Republic of Korea	785943	15 Apr 2019	Registered
OPAXIO	Switzerland	579569	03 Jun 2018	Registered
OPAXIO	Taiwan	1345996	15 Jan 2019	Registered
OPAXIO	Uruguay	39261		Filed
OPAXIO	Venezuela	2010/010188		Filed

Confidential Treatment Requested

Exhibit B

Press Release

LOGO

Cell Therapeutics Reaches Agreement to Reacquire Rights to Two Anti-Cancer Compounds

SEATTLE, [Date XX], 2013– Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that it has reached an agreement with Novartis to reacquire rights to two anti-cancer compounds — pixantrone (PIXUVRI ^® ) and paclitaxel poliglumex (Opaxio ^TM ). Under the terms of the previous agreement, CTI has been responsible for development and commercialization activities and expenses for both compounds to date. Upon the effective date of termination, CTI will regain all rights that had been granted to Novartis. In exchange for Novartis’ agreement to return such rights to CTI, CTI has agreed to make certain potential payments to Novartis based on sales of Opaxio and PIXUVRI and on any sublicense and certain other amounts payable to CTI.

“We are pleased that Novartis and CTI were able to reach a mutually beneficial agreement regarding rights to PIXUVRI and Opaxio,” stated James A. Bianco, M.D., CTI’s President and CEO. “Regaining full rights to these two anti-cancer agents — one currently marketed in Europe and the other completing late-stage development — provides us with the flexibility to manage these assets within the context of our overall product portfolio strategy. PIXUVRI is a first-in-class aza-anthracenedione with unique structural and physiochemical properties and the first approved therapy in the European Union for the treatment of patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Opaxio is completing Phase 3 development as maintenance therapy in patients with ovarian cancer and is also being studied in Phase 2 trials for patients with malignant brain cancer. We believe these drugs could have an important impact in the treatment of patients with cancer.”

About PIXUVRI

PIXUVRI ^® (pixantrone) is a novel aza-anthracenedione with unique structural and physiochemical properties. Unlike related compounds, PIXUVRI forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. PIXUVRI was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite — both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow PIXUVRI to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.

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In May 2012, the European Commission (EC) granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu.

CTI is currently accruing patients into a Phase 3 trial comparing PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. PIXUVRI does not have marketing approval in the United States.

About Opaxio

Opaxio™ (paclitaxel poliglumex) is an investigational, biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol ^® , to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is inactive, potentially sparing normal tissue’s exposure to high levels of paclitaxel and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to macromolecules such as Opaxio. Based on preclinical studies, it appears that Opaxio is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, thereby allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing active paclitaxel. Unlike standard radiosensitizing agents, Opaxio appears tumor selective and does not appear to enhance radiation toxicity to normal tissues.

About Cell Therapeutics, Inc.

CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com .

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI’s securities. Such statements include, but are not limited to, statements regarding CTI’s expectations with respect to the development of the Company and its product and product candidate portfolio, the anticipated benefits and strategic flexibility expected to result from CTI having regained the rights described herein, that PIXURI and Opaxio could have an important impact in the treatment of patients with cancer, that Opaxio may be preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, thereby allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel, and that Opaxio may be tumor selective and may not enhance radiation toxicity to normal tissues. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks that PIXUVRI may fail to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors; that results in future studies or actual results of PIXUVRI may differ from the results of past studies; that CTI may not be able complete a post-marketing study aimed at confirming the clinical benefit

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observed in the PIX301 trial; that the conditional marketing authorization for PIXUVRI may not be renewed; that CTI may not obtain favorable reimbursement or pricing determinations for PIXUVRI in certain markets in the E.U. as planned, and risks associated with the biopharmaceutical industry in general and with CTI and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI may experience delays in the commencement of preclinical and clinical studies, risks related to the costs of developing, producing and selling PIXUVRI, Opaxio, and CTI’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI’s operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI’s average net operating burn rate may increase, that CTI will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI’s most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.

PIXUVRI is a registered trademark and Opaxio is a trademark of Cell Therapeutics, Inc. All other trademarks are the property of their respective owners.

Source: Cell Therapeutics, Inc.

# # #

Contacts:

Monique Greer

+1 206-272-4343

mgreer@ctiseattle.com

Ed Bell

+1 206-282-7100

ebell@ctiseattle.com

In Europe:

CTI Life Sciences Limited, Milan Branch

Laura Villa

+39 02 89659706

lvilla@cti-lifesciences.com

CTI_EUInvestors@CTI-Lifesciences.com

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Schedule I

Original Agreement

[Attached Hereto]

[The Original Agreement has been omitted, as material portions thereof have been previously filed with the Securities and Exchange Commission as Exhibit 10.1 to Cell Therapeutics’ Current Report on Form 8-K filed on September 18, 2006, and is incorporated herein by reference.]

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Exhibit 10.3

**	Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

****	Indicates that the amount of information omitted was a page or more in length, and such information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

AMENDMENT No. 4

TO WHOLESALE DISTRIBUTION AGREEMENT

T HIS A MENDMENT N O . 4 (“Amendment No. 4”) to the Wholesale Distribution Agreement between CTI Life Sciences Limited (“CTILS”) and Max Pharma GmbH (“Wholesaler”) dated March 26, 2013, as amended (collectively, the “Agreement”) is entered into effective January 1, 2014.

The parties hereby agree as follows:

1.	Schedule 1 of the Agreement is hereby deleted in its entirety and replaced with Schedule 1 attached hereto.

2.	Section 1.16 of the Agreement is deleted in its entirety and replaced with the following language:

“Territory” means the Federal Republic of Germany, Austria, Poland, the Czech Republic and the Slovak Republic, and any additional countries agreed between the Parties in writing from time to time after the Effective Date.

