UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended December 31, 2011 |
or
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____________ to _____________ |
Commission File No. 001-31326
SENESCO TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Delaware | 84-1368850 |
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
721 Route 202/206, Suite 130
Bridgewater, New Jersey 08807
(Address of principal executive offices)
(908) 864-4444
(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, a non-accelerated filer or a smaller reporting company. See definitions of “accelerated filer”, “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ¨ | Accelerated filer ¨ |
Non-accelerated filer ¨ | Smaller reporting company x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes: ¨ | No x |
88,026,028 shares of the issuer’s common stock, par value $0.01 per share, were outstanding as of January 31, 2012.
SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY
TABLE OF CONTENTS
Page | ||
PART I. FINANCIAL INFORMATION. | ||
Item 1. | Financial Statements (Unaudited) | 1 |
CONDENSED CONSOLIDATED BALANCE SHEETS
as of December 31, 2011 and June 30, 2011 |
2 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three Months and Six Months Ended December 31, 2011 and 2010, and From Inception on July 1, 1998 through December 31, 2011 |
3 | |
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
For the Six Months Ended December 31, 2011 |
4 | |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Six Months Ended December 31, 2011 and 2010, and From Inception on July 1, 1998 through December 31, 2011 |
5 | |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | 6 | |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 14 |
Overview | 14 | |
Liquidity and Capital Resources | 19 | |
Changes to Critical Accounting Policies and Estimates | 21 | |
Results of Operations | 22 | |
Off-Balance Sheet Arrangements | 28 | |
Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 29 |
Item 4. | Controls and Procedures | 29 |
PART II. OTHER INFORMATION. | ||
Item 1. | Legal Proceedings. | 30 |
Item 1A. | Risk Factors. | 30 |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds. | 46 |
Item 3. | Defaults Upon Senior Securities | 46 |
Item 4. | [REMOVED AND RESERVED] | 46 |
Item 5. | Other Information. | 46 |
Item 6. | Exhibits. | 46 |
SIGNATURES | 48 |
i |
PART I. FINANCIAL INFORMATION .
Item 1. | Financial Statements (Unaudited). |
Certain information and footnote disclosures required under United States generally accepted accounting principles have been condensed or omitted from the following consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission. However, Senesco Technologies, Inc., a Delaware corporation, and its wholly owned subsidiary, Senesco, Inc., a New Jersey corporation (collectively, “Senesco” or the “Company”), believe that the disclosures are adequate to assure that the information presented is not misleading in any material respect.
The results of operations for the interim periods presented herein are not necessarily indicative of the results to be expected for the entire fiscal year.
1 |
SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
December 31, | June 30, | |||||||
2011 | 2011 | |||||||
ASSETS | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | 1,552,898 | $ | 3,609,954 | ||||
Prepaid research supplies and expenses | 1,657,140 | 1,446,064 | ||||||
Total Current Assets | 3,210,038 | 5,056,018 | ||||||
Equipment, furniture and fixtures, net | 7,048 | 3,782 | ||||||
Intangibles, net | 3,634,869 | 3,524,731 | ||||||
Deferred income tax assets, net | - | - | ||||||
Security deposit | 5,171 | 12,358 | ||||||
TOTAL ASSETS | $ | 6,857,126 | $ | 8,596,889 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable | $ | 443,752 | $ | 559,525 | ||||
Accrued expenses | 802,307 | 509,806 | ||||||
Line of credit | 2,199,108 | 2,199,108 | ||||||
Total Current Liabilities | 3,445,167 | 3,268,439 | ||||||
Warrant liabilities | 478,948 | 711,259 | ||||||
Grant payable | 99,728 | 99,728 | ||||||
TOTAL LIABILITIES | 4,023,843 | 4,079,426 | ||||||
STOCKHOLDERS' EQUITY: | ||||||||
Preferred stock, $0.01 par value, authorized 5,000,000 shares | ||||||||
Series A 10,297 shares issued and 3,645 and 3,690 shares outstanding, respectively (liquidation preference of $3,736,125 and $3,792,252 at December 31, 2011 and June 30, 2011, respectively) | 37 | 37 | ||||||
Series B 1,200 shares issued and outstanding (liquidation preference of $1,230,000 and $1,230,000 at December 31, 2011 and June 30, 2011, respectively) | 12 | 12 | ||||||
Common stock, $0.01 par value, authorized 350,000,000 shares, issued and outstanding 80,864,443 and 77,769,677, respectively | 808,644 | 777,697 | ||||||
Capital in excess of par | 66,376,039 | 64,488,152 | ||||||
Deficit accumulated during the development stage | (64,351,449 | ) | (60,748,435 | ) | ||||
Total Stockholders' Equity | 2,833,283 | 4,517,463 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 6,857,126 | $ | 8,596,889 |
See Notes to Condensed Consolidated Financial Statements
2 |
SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Cumulative | ||||||||||||||||||||
Three months ended December 31, | Six months ended December 31, | Amounts from | ||||||||||||||||||
2011 | 2010 | 2011 | 2010 | Inception | ||||||||||||||||
Revenue | $ | 200,000 | $ | - | $ | 200,000 | $ | - | $ | 1,790,000 | ||||||||||
Operating expenses: | ||||||||||||||||||||
General and administrative | 904,621 | 706,685 | 1,550,580 | 1,375,569 | 30,441,113 | |||||||||||||||
Research and development | 751,517 | 798,352 | 1,385,703 | 2,334,859 | 20,055,061 | |||||||||||||||
Total operating expenses | 1,656,138 | 1,505,037 | 2,936,283 | 3,710,428 | 50,496,174 | |||||||||||||||
Loss from operations | (1,456,138 | ) | (1,505,037 | ) | (2,736,283 | ) | (3,710,428 | ) | (48,706,174 | ) | ||||||||||
Other non-operating income (expense) | ||||||||||||||||||||
Grant income | - | 244,479 | - | 244,479 | 244,479 | |||||||||||||||
Fair value – warrant liability | (39,392 | ) | 149,910 | 232,311 | 469,386 | 8,089,978 | ||||||||||||||
Sale of state income tax loss – net | - | - | - | - | 586,442 | |||||||||||||||
Other noncash (expense) income, net | - | (4,604 | ) | - | (115,869 | ) | 205,390 | |||||||||||||
Loss on extinguishment of debt | - | - | - | - | (361,877 | ) | ||||||||||||||
Write-off of patents abandoned | - | - | - | - | (1,588,087 | ) | ||||||||||||||
Amortization of debt discount and financing costs | - | - | - | - | (11,227,870 | ) | ||||||||||||||
Interest expense – convertible notes | - | - | - | - | (2,027,930 | ) | ||||||||||||||
Interest (expense) income - net | (32,041 | ) | (21,311 | ) | (62,582 | ) | (39,607 | ) | 348,474 | |||||||||||
Net loss | (1,527,571 | ) | (1,136,563 | ) | (2,566,554 | ) | (3,152,039 | ) | (54,437,175 | ) | ||||||||||
Preferred dividends | (127,614 | ) | (675,608 | ) | (1,036,460 | ) | (1,682,014 | ) | (9,914,274 | ) | ||||||||||
Loss applicable to common shares | $ | (1,655,185 | ) | $ | (1,812,171 | ) | $ | (3,603,014 | ) | $ | (4,834,053 | ) | $ | (64,351,449 | ) | |||||
Basic and diluted net loss per common share | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.05 | ) | $ | (0.08 | ) | ||||||||
Basic and diluted weighted-average number of common shares outstanding | 80,832,267 | 67,978,776 | 80,061,012 | 62,773,481 |
See Notes to Condensed Consolidated Financial Statements
3 |
SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE SIX MONTHS ENDED DECEMBER 31, 2011
(unaudited)
Deficit | ||||||||||||||||||||||||||||
Accumulated | ||||||||||||||||||||||||||||
During the | ||||||||||||||||||||||||||||
Capital in Excess | Development | Stockholders' | ||||||||||||||||||||||||||
Preferred Stock | Common Stock | of Par Value | Stage | Equity | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||
Balance at June 30, 2011 | 4,890 | $ | 49 | 77,769,677 | $ | 777,697 | $ | 64,488,152 | $ | (60,748,435 | ) | $ | 4,517,463 | |||||||||||||||
Issuance of common stock at prices ranging from $0.27 per share to $0.31 per share | - | - | 1,817,557 | 18,175 | 487,075 | - | 505,250 | |||||||||||||||||||||
Commissions and other fees related to the issuance of common stock | - | - | - | - | (32,031 | ) | - | (32,031 | ) | |||||||||||||||||||
Preferred stock converted into common stock | (45 | ) | 155,556 | 1,555 | (1,555 | ) | - | - | ||||||||||||||||||||
Issuance of common stock in lieu of cash payment for dividends | - | - | 1,121,653 | 11,217 | 248,370 | (137,335 | ) | 122,252 | ||||||||||||||||||||
Deemed dividend - Preferred Stock | - | - | - | - | 778,000 | (778,000 | ) | - | ||||||||||||||||||||
Fair market value of options and warrants vested | - | - | - | - | 408,028 | - | 408,028 | |||||||||||||||||||||
Dividends accrued and unpaid at December 31, 2011 | - | - | - | - | - | (121,125 | ) | (121,125 | ) | |||||||||||||||||||
Net loss | - | - | - | - | - | (2,566,554 | ) | (2,566,554 | ) | |||||||||||||||||||
Balance July 1, 1998 (inception) through December 31, 2011 | 4,845 | $ | 49 | 80,864,443 | $ | 808,644 | $ | 66,376,039 | $ | (64,351,449 | ) | $ | 2,833,283 |
See Notes to Condensed Consolidated Financial Statements
4 |
SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Cumulative | ||||||||||||
Six months ended December 31, | Amounts from | |||||||||||
2011 | 2010 | Inception | ||||||||||
Cash flows from operating activities: | ||||||||||||
Net loss | $ | (2,566,554 | ) | $ | (3,152,039 | ) | $ | (54,437,175 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Noncash capital contribution | - | - | 85,179 | |||||||||
Noncash conversion of accrued expenses into equity | - | - | 131,250 | |||||||||
Noncash income related to change in fair value of warrant liability | (232,311 | ) | (469,386 | ) | (8,411,237 | ) | ||||||
Noncash charge for change in warrant terms | - | 115,869 | 115,869 | |||||||||
Issuance of common stock and warrants for interest | - | - | 2,003,386 | |||||||||
Issuance of common stock for services | - | - | 53,800 | |||||||||
Stock-based compensation expense | 408,028 | 404,734 | 11,747,977 | |||||||||
Depreciation and amortization | 118,986 | 69,304 | 961,268 | |||||||||
Write-off of intangibles | 1,588,087 | |||||||||||
Deferred rent | (4,030 | ) | - | |||||||||
Amortization of convertible note discount | - | - | 10,000,000 | |||||||||
Amortization of deferred financing costs | - | - | 1,227,869 | |||||||||
Loss on extinguishment of debt | - | - | 361,877 | |||||||||
(Increase) decrease in operating assets: | ||||||||||||
Prepaid expenses and other current assets | (211,076 | ) | (3,181 | ) | (1,657,140 | ) | ||||||
Security deposit | 7,187 | - | (5,171 | ) | ||||||||
Increase (decrease) in operating liabilities: | ||||||||||||
Accounts payable | (115,773 | ) | 68,575 | 443,752 | ||||||||
Accrued expenses | 293,628 | (107,640 | ) | 856,183 | ||||||||
Net cash used in operating activities | (2,297,885 | ) | (3,077,794 | ) | (34,934,226 | ) | ||||||
Cash flows from investing activities: | ||||||||||||
Patent costs | (227,929 | ) | (258,276 | ) | (6,006,606 | ) | ||||||
Purchase of equipment, furniture and fixtures | (4,461 | ) | (2,026 | ) | (184,666 | ) | ||||||
Net cash (used in) provided by investing activities | (232,390 | ) | (260,302 | ) | (6,191,272 | ) | ||||||
Cash flows from financing activities: | ||||||||||||
Proceeds from grant | - | - | 99,728 | |||||||||
Proceeds from draw-down on line of credit | - | - | 2,199,108 | |||||||||
Proceeds from issuance of bridge notes | - | - | 525,000 | |||||||||
Proceeds from issuance of preferred stock and warrants, net | - | - | 10,754,841 | |||||||||
Redemption of convertible notes and warrants | - | - | (2,160,986 | ) | ||||||||
Proceeds from issuance of convertible notes | - | - | 9,340,000 | |||||||||
Deferred financing costs | - | - | (651,781 | ) | ||||||||
Proceeds from issuance of common stock and warrants, net and exercise of warrants and options | 473,219 | 149,277 | 22,572,486 | |||||||||
Net cash provided by financing activities | 473,219 | 149,277 | 42,678,396 | |||||||||
Net (decrease) increase in cash and cash equivalents | (2,057,056 | ) | (3,188,819 | ) | 1,552,898 | |||||||
Cash and cash equivalents at beginning of period | 3,609,954 | 8,026,296 | - | |||||||||
Cash and cash equivalents at end of period | $ | 1,552,898 | $ | 4,837,477 | $ | 1,552,898 | ||||||
Supplemental disclosure of non-cash transactions: | ||||||||||||
Conversion of convertible note into common stock | $ | - | $ | - | $ | 10,000,000 | ||||||
Conversion of bridge notes into common stock | - | - | 534,316 | |||||||||
Conversion of preferred stock into common stock | 1,555 | 122,148 | 208,886 | |||||||||
Allocation of preferred stock proceeds to warrants and beneficial conversion feature | - | - | 7,449,780 | |||||||||
Allocation of convertible debt proceeds to warrants and beneficial conversion feature | - | 360,733 | 9,340,000 | |||||||||
Warrants issued for financing costs | - | - | 690,984 | |||||||||
Issuance of common stock for interest payments on convertible notes | - | - | 2,003,386 | |||||||||
Issuance of common stock for dividend payments on preferred stock | 259,587 | 1,188,156 | 3,324,377 | |||||||||
Issuance of common stock in settlement of accounts payable | - | - | 175,000 | |||||||||
Dividends accrued on preferred stock | (1,127 | ) | 133,125 | 121,125 | ||||||||
Supplemental disclosure of cash flow information: | ||||||||||||
Cash paid for interest | 66,788 | 53,387 | 303,922 |
See Notes to Condensed Consolidated Financial Statements
5 |
SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 1 - Basis of Presentation:
The financial statements included herein have been prepared by Senesco Technologies, Inc. (the “Company”), without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with United States generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2011, as amended.
In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all adjustments, consisting solely of those which are of a normal recurring nature, necessary to present fairly its financial position as of December 31, 2011, the results of its operations and cash flows for the three months and six months ended December 31, 2011 and 2010 .
Interim results are not necessarily indicative of results for the full fiscal year.
Note 2 – Liquidity:
As shown in the accompanying condensed consolidated financial statements, the Company has a history of losses with a deficit accumulated during the development stage from July 1, 1998 (inception) through December 31, 2011 of $64,351,449. Additionally, the Company has generated minimal revenues by licensing its technology for certain crops to companies willing to share in its development costs. In addition, the Company’s technology may not be ready for commercialization for several years. The Company expects to continue to incur losses for the next several years because it anticipates that its expenditures on research and development and administrative activities will significantly exceed its revenues during that period. The Company cannot predict when, if ever, it will become profitable.
