þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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52-1256615
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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Large accelerated filer
o
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Accelerated filer
þ
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
o
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PART I: FINANCIAL INFORMATION
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||
Page
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||
Item 1.
|
Financial Statements (Unaudited)
|
|
Balance Sheets
|
1 | |
Statements of Operations
|
2 | |
Statements of Comprehensive Loss
|
3 | |
Statements of Cash Flows
|
4 | |
Notes to Financial Statements
|
5-14 | |
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
15 |
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
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20 |
Item 4.
|
Controls and Procedures
|
20 |
PART II: OTHER INFORMATION
|
||
Item 1.
|
Legal Proceedings
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21 |
Item 1A.
|
Risk Factors
|
21 |
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
31 |
Item 3.
|
Defaults Upon Senior Securities
|
31 |
Item 4.
|
Mine Safety Disclosures
|
31 |
Item 5.
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Other Information
|
31 |
Item 6.
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Exhibits
|
31 |
SIGNATURES
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33 |
March 31, 2013
(unaudited)
|
December 31,
2012
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 20,366,679 | $ | 14,991,488 | ||||
Investment securities – available for sale, at fair value
|
25,202,875 | 8,037,620 | ||||||
Accrued interest receivable on investment securities
|
283,082 | 65,925 | ||||||
Advances and deposits for investigator grants
|
131,706 | 246,252 | ||||||
Other current assets
|
430,451 | 307,699 | ||||||
Total current assets
|
46,414,793 | 23,648,984 | ||||||
Property and equipment
(at cost, less accumulated
depreciation of $999,961 and $924,961, respectively)
|
1,039,621 | 1,114,621 | ||||||
Other assets:
|
||||||||
Deposits, deferred fees and other assets
|
477,293 | 567,188 | ||||||
Patent licensing fees, net
|
26,250 | 28,125 | ||||||
Total other assets
|
503,543 | 595,313 | ||||||
Total assets
|
$ | 47,957,957 | $ | 25,358,918 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 4,180,805 | $ | 2,339,768 | ||||
Accrued liabilities
|
1,097,445 | 1,254,979 | ||||||
Notes payable - current portion
|
1,883,752 | 1,410,455 | ||||||
Deferred revenue - current portion | 500,000 | - | ||||||
Total current liabilities
|
7,662,002 | 5,005,202 | ||||||
Common stock warrant liability
|
3,635 | 4,283,932 | ||||||
Notes payable – non-current portion
|
3,173,389 | 3,661,147 | ||||||
Deferred revenue - non-current portion | 4,375,000 | - | ||||||
Other non-current liabilities
|
442,950 | 446,779 | ||||||
Total liabilities
|
15,656,976 | 13,397,060 | ||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.01 par value: 100,000 shares authorized and 20,000 and 5,000 shares issued at March 31, 2013 and December 31, 2012
and 5,037 and -0- shares outstanding at March 31, 2013 and
December 31, 2012, respectively
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50 | – | ||||||
Common stock, $0.01 par value; 75,000,000 shares authorized and 51,497,856 and 37,967,708 shares issued at March 31, 2013
and December 31, 2012 and 50,835,477 and 37,302,785 shares outstanding at March 31, 2013 and December 31, 2012, respectively
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514,979 | 379,677 | ||||||
Additional paid-in capital
|
190,743,338 | 165,276,069 | ||||||
Accumulated other comprehensive loss
|
(158,556 | ) | (126,607 | ) | ||||
Accumulated deficit
|
(156,118,622 | ) | (150,876,770 | ) | ||||
Subtotal
|
34,981,189 | 14,652,369 | ||||||
Treasury stock, at cost (662,379 and 664,921 shares at
March 31, 2013 and December 31, 2012, respectively)
|
(2,680,208 | ) | (2,690,511 | ) | ||||
Total stockholders' equity
|