3.	Section 2.1(b) of the Agreement is hereby deleted in its entirety and replaced with the following language:

“In conjunction with the appointment under Section 2.1(a), Wholesaler agrees to purchase, sell and distribute the Product in the Territory on its own account (the “Services”). Wholesaler also agrees to provide logistics services with respect to the Product, including the disposition function, the transport function, the transshipment function, the storage function and the information function (the “ Logistics Services ”). Wholesaler shall perform Services and Logistics Services in compliance with all applicable laws, rules and regulations.”

4.	Section 6.3 of the Agreement is hereby deleted in its entirety and replaced with the following language:

“The Products shipped by CTILS will at the time of delivery have a remaining shelf-life of at least fourteen (14) months, and will be marked in accordance with CTILS’s instructions and properly packed and secured so as to reach their destination in an undamaged condition in the ordinary course of events. From time to time, upon mutual agreement of CTILS and Wholesaler, Product with a remaining shelf-life of less than fourteen (14) months will be delivered to and purchased by Wholesaler. CTILS will provide a certificate of analysis and a certificate of release with each batch of Product delivered.”

5.	Section 4.8 of the Agreement is hereby deleted in its entirety and replaced with the following language:

“ Special Pricing Arrangements .

(a)

Within the Federal Republic of Germany (“Germany”), inpatient hospital customers of CTILS or Wholesaler are not eligible to automatically receive the Germany section §130b negotiated per vial discount of ** for Product. Wholesaler agrees to pre-screen customer orders in the Territory to identify when a customer is purchasing Product for hospital inpatient treatment. Wholesaler agrees to notify CTILS within 7 days of all such occurrences so that CTILS may address special pricing arrangements with such customer.

(b)

From time to time, a customer of CTILS or Wholesaler in the Territory may request that Wholesaler sell Product to such customer at a price that is different than the price paid by the Wholesaler to CTILS for the Product. If authorized in advance in writing by CTILS, the price paid by the Wholesaler to CTILS for the Product shall be adjusted based upon the new pricing arrangement for such customer for Product as follows:

(i) When such customer’s new selling price for Product is above the amount paid by the Wholesaler to CTILS for Product, the Wholesaler agrees to reimburse CTILS within 30 days for the difference between the price paid by such customer and the price paid by Wholesaler to CTILS for Product.

(ii) When such customer’s new selling price for Product is below the amount paid by the Wholesaler to CTILS for Product, Wholesaler will be entitled to receive and CTILS will extend a credit note to Wholesaler for the difference between the price paid by Wholesaler to CTILS and the price paid by such customer to Wholesaler for the Product.”

6.	Article IV of the Agreement is hereby amended by adding the following new Section 4.9:

“ Pricing Adjustments.

(a)

Wholesaler will reimburse CTILS ** for Product sales that occurred in Germany from December 17, 2013 to December 31, 2013 within thirty (30) days of the effective date of this Amendment No. 4.

(b)

On January 1, 2014, Wholesaler will provide CTILS with a statement representing the number of vials of Product held in inventory by Wholesaler at the close of business on December 31, 2013. CTILS will extend a credit note to Wholesaler for **, calculated by multiplying the number of vials ** of Product held by Wholesaler in inventory at the close of business on December 31, 2013 multiplied by **.”

Unless otherwise defined herein, capitalized terms used in this Amendment No. 4 shall have the meanings assigned thereto in the Agreement. Except as amended herein, all other terms and conditions of the Agreement as previously amended shall remain the same and in full force and effect.

I N WITNESS WHEREOF , the parties hereby accept and agree to the terms and conditions of this Amendment No. 4.


CTI LIFE SCIENCES LIMITED		MAX PHARMA GMBH

By:	/s/ Jim Fong	By:	/s/ Michael Kvestzer
Name:	Jim Fong	Name:	Michael Kvestzer
Title:	Director	Title:	GM
Date:	2/27/14	Date:	2/25/14

SCHEDULE 1

Product and Consideration

Effective Date : January 1, 2014

Selling Price-Federal Republic of Germany


PRODUCT		Price Per Vial of Product Charged to Wholesaler
PIXUVRI®; SKU # CLB-F-673-85519-GER		****

Selling Price-Austria


PRODUCT		Price Per Vial of Product Charged to Wholesaler
PIXUVRI®; SKU # CLB-F-673-85519-AUS		**

Selling Price-Poland


PRODUCT		Price Per Vial of Product Charged to Wholesaler
PIXUVRI®; SKU # CLB-F-673-85519-GER		**

EXHIBIT 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO

SECURITIES EXCHANGE ACT OF 1934 RULES 13a-14(a) AND 15d-14(a)

AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, James A. Bianco, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Cell Therapeutics, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions) of internal control over financial reporting:

(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.

EXHIBIT 31.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER

PURSUANT TO

SECURITIES EXCHANGE ACT OF 1934 RULES 13a-14(a) AND 15d-14(a)

AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Louis A. Bianco, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Cell Therapeutics, Inc.;

(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.

EXHIBIT 32

CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER

PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I, James A. Bianco, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, in my capacity as an officer of Cell Therapeutics, Inc., that, to my knowledge, the Quarterly Report of Cell Therapeutics, Inc. on Form 10-Q for the fiscal quarter ended March 31, 2014 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of Cell Therapeutics, Inc.

A signed original of this written statement required by Section 906 has been provided to Cell Therapeutics, Inc. and will be retained by Cell Therapeutics, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

I, Louis A. Bianco, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, in my capacity as an officer of Cell Therapeutics, Inc., that, to my knowledge, the Quarterly Report of Cell Therapeutics, Inc. on Form 10-Q for the fiscal quarter ended March 31, 2014 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of Cell Therapeutics, Inc.