As of December 31, 2011, the Company had cash and cash equivalents in the amount of $1,552,898, which consisted of checking accounts and money market funds. In January 2012, the Company received net proceeds in the amount of approximately $1,805,000 from the issuance of common stock and warrants. The Company estimates that its cash and cash equivalents as of December 31, 2011 plus the net proceeds received from the issuance of common stock and warrants in January 2012 will cover its expenses through August 2012.
In December 2010, the Company entered into an At Market Issuance Sales Agreement (“ATM”) whereby it may issue up to $5,500,000 of Common Stock under this facility.
The Company will need additional capital and plans to raise additional capital through the placement of debt instruments or equity or both. However, the Company may not be able to obtain adequate funds for its operations when needed or on acceptable terms. If the Company is unable to raise additional funds, it will need to do one or more of the following:
6 |
· | delay, scale-back or eliminate some or all of its research and product development programs; |
· | license third parties to develop and commercialize products or technologies that it would otherwise seek to develop and commercialize itself; |
· | seek strategic alliances or business combinations; |
· | attempt to sell the Company; |
· | cease operations; or |
· | declare bankruptcy. |
Note 3 – Intangible Assets:
The Company conducts research and development activities, the cost of which is expensed as incurred, in order to generate patents that can be licensed to third parties in exchange for license fees and royalties. Because the patents are the basis of the Company’s future revenue, the patent costs are capitalized. The capitalized patent costs represent the outside legal fees incurred by the Company to submit and undertake all necessary efforts to have such patent applications issued as patents.
The length of time that it takes for an initial patent application to be approved is generally between four to six years. However, due to the unique nature of each patent application, the actual length of time may vary. If a patent application is denied, the associated cost of that application would be written off. However, the Company has not had any patent applications denied as of December 31, 2011. Additionally, should a patent application become impaired during the application process, the Company would write down or write off the associated cost of that patent application.
Issued patents and agricultural patent applications pending are being amortized over a period of 17 years from inception. The Company assesses the impairment in value of intangible assets whenever events or circumstances indicate that their carrying value may not be recoverable. Factors the Company considers important which could trigger an impairment review include the following:
• | significant negative industry trends; |
• | significant underutilization of the assets; |
• | significant changes in how the Company uses the assets or its plans for their use; and |
• | changes in technology and the appearance of competing technology. |
If a triggering event occurs and the Company's review determines that the future undiscounted cash flows related to the groups, including these assets, will not be sufficient to recover their carrying value, the Company will reduce the carrying values of these assets down to its estimate of fair value and continue amortizing them over their remaining useful lives. To date, except for certain patents and patents pending that the Company abandoned during the year ended June 30, 2011, the Company has not recorded any impairment of intangible assets.
Note 4 - Loss Per Share:
Net loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares assumed to be outstanding during the period of computation. Diluted earnings per share is computed similar to basic earnings per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive.
7 |
For all periods presented, basic and diluted loss per share are the same, as any additional Common Stock equivalents would be anti-dilutive. Potentially dilutive shares of Common Stock have been excluded from the calculation of the weighted average number of dilutive common shares.
As of December 31, 2011, there were 87,237,290 additional potentially dilutive shares of Common Stock. These additional shares include 17,944,444 shares issuable upon conversion of the Preferred Stock, and 69,292,846 shares issuable upon the exercise of outstanding options and warrants. As of December 31, 2010, there were 84,111,290 additional potentially dilutive shares of Common Stock. These additional shares included 17,750,000 shares issuable upon conversion of Preferred Stock and 66,361,290 shares issuable upon the exercise of outstanding options and warrants.
Note 5 – Share-Based Transactions:
The terms and vesting schedules for share-based awards vary by type of grant and the employment status of the grantee. Generally, the awards vest based upon time-based conditions.
The fair value of each stock option and warrant granted or vesting has been determined using the Black-Scholes model. The material factors incorporated in the Black-Scholes model in estimating the value of the options and warrants include the following:
Three Months Ended | Six Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Warrants granted | None | 5,000 | None | 305,000 | ||||||||||||
Options granted | 647,500 | 4,115,892 | 4,860,500 | 4,115,892 | ||||||||||||
Estimated life in years (1) | 3.0-5.5 | 5.0-10.0 | 3.0-10.0 | 5.0-10.0 | ||||||||||||
Risk-free interest rate (2) | 0.4%-0.9 | % | 1.5%-2.9 | % | 0.4%-1.9 | % | 1.3% – 2.9 | % | ||||||||
Volatility | 91%-104 | % | 104 | % | 91%-105 | % | 104 | % | ||||||||
Dividend paid | None | None | None | None |
(1) | Expected life for employee based stock options was estimated using the “simplified” method, as allowed under the provisions of the securities and exchange commission – accounting bulletin no.110. |
(2) | Represents the interest rate on a U.S. Treasury security with a maturity date corresponding to that of the option or warrant term. |
The economic values of the options will depend on the future price of the Company's Common Stock, which cannot be forecast with reasonable accuracy.
8 |
A summary of changes in the stock option plan for the six months ended December 31, 2011 is as follows:
Weighted-Average | ||||||||
Number of Options | Exercise Price | |||||||
Outstanding at July 1, 2011 | 11,348,314 | $ | 0.78 | |||||
Granted | 4,860,500 | 0.23 | ||||||
Exercised | — | — | ||||||
Expired | (975,000 | ) | 2.32 | |||||
Outstanding at December 31, 2011 | 15,233,814 | $ | 0.50 | |||||
Exercisable at December 31, 2011 | 9,116,436 | $ | 0.66 | |||||
Not Exercisable at December 31, 2011 | 6,117,378 | $ | 0.27 |
The weighted average grant date fair value of options granted during the six months ended December 31, 2011 and 2010 was $0.17 and $0.45, respectively.
As of December 31, 2011, the aggregate intrinsic value of stock options outstanding was $159,690, with a weighted-average remaining term of 8.1 years. The aggregate intrinsic value of stock options exercisable at that same date was $59,725, with a weighted-average remaining term of 7.3 years. As of December 31, 2011, the Company has 9,782,789 shares available for future stock option grants.
Stock-based compensation expense for the three months ended December 31, 2011 and December 31, 2010 amounted to $284,477 and $186,121, respectively.
Stock-based compensation expense for the six months ended December 31, 2011 and December 31, 2010 amounted to $408,028 and $404,734, respectively.
As of December 31, 2011, total stock-based compensation expense not yet recognized related to stock option grants amounted to approximately $1,388,000 , which will be recognized over the next 45 months.
Note 6 –Loan Payable:
On February 17, 2010, the Company entered into a credit agreement with JMP Securities LLC. The agreement provides the Company with, subject to certain restrictions, including the existence of suitable collateral, up to a $3.0 million line of credit upon which the Company may draw at any time (the “Line of Credit”). Any draws upon the Line of Credit accrue at a monthly interest rate of the broker rate in effect at the interest date (which was 3.75% at December 31, 2011), plus 2.0%. There are no other conditions or fees associated with the Line of Credit. The Line of Credit is not secured by any assets of the Company, but it is secured by certain assets of a member of the Company’s Board of Directors, Harlan W. Waksal, M.D., which security interest is currently held by JMP Securities. In April 2011, we were required to enter into a new demand note with the clearing agent for JMP Securities in connection with the Line of Credit.
Total interest expense recorded under the Line of Credit for the three months ended December 31, 2011 and 2010 amounted to $33,479 and $26,715, respectively.
9 |
Total interest expense recorded under the Line of Credit for the six months ended December 31, 2011 and 2010 amounted to $66,788 and $53,387, respectively.
Note 7 – Income Taxes:
No provision for income taxes has been made for the three months and six months ended December 31, 2011 and 2010 given the Company’s losses in 2011 and 2010 and available net operating loss carryforwards. A benefit has not been recorded as the realization of the net operating losses is not assured and the timing in which the Company can utilize its net operating loss carryforwards in any year or in total may be limited by provisions of the Internal Revenue Code regarding changes in ownership of corporations.
Note 8 - Fair Value Measurements:
The following tables provide the assets and liabilities carried at fair value measured on a recurring basis as of December 31, 2011 and June 30, 2011:
Fair Value Measurement at | ||||||||||||||||
Carrying | December 31, 2011 | |||||||||||||||
Value | Level 1 | Level 2 | Level 3 | |||||||||||||
Assets: | ||||||||||||||||
Cash and cash equivalents | $ | 1,552,898 | $ | 1,552,898 | $ | - | $ | - | ||||||||
Liabilities: | ||||||||||||||||
Warrant Liabilities | $ | 478,948 | $ | - | $ | - | $ | 478,948 |
Fair Value Measurement at | ||||||||||||||||
Carrying | June 30, 2011 | |||||||||||||||
Value | Level 1 | Level 2 | Level 3 | |||||||||||||
Assets: | ||||||||||||||||
Cash and cash equivalents | $ | 3,609,954 | $ | 3,609,954 | $ | - | $ | - | ||||||||
Liabilities: | ||||||||||||||||
Warrant Liabilities | $ | 711,259 | $ | - | $ | - | $ | 711,259 |
The following table summarizes the changes in fair value of the Company’s Level 3 financial instruments:
Six months ended December 31, | ||||||||
2011 | 2010 | |||||||
Beginning Balance | $ | 711,259 | $ | 2,493,794 | ||||
Reclassification to equity due to change in terms of common stock warrants | - | (1,121,733 | ) | |||||
Gain due to change in fair value of warrant liabilities, net | (232,311 | ) | (469,386 | ) | ||||
Ending Balance | $ | 478,948 | $ | 902,675 |
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Note 9 – Warrant Liabilities:
The warrant liabilities represent the fair value of Common Stock purchase warrants, which have exercise price reset features and cash settlement features.
The fair value of the warrants that have exercise price reset features is estimated using an adjusted Black-Scholes model. The Company computes valuations, each quarter, using the Black-Scholes model for such warrants to account for the various possibilities that could occur due to changes in the inputs to the Black-Scholes model as a result of contractually-obligated changes. The Company effectively weights each calculation based on the likelihood of occurrence to determine the value of the derivative at the reporting date. The fair value of the warrants that have cash settlement features is estimated using the Black-Scholes model.
During the six months ended December 31, 2011 and 2010, the Company revalued all of the remaining warrant liabilities, using the adjusted Black-Scholes and Black-Scholes models. A gain on the change in fair value of the warrant liabilities in the amount of $232,311 and $469,386 was recorded in the Condensed Consolidated Statement of Operations for the six months ended December 31, 2011 and 2010, respectively.
At December 31, 2011 and 2010, there were an aggregate of 21,307,814 and 22,870,314 warrants, respectively, included in the fair value of the warrant liabilities, which are valued at $478,948 and $902,675, respectively.
The assumptions used to value the warrants were as follows:
December 31, 2011 | June 30, 2011 | |||||||
Warrants issued on December 20, 2007 | ||||||||
Estimated life in years | 1.00 | 1.50 | ||||||
Risk-free interest rate (1) | 0.12 | % | 0.45 | % | ||||
Volatility | 74 | % | 79 | % | ||||
Dividend paid | None | None | ||||||
Warrants issued on June 30, 2008 | ||||||||
Estimated life in years | 1.50 | 2.00 | ||||||
Risk-free interest rate (1) | 0.20 | % | 0.45 | % | ||||
Volatility | 79 | % | 79 | % | ||||
Dividend paid | None | None | ||||||
Warrants issued on April 1, 2010 | ||||||||
Estimated life in years | 3.25 | 3.75 | ||||||
Risk-free interest rate (1) | 0.41 | % | 1.29 | % | ||||
Volatility | 88 | % | 107 | % | ||||
Dividend paid | None | None |
(1) | Represents the interest rate on a U.S. Treasury security with a maturity date corresponding to that of the warrant term. |
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Note 10- At Market Issuance Sales Agreement
On December 22, 2010, the Company entered into an At Market Issuance Sales Agreement (the “ATM”) under which the Company, from time to time, may issue and sell shares of its Common Stock, par value $0.01 per share, with an aggregate offering price of up to $5,500,000.
During the six months ended December 31, 2011, the Company issued 1,817,557 shares of Common Stock under the ATM for gross proceeds in the amount of $505,250 and net proceeds in the amount of $473,219. From the inception of the ATM through December 31, 2011, the Company has issued 7,729,014 shares of Common Stock under the ATM for gross proceeds in the amount of $2,358,670.
Note 11 –Preferred Stock
On July 18, 2011, in connection with the Company’s ATM facility discussed above, the conversion price on the then outstanding 4,860 shares of Preferred Stock was adjusted from $0.30 to $0.27, resulting in an additional 1,800,000 shares of Common Stock that will be issued upon conversion of the then outstanding Preferred Stock. In connection with the adjustments to the conversion price, due to a beneficial conversion feature, an additional dividend in the amount of $778,000 was recorded as an increase to both additional paid-in capital and accumulated deficit . As a result of the resets to the conversion price, each share of Preferred Stock is convertible into 3,704 shares of Common Stock (a conversion price of $0.27).
During the six months ended December 31, 2011, 45 shares of Preferred Stock were converted into 155,556 shares of Common Stock. During the six months ended December 31, 2011, the Company issued an additional 1,121,653 shares of Common Stock for the payment of dividends in the amount of $1,037,587. Total dividends payable on the outstanding 4,845 shares of Preferred Stock at December 31, 2011 amounted to $121,125.
Note 12 – Subsequent Event
On January 6, 2012, the Company entered into a securities purchase agreement to raise $1,862,012 in gross proceeds through the sale of 7,161,585 shares of its common stock. The investors, excluding officers and directors of Senesco or funds affiliated with such officers or directors participating in the offering, also received 50% warrant coverage at an exercise price of $0.286 per share. The common stock and 50% warrant coverage (the “Unit”) was priced at $0.26 per Unit.
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Note 13 – Recent Accounting Pronouncements
In April 2011, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2011-04 “Fair Value Measurement: Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs” (“ASU 2011-04”). ASU 2011-04 amends current fair value measurement and disclosure guidance to include increased transparency around valuation inputs and investment categorization. The new guidance is effective for the fiscal year and interim periods beginning after December 15, 2011. The adoption of ASU 2011-04 is not expected to have a material impact on the Company’s Consolidated Financial Statements.
Management does not believe there would have been a material effect on the accompanying financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current period.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis should be read in conjunction with our condensed consolidated financial statements and the related notes thereto included in this Quarterly Report on Form 10-Q. The discussion and analysis may contain forward-looking statements that are based upon current expectations and entail various risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this report.
Overview
Our Business
The primary business of Senesco Technologies, Inc., a Delaware corporation incorporated in 1999, and its wholly-owned subsidiary, Senesco, Inc., a New Jersey corporation incorporated in 1998, collectively referred to as “Senesco,” “we,” “us” or “our,” is to utilize our patented and patent-pending technology related to certain genes, primarily eukaryotic translation initiation Factor 5A, or Factor 5A, and deoxyhypusine synthase, or DHS, and related technologies for human therapeutic applications to develop novel approaches to treat cancer and inflammatory diseases.
For agricultural applications, we have licensed applications of the Factor 5A, DHS and Lipase platforms to enhance the quality, productivity and stress resistance of fruits, flowers, vegetables, agronomic and biofuel feedstock crops through the control of cell death, referred to herein as senescence, and growth in plants.