32,300,981 | 11,961,858 | ||||||
Total liabilities and stockholders' equity
|
$ | 47,957,957 | $ | 25,358,918 |
Three Months Ended
March 31,
|
||||||||
2013
|
2012
|
|||||||
Licensing revenue
|
$ | 125,000 | $ |
─
|
||||
Operating expenses:
|
||||||||
Research and development
|
3,203,177 | 4,693,007 | ||||||
General and administrative
|
1,688,729 | 1,570,466 | ||||||
Total operating expenses
|
4,891,906 | 6,263,473 | ||||||
Loss from operations
|
(4,766,906 | ) | (6,263,473 | ) | ||||
Other income (expense):
|
||||||||
Gain from valuation of common stock warrant liability
|
4,280,297 | 77,600 | ||||||
Investment income, net
|
16,563 | 5,333 | ||||||
Interest expense
|
(180,928 | ) | (5,701 | ) | ||||
Total other income, net
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4,115,932 | 77,232 | ||||||
Net Loss
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(650,974 | ) | (6,186,241 | ) | ||||
Non-cash deemed dividends from
beneficial conversion feature on
convertible preferred stock
|
(4,601,410 | ) | – | |||||
Net loss attributable to common shareholders
|
$ | (5,252,384 | ) | $ | (6,186,241 | ) | ||
Net loss attributable to common
shareholders per common share
– basic and diluted
|
$ | (0.12 | ) | $ | (0.19 | ) | ||
Weighted average shares outstanding – basic and diluted
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42,996,004 | 33,197,196 |
Three Months Ended
March 31,
|
||||||||
2013
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2012
|
|||||||
Other comprehensive loss
|
||||||||
Changes in:
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||||||||
Realized loss on investment securities recognized in investment income, net
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$
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53,740
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$
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128,560
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||||
Unrealized loss on investment securities
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(85,689
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)
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(129,776
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)
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||||
Other comprehensive loss
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(31,949
|
)
|
(1,216
|
)
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||||
Net loss
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(650,974
|
) |
$
|
(6,186,241
|
)
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|||
Total comprehensive loss
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$
|
(682,923
|
) |
$
|
(6,187,457
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)
|
Three Months Ended
March 31,
|
||||||||
2013
|
2012
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(650,974
|
) |
$
|
(6,186,241
|
)
|
||
Non-cash items included in net income (loss):
|
||||||||
Depreciation and amortization
|
76,875
|
53,955
|
||||||
Change in fair value of common stock warrant liability
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(4,280,297
|
)
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(77,600
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)
|
||||
Deferred revenue | 4,875,000 | - | ||||||
Stock-based compensation
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263,192
|
305,127
|
||||||
Treasury shares issued for services and 401(k) matching contribution
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20,835
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50,384
|
||||||
Change in deferred rent liability
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(3,829
|
)
|
65,467
|
|||||
Net changes in:
|
||||||||
Accrued interest on short term investments and other current assets
|
(194,100
|
)
|
(216,934
|
)
|
||||
Accounts payable
|
1,841,037
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(301,358
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)
|
|||||
Accrued liabilities
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(157,534