Human Therapeutic Applications
We believe that our Factor 5A gene regulatory technology could have broad applicability in the human therapeutic field, by either inducing or inhibiting programmed cell death, also known as apoptosis, which is the natural process the human body goes through in order to eliminate redundant or defective cells. Inducing apoptosis is useful in treating cancer where the defective cancer cells have failed to respond to the body’s natural apoptotic signals. Conversely, inhibiting apoptosis may be useful in preventing, ameliorating or treating an exaggerated, acute immune response in a wide range of inflammatory and ischemic diseases attributable to or aggravated by premature apoptosis.
SNS01-T for Multiple Myeloma
We have developed a therapeutic candidate, SNS01-T, an improved formulation of SNS01, for the potential treatment of multiple myeloma. SNS01-T utilizes our Factor 5A technology and comprises of two active components: a DNA plasmid, or pDNA, expressing human eIF5A containing a lysine to arginine substitution at amino acid position 50, or eIF5A K50R, and a short inhibitory RNA, or siRNA. These two components are combined in a fixed ratio with a polymer, polyethyleneimine, or PEI, which enables self-assembly of the DNA and RNA into nanoparticles with demonstrated enhanced delivery to tissues and protection from degradation in the blood stream. Under the control of a B cell selective promoter, SNS01-T’s DNA plasmid up-regulates the apoptotic pathways within cancer cells by preferentially expressing the stable arginine form of the Factor 5A death message in target cells. The siRNA reduces expression of the hypusine form of Factor 5A that supports cell survival and proliferation. The siRNA also down-regulates anti-apoptotic proteins, such as NFkB, ICAM and pro-inflammatory cytokines, which protect malignant cells from apoptosis and promote cell growth in multiple myeloma. The PEI, a cationic polymer, promotes auto-assembly of a nanoparticle with the other two components for intravenous delivery and protects the combination from degradation in the bloodstream until it is taken up by the tumor cell, where the siRNA and DNA plasmid are released.
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We have performed efficacy, toxicological and dose-finding studies in vitro in non-human and human cells and in-vivo in mice for SNS01. Our efficacy studies in severe combined immune-deficient, or SCID, mice with subcutaneous human multiple myeloma tumors tested SNS01 dose ranging from 0.15 mg/kg to 1.5 mg/kg. In these studies, mice treated with a dose of either 0.75 mg/kg or 1.5 mg/kg both showed, compared to relevant controls, a 91% reduction in tumor volume and a decrease in tumor weight of 87% and 95%, respectively. For mice that received smaller doses of either 0.38 mg/kg or 0.15 mg/kg, there was also a reduction in tumor volume of 73% and 61%, respectively, and weight of 74% and 36%, respectively. All SNS01 treated mice survived. This therapeutic dose range study provided the basis for a non-good laboratory practices, or GLP, 8-day maximum tolerated dose study in which normal mice received two intravenous doses of increasing amounts of SNS01 (from 2.2 mg/kg). Body weight, organ weight and serum levels of liver enzymes were used as clinical indices to assess toxicity. A dose between 2.2 mg/kg and 2.9 mg/kg was well tolerated with respect to these clinical indices, and the survival rate at 2.9 mg/kg was 80%. Mice receiving above 2.9 mg/kg of SNS01 showed evidence of morbidity and up to 80% mortality. The 2.9 mg/kg threshold was therefore determined to be the maximum tolerated dose in mice in this study. We have also completed our pivotal GLP toxicology studies in mice and dogs, employing SNS01-T, an improved formulation of SNS01, and have an open investigational new drug application, or IND, with the United States Food and Drug Administration, or FDA. We have also been granted orphan drug status for SNS01-T by the FDA for the potential treatment of multiple myeloma.
We have initiated a Phase 1b/2a clinical study with SNS01-T in multiple myeloma patients. The clinical study is an open-label, multiple-dose, dose-escalation study, which will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to relapsed or refractory multiple myeloma patients. The study design calls for four cohorts of three to six patients each. Patients in each cohort will receive twice-weekly dosing for six weeks followed by a four-week safety data review period before escalating to a higher dose level in the next cohort. While the primary objective of the initial study is to evaluate safety and tolerability, the effect of SNS01-T on tumor response will also be evaluated using multiple, well-established criteria including measurement of the monoclonal protein, or M-protein. We have selected Mayo Clinic as a clinical site and are considering adding an additional site. The study is open and we have begun treating patients.
Additionally, we have recently demonstrated in human multiple myeloma cell lines that there may be an additional benefit to combining SNS01-T with other approved myeloma drugs, such as bortezomib and lenalidomide. We have shown, in vitro, that these drugs are up to forty (40) times more effective in inhibiting cell growth when used in combination with SNS01-T. These results further reinforce the significance of our target and will guide us in designing future clinical studies.
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SNS01-T for other B cell cancers
We have demonstrated in mice that we can inhibit the growth of both human mantle cell and diffuse large B-cell lymphoma in a dose dependent manner.
We have also demonstrated that the combination of lenalidomide and SNS01-T performs better than either treatment alone in mouse xenograft models of human mantle cell lymphoma. When SCID mice, implanted with an aggressive human mantle cell lymphoma cell line (JVM2), were treated with either 15 mg/kg lenalidomide (5 times weekly by intra-peritoneal injection) or 0.375 mg/kg SNS01-T (twice weekly by intravenous injection) there was a growth delay of 4 days and 14 days, respectively. Mice treated with a combination of both drugs using the same dose levels and dosing regimens exhibited a tumor growth delay of 27 days (p value = 0.0008).
The median survival of mice treated with control nanoparticles was 21 days. Mice treated with lenalidomide or SNS01-T had a median survival of 28 days (33 % increase) and 37 days (76 % increase), respectively. Mice treated with the drug combination had a median survival of 52 days, an increase in survival of 148 %. Survival analysis using the Kaplan-Meier method revealed that treatment of mice with the drug combination resulted in statistically significant increases in survival compared to both SNS01-T (p value = 0.002) and lenalidomide (p value = 0.007) alone.
We believe that the results of these studies not only support moving forward in multiple myeloma, but also support extending our clinical evaluation of SNS01-T in other B-cell cancers.
We may consider other human diseases in order to determine the role of Factor 5A and SNS01-T.
We may further expand our research and development program beyond the initiatives listed above to include other diseases and research centers.
Agricultural Applications
Our agricultural research focuses on the discovery and development of certain gene technologies, which are designed to confer positive traits on fruits, flowers, vegetables, forestry species and agronomic crops.
We have licensed this technology to various strategic partners. We may continue to license this technology, as opportunities present themselves, to additional strategic partners and/or enter into joint collaborations or ventures.
Our ongoing research and development initiatives for agriculture include assisting our license partners to:
· | further develop and implement the DHS and Factor 5A gene technology in banana, canola, cotton, turfgrass, rice, alfalfa, corn, soybean and trees; and |
· | test the resultant crops for new beneficial traits such as increased yield, increased tolerance to environmental stress, disease resistance and more efficient use of fertilizer. |
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Agricultural Development and License Agreements
Effective December 22, 2011, the Company re-structured its research and development agreement with Rahan Meristem (1998) Ltd (“Rahan”) to reflect the priorities of both Companies. The new agreement is an amendment to the original research and development agreement, dated May 1999, that provided Rahan access to the Company’s proprietary technology enabling the two Companies to engage in a jointly-funded research and development program relating to the development and production of banana plants with improved traits. The new agreement re-structures the collaboration from a cost and profit sharing arrangement to a license agreement, which provides Senesco with a mid- to upper-single digit royalty on incremental revenue as defined in the agreement, from the sale of Rahan’s banana seedling products containing the Company’s technology without any future payments by Senesco for the costs of development and commercialization. If a product, which incorporates Senesco technology, is commercialized by Rahan, the royalties will be payable from first commercial sale for the longer of ten (10) years or the expiration of the last valid patent on a country-by-country basis.
As of December 31, 2011, we have eight (8) active license agreements with established agricultural biotechnology companies.
Agricultural Development Program
Generally, projects with our licensees begin by transforming seed or germplasm to incorporate our technology. Those seeds or germplasm are then grown in our partners’ greenhouses. After successful greenhouse trials, our partners will transfer the plants to the field for field trials. After completion of successful field trials, our partners may have to apply for and receive regulatory approval prior to initiation of any commercialization activities.
Generally, the approximate time to complete each sequential development step is as follows:
Seed Transformation | approximately 1 to 2 years |
Greenhouse | approximately 1 to 2 years |
Field Trials | approximately 2 to 5 years |
The actual amount of time spent on each development phase depends on the crop, its growth cycle and the success of the transformation achieving the desired results. As such, the amount of time for each phase of development could vary, or the time frames may change.
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The status of each of our projects with our partners is as follows:
Project | Partner | Status | ||
Banana | Rahan Meristem | |||
- Shelf Life | Field trials | |||
- Disease Resistance | Field trials | |||
Trees | Arborgen | |||
- Growth | Field trials | |||
Alfalfa | Cal/West | Field trials | ||
Corn | Monsanto | Field trials | ||
Cotton | Bayer | Greenhouse | ||
Canola | Bayer | Field trials | ||
Rice | Bayer | Greenhouse | ||
Soybean | Monsanto | Field trials | ||
Turfgrass | The Scotts Company | Greenhouse |
Commercialization by our partners may require a combination of traits in a crop, such as both shelf life and disease resistance, or other traits.
Based upon our commercialization strategy, we anticipate that there may be a significant period of time before plants enhanced using our technology reach consumers.
Intellectual Property
We have twenty-four (24) issued patents from the United States Patent and Trademark Office, or PTO, and seventy-eight (78) issued patents from foreign countries. Of our one hundred and two (102) domestic and foreign issued patents, sixty-six (66) are for the use of our technology in agricultural applications and thirty-six (36) relate to human therapeutics applications.
In addition to our one hundred and two (102) patents, we have a wide variety of patent applications, including divisional applications and continuations -in-part, in process with the PTO and internationally. We intend to continue our strategy of enhancing these new patent applications through the addition of data as it is collected.
Our agricultural patents are generally set to expire in 2019 in the United States and 2025 outside the United States. Our core human therapeutic technology patents are set to expire in 2021 in the United States and 2025 outside the United States, and our patents related to multiple myeloma are set to expire, both in and outside the United States in 2029. To the extent our patents have different expiration dates abroad than in the United States, we are currently developing a strategy to extend the United States expiration dates to the foreign expiration dates.
During Fiscal 2011, we reviewed our patent portfolio in order to determine if we could reduce our cost of patent prosecution and maintenance. We identified several patents and patents pending that we believe we no longer need to maintain without having a material impact on the portfolio. We determined that we would no longer incur the cost to prosecute or maintain those patents or patents pending and may allow them to lapse when the next payment was due. Therefore, some of the issued patents may be allowed to lapse in the future.
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Liquidity and Capital Resources
Overview
For the six months ended December 31, 2011, net cash of $2,297,885 was used in operating activities primarily due to a net loss of $2,566,554, which was reduced by non-cash expenses, net of non-cash income, of $294,703. Cash used in operating activities was also increased by changes in operating assets and liabilities in the amount of $26,034.
The $26,034 change in operating assets and liabilities was primarily the result of an increase in prepaid expenses in the amount of $211,076 offset by a net increase in accounts payable and accrued expenses in the amount of $177,855 and a repayment of a security deposit in the amount of $7,187.
During the six months ended December 31, 2011, cash used for investing activities amounted to $232,390, which was primarily related to patent costs incurred.
Cash provided by financing activities during the six months ended December 31, 2011 amounted to $473,219, which was related to the placement of common stock through our $5,500,000 ATM facility.
As of December 31, 2011, our cash balance totaled $1,552,898, and we had a working capital deficit of $235,129.
In January 2012, we received net proceeds of approximately $1,805,000 from the issuance of common stock and warrants.
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Contractual Obligations
The following table lists our cash contractual obligations as of December 31, 2011:
Payments Due by Period | ||||||||||||||||||||
Contractual Obligations | Total |
Less than
1 year |
1 - 3 years | 3 - 5 years |
More than
5 years |
|||||||||||||||
Research and Development Agreements (1) | $ | 864,424 | $ | 646,215 | $ | 218,219 | $ | — | $ | — | ||||||||||
Facility, Rent and Operating Leases (2) | $ | 96,952 | $ | 34,218 | $ | 62,734 | $ | — | $ | — | ||||||||||
Employment, Consulting and Scientific Advisory Board Agreements (3) | $ | 126,250 | $ | 46,250 | $ | 80,000 | $ | — | $ | — | ||||||||||
Total Contractual Cash Obligations | $ | 1,087,636 | $ | 726,683 | $ | 360,953 | $ | — | $ | — |
(1) | Certain of our research and development agreements disclosed herein provide that payment is to be made in Canadian dollars and, therefore, the contractual obligations are subject to fluctuations in the exchange rate. |
(2) | The lease for our office space in Bridgewater, New Jersey is subject to certain escalations for our proportionate share of increases in the building’s operating costs. |
(3) | Certain of our consulting agreements provide for automatic renewal, which is not reflected in the table, unless terminated earlier by the parties to the respective agreements. |
We expect our capital requirements to increase significantly over the next several years as we commence new research and development efforts, increase our business and administrative infrastructure and embark on developing in-house business capabilities and facilities. Our future liquidity and capital funding requirements will depend on numerous factors, including, but not limited to, the levels and costs of our research and development initiatives and the cost and timing of the expansion of our business development and administrative staff.
We anticipate that, based upon our cash balance as of December 31, 2011 and the net proceeds from the issuance of common stock and warrants in January 2012, we will be able to fund our operations through August 31 , 2012. However, we have the ability to raise additional capital through our ATM facility, utilize our unused line of credit and, if necessary, delay certain costs. Over such period, we plan to fund our research and development and commercialization activities by:
· | utilizing our current cash balance and investments; |
· | the placement of additional equity or debt instruments; |
· | achieving some of the milestones set forth in our current licensing agreements; and |
· | the possible execution of additional licensing agreements for our technology. |
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We cannot assure you that we will be able to raise money through any of the foregoing transactions on favorable terms, if at all.
Changes to Critical Accounting Policies and Estimates
There have been no changes to our critical accounting policies and estimates as set forth in our Annual Report on Form 10-K for the fiscal year ended June 30, 2011, as amended.
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Results of Operations
Three Months Ended December 31, 2011 and Three Months Ended December 31, 2010
The net loss for the three months ended December 31, 2011 was $1,527,571. The net loss for the three months ended December 31, 2010 was $1,136,563. Such a change represents an increase in net loss of $391,008, or 34.4%. This increase in net loss was the result of a decrease in other non-operating income and an increase in general and administrative expenses which was partially offset by a decrease in research and development costs and an increase in revenue.
Revenue
Total revenue in the amount of $200,000 for the three months ended December 31, 2011 consisted of a milestone payment in connection with an agricultural license agreement.
There was no revenue during the three months ended December 31, 2010.
We anticipate that we will receive future milestone payments in connection with our current agricultural development and license agreements. Additionally, we may receive future royalty payments from our license agreements when our partners commercialize their crops containing our technology. However, it is difficult for us to determine our future revenue expectations because our future milestone payments are primarily contingent on our partners successful implementation of their development plan, we have no history of receiving royalties and the timing and outcome of our experiments, the timing of signing new partner agreements and the timing of our partners moving through the development process into commercialization is difficult to accurately predict.