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)
|
579,323
|
|||||
Net cash provided by (used in) operating activities:
|
1,790,205
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(5,727,877
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)
|
|||||
Cash flows from investing activities:
|
||||||||
Purchases of investment securities
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(20,245,204
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)
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(10,309,461
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)
|
||||
Proceeds from sale and maturity of investment securities
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3,048,000
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5,237,504
|
||||||
Purchases of property and equipment
|
–
|
(177,600
|
)
|
|||||
Net cash used in investing activities
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(17,197,204
|
)
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(5,249,557
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from sale of Preferred Stock,
net of issuance costs
|
13,648,663
|
–
|
||||||
Proceeds from sale of common stock equity, net of issuance costs
|
6,711,173
|
–
|
||||||
Proceeds from exercise of common stock warrants
|
261,944
|
–
|
||||||
Proceeds from exercise of options to purchase common stock
|
174,871
|
–
|
||||||
Principal payments on notes payable
|
(14,461
|
)
|
(46,341
|
)
|
||||
Net cash provided by (used in) financing activities
|
20,782,190
|
(46,341
|
)
|
|||||
Increase (decrease) in cash and cash equivalents
|
5,375,191
|
(11,023,775)
|
||||||
Cash and cash equivalents at beginning of period
|
14,991,488
|
20,145,854
|
||||||
Cash and cash equivalents at end of period
|
$
|
20,366,679
|
$
|
9,122,079
|
||||
Supplemental disclosures of cash flow information:
|
||||||||
Interest paid
|
$
|
180,928
|
$
|
5,701
|
March 31, 2013
|
December 31, 2012
|
|||||||||||||||
Cost
|
Fair Value
|
Cost
|
Fair Value
|
|||||||||||||
Corporate bond maturities
|
||||||||||||||||
Within 3 months
|
$
|
3,108,805
|
$
|
3,003,280
|
$
|
3,053,740
|
$
|
3,002,350
|
||||||||
Between 3-12 months
|
22,252,626
|
22,199,595
|
5,110,487
|
5,035,270
|
||||||||||||
Total
|
$
|
25,361,431
|
$
|
25,202,875
|
$
|
8,164,227
|
$
|
8,037,620
|
March 31, 2013
|
December 31, 2012
|
|||||||||||||||
Description of Securities
|
Fair Value
|
Gross
Unrealized
Holding
Losses
|
Fair
Value
|
Gross
Unrealized
Holding
Gains
|
||||||||||||
Available for Sale
|
||||||||||||||||
Bonds – corporate issuances (all unrealized holding losses are less than 12 months at date of measurement)
|
$
|
25,202,875
|
$
|
(158,556
|
)
|
$
|
8,037,620
|
$
|
(126,607
|
)
|
Three Months Ended
March 31,
|
||||||||
2013
|
2012
|
|||||||
Interest and dividend income
|
$
|
70,303
|
$
|
133,893
|
||||
Realized losses
|
(53,740
|
)
|
(128,560
|
)
|
||||
$
|
16,563
|
$
|
5,333
|
Level 1
: Quoted prices (unadjusted) or identical assets or liabilities in active markets that the entity has the ability to access as of the measurement date;
|
Level 2
: Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data; and
|
Level 3
: Significant unobservable inputs that reflect a reporting entity’s own assumptions that market participants would use in pricing an asset or liability.
|
Total Fair
Value on the
Balance
Sheet
|
Quoted Prices
In Active
Markets For
Identical Assets
/Liabilities
(Level 1)
|
Significant
Other
Observable
Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
|||||||||||||
Assets:
|
||||||||||||||||
As of March 31, 2013
|
||||||||||||||||
Short-term investments available for sale
|
||||||||||||||||
Bonds – corporate issuances
|
$
|
25,202,875
|
$
|
25,202,875
|
$
|
−
|
$
|
−
|
||||||||
As of December 31, 2012
|
||||||||||||||||
Short-term investments available for sale
|
||||||||||||||||
Bonds – corporate issuances
|
$
|
8,037,620
|
$
|
8,037,620
|
$
|
−
|
$
|
−
|
||||||||
Liabilities:
|
||||||||||||||||
As of March 31, 2013
|
||||||||||||||||
Common stock warrant liability
|
$
|
3,635
|
$
|
−
|
$
|
−
|
$
|
3,635
|
||||||||
As of December 31, 2012
|
||||||||||||||||
Common stock warrant liability
|
$
|
4,283,932
|
$
|
−
|
$
|
−
|
$
|
4,283,932
|
March 31,
2013
|
December 31, 2012
|
|||||||
Amounts due to Contract Research Organizations and
other contractual agreements
|
$
|
801,696
|
$
|
827,989
|
||||
Accrued payroll and related benefits
|
163,063
|
338,365
|
||||||
Accrued professional fees
|
78,900
|
37,400
|
||||||
Other
|
53,786
|
51,225
|
||||||
Total
|
$
|
1,097,445
|
$
|
1,254,979
|
Credit
Agreement
|
||||
For the year ending March 31:
|
||||
2014
|
$
|
1,826,612
|
||
2015
|
2,053,182
|
|||
2016
|
1,120,206
|
|||
$
|
5,000,000
|
Three Months ended March 31,
|
||||||||
2013
|
2012
|
|||||||
Risk-free interest rate
|
0.85%
|
2.97%
|
||||||
Expected volatility
|
83.41%
|
80.8-81.3%
|
||||||
Expected life (in years)
|
5.25
|
6.00 – 6.30
|
||||||
Expected forfeiture rate
|
5%
|
7.5%
|
||||||
Expected dividend yield
|
0.0%
|
0.0%
|
Stock Options
|
Restricted Stock Awards
|
Weighted | ||||||||||||||||||
Equity Awards
|
Options
Outstanding
|
Weighted
Average
Exercise
Price
|
Non-vested
Restricted
Stock
Outstanding
|
Weighted
Average
Grant Date
Fair Value
|
Average
Contractual
Terms of
Equity Awards
(in years)
|
|||||||||||||||
Equity awards outstanding at December 31, 2012
|
3,264,880 | $ | 3.25 | 19,337 | $ | 3.2 | ||||||||||||||
Equity awards granted
|
15,000 | $ | 1.30 | – | $ | – | ||||||||||||||
Equity awards exercised
|
(49,266 | ) | $ | 3.57 | – | $ | – | |||||||||||||
Equity awards forfeited, cancelled or expired
|
(3,333 | ) | $ | 6.45 | – | $ | – | |||||||||||||
Equity awards outstanding at March 31, 2013
|
3,227,281 | $ | 3.25 | 19,337 | $ | 3.2 | 6.6 | |||||||||||||
Aggregate intrinsic value of outstanding awards March 31, 2013
|
$ | – | $ | 61,813 | ||||||||||||||||
Equity awards exercisable at March 31, 2013
|
2,306,490 | $ | 3.52 | 5.7 | ||||||||||||||||
Aggregate intrinsic value of awards exercisable at March 31, 2013
|
$ | – |
Warrants
|
Number of Warrants Issued
|
Weighted Average Exercise Price
|
||||||
Warrants outstanding at December 31, 2012
|
7,863,653 | $ | 3.37 | |||||
Warrants granted in connection with the Preferred Stock Offering as more fully described in Note 9
|
6,036,219 | $ | 1.18 | |||||
Warrants exercised for common stock
|
(71,250 | ) | 3.25 | |||||
Warrants outstanding at March 31, 2013
|
13,828,622 | $ | 2.42 | |||||
Aggregate intrinsic value of outstanding warrants at March 31, 2013
|
$ | – | ||||||
Weighted average remaining contractual terms (years)
|
4.23 |
March 31, 2013
|
December 31, 2012
|
|||||||
Risk-free interest rate
|
0.77
|
%
|
0.73
|
%
|
||||
Expected volatility
|
65.8
|
%
|
92.0
|
%
|
||||
Expected life (in years)
|
1.00
|
1.13
|
||||||
Expected forfeiture rate
|
0.0
|
%
|
0.0
|
%
|
||||
Expected dividend yield
|
0.00
|
%
|
0.00
|
%
|
Beginning balance as of January 1, 2013
|
$
|
4,283,932
|
||
Issuances
|
-
|
|||
Gain from the adjustment for the change in fair value included in net income
|
(4,280,297
|
) | ||
Ending balance as of March 31, 2013
|
$
|
3,635
|
Three Months Ended March 31,
|
||||||||||||||||
($ amounts in 000’s)
|
Change
Increase (Decrease)
|
|||||||||||||||
2013
|
2012
|
$
|
%
|
|||||||||||||
Licensing Revenue:
|
$
|
125
|
$
|
–
|
$
|
125
|
100
|
%
|
||||||||
Operating Expenses:
|
||||||||||||||||
Clinical Research
|
$
|
2,033
|
$
|
3,509
|
$
|
(1,476
|
)
|
(42.1)
|
%
|
|||||||
Chemistry, Manufacturing and Controls
|
1,170
|
1,184
|
(14
|
)
|
(1.1
|
%
|
||||||||||
Research and development
|
3,203
|
4,963
|
(1,490
|
)
|
(30.0)
|
%
|
||||||||||
General and administrative
|
1,689
|
1,570
|
119
|
7.6
|
%
|
|||||||||||
Total operating expenses
|
$
|
4,892
|
$
|
6,263
|
$
|
(1,371
|
)
|
(21.9)
|
%
|
|||||||
Loss from operations
|
$
|
(657
|
) |
$
|
(6,263
|
)
|
$
|
5,612
|
89.6
|
%
|
·
|
issue equity securities that would dilute our current stockholders’ percentage ownership;
|
·
|
incur substantial debt that may place strains on our operations;
|
·
|
spend substantial operational, financial and management resources in integrating new businesses, personnel intellectual property, technologies and products;
|
·
|
assume substantial actual or contingent liabilities;