General and Administrative Expenses
Three Months Ended December 31, | ||||||||||||||||
2011 | 2010 | Change | % | |||||||||||||
(in thousands, except % values) | ||||||||||||||||
Payroll and benefits | $ | 159 | $ | 136 | $ | 23 | 16.9 | % | ||||||||
Investor relations | 75 | 57 | 18 | 31.6 | % | |||||||||||
Professional fees | 265 | 160 | 105 | 65.6 | % | |||||||||||
Director fees | (29 | ) | (14 | ) | (15 | ) | (107.1 | )% | ||||||||
Depreciation and amortization | 62 | 35 | 27 | 77.1 | % | |||||||||||
Other general and administrative | 104 | 163 | (59 | ) | (36.2 | )% | ||||||||||
636 | 537 | 99 | 18.4 | % | ||||||||||||
Stock-based compensation | 269 | 170 | 99 | 58.2 | % | |||||||||||
Total general and administrative | $ | 905 | $ | 707 | $ | 198 | 28.0 | % |
· | Payroll and benefits for the three months ended December 31, 2011 was higher than for the three months ended December 31, 2010, primarily as a result of salary increases effective July 1, 2011 and a 401K contribution made during the three months ended December 31, 2011. There was no 401K contribution during the three months ended December 31, 2010 |
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· | Investor relations fees for the three months ended December 31, 2011 was higher than the for three months ended December 31, 2010, primarily as a result of the costs related to the annual meeting held in December 2011, which was partially offset by lower consultant fees. There was no annual meeting during the three months ended December 31, 2010. |
· | Professional fees for the three months ended December 31, 2011 was higher than for the three months ended December 31, 2010, primarily as a result of an increase in legal fees, which was partially offset by a decrease in accounting fees. Legal fees increased primarily due to fees incurred in connection with the exploration of alternative uses of our technology. Accounting fees decreased primarily due to the use of a consultant for a special project during the three months ended December 31, 2010. There were no special projects during the three months ended December 31, 2011. |
· | Director fees for the three months ended December 31, 2011 was lower than for the three months ended December 31, 2010, primarily as a result of fewer meetings being held during the three months ended December 31, 2011. |
· | Depreciation and amortization for the three months ended December 31, 2011 was higher than for the three months ended December 31, 2010, primarily as a result of an increase in amortization of patent costs. |
· | Other general and administrative expenses for the three months ended December 31, 2011 was lower than for the three months ended December 31, 2010, primarily due to a decrease in consultant and travel costs. |
· | Stock-based compensation for the three months ended December 31, 2011 was higher than for the three months ended December 31, 2010, primarily due to the black-scholes value on a greater number of options vesting during the three months ended December 31, 2011. |
We expect cash-based general and administrative expenses to remain relatively unchanged over the next twelve months.
Research and Development Expenses
Three Months Ended December 31, | ||||||||||||||||
2011 | 2010 | Change | % | |||||||||||||
(in thousands, except % values) | ||||||||||||||||
Payroll | $ | 42 | $ | 40 | $ | 2 | 5.0 | % | ||||||||
Research contract with the University of Waterloo | 138 | 150 | (12 | ) | (8.0 | )% | ||||||||||
Other research and development | 557 | 592 | (35 | ) | (5.9 | )% | ||||||||||
737 | 782 | (45 | ) | (5.8 | )% | |||||||||||
Stock-based compensation | 15 | 16 | (1 | ) | (6.3 | )% | ||||||||||
Total research and development | $ | 752 | $ | 798 | $ | (46 | ) | (5.8 | )% |
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· | Payroll for the three months ended December 31, 2011 was higher than for the three months ended December 31, 2010, primarily as a result of a salary increases effective July 1, 2011. |
· | The cost associated with the research contract with the University of Waterloo for the three months ended December 31, 2011 was lower than for the three months ended December 31, 2010, primarily due to a reduction in amount being funded for agricultural research, effective March 1, 2011. |
· | Other research and development costs for the three months ended December 31, 2011 was lower than for the three months ended December 31, 2010, primarily due to a decrease in the costs incurred in connection with our development of SNS01-T for multiple myeloma. Specifically, during the three months ended December 31, 2010, we incurred significant costs related to our pivotal toxicology study and other preclinical work that we did not incur during the three months ended December 31, 2011. This was partially offset by costs incurred related to the performance of the phase 1b/2a clinical trial for multiple myeloma which were not incurred during the three months ended December 31, 2010. |
· | Stock-based compensation for the three months ended December 31, 2011 was lower than for the three months ended December 31, 2010, primarily due to a lower black-sholes value of the options vesting and unvested. |
The breakdown of our research and development expenses between our agricultural and human therapeutic research programs is as follows:
· | Agricultural research expenses for the three months ended December 31, 2011 was lower than for the three months ended December 31, 2010, primarily due to a reduction in the funding for agricultural research at the University of Waterloo. |
· | Human therapeutic research expenses for the three months ended December 31, 2011 was lower than for the three months ended December 31, 2010, primarily as a result of the timing of certain aspects of the development of our drug candidate, SNS01-T, for treating multiple myeloma. Specifically, during the three months ended December 31, 2010, we incurred costs related to our pivotal toxicology studies and other pre-clinical work that we did not incur during the three months ended December 31, 2011. This was mostly offset by costs incurred related to the performance of the Phase 1b/2a clinical trial for multiple myeloma which were not incurred during the three months ended December 31, 2010. |
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We expect our human therapeutic research program to increase as a percentage of the total research and development expenses as we continue our current research projects and begin new human therapeutic initiatives, in particular as they relate to the clinical development of our drug candidate, SNS01-T, for treating multiple myeloma and other cancers. Additionally, effective January 1, 2012, we will no longer incur development costs in connection with the Rahan Meristem banana project as we converted the joint collaboration agreement into a license agreement.
Other non-operating income and expense
Fair value – warrant liability
On December 31, 2011, the amount of the warrant liability was adjusted to $478,948 from $439,556 at September 30, 2011.
On December 31, 2010, the amount of the warrant liability was adjusted to $902,675 from $1,207,452 at September 30, 2010.
Six Months Ended December 31, 2011 and Six Months Ended December 31, 2010
The net loss for the six months ended December 31, 2011 was $2,566,554. The net loss for the six months ended December 31, 2010 was $3,152,039. Such a change represents a decrease in net loss of $585,485, or 18.6%. This decrease in net loss was primarily the result of an increase in revenue and a decrease research and development costs, which was partially offset by an increase in general and administrative expenses and a decrease in other non-operating income.
Revenue
Total revenue in the amount of $200,000 for the six months ended December 31, 2011 consisted of a milestone payment in connection with an agricultural license agreement.
There was no revenue during the six months ended December 31, 2010.
We anticipate that we will receive future milestone payments in connection with our current agricultural development and license agreements. Additionally, we may receive future royalty payments from our license agreements when our partners commercialize their crops containing our technology. However, it is difficult for us to determine our future revenue expectations because our future milestone payments are primarily contingent on our partners successful implementation of their development plan, we have no history of receiving royalties and the timing and outcome of our experiments, the timing of signing new partner agreements and the timing of our partners moving through the development process into commercialization is difficult to accurately predict.
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General and Administrative Expenses
Six Months Ended December 31, | ||||||||||||||||
2011 | 2010 | Change | % | |||||||||||||
(in thousands, except % values) | ||||||||||||||||
Payroll and benefits | $ | 296 | $ | 286 | $ | 10 | 3.5 | % | ||||||||
Investor relations | 120 | 106 | 14 | 13.2 | % | |||||||||||
Professional fees | 403 | 265 | 138 | 52.1 | % | |||||||||||
Director fees | 21 | 24 | (3 | ) | (1.3 | )% | ||||||||||
Depreciation and amortization | 119 | 69 | 50 | 72.5 | % | |||||||||||
Other general and administrative | 207 | 251 | (44 | ) | (17.5 | )% | ||||||||||
1,166 | 1,001 | 165 | 16.5 | % | ||||||||||||
Stock-based compensation | 385 | 374 | 11 | 2.9 | % | |||||||||||
Total general and administrative | $ | 1,551 | $ | 1,375 | $ | 176 | 12.8 | % |
· | Payroll and benefits for the six months ended December 31, 2011 was higher than for the six months ended December 31, 2010, primarily as a result of a 401K contribution made during the six months ended December 31, 2011. There was no 401K contribution during the six months ended December 31, 2010 |
· | Investor relations fees for the six months ended December 31, 2011 was higher than for the six months ended December 31, 2010, primarily as a result of the costs related to the annual meeting held in December 2011, which was partially offset by lower consultant fees. There was no annual meeting during the six months ended December 31, 2010. |
· | Professional fees for the six months ended December 31, 2011 was higher than for the six months ended December 31, 2010, primarily as a result of an increase in legal and accounting fees. Legal fees increased primarily due to fees incurred in connection with the exploration of alternative uses of our technology and discounts on legal fees that were recorded during the six months ended December 31, 2010 but were not available during the six months ended December 31, 2011. Accounting fees increased primarily due to the use of a consultant to prepare a valuation of the Company’s intangible assets. |
· | Director fees for the six months ended December 31, 2011 was lower than for the six months ended December 31, 2010, primarily as a result of fewer meetings being held during the six months ended December 31, 2011. |
· | Depreciation and amortization for the six months ended December 31, 2011 was higher than for the six months ended December 31, 2010, primarily as a result of an increase in amortization of patent costs. |
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· | Other general and administrative expenses for the six months ended December 31, 2011 was lower than for the six months ended December 31, 2010, primarily due to a decrease in consultant costs and rent, which was partially offset by an increase in insurance costs. |
· | Stock-based compensation for the six months ended December 31, 2011 was higher than for the six months ended December 31, 2010, primarily due to the black-scholes value on a greater number of options outstanding vesting during the six months ended December 31, 2011, which was mostly offset by fewer warrants being issued to consultants during the six months ended December 31, 2011. |
We expect cash-based general and administrative expenses to remain relatively unchanged over the next twelve months.
Research and Development Expenses
Six Months Ended December 31, | ||||||||||||||||
2011 | 2010 | Change | % | |||||||||||||
(in thousands, except % values) | ||||||||||||||||
Payroll | $ | 82 | $ | 95 | $ | (13 | ) | (13.7 | )% | |||||||
Research contract with the University of Waterloo | 290 | 315 | (25 | ) | (7.9 | )% | ||||||||||
Other research and development | 991 | 1,894 | (903 | ) | (47.7 | )% | ||||||||||
1,363 | 2,304 | (941 | ) | (40.8 | )% | |||||||||||
Stock-based compensation | 23 | 31 | (8 | ) | (25.8 | )% | ||||||||||
Total research and development | $ | 1,386 | $ | 2,335 | $ | (949 | ) | (40.6 | )% |
· | Payroll for the six months ended December 31, 2011 was lower than for the six months ended December 31, 2010, primarily as a result of a bonus that was paid to the VP-Research during the six months ended December 31, 2010. There were no bonuses paid during the six months ended December 31, 2011. |
· | The cost associated with the research contract with the University of Waterloo for the six months ended December 31, 2011 was lower than for the six months ended December 31, 2010, primarily due to a reduction in amount being funded for agricultural research, effective March 1, 2011. |
· | Other research and development costs for the six months ended December 31, 2011 was lower than for the six months ended December 31, 2010, primarily due to a decrease in the costs incurred in connection with our development of SNS01-T for multiple myeloma. Specifically, during the six months ended December 31, 2010, we incurred significant costs related to our pivotal toxicology study and other preclinical work that we did not incur during the six months ended December 31, 2011. This was partially offset by costs incurred related to the performance of the Phase 1b/2a clinical trial for multiple myeloma which were not incurred during the six months ended December 31, 2010. |
· | Stock-based compensation for the six months ended December 31, 2011 was lower than for the six months ended December 31, 2010, primarily due to a lower black-sholes value of the options vesting. |
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The breakdown of our research and development expenses between our agricultural and human therapeutic research programs is as follows:
· | Agricultural research expenses for the six months ended December 31, 2011 was lower than for the six months ended December 31, 2010, primarily due to a reduction in the funding for agricultural research at the University of Waterloo. |
· | Human therapeutic research expenses for the six months ended December 31, 2011 was lower than for the six months ended December 31, 2010, primarily as a result of the timing of certain aspects of the development of our drug candidate, SNS01-T, for treating multiple myeloma. Specifically, during the six months ended December 31, 2010, we incurred costs related to our pivotal toxicology studies and other pre-clinical work that we did not incur during the six months ended December 31, 2011. This was partially offset by costs incurred related to the performance of the Phase 1b/2a clinical trial for multiple myeloma which were not incurred during the six months ended December 31, 2010. |
We expect our human therapeutic research program to increase as a percentage of the total research and development expenses as we continue our current research projects and begin new human therapeutic initiatives, in particular as they relate to the clinical development of our drug candidate, SNS01-T, for treating multiple myeloma and other cancers. Additionally, effective January 1, 2012, we will no longer incur development costs in connection with the Rahan Meristem banana project as we converted the joint collaboration agreement into a license agreement.
Other non-operating income and expense
Fair value – warrant liability
On December 31, 2011, the amount of the warrant liability was adjusted to $478,948 from $711,259 at June 30, 2011.
On December 31, 2010, the amount of the warrant liability was adjusted to $902,675 from $2,493,794 at June 30, 2010.
Off Balance-Sheet Arrangements
We do not have any off balance-sheet arrangements.
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Item 3. | Quantitative and Qualitative Disclosures about Market Risk. |
Foreign Currency Risk
Our financial statements are denominated in United States dollars and, except for our agreement with the University of Waterloo, which is denominated in Canadian dollars, all of our contracts are denominated in United States dollars. Therefore, we believe that fluctuations in foreign currency exchange rates will not result in any material adverse effect on our financial condition or results of operations. In the event we derive a greater portion of our revenues from international operations or in the event a greater portion of our expenses are incurred internationally and denominated in a foreign currency, then changes in foreign currency exchange rates could effect our results of operations and financial condition.
Interest Rate Risk
We invest in high-quality financial instruments, primarily money market funds, with an effective duration of the portfolio of less than one year, which we believe are subject to limited credit risk. We currently do not hedge our interest rate exposure. Due to the short-term nature of our investments, we do not believe that we have any material exposure to interest rate risk arising from our investments.
Item 4. | Controls and Procedures. |
(a) Evaluation of disclosure controls and procedures.
The principal executive officer and principal financial officer have evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) as of December 31, 2011. Based on this evaluation, they have concluded that our disclosure controls and procedures were effective to ensure that the information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s, or SEC, rules and forms, and to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 is accumulated and communicated to our management, including our principal executive and principal financial officers, to allow timely decisions regarding required disclosure.
(b) Changes in internal controls.
No change in our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934) occurred during the three month period ended December 31, 2011 that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.
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PART II. OTHER INFORMATION .
Item 1. Legal Proceedings.
None |
Item 1A. Risk Factors.
The more prominent risks and uncertainties inherent in our business are described below. However, additional risks and uncertainties may also impair our business operations. If any of the following risks actually occur, our business, financial condition or results of operations may suffer.
Risks Related to Our Business
We have a limited operating history and have incurred substantial losses and expect to incur future losses .
We are a development stage biotechnology company with a limited operating history and limited assets and capital. We have incurred losses each year since inception and had an accumulated deficit of $64,351,449 at December 31, 2011. We have generated minimal revenues by licensing our technology for certain crops to companies willing to share in our development costs. In addition, our technology may not be ready for commercialization for several years. We expect to continue to incur losses for the next several years because we anticipate that our expenditures on research and development and administrative activities will significantly exceed our revenues during that period. We cannot predict when, if ever, we will become profitable.
We will need additional capital to fund our operations until we are able to generate a profit.
Our operations to date have required significant cash expenditures. Our future capital requirements will depend on the results of our research and development activities, preclinical and clinical studies, and competitive and technological advances.
We will need to obtain more funding in the future through collaborations or other arrangements with research institutions and corporate partners, or public and private offerings of our securities, including debt or equity financing. We may not be able to obtain adequate funds for our operations from these sources when needed or on acceptable terms. Future collaborations or similar arrangements may require us to license valuable intellectual property to, or to share substantial economic benefits with, our collaborators. If we raise additional capital by issuing additional equity or securities convertible into equity, our stockholders may experience dilution and our share price may decline. Any debt financing may result in restrictions on our spending.
If we are unable to raise additional funds, we will need to do one or more of the following:
· | delay, scale-back or eliminate some or all of our research and product development programs; |
· | provide licenses to third parties to develop and commercialize products or technologies that we would otherwise seek to develop and commercialize ourselves; |
· | seek strategic alliances or business combinations; |
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· | attempt to sell our company; |
· | cease operations; or |
· | declare bankruptcy. |
We believe that at the projected rate of spending we should have sufficient cash to maintain our present operations through August 2012. However, we have the ability to raise additional capital through our ATM facility, utilize our unused line of credit and, if necessary, delay certain costs.
We may be adversely affected by the current economic environment.
Our ability to obtain financing, invest in and grow our business, and meet our financial obligations depends on our operating and financial performance, which in turn is subject to numerous factors. In addition to factors specific to our business, prevailing economic conditions and financial, business and other factors beyond our control can also affect our business and ability to raise capital. We cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.
Materials necessary to manufacture some of our compounds currently under development may not be available on commercially reasonable terms, or at all, which may delay our development and commercialization of these compounds.
Some of the materials necessary for the manufacture of our compounds under development may, from time to time, be available either in limited quantities, or from a limited number of manufacturers, or both. Our contract manufacturers need to obtain these materials for our clinical trials and, potentially, for commercial distribution when and if we obtain marketing approval for these compounds. Suppliers may not sell us these materials at the time we need them or on commercially reasonable terms. If we are unable to obtain the materials needed to conduct our clinical trials, product testing and potential regulatory approval could be delayed, adversely affecting our ability to develop the product candidates. Similarly, if we are unable to obtain critical manufacturing materials after regulatory approval has been obtained for a product candidate, the commercial launch of that product candidate could be delayed or there could be a shortage in supply, which could materially affect our ability to generate revenues from that product candidate. If suppliers increase the price of manufacturing materials, the price for one or more of our products may increase, which may make our products less competitive in the marketplace. If it becomes necessary to change suppliers for any of these materials or if any of our suppliers experience a shutdown or disruption at the facilities used to produce these materials, due to technical, regulatory or other reasons, it could harm our ability to manufacture our products.
We depend on a single principal technology and, if our technology is not commercially successful, we will have no alternative source of revenue .
Our primary business is the development and licensing of technology to identify, isolate, characterize and promote or silence genes which control the death of cells in humans and plants. Our future revenue and profitability critically depend upon our ability, or our licensees’ ability, to successfully develop apoptosis and senescence gene technology and later license or market such technology. We have conducted experiments on certain crops with favorable results and have conducted certain preliminary cell-line and animal experiments, which have provided us with data upon which we have designed additional research programs. However, we cannot give any assurance that our technology will be commercially successful or economically viable for any crops or human therapeutic applications.
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In addition, no assurance can be given that adverse consequences might not result from the use of our technology such as the development of negative effects on humans or plants or reduced benefits in terms of crop yield or protection. Our failure to obtain market acceptance of our technology or the failure of our current or potential licensees to successfully commercialize such technology would have a material adverse effect on our business.
We outsource all of our research and development activities and, if we are unsuccessful in maintaining our alliances with these third parties, our research and development efforts may be delayed or curtailed.
We rely on third parties to perform all of our research and development activities. Our research and development efforts take place at the University of Waterloo in Ontario, Canada, where our technology was discovered, at other commercial research facilities and with our comme rcial partners. At this time, we do not have the internal capabilities to perform our own research and development activities. Accordingly, the failure of third party research partners to perform under agreements entered into with us, or our failure to renew important research agreements with these third parties, may delay or curtail our research and development efforts.
We have significant future capital needs and may be unable to raise capital when needed, which could force us to delay or reduce our research and development efforts.
As of December 31, 2011, we had a cash balance of $1,552,898 and a working capital deficit of $235,129. Using our availab le reserves as of December 31, 2011 and the net proceeds of the public offering on January 6, 2012, we believe that we can operate according to our current business plan through August 2012. However, we have the ability to raise additional capital through our ATM facility, utilize our unused line of credit and, if necessary, delay certain costs.
To date, we have generated minimal revenues and anticipate that our operating costs will exceed any revenues generated over the next several years. Therefore, we will be required to raise additional capital in the future in order to operate in accordance with our current business plan, and this funding may not be available on favorable terms, if at all. If we are unable to raise additional funds, we will need to do one or more of the following:
· | delay, scale back or eliminate some or all of our research and development programs; |
· | provide a license to third parties to develop and commercialize our technology that we would otherwise seek to develop and commercialize ourselves; |
· | seek strategic alliances or business combinations; |
· | attempt to sell our company; |
· | cease operations; or |
· | declare bankruptcy. |
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In addition, in connection with any funding, if we need to issue more equity securities than our certificate of incorporation currently authorizes, or more than 20% of the shares of our common stock outstanding, we may need stockholder approval. If stockholder approval is not obtained or if adequate funds are not available, we may be required to curtail operations significantly or to obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies, product candidates, products or potential markets. Investors may experience dilution in their investment from future offerings of our common stock. For example, if we raise additional capital by issuing equity securities, such an issuance would reduce the percentage ownership of existing stockholders. In addition, assuming the exercise of all options and warrants outstanding and the conversion of the preferred stock into common stock, as of December 31, 2011, we had 151,258,135 shares of common stock authorized but unissued and unreserved, which may be issued from time to time by our board of directors. Furthermore, we may need to issue securities that have rights, preferences and privileges senior to our common stock. Failure to obtain financing on acceptable terms would have a material adverse effect on our liquidity.
Since our inception, we have financed all of our operations through equity and debt financings. Our future capital requirements depend on numerous factors, including:
· | the scope of our research and development; |
· | our ability to attract business partners willing to share in our development costs; |
· | our ability to successfully commercialize our technology; |
· | competing technological and market developments; |
· | our ability to enter into collaborative arrangements for the development, regulatory approval and commercialization of other products; and |
· | the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights. |
Our business depends upon our patents and proprietary rights and the enforcement of these rights. Our failure to obtain and maintain patent protection may increase competition and reduce demand for our technology.
As a result of the substantial length of time and expense associated with developing products and bringing them to the marketplace in the biotechnology and agricultural industries, obtaining and maintaining patent and trade secret protection for technologies, products and processes is of vital importance. Our success will depend in part on several factors, including, without limitation:
· | our ability to obtain patent protection for our technologies and processes; |
· | our ability to preserve our trade secrets; and |
· | our ability to operate without infringing the proprietary rights of other parties both in the United States and in foreign countries. |
As of December 31, 2011, we have been issued twenty-four (24) patents by the PTO and seventy-eight (78) patents from foreign countries . We have also filed numerous patent applications for our technology in the United States and in several foreign countries, which technology is vital to our primary business, as well as several continuations in part on these patent applications. Our success depends in part upon the grant of patents from our pending patent applications.
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Although we believe that our technology is unique and that it will not violate or infringe upon the proprietary rights of any third party, we cannot assure you that these claims will not be made or if made, could be successfully defended against. If we do not obtain and maintain patent protection, we may face increased competition in the United States and internationally, which would have a material adverse effect on our business.
Since patent applications in the United States are maintained in secrecy until patents are issued, and since publication of discoveries in the scientific and patent literature tend to lag behind actual discoveries by several months, we cannot be certain that we were the first creator of the inventions covered by our pending patent applications or that we were the first to file patent applications for these inventions.
In addition, among other things, we cannot assure you that:
· | our patent applications will result in the issuance of patents; |
· | any patents issued or licensed to us will be free from challenge and if challenged, would be held to be valid; |
· | any patents issued or licensed to us will provide commercially significant protection for our technology, products and processes; |
· | other companies will not independently develop substantially equivalent proprietary information which is not covered by our patent rights; |
· | other companies will not obtain access to our know-how; |
· | other companies will not be granted patents that may prevent the commercialization of our technology; or |
· | we will not incur licensing fees and the payment of significant other fees or royalties to third parties for the use of their intellectual property in order to enable us to conduct our business. |
Our competitors may allege that we are infringing upon their intellectual property rights, forcing us to incur substantial costs and expenses in resulting litigation, the outcome of which would be uncertain.
Patent law is still evolving relative to the scope and enforceability of claims in the fields in which we operate. We are like most biotechnology companies in that our patent protection is highly uncertain and involves complex legal and technical questions for which legal principles are not yet firmly established. In addition, if issued, our patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products, or provide us with any competitive advantage.
The PTO and the courts have not established a consistent policy regarding the breadth of claims allowed in biotechnology patents. The allowance of broader claims may increase the incidence and cost of patent interference proceedings and the risk of infringement litigation. On the other hand, the allowance of narrower claims may limit the scope and value of our proprietary rights.
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The laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary rights in these foreign countries.
We could become involved in infringement actions to enforce and/or protect our patents. Regardless of the outcome, patent litigation is expensive and time consuming and would distract our management from other activities. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we could because they have substantially greater resources. Uncertainties resulting from the initiation and continuation of any patent litigation could limit our ability to continue our operations.
If our technology infringes the intellectual property of our competitors or other third parties, we may be required to pay license fees or damages.
If any relevant claims of third party patents that are adverse to us are upheld as valid and enforceable, we could be prevented from commercializing our technology or could be required to obtain licenses from the owners of such patents. We cannot assure you that such licenses would be available or, if available, would be on acceptable terms. Some licenses may be non-exclusive and, therefore, our competitors may have access to the same technology licensed to us. In addition, if any parties successfully claim that the creation or use of our technology infringes upon their intellectual property rights, we may be forced to pay damages, including treble damages.
Our security measures may not adequately protect our unpatented technology and, if we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology may be adversely affected.
Our success depends upon know-how, unpatentable trade secrets, and the skills, knowledge and experience of our scientific and technical personnel. As a result, all employees agreed to a confidentiality provision in their employment agreement that prohibited the disclosure of confidential information to anyone outside of our company, during the term of employment and for five (5) years thereafter. The employment agreements have since been terminated, but the period of confidentiality is still in effect. We also require all employees to disclose and assign to us the rights to their ideas, developments, discoveries and inventions. We also attempt to enter into similar agreements with our consultants, advisors and research collaborators. We cannot assure you that adequate protection for our trade secrets, know-how or other proprietary information against unauthorized use or disclosure will be available.
We occasionally provide information to research collaborators in academic institutions and request that the collaborators conduct certain tests. We cannot assure you that the academic institutions will not assert intellectual property rights in the results of the tests conducted by the research collaborators, or that the academic institutions will grant licenses under such intellectual property rights to us on acceptable terms, if at all. If the assertion of intellectual property rights by an academic institution is substantiated, and the academic institution does not grant intellectual property rights to us, these events could limit our ability to commercialize our technology.
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As we evolve from a company primarily involved in the research and development of our technology into one that is also involved in the commercialization of our technology, we may have difficulty managing our growth and expanding our operations.
As our business grows, we may need to add employees and enhance our management, systems and procedures. We may need to successfully integrate our internal operations with the operations of our marketing partners, manufacturers, distributors and suppliers to produce and market commercially viable products. We may also need to manage additional relationships with various collaborative partners, suppliers and other organizations. Although we do not presently conduct research and development activities in-house, we may undertake those activities in the future. Expanding our business may place a significant burden on our management and operations. We may not be able to implement improvements to our management information and control systems in an efficient and timely manner and we may discover deficiencies in our existing systems and controls. Our failure to effectively respond to such changes may make it difficult for us to manage our growth and expand our operations.
We have no marketing or sales history and depend on third party marketing partners. Any failure of these parties to perform would delay or limit our commercialization efforts.
We have no history of marketing, distributing or selling biotechnology products, and we are relying on our ability to successfully establish marketing partners or other arrangements with third parties to market, distribute and sell a commercially viable product both here and abroad. Our business plan envisions creating strategic alliances to access needed commercialization and marketing expertise. We may not be able to attract qualified sub-licensees, distributors or marketing partners, and even if qualified, these marketing partners may not be able to successfully market agricultural products or human therapeutic applications developed with our technology. If our current or potential future marketing partners fail to provide adequate levels of sales, our commercialization efforts will be delayed or limited and we may not be able to generate revenue.
We will depend on joint ventures and strategic alliances to develop and market our technology and, if these arrangements are not successful, our technology may not be developed and the expenses to commercialize our technology will increase.
In its current state of development, our technology is not ready to be marketed to consumers. We intend to follow a multi-faceted commercialization strategy that involves the licensing of our technology to business partners for the purpose of further technological development, marketing and distribution. We have and are seeking business partners who will share the burden of our development costs while our technology is still being developed, and who will pay us royalties when they market and distribute products incorporating our technology upon commercialization. The establishment of joint ventures and strategic alliances may create future competitors, especially in certain regions abroad where we do not pursue patent protection. If we fail to establish beneficial business partners and strategic alliances, our growth will suffer and the continued development of our technology may be harmed.
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Competition in the human therapeutic and agricultural biotechnology industries is intense and technology is changing rapidly. If our competitors market their technology faster than we do, we may not be able to generate revenues from the commercialization of our technology.
Many human therapeutic and agricultural biotechnology companies are engaged in research and development activities relating to apoptosis and senescence. The market for plant protection and yield enhancement products is intensely competitive, rapidly changing and undergoing consolidation. We may be unable to compete successfully against our current and future competitors, which may result in price reductions, reduced margins and the inability to achieve market acceptance for products containing our technology. Our competitors in the field of plant senescence gene technology are companies that develop and produce transgenic plants and include major international agricultural companies, specialized biotechnology companies, research and academic institutions and, potentially, our joint venture and strategic alliance partners. These companies include: Mendel Biotechnology, Inc.; Renessen LLC; Exelixis Plant Sciences, Inc.; and Syngenta International AG; among others. Some of our competitors that are involved in apoptosis research include: Celgene, Inc.; Takeda/Millennium; ONYX Pharmaceuticals, Inc.; Amgen Inc.; Centocor, Inc.; Novartis AG; and Genta Incorporated. Many of these competitors have substantially greater financial, marketing, sales, distribution and technical resources than us and have more experience in research and development, clinical trials, regulatory matters, manufacturing and marketing. We anticipate increased competition in the future as new companies enter the market and new technologies become available. Our technology may be rendered obsolete or uneconomical by technological advances or entirely different approaches developed by one or more of our competitors, which will prevent or limit our ability to generate revenues from the commercialization of our technology.
Our business is subject to various government regulations and, if we or our licensees are unable to obtain regulatory approval, we may not be able to continue our operations.
At present, the U.S. federal government regulation of biotechnology is divided among three agencies:
· | the United States Department of Agriculture, or USDA, regulates the import, field testing and interstate movement of specific types of genetic engineering that may be used in the creation of transgenic plants; |
· | the United States Environmental Protection Agency, or EPA, regulates activity related to the invention of plant pesticides and herbicides, which may include certain kinds of transgenic plants; and |
· | the FDA regulates foods derived from new plant varieties. |
The FDA requires that transgenic plants meet the same standards for safety that are required for all other plants and foods in general. Except in the case of additives that significantly alter a food’s structure, the FDA does not require any additional standards or specific approval for genetically engineered foods, but expects transgenic plant developers to consult the FDA before introducing a new food into the marketplace.
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Use of our technology, if developed for human therapeutic applications, is also subject to FDA regulation. The FDA must approve any drug or biologic product before it can be marketed in the United States. In addition, prior to being sold outside of the United States, any products resulting from the application of our human therapeutic technology must be approved by the regulatory agencies of foreign governments. Prior to filing a new drug application or biologics license application with the FDA, we would have to perform extensive clinical trials, and prior to beginning any clinical trial, we would need to perform extensive preclinical testing which could take several years and may require substantial expenditures.
We believe that our current agricultural activities, which to date have been confined to research and development efforts, do not require licensing or approval by any governmental regulatory agency. However, we are performing clinical trials in connection with our human therapeutic applications, which is subject to FDA approval. Additionally, federal, state and foreign regulations relating to crop protection products and human therapeutic applications developed through biotechnology are subject to public concerns and political circumstances, and, as a result, regulations have changed and may change substantially in the future. Accordingly, we may become subject to governmental regulations or approvals or become subject to licensing requirements in connection with our research and development efforts. We may also be required to obtain such licensing or approval from the governmental regulatory agencies described above, or from state agencies, prior to the commercialization of our genetically transformed plants and human therapeutic technology. In addition, our marketing partners who utilize our technology or sell products grown with our technology may be subject to government regulations. If unfavorable governmental regulations are imposed on our technology or if we fail to obtain licenses or approvals in a timely manner, we may not be able to continue our operations.
Preclinical studies of our human therapeutic applications may be unsuccessful, which could delay or prevent regulatory approval.
Preclinical studies may reveal that our human therapeutic technology is ineffective or harmful, and/or may be unsuccessful in demonstrating efficacy and safety of our human therapeutic technology, which would significantly limit the possibility of obtaining regulatory approval for any drug or biologic product manufactured with our technology. The FDA requires submission of extensive preclinical, clinical and manufacturing data to assess the efficacy and safety of potential products. Any delay in receiving approval for any applicable IND from the FDA would result in a delay in the commencement of the related clinical trial. Additionally, we could be required to perform additional preclinical studies prior to the FDA approving any applicable IND. Furthermore, the success of preliminary studies does not ensure commercial success, and later-stage clinical trials may fail to confirm the results of the preliminary studies.
Our success will depend on the success of our clinical trials of our human therapeutic applications.
It may take several years to complete the clinical trials of a product, and failure of one or more of our clinical trials can occur at any stage of testing. We believe that the development of our product candidate involves significant risks at each stage of testing. If clinical trial difficulties and failures arise, our product candidate may never be approved for sale or become commercially viable.
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There are a number of difficulties and risks associated with clinical trials. These difficulties and risks may result in the failure to receive regulatory approval to sell our product candidate or the inability to commercialize our product candidate. The possibility exists that:
· | we may discover that the product candidate does not exhibit the expected therapeutic results in humans, may cause harmful side effects or have other unexpected characteristics that may delay or preclude regulatory approval or limit commercial use if approved; |
· | the results from early clinical trials may not be statistically significant or predictive of results that will be obtained from expanded advanced clinical trials; |
· | institutional review boards or regulators, including the FDA, may hold, suspend or terminate our clinical research or the clinical trials of our product candidate for various reasons, including noncompliance with regulatory requirements or if, in their opinion, the participating subjects are being exposed to unacceptable health risks; |
· | subjects may drop out of our clinical trials; |
· | our preclinical studies or clinical trials may produce negative, inconsistent or inconclusive results, and we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials; and |
· | the cost of our clinical trials may be greater than we currently anticipate. |
Clinical trials for our human therapeutic technology will be lengthy and expensive and their outcome is uncertain.
Before obtaining regulatory approval for the commercial sales of any product containing our technology, we must demonstrate through clinical testing that our technology and any product containing our technology is safe and effective for use in humans. Conducting clinical trials is a time-consuming, expensive and uncertain process and typically requires years to complete. In our industry, the results from preclinical studies and early clinical trials often are not predictive of results obtained in later-stage clinical trials. Some products and technologies that have shown promising results in preclinical studies or early clinical trials subsequently fail to establish sufficient safety and efficacy data necessary to obtain regulatory approval. At any time during clinical trials, we or the FDA might delay or halt any clinical trial for various reasons, including:
· | occurrence of unacceptable toxicities or side effects; |
· | ineffectiveness of the product candidate; |
· | negative or inconclusive results from the clinical trials, or results that necessitate additional studies or clinical trials; |
· | delays in obtaining or maintaining required approvals from institutions, review boards or other reviewing entities at clinical sites; |
· | delays in patient enrollment; or |
· | insufficient funding or a reprioritization of financial or other resources. |
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Any failure or substantial delay in successfully completing clinical trials and obtaining regulatory approval for our product candidates could severely harm our business.
If our clinical trials for our product candidates are delayed, we would be unable to commercialize our product candidates on a timely basis, which would materially harm our business.
Planned clinical trials may not begin on time or may need to be restructured after they have begun. Clinical trials can be delayed for a variety of reasons, including delays related to:
· | obtaining an effective IND or regulatory approval to commence a clinical trial; |
· | negotiating acceptable clinical trial agreement terms with prospective trial sites; |
· | obtaining institutional review board approval to conduct a clinical trial at a prospective site; |
· | recruiting qualified subjects to participate in clinical trials; |
· | competition in recruiting clinical investigators; |
· | shortage or lack of availability of supplies of drugs for clinical trials; |
· | the need to repeat clinical trials as a result of inconclusive results or poorly executed testing; |
· | the placement of a clinical hold on a study; |
· | the failure of third parties conducting and overseeing the operations of our clinical trials to perform their contractual or regulatory obligations in a timely fashion; and |
· | exposure of clinical trial subjects to unexpected and unacceptable health risks or noncompliance with regulatory requirements, which may result in suspension of the trial. |
We believe that our product candidate has significant milestones to reach, including the successful completion of clinical trials, before commercialization. If we have significant delays in or termination of clinical trials, our financial results and the commercial prospects for our product candidates or any other products that we may develop will be adversely impacted. In addition, our product development costs would increase and our ability to generate revenue could be impaired.
Any inability to license from third parties their proprietary technologies or processes which we use in connection with the development of our technology may impair our business.
Other companies, universities and research institutions have or may obtain patents that could limit our ability to use our technology in a product candidate or impair our competitive position. As a result, we would have to obtain licenses from other parties before we could continue using our technology in a product candidate. Any necessary licenses may not be available on commercially acceptable terms, if at all. If we do not obtain required licenses, we may not be able to develop our technology into a product candidate or we may encounter significant delays in development while we redesign methods that are found to infringe on the patents held by others.
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Even if we receive regulatory approval, consumers may not accept products containing our technology, which will prevent us from being profitable since we have no other source of revenue.
We cannot guarantee that consumers will accept products containing our technology. Recently, there has been consumer concern and consumer advocate activism with respect to genetically-engineered agricultural consumer products. The adverse consequences from heightened consumer concern in this regard could affect the markets for agricultural products developed with our technology and could also result in increased government regulation in response to that concern. If the public or potential customers perceive our technology to be genetic modification or genetic engineering, agricultural products grown with our technology may not gain market acceptance.
We face potential product liability exposure far in excess of our limited insurance coverage.
We may be held liable if any product we or our collaborators develop causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing or sale. Regardless of merit or eventual outcome, product liability claims could result in decreased demand for our product candidates, injury to our reputation, withdrawal of patients from our clinical trials, substantial monetary awards to trial participants and the inability to commercialize any products that we may develop. These claims might be made directly by consumers, health care providers, pharmaceutical companies or others selling or testing our products. We have obtained limited product liability insurance coverage for our clinical trials; however, our insurance may not reimburse us or may not be sufficient to reimburse us for expenses or losses we may suffer. Moreover, if insurance coverage becomes more expensive, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. If we obtain marketing approval for any of our product candidates, we intend to expand our insurance coverage to include the sale of commercial products, but we may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing. On occasion, juries have awarded large judgments in class action lawsuits for claims based on drugs that had unanticipated side effects. In addition, the pharmaceutical and biotechnology industries, in general, have been subject to significant medical malpractice litigation. A successful product liability claim or series of claims brought against us could harm our reputation and business and would decrease our cash reserves.
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We depend on our key personnel and, if we are not able to attract and retain qualified scientific and business personnel, we may not be able to grow our business or develop and commercialize our technology.
We are highly dependent on our scientific advisors, consultants and third-party research partners. Our success will also depend in part on the continued service of our key employees and our ability to identify, hire and retain additional qualified personnel in an intensely competitive market. Although we have a research agreement with Dr. John Thompson, this agreement may be terminated upon short or no notice. Additionally, we do not have employment agreements with our key employees. We do not maintain key person life insurance on any member of management. The failure to attract and retain key personnel could limit our growth and hinder our research and development efforts.
Certain provisions of our charter, by-laws, Delaware law and stock plans could make a takeover difficult.
Certain provisions of our certificate of incorporation and by-laws could make it more difficult for a third party to acquire control of us, even if the change in control would be beneficial to stockholders. Our certificate of incorporation authorizes our board of directors to issue, without stockholder approval, except as may be required by the rules of the NYSE Amex, 5,000,000 shares of preferred stock with voting, conversion and other rights and preferences that could adversely affect the voting power or other rights of the holders of our common stock.
In addition, we are subject to the Business Combination Act of the Delaware General Corporation Law which, subject to certain exceptions, restricts certain transactions and business combinations between a corporation and a stockholder owning 15% or more of the corporation’s outstanding voting stock for a period of three years from the date such stockholder becomes a 15% owner. These provisions may have the effect of delaying or preventing a change of control of us without action by our stockholders and, therefore, could adversely affect the value of our common stock.
Furthermore, in the event of our merger or consolidation with or into another corporation, or the sale of all or substantially all of our assets in which the successor corporation does not assume our outstanding equity awards or issue equivalent equity awards, our current equity plans require the accelerated vesting of such outstanding equity awards.
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Risks Related to Our Common Stock
We currently do not meet the NYSE Amex continued listing standards. If our common stock is delisted from the NYSE Amex, we may not be able to list on any other stock exchange, and our common stock may be subject to the “penny stock” regulations which may affect the ability of our stockholders to sell their shares.
The NYSE Amex requires us to meet minimum financial requirements in order to maintain our listing. Currently, we do not meet the $6,000,000 minimum net worth continued listing requirement of the NYSE Amex Exchange and have received a notice of noncompliance from the NYSE Amex Exchange. We submitted a plan of compliance on November 17, 2011 to the NYSE Amex Exchange discussing how we intend to regain compliance with the continued listing requirements. The NYSE Amex Exchange has accepted our plan and granted us an extension until July 20, 2012 to regain compliance with the NYSE Amex’s continuing listing standards, however, if we are unable to meet the plan, it is possible that we will be delisted. If we are delisted from the NYSE Amex, our common stock likely will become a “penny stock.” In general, regulations of the SEC define a “penny stock” to be an equity security that is not listed on a national securities exchange and that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions. If our common stock becomes a penny stock, additional sales practice requirements would be imposed on broker-dealers that sell such securities to persons other than certain qualified investors. For transactions involving a penny stock, unless exempt, a broker-dealer must make a special suitability determination for the purchaser and receive the purchaser’s written consent to the transaction prior to the sale. In addition, the rules on penny stocks require delivery, prior to and after any penny stock transaction, of disclosures required by the SEC.
If our stock is not accepted for listing on the NYSE Amex, we will make every possible effort to have it listed on the Over the Counter Bulletin Board, or the OTC Bulletin Board. If our common stock was to be traded on the OTC Bulletin Board, the Securities Exchange Act of 1934, as amended, and related SEC rules would impose additional sales practice requirements on broker-dealers that sell our securities. These rules may adversely affect the ability of stockholders to sell our common stock and otherwise negatively affect the liquidity, trading market and price of our common stock.
We believe that the listing of our common stock on a recognized national trading market, such as the NYSE Amex, is an important part of our business and strategy. Such a listing helps our stockholders by providing a readily available trading market with current quotations. Without that, stockholders may have a difficult time getting a quote for the sale or purchase of our stock, the sale or purchase of our stock would likely be made more difficult and the trading volume and liquidity of our stock would likely decline. The absence of such a listing may adversely affect the acceptance of our common stock as currency or the value accorded it by other parties. In that regard, the absence of a listing on a recognized national trading market will also affect our ability to benefit from the use of our operations and expansion plans, including for use in licensing agreements, joint ventures, the development of strategic relationships and acquisitions, which are critical to our business and strategy and none of which is currently the subject of any agreement, arrangement or understanding, with respect to any future financing or strategic relationship we may undertake. A delisting from the NYSE Amex could result in negative publicity and could negatively impact our ability to raise capital in the future.
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Our management and other affiliates have significant control of our common stock and could significantly influence our actions in a manner that conflicts with our interests and the interests of other stockholders.
As of December 31, 2011, our executive officers and directors together beneficially own approximately 32.7% of the outstanding shares of our common stock, assuming the conversion of preferred stock and exercise of options and warrants which are currently exercisable or will become exercisable within 60 days of December 31, 2011, held by these stockholders. As a result, these stockholders, acting together, will be able to exercise significant influence over matters requiring approval by our stockholders, including the election of directors, and may not always act in the best interests of other stockholders. Such a concentration of ownership may have the effect of delaying or preventing a change in control of us, including transactions in which our stockholders might otherwise receive a premium for their shares over then-current market prices.
A significant portion of our total outstanding shares of common stock may be sold in the market in the near future, which could cause the market price of our common stock to drop significantly.
As of December 31, 2011, we had 80,864,443 shares of our common stock issued and outstanding and 4,845 shares of convertible preferred stock outstanding which can convert into 17,944,444 shares of common stock. Approximately 34,164,431 shares of such shares are registered pursuant to registration statements on Form S-3 and 64,644,456 of which are either eligible to be sold under SEC Rule 144 or are in the public float. In addition, we have registered 35,890,007 shares of our common stock underlying warrants previously issued on Form S-3 registration statements and we registered 23,005,003 shares of our common stock underlying options granted or to be granted under our stock option plan. Consequently, sales of substantial amounts of our common stock in the public market, or the perception that such sales could occur, may have a material adverse effect on our stock price.
Our common stock has a limited trading market, which could limit your ability to resell your shares of common stock at or above your purchase price.