|
·
|
reprioritize our development programs and even cease development and commercialization of our drug candidates;
|
·
|
suffer the loss of key personnel, or
|
·
|
merge with, or otherwise enter into a business combination with, another company in which our stockholders would receive cash or shares of the other company or a combination of both on terms that certain of our stockholders may not deem desirable.
|
●
|
fluctuations in our quarterly operating results or the operating results of our competitors;
|
●
|
variance in our financial performance from the expectations of investors;
|
●
|
changes in the estimation of the future size and growth rate of our markets;
|
●
|
changes in accounting principles or changes in interpretations of existing principles, which could affect our financial results;
|
●
|
failure of our products to achieve or maintain market acceptance or commercial success;
|
●
|
conditions and trends in the markets we serve;
|
●
|
changes in general economic, industry and market conditions;
|
●
|
success of competitive products and services;
|
●
|
changes in market valuations or earnings of our competitors;
|
●
|
changes in our pricing policies or the pricing policies of our competitors;
|
●
|
announcements of significant new products, contracts, acquisitions or strategic alliances by us or our competitors;
|
●
|
changes in legislation or regulatory policies, practices or actions;
|
●
|
the commencement or outcome of litigation involving our company, our general industry or both;
|
●
|
recruitment or departure of key personnel;
|
●
|
changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;
|
●
|
actual or expected sales of our common stock by our stockholders; and
|
●
|
the trading volume of our common stock.
|
Item 6.
|
||
Certificate of Designation of Preferences, Rights and Limitations of Series A 0% Convertible Preferred Stock, incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company, filed on February 26, 2013.
|
||
4.1
|
Form of Common Stock Purchase Warrant, incorporated herein by reference to Exhibit 4.1 to the Current Report on Form 8-K of the Company, filed on February 26, 2013.
|
|
10.1+***
|
Technology Development Contract, dated January 18, 2013, by and between Celsion Corporation and Zhejiang Hisun Pharmaceutical Co., Ltd.
|
|
10.3
|
Controlled Equity Offering
SM
Sales Agreement, dated February 1, 2013, by and between Celsion Corporation and Cantor Fitzgerald & Co., incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company, filed with the SEC on February 1, 2013.
|
|
10.4
|
Securities Purchase Agreement, dated February 22, 2013, by and among Celsion Corporation and the purchasers named therein, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company, filed with the SEC on February 26, 2013.
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||
31.2+
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||
+
|
Filed herewith.
|
|
The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in XBRL (Extensible Business Reporting Language): (i) the unaudited Balance Sheets, (ii) the unaudited Statements of Operations, (iii) the unaudited Statements of Comprehensive Loss, (iv) the unaudited Statements of Cash Flows, (v) the unaudited Statements of Change in Stockholders' Equity (Deficit), and (vi) Notes to Financial Statements.
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||
*
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Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Securities Exchange Act, except as otherwise stated in such filing.
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**
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Exhibit 101 is being furnished and, in accordance with Rule 406T of Regulation S-T, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Securities Exchange Act.
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|
***
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Portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, amended, and the omitted material has been separately filed with the Securities and Exchange Commission.