Our common stock is quoted on the NYSE Amex and currently has a limited trading market. The NYSE Amex requires us to meet minimum financial requirements in order to maintain our listing. Currently, we do not meet the continued listing requirements of the NYSE Amex. If we do not regain compliance with the continued listing standards, we could be delisted. We cannot assure you that an active trading market will develop or, if developed, will be maintained. As a result, our stockholders may find it difficult to dispose of shares of our common stock and, as a result, may suffer a loss of all or a substantial portion of their investment.
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The market price of our common stock may fluctuate and may drop below the price you paid.
We cannot assure you that you will be able to resell the shares of our common stock at or above your purchase price. The market price of our common stock may fluctuate significantly in response to a number of factors, some of which are beyond our control. These factors include:
· | quarterly variations in operating results; |
· | the progress or perceived progress of our research and development efforts; |
· | changes in accounting treatments or principles; |
· | announcements by us or our competitors of new technology, product and service offerings, significant contracts, acquisitions or strategic relationships; |
· | additions or departures of key personnel; |
· | future offerings or resales of our common stock or other securities; |
· | stock market price and volume fluctuations of publicly-traded companies in general and development companies in particular; and |
· | general political, economic and market conditions. |
For example, during the quarter ended December 31, 2011, our common stock traded between $0.16 and $0.29 per share .
Because we do not intend to pay, and have not paid, any cash dividends on our shares of common stock, our stockholders will not be able to receive a return on their shares unless the value of our common stock appreciates and they sell their shares.
We have never paid or declared any cash dividends on our common stock, and we intend to retain any future earnings to finance the development and expansion of our business. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. Therefore, our stockholders will not be able to receive a return on their investment unless the value of our common stock appreciates and they sell their shares.
Our stockholders may experience substantial dilution as a result of the conversion of convertible preferred stock, the exercise of options and warrants to purchase our common stock, or due to anti-dilution provisions relating to any on the foregoing.
As of December 31, 2011, we have outstanding 4,845 shares of convertible preferred stock which may convert into 17,944,444 shares of our common stock and warrants to purchase 54,059,032 shares of our common stock. In addition, as of December 31, 2011, we have reserved 25,016,603 shares of our common stock for issuance upon the exercise of options granted or available to be granted pursuant to our stock option plan, all of which may be granted in the future. Furthermore, in connection with the preferred stock agreements, we are required to reserve an additional 20,857,343 shares of common stock. The conversion of the convertible preferred stock and the exercise of these options and warrants will result in dilution to our existing stockholders and could have a material adverse effect on our stock price. The conversion price of the convertible preferred stock and certain warrants are also subject to certain anti-dilution adjustments.
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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds. |
None |
Item 3. | Defaults Upon Senior Securities. |
None |
Item 4. | [REMOVED AND RESERVED] |
Item 5. | Other Information. |
None |
Item 6. | Exhibits. |
Exhibits.
Exhibit No. | Description | |
3.1 | Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Senesco Technologies, Inc. filed with the State of Delaware on December 22, 2011. (filed herewith) | |
10.1 + | Amended and Restated Agreement by and between Rahan Meristem (1998) LTD., Senesco Technologies, Inc. and Senesco, Inc. dated December 22, 2011. (filed herewith) | |
10.2 | Form of Warrant. ( Incorporated by reference to Exhibit 4.1 of Senesco Technologies, Inc. current report on Form 8-K filed on January 9, 2012) | |
10.3 | Form of Securities Purchase Agreement. ( Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc. current report on Form 8-K filed on January 9, 2012) | |
31.1 | Certification of principal executive officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. (filed herewith) | |
31.2 | Certification of principal financial and accounting officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. (filed herewith) | |
32.1 | Certification of principal executive officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350. (furnished herewith) | |
32.2 | Certification of principal financial and accounting officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350. (furnished herewith) | |
101.1 | Financial Statements from the Quarterly Report on Form 10-Q of Senesco Technologies, Inc. for the quarter ended December 31, 2011, filed on February 14, 2012, formatted in XBRL: (i) the Condensed Consolidated Balance Sheets; (ii) the Condensed Consolidated Statements of Operations; (iii) the Condensed Consolidated Statements of Stockholder’s Equity; (iv) the Condensed Consolidated Statements of Cash Flows and (v) the Notes to Condensed Consolidated Financial Statements. (filed herewith) |
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Exhibit No. | Description | |
+ Portions of this Exhibit have been redacted pursuant to a confidential treatment request filed with the SEC. |
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SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SENESCO TECHNOLOGIES, INC. | ||
DATE: February 14, 2012 | By: | /s/ Leslie J. Browne |
Leslie J. Browne, Ph.D., President | ||
and Chief Executive Officer | ||
(Principal Executive Officer) | ||
DATE: February 14, 2012 | By: | /s/ Joel Brooks |
Joel Brooks, Chief Financial Officer, Secretary and Treasurer | ||
(Principal Financial and Accounting Officer) |
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Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “***”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
AMENDED AND RESTATED AGREEMENT
This Amended and Restated Agreement (“Agreement”) is entered into by and among Senesco, Inc., a New Jersey corporation, Senesco Technologies Inc., a Delaware Corporation and its wholly owned subsidiary (together, the “ Company ”), and Rahan Meristem (1998) LTD, an Israeli Company (“ Recipient ”) as of December 22, 2011 (the “ Effective Date ”).
WHEREAS, the parties entered into that certain Agreement dated May 17, 1999 (“ Joint Venture Agreement ”) whereby the parties set forth their agreement to engage in joint research and development work relating to the development and production of transgenic banana plants with delayed senescence and Sigatoka resistance, traits and improvements produced by suppressing the expression of the lipase gene and other derived technology related to eukaryotic translation initiation factor 5A-1 (“ eIF5A ”) or deoxyhypusine synthase (“ DHS ”);
WHEREAS, the joint venture entity was never formed;
WHEREAS, the parties wish to amend and restate the Joint Venture Agreement so as to convert the Joint Venture Agreement from a joint venture structure to a license agreement pursuant to the terms of this Agreement;
WHEREAS, the Company owns or Controls (as defined below) those patents set forth on Schedule A , and has the right to grant certain rights and licenses thereunder as set forth herein; and
WHEREAS, Recipient wishes to obtain, and Company wishes to convey to Recipient, an exclusive worldwide license to such patents.
NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements hereinafter set forth, the sufficiency of which is hereby acknowledged, the parties to this Agreement mutually agree as follows:
1. DEFINITIONS. For purposes of this Agreement, the following initially capitalized terms in this Agreement, whether used in the singular or plural, shall have the following meanings:
1.1 “ Affiliate ” shall mean any corporation, company, partnership, joint venture and/or firm which controls, is controlled by, or is under common control with a specified person or entity. For purposes of this definition, “Control” shall mean (a) in the case of corporate entities, direct or indirect ownership of more than 50% of the stock or shares entitled to vote for the election of directors; and (b) in the case of non-corporate entities, direct or indirect ownership of more than 50% of the equity interest with the power to direct the management and policies of such non-corporate entities. The parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such cases such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity.
1.2 “ Agreement ” shall mean this Agreement together with all exhibits, schedules and appendices attached to this Agreement, all as respectively amended, modified or supplemented by the parties in accordance with the terms of this Agreement.
1.3 “ Annual Net Sales ” shall mean the total and aggregate Net Sales achieved during any successive period of twelve (12) consecutive calendar months.
1.4 “ Change of Hands ” shall mean the announcement of any agreement or the consummation of any event or transaction whereby Recipient (i) sells to any Third Party in one or more related transactions assets representing all of Recipient’s assets (including intellectual property rights); (ii) enters into a merger or reorganization or similar transaction with a Third Party as a result of which, immediately following such transaction, less than a majority of the voting power of the voting stock of the surviving entity is beneficially owned by Recipient; or (iii) enters into any transaction (including, without limitation, any stock acquisition, merger or consolidation) whereby a Third Party acquires a majority of the voting power of the voting stock of Recipient.
1.5 “ Company Intellectual Property ” shall mean Company Patent rights along with Know-How owned or Controlled by the Company as of the Effective Date that is necessary to research, develop, make or commercialize the Products in the Territory.
1.6 “ Company Patent Rights ” shall mean all Patents Rights owned or Controlled by Company set forth on Schedule A .
1.7 “ Controlled ” or “ Controls ”, when used in reference to Patent Rights or Know-How, shall mean the legal authority or right of a party hereto (or any of its Affiliates) to grant a license or sublicense under such Patent Rights to another, or to disclose to and authorize another to use such Know-How, without breaching the terms of any agreement with a third party, infringing upon the intellectual property rights of a third party, or misappropriating the proprietary or trade secret information of a third party. In the event that consent of a third party is needed to grant a license or sublicense under such Patent Rights to another, or to disclose to and authorize another to use such Know-How , then the party granting such license or sublicense must use reasonable efforts to secure such consent.
1.8 “ Incremental Net Sales ” means Net Sales in the Territory of a Product that is greater of (a) *** or (b) *** .
1.9 “ Know-How ” shall mean any and all information (other than that contained in patents and patent applications) owned by a party pertaining to the development, design, manufacture or use of that party’s technology identified herein, including without limitations information consisting of or embodied in documents, drawings, photographs, sketches, designs and formulations, as well as samples, compositions and sources of supply, and other related technical information.
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1.10 “ Net Sales ” shall mean the gross sale price invoiced by Recipient, Recipient’s Affiliates and Sublicensees for the sales of Products to Third Parties in the Territory, on a country by country basis, less deductions actually allowed and consistently applied by using generally accepted accounting principles for: (a) trade and/or quantity discounts and (b) credits or allowances for rejections or returns or allowances given in lieu of allowed returns.
1.11 “ Patent Rights ” shall mean any patents or patent applications and any continuations, continuations-in-part, divisions, provisionals, substitutions, patents of addition, reissues, reexamination, renewals or extensions thereof (including any supplemental patent certificates) and any confirmation patent or registration patent, and all foreign counterparts of any of the foregoing.
1.12 “ Products ” shall mean all transgenic banana plants with delayed senescence and any other improvements thereto produced by modulating the expression of the lipase gene or through the utilization of any other technology related to eIF5A or DHS.
1.13 “ Recipient Patent Rights ” shall mean all Patents Rights owned or Controlled by Recipient set forth on Schedule B .
1.14 “ Sublicensee ” shall mean a person, other than a Recipient Affiliate, to whom Recipient has sublicensed any of its rights pursuant to Section 2.2.
1.15 “ Territory ” shall mean all the countries and territories of the world.
1.16 “ Third Party ” shall mean a person or entity other than a party hereto, its Affiliates, or, in the case of Recipient, any Sublicensee.
2. LICENSE GRANT.
2.1 Grant to Recipient . Subject to the terms and conditions of this Agreement, Company hereby grants to Recipient a worldwide, exclusive right and license, with the right to sublicense, under the Company Intellectual Property, to research, develop, make or commercialize the Products in the Territory.
2.2 Sublicenses . All sublicenses of the rights granted to Recipient under this Section 2 shall be pursuant to written agreements. Each such agreement with a Sublicensee shall include a limitation to prevent the Sublicensee from manipulating the Company Intellectual Property without the consent of Company, such consent not to be unreasonably withheld.
2.3 No Further Rights. Except as expressly provided in this Section 2, no other license or right in, to or under the Company Intellectual Property or any other intellectual property, Know-How or proprietary rights of Company is granted or implied under this Agreement. Upon execution of this Agreement, the Joint Venture Agreement shall terminate; provided , that, pursuant to Section 20.13 of the Joint Venture Agreement, those relevant provisions of the Joint Venture Agreement shall survive.
2.4 Limitation on Use of Company Intellectual Property. Recipient shall store, handle and use the Company Intellectual Property in accordance with all applicable laws, rules and regulations and shall not use the Company Intellectual Property for any purpose other than that described in this Agreement.
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2.5 Limitation for Jointly Held Patents. To extent any of the Company Intellectual Property are jointly owned with Third Parties, the license granted hereunder with respect to such jointly owned Company Intellectual Property is limited to exclude any grant of rights that would require the consent of such Third Party (which has not already been obtained as of the Effective Date) or obligate Company to make payments to or share proceeds with such Third Party.
3. DEVELOPMENT AND COMMERCIALIZATION.
3.1 Development and Commercialization of Product . Recipient shall be solely responsible for developing and commercializing the Products and shall use reasonable commercial efforts to do so. Except for the one-time payment set forth in Section 4.1, Recipient shall bear all costs and expenses associated with development and commercialization of the Products. Recipient shall achieve the development, commercialization and sales milestones set out in Schedule C .
3.2 Development and Commercialization of Plan . Recipient shall conduct the development and commercialization of each Product pursuant to an annual development and commercialization plan (“ Plan ”) that is developed using in good faith. During the Term of this Agreement, Recipient shall deliver the Plan to the Company on an annual basis by November 1st each year. The Plan shall set forth the expected development and commercialization activities to be performed by Recipient in the upcoming year.
4. PAYMENTS.
4.1 Development and Commercialization Fee . Upon signing of this Agreement, the Company will pay Recipient *** to reimburse Recipient for the Company’s share of the cost to develop and commercialize the Product.
4.2 Royalties .
(a) Recipient will pay royalties to Company at the annual rate of *** of aggregate Incremental Net Sales of Products in the Territory (“ Royalties ”).
(b) For purposes of the foregoing calculation, sales of Products between or among Recipient, its Affiliates and Sublicensees shall be disregarded if such Products are intended for resale to a Third Party. In addition, If Recipient, its sublicensees or their respective Affiliates sells a Product to a Third Party who also purchases other products or services from Recipient, its sublicensees or their respective Affiliates, and Recipient, its sublicensees or their respective Affiliates discounts the purchase price of such Product to a greater degree than it generally discounts the price of its other products or services to such customer, then in such case the Incremental Net Sales for the sale of such Product to such Third Party shall equal the arm’s length price that Third Parties would generally pay for the Product alone when not purchasing any other product or service from Recipient, its sublicensee or their respective Affiliates. For purposes of this provision, “discounting” includes establishing a price for a Product at a discount of five percent (5%) or more from the average sales price.
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(c) If there is a Change in Hand of Recipient, the Company may choose to receive, in its sole discretion, either:
(i) a *** royalty on aggregate Incremental Net Sales of Products in the Territory up to *** in royalties, and thereafter, *** of aggregate Incremental Net Sales of Products in the Territory; or
(ii) Upon commencement of marketing, *** and a *** royalty on aggregate Incremental Net Sales of Products in the Territory up to *** in royalties, and thereafter, *** of aggregate Incremental Net Sales of Products in the Territory.
4.3 Term for Royalty Payments . Royalties shall be payable on a country-by-country basis from the First Commercial Sale (as defined below) and for the longer of (i) ten (10) years thereafter or (ii) if the Company Intellectual Property used to produce the relevant Product is covered by any Company Patent Rights issued in such country as of the date of the First Commercial Sale, Royalties shall be payable in such country until the expiration or invalidation of the last to expire, or be invalidated, of such Company Patent Rights (collectively, the “ Royalty Term ”). For purposes of this Section 4.3, “ First Commercial Sale ” shall mean the first shipment of a Product by Recipient, a Recipient Affiliate or a Sublicensee to an end user in a country in the Territory following applicable regulatory approval by the appropriate governmental entity or entities necessary for commercial sale of such Product in such country.
4.4 Reports and Records .
(a) Reports . After the commencement of the Royalty Term, Recipient shall furnish or cause to be furnished to Company on a quarterly basis within sixty (60) days after the end of each calendar quarter during the term of this Agreement, a written report showing the Net Sales of Products in each country in the Territory. The payment of royalty amounts shall be made concurrently with such reports.
(b) Records and Audits .
(i) Recipient shall keep, and shall require its Affiliates and Sublicensees to keep, complete and accurate records of their sales of Products in sufficient detail to allow the accruing Royalties to be determined accurately, and to maintain such records for a minimum of three (3) years following the end of the quarter during which such sales occurred.
(ii) Company shall have the right for a period of one (1) year after receiving any report or statement from Recipient with respect to Royalties due and payable, to appoint an independent certified public accountant reasonably acceptable to Recipient to inspect the relevant records of Recipient (and, to the extent applicable, its Affiliates and Sublicensees) to verify such report or statement.
(iii) Recipient shall make such records available for inspection by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Company, solely to verify the accuracy of the reports and payments. Such inspection right shall not be exercised more than once in any calendar year.
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(iv) Company agrees to hold in strict confidence all information concerning royalty payments and reports, and all information learned in the course of any audit or inspection (and not to make copies of such reports and information), except to the extent necessary for Company to reveal such information in order to enforce its rights under this Agreement or if disclosure is required by law, regulation or judicial order. The results of each inspection, if any, shall be binding on both parties.
(v) Company shall pay for such inspections, except that in the event there is any upward adjustment in aggregate Royalties payable for any year shown by such inspection of more than fifteen percent (15%) of the amount paid, Recipient shall pay for such inspection.
4.5 Tax Withholding . The withholding tax, duties, and other levies (if any) applied by a government of any country of the Territory on payments made by Recipient to Company hereunder shall be borne by Company. Recipient, its Affiliates and Sublicensees shall cooperate with Company to enable Company to claim exemption therefrom under any double taxation or similar agreement in force and shall provide to Company proper evidence of payments of withholding tax and assist Company by obtaining or providing in as far as possible the required documentation for the purpose of Company’s tax returns.
4.6 Currency Exchange . With respect to Net Sales invoiced in U.S. dollars, the Net Sales and the amounts due to Company hereunder shall be expressed in U.S. dollars. With respect to Net Sales invoiced in a currency other than U.S. dollars, the Net Sales shall be expressed in the domestic currency of the entity making the sale, together with the Dollar equivalent, calculated using the arithmetic average of the spot rates on the last business day of each month of the calendar quarter in which the Net Sales were made (or, in the case of Sublicensees, such other method(s) as such Sublicensees customarily use for such purposes). The “closing mid-point rates” found in the “dollar spot forward against the dollar” table published by The Financial Times or any other publication as agreed to by the parties shall be used as the source of spot rates to calculate the average as defined in the preceding sentence. All payments shall be made in U.S. dollars. If at any time legal restrictions in any country in the Territory prevent the prompt remittance of any payments with respect to sales in that country, Recipient shall have the right and option to make such payments by depositing the amount thereof in local currency to Company’s account in a bank or depository in such country.
4.7 Interest on Late Payments. All amounts owed hereunder which are not paid when due shall bear interest at the rate of eight percent (8%) per year or the maximum rate allowed by applicable law, whichever is less.
5. INTELLECTUAL PROPERTY.
5.1 Inventions .
(a) Ownership . Any and all inventions or improvements to the Company Intellectual Property, whether or not patentable, derived from or directly resulting from Recipient’s use of the Company Intellectual Property pursuant to this Agreement shall be disclosed to Company. The parties agree that:
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(i) ownership of any and all inventions or improvements to the extent primarily related to Recipient Patent Rights shall be solely owned by Recipient;
(ii) ownership any and all inventions or improvements to the Company Intellectual Property conceived and reduced to practice by Recipient during the term of this Agreement (each, an “ Invention ”) shall be jointly owned by the parties; and
(iii) any and all other inventions or improvements created solely by the Company during the Term of this Agreement shall be solely owned by the Company.
(b) Disposition of Inventions . If the Company is deemed the owner or Recipient is deemed a joint owner (with Company) of a patentable invention or improvement, then Recipient shall assign, and herby does assign, the ownership of such patentable invention or improvement to the Company. If the Recipient is deemed a joint owner (with the Company) of an Invention, the Company shall grant Recipient an exclusive, worldwide, license under such Invention to develop, use, make, have made, market, offer to sell, sell, have sold and import or export banana and plantain plant species. Each party shall execute such instruments and other documents, and shall perform such additional acts, as may be necessary or reasonably requested by the other party in order to formalize the disposition of any and all inventions or improvements set forth herein.
5.2 Prosecution and Maintenance of Patents .
(a) Patent Filing and Prosecution of Company Patent Rights . Company agrees to use commercially reasonable efforts, at its sole cost and expense, to file, prosecute and maintain patent applications and patents covering the Company Patent Rights including, without limitation, their compositions of matter, methods of production and uses, in all major market countries. For the purposes of this Section 5.2, prosecution of patent applications shall mean through final patent office appeal and any interference proceedings or the like, including, without limitation, re-issue applications and re-examination proceedings. For the purposes of this Section 5.2, Maintenance of patents includes, without limitation, paying annuities/maintenance fees, fully responding to any correspondence sent from a country’s intellectual property office, and completing any examination or other proceedings, if applicable. Subject to Section 5.1 above, all such patent applications and patents shall be deemed Company Patent Rights for purposes of this Agreement.
(b) Patent Filing and Prosecution of Recipient and Joint Patent Rights . If Recipient is deemed an owner or a joint owner (with Company) of an Invention, then Recipient agrees to use commercially reasonable efforts, at its sole cost and expense, to file, prosecute and maintain patent applications and patents covering the such Patent Rights including, without limitation, their compositions of matter, methods of production and uses, in all major market countries. If any cost or expense pursuant to this Section is paid for by the Company, the Recipient shall reimburse the Company for such cost or expense within thirty (30) days of receipt of an invoice by the Company. Section 4.7 shall apply to any late payments under this Section.
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(c) Cooperation . The party filing, prosecuting or maintaining a patent (the “ Filing Party ”) will consult with the other party (the “ Non-Filing Party ”) and will keep such party continuously informed of all matters relating to the preparation, filing, prosecution and maintenance of Patent Rights, including, but not limited to, disclosing to the Non-Filing Party the complete text of all patent applications. In addition, the Filing Party will provide the Non-Filing Party with copies of all material correspondence with the applicable patent office in such a manner to allow the Non-Filing Party a meaningful opportunity to comment.
(d) Discontinuance . If the Filing Party does not wish to continue prosecution or maintenance of a patent application or patent, then it shall give at least thirty (30) days advance notice, and in no event less than a reasonable period of time, for the Non-Filing Party to act in its stead. Discontinuance may be elected on a country-by-country basis or for a patent application or patent series in total. The Non-Filing Party may elect at its sole discretion to continue prosecution or maintenance of any discontinued Patent Rights at its sole expense. The Non-Filing Party shall then own any such Patent Rights, and the Filing Party shall execute such documents and perform such acts as may be reasonably necessary for the Non-Filing Party to continue prosecution or maintenance, including assigning ownership of such Patent Rights to the Non-Filing Party.
5.3 Infringement Claims by Third Parties . If the actual or planned manufacture, use or sale of Products under Company Intellectual Property results in a claim or a threatened claim by a third party against a party hereto for patent infringement or for inducing or contributing to patent infringement (“ Infringement Claim ”), the party first having notice of an Infringement Claim shall promptly notify the other in writing. The notice shall set forth the facts of the Infringement Claim in reasonable detail.
5.4 Infringement Claims Against Third Parties
(a) Notice . If any Company Patent Rights are infringed by a third party, the party to this Agreement first having knowledge of such infringement, or knowledge of a reasonable probability of such infringement, shall promptly notify the other in writing. The notice shall set forth the facts of such infringement in reasonable detail.
(b) Institution of Proceedings . Company shall take reasonable actions to protect Company Patent Rights from infringement. Company shall use reasonable efforts to institute, prosecute and control, with its own counsel and at its own expense any action or proceeding with respect to infringement of the claims of such Company Patent Rights, and Recipient shall have the right, but not the obligation, at its own expense, to be represented in such action by its own counsel.
(c) Failure to Institute Proceedings . If Company fails to institute, prosecute, and control such action or prosecution and fails to do so within a period of one hundred twenty (120) days after receiving notice of the infringement, Recipient shall have the right to bring and control any such action by counsel of its own choice and at its expense, and Company shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. If Recipient brings any such action or proceeding, Company may be joined as a party plaintiff if necessary for the action or proceeding to proceed and, in case of joining, Company agrees to give Recipient reasonable assistance and authority to file and to prosecute such suit.
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(d) Division of Damages Award . Each party shall recover their respective actual out-of-pocket expenses, or equitable proportions thereof, associated with any litigation or settlement thereof from any recovery made by any party. Any excess amount shall be provided to the party instituting such action.
(e) Settlement . The parties shall keep each other informed of the status of and of their respective activities regarding any litigation or settlement thereof concerning Company Patent Rights; provided , however , that no settlement or consent judgment or other voluntary final disposition of a suit under this Section 5.4 may be undertaken without the consent of the other party, if such settlement would require the other party to be subject to an injunction, to make a monetary payment or would otherwise adversely affect the other party’s rights under this Agreement.
6. REPRESENTATIONS AND WARRANTIES.
6.1 Company Representations and Warranties . Company represents and warrants to Recipient as follows:
(a) This Agreement has been duly executed and delivered by Company and constitutes the valid and binding obligation of Company, enforceable against Company in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of Company, its officers and directors.
(b) As of the Effective Date, Company owns or Controls the rights necessary to grant the license herein, and the granting of the license to Recipient hereunder does not violate any right (known to Company) of any Third Party.
(c) The execution, delivery and performance of this Agreement by Company does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, and, to the best of its knowledge, does not violate any material law or regulation of any court, governmental body or administrative or other agency having authority over it.
(d) Company is not currently a party to, and during the term of this Agreement will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement.
(e) Company is not subject to any order, decree or injunction by a court of competent jurisdiction which prevents or materially delays the consummation of the transactions contemplated by this Agreement.
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6.2 Recipient Representations and Warranties . Recipient represents and warrants to Company as follows:
(a) This Agreement has been duly executed and delivered by Recipient and constitutes the valid and binding obligation of Recipient, enforceable against Recipient in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of Recipient, its officers and directors.
(b) The execution, delivery and performance of this Agreement by Recipient does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, and, to the best of its knowledge, does not violate any material law or regulation of any court, governmental body or administrative or other agency having authority over it.
(c) Recipient is not currently a party to, and during the term of this Agreement will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement.
(d) Recipient is not subject to any order, decree or injunction by a court of competent jurisdiction which prevents or materially delays the consummation of the transactions contemplated by this Agreement.
(e) Recipient is not aware of any material information indicating that the development, marketing and commercialization of a Product is not feasible within a reasonable time from the Effective Date. In addition, Recipient is not aware of any plans not to continue the research, development and commercialization contemplated by this Agreement.
6.3 Disclaimer of Warranties. EXCEPT FOR THE WARRANTIES EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES, AND EACH PARTY EXPRESSLY DISCLAIMS, ANY OTHER REPRESENTATIONS OR WARRANTIES TO THE OTHER PARTY WITH RESPECT TO THE COMPANY INTELLECTUAL PROPERTY, COMPANY PATENT RIGHTS OR OTHERWISE UNDER THIS AGREEMENT, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT.
7. CONFIDENTIALITY.
7.1 Confidentiality . During the term of this Agreement, and for a period of five (5) years thereafter, each party hereto will maintain in confidence all information disclosed by the other party hereto (“ Confidential Information ”). Neither party shall use, disclose or grant use of such Confidential Information except as permitted under this Agreement. Each party shall use commercially reasonable efforts to ensure that its and its Affiliates’ officers, directors, employees, agents and consultants only make use of Confidential Information for the purpose of this Agreement and do not disclose or make any unauthorized use of such Confidential Information. Each party shall promptly notify the other upon discovery of any unauthorized use or disclosure of Confidential Information. Confidential Information shall not include any information which and to the extent:
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(a) was already known to the receiving party, other than under an obligation of confidentiality, at the time of disclosure by the other party;
(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the other party;
(c) becomes generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving party in breach of this Agreement;
(d) was disclosed to the receiving party, other than under an obligation of confidentiality, by a third party who had no obligation to the other party not to disclose such information; or
(e) was independently developed by the receiving party without reference to the disclosure by the other party.
7.2 Recipient and Company shall keep the financial terms and specific provisions of this Agreement confidential. However, either party may provide a copy of this Agreement to third parties, subject to an appropriate confidentiality agreement, in connection with capital raising, financing or other due diligence activities. Furthermore, Recipient and Company acknowledge that either party may be obligated to disclose the terms of this Agreement and make the complete text of this Agreement publicly available in the event a registration statement with respect to the sale of shares of capital stock is filed, or if the company otherwise becomes a public company; in such event, the financial terms of this Agreement shall be redacted in the copy that is made public to the maximum extent that counsel advises is permissible.
7.3 Each party may disclose Confidential Information to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, or complying with any applicable statute or governmental regulation, provided such party has given the disclosing party prompt written notice allowing it to limit such disclosure. In addition, either party may disclose Confidential Information to its Affiliates and to its Sublicensees; provided , however , in connection with any such disclosure the disclosing party shall secure confidential treatment of such Confidential Information.
7.4 Publication. No party may publish confidential or proprietary information of the other party without the consent of the other party. The reviewing party shall have thirty (30) days from receipt of the proposed oral disclosure or written publication to provide comments and/or proposed changes to the disclosing party. The review period may be extended for an additional sixty (60) days to permit the reviewing party to file one or more patent applications as it deems appropriate. This Section 7.4 shall be inapplicable to the publication of information presented in substantially the same form as was previously published or disclosed to the public, and to any other disclosures which, on the advice of counsel, are required by law to be disclosed.
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7.5 Equitable Relief. The receiving party agrees that, due to the unique nature of the Confidential Information, the unauthorized disclosure or use of the Confidential Information of the disclosing party will cause irreparable harm and significant injury to the disclosing party, the extent of which will be difficult to ascertain and for where there will be no adequate remedy at law. Accordingly, the receiving party agrees that the disclosing party, in addition to any other available remedies, shall have the right to seek an immediate injunction and other equitable relief enjoining any breach or threatened breach of the Agreement without the necessity of posting any bond or other security. The receiving party shall notify the disclosing party in writing immediately upon the receiving party’s becoming aware of any such breach or threatened breach.
8. TERM AND TERMINATION.
8.1 Term . Unless earlier terminated as provided herein, the term of this Agreement shall commence as of the Effective Date and shall remain in full force and effect until the end of the Royalty Term (“ Term ”).
8.2 Termination for Insolvency . The Company may terminate this Agreement immediately upon delivery of written notice to Recipient (a) upon the institution by or against Recipient of insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of the other party’s debts; provided , however , with respect to involuntary proceedings, that such proceedings are not dismissed within sixty (60) days; (b) upon Recipient making an assignment for the benefit of creditors; or (c) upon