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CELSION CORPORATION
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||
Registrant
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||
By:
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/s/ Michael H. Tardugno
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Michael H. Tardugno
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||
President and Chief Executive Officer
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||
By:
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/s/ Gregory Weaver
|
|
Gregory Weaver
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||
Senior Vice President and Chief Financial Officer
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Technology Development Contract
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Project Title: Development Project of Thermodox
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Party A: ZheJiang Hisun Pharmaceutical Co., Ltd.
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Party B: CELSION CORPORATION (CLSN)
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Date: January 18, 2013
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Venue: TaiZhou, ZheJiang,China
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Valid Term: Jan. 2013 to Jan. 2023
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Contract No.
:
TD130101
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Technology Development Contract
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Party A:
ZheJiang Hisun Pharmaceutical Co., Ltd.
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Address
:
WaiSha Road 46#,Jiaojiang District, TaiZhou City, ZheJiang Province, 318000
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Legal representative
:
[***]
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Project Contact:
[***]
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Tel:
[***]
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Email:
[***]
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Party B:
CELSION CORPORATION (CLSN)
|
Address:
997 Lenox Drive, Suite 100
Lawrenceville, NJ 08648, USA
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Legal representative:
Michael Tardugno
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Project Contact:
[***]
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Tel:
[***]
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Email:
[***]
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Whereas:
(A) The Thermodox is the product with the thermosensitive liposomes as the carrier to encapsulate doxorubicin (a kind of the chemotherapeutics with the most extensive application). By combined utilization with the thermo-therapeutic apparatus such as radiofrequency ablation, the Thermodox has the effect of targeted therapy to tumour tissue with the characteristics of highly local concentration and long retention period, which is clinically proven to be able to apparently prolong Progression Free Survivial (PFS) and treat liver cancer without standard therapy. The technology of thermosensitive liposomes is patented and could be developed for the conbination with the other oncology drugs to treat the various kinds of tumors.
(B) Party A is the oncological drug manufacturer with the market leadership in China and wishes to engage in the technology development of the Thermodox with the purpose of commercialization, in China mainland, Hong Kong and Macao (the “China Territory”).
(C) Party B possesses the intellectual property, including patents in research and development of the thermosensitive liposomes and wishes to conduct the development in cooperation with Party A so as to realize the marketing and commercialization of ThermoDox in the China Territory (including mainland China, Hong Kong and Macau) as early as possible.
|
Therefore, both Parties, through consultation on the basis of equality, hereby agree to as follows, which shall be abided by both Parties:
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Clause 1.
The requirements of the research and development project under this Contract are as follows:
|
Party A and Party B shall develop in cooperation, with details as: (1) Party B shall conduct the research and development of the thermosensitive liposome with the purpose of exploitation through advanced technology at the site of Party B and; (2) Party A shall pay the fee for research and development and provide other necessary assistances as provided in this Contract.
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1
.
Scope of Technology Development:
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(1) API: manufacturing process and details, data for stability research, detailed specification and analysis program, reference substance, impurities etc.;
(2) Finished product: manufacturing process and details, data for stability research, detailed specification and analysis program, details and sources of equipments, etc.;
(3) The pharmaceutical research data to be filed for regulatory registration with respect to the Item (1) and (2) set forth above.
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2. Technical standards:
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[***]
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Clause 2.
Work scope and responsibility of Party B:
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1. Party B shall provide product research and development progress summary to Party A periodically, which shall be confirmed in writing by both parties’ technical personnel.
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2. Party B shall arrange the personnel with sufficient abilities and qualifications (“developers”) to conduct research and development work under this Contract, and shall provide the cost & expense list.
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Clause 3.
Work scope and responsibility of Party A:
|
1. Party A shall arrange the personnel with sufficient abilities and qualifications to communicate with developers of Party B.
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2. Party A should pay the research and development fee in time.
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Clause 4.
Party A shall pay the research and development fee as follows:
|
1. Total cost of the research and development fee: 5,000,000 USD
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2. The research and development fee shall be paid in a lump sum by Party A to Party B.
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Payment Method and Schedule is as follows:
Payment Method: in a lump sum.
Payment Schedule:
[***]
|
Taxation: Party A shall be responsible for the tax levied by China government, while Party B shall be responsible for the tax payable to United States government.
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Clause 5.
This Agreement shall not be amended other than by way of mutual agreement in writing.
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Clause 6.
Party B shall not subcontract the research and development tasks of the project under this Contract in part or in whole to any third party without Party A’s prior consent.
|
Clause 7.
During the term of this Contract, if any party identifies any technical risk that may lead to failure or partial failure of the research and development project in question, it should notify the other party within five (5) days so as for both parties to determine whether or not the project should continue. The detailed description of such failure shall be stated in a supplemental agreement in the future. If the identifying party fails to notify the other party within five (5) days nor to take any and all appropriate measures to prevent aggravation of the losses, the party shall bear the aggravated losses so caused.
|
Clause 8.
Both parties shall abide by the confidentiality and obligations as follows:
|
The confidentiality period of this contract is the term of this Contract and ten years thereafter.
|
Party A:
|
1. Confidentiality content (including technical information and management information): same as the content of technology development.
|
2. Confidentiality personnel: all related personnel of Party A
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Party B:
|
1. Confidentiality content (including technical information and management information): same as the content of technology development.
|
2. Confidentiality related personnel: all related personnel of Party B
|
Clause 9:
It is agreed that, the subsequent research and development investment, the rights to commercialization and distribution of ThermoDox in the China Territory, and the belonging of both Parties’ rights with respect thereto, shall be agreed upon by signing a separate contract, if the development of this project turns out to be successful.
|
Clause 10.
Party B has the obligation to provide technical materials, technical interpretation to party A for patent retrieval and review, in order to ensure that there is no infringement of any third party’s intellectual property rights. Failing which Party B shall be responsible for any losses therefrom caused to Party A.
|
Clause 11.
It is agreed that, during the term of this contract, Party A appoints [***] as its project contact and Party B appoints [***] as its project contact. The project contacts shall undertake the responsibilities as follows:
|
1
.
Party B’s project contact is party B’s project leader;
|
2
.
Party A’s project contact is party A’s project leader;
|
If any Party changes its project contact, it shall notify the other party in writing in a timely manner. The party who fails to carry out the notice in time and affect the performance of this Contract or result in any losses shall undertake the responsibility on losses that resulted.
|
Clause 12.
This Contract shall be governed by [***].
|
Clause 13.
Any disputes arising from the execution of this Contract shall be submitted to [***] for arbitration at [***]. The language for arbitration shall be Chinese and English. The arbitration award shall be final and binding upon both parties.
|
Clause 14.
The Contract shall be executed in duplicate, with each individual copy having equal legal effect.
|
Clause 15.
This Contract will take into effect upon execution by both parties
|
Party A:
Zhejiang Hisun Pharmaceutical Co. Ltd.
|
Legal representative:[***]
|
Date: January 18, 2013
|
Party B:
CELSION CORPORATION (CLSN)
|
Legal representative:
/s/ Michael H. Tardugno
President and CEO
|
Date: January 12, 2013
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Celsion Corporation;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15 (f)), for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Celsion Corporation
|
||
May 9, 2013
|
By:
|
/s/
Michael H. Tardugno
|
Michael H. Tardugno
|
||
President and Chief Executive Officer
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Celsion Corporation;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15 (f)), for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Celsion Corporation
|
||
May 9, 2013
|
By:
|
/s/
Gregory Weaver
|
Gregory Weaver
|
||
Senior Vice President and Chief Financial Officer
|
May 9, 2013
|
By:
|
/s/ Michael H. Tardugno
|
Michael H. Tardugno
|
||
President and Chief Executive Officer
|
May 9, 2013
|
By:
|
/s/ Gregory Weaver
|
Gregory Weaver
|
||
Senior Vice President and Chief Financial Officer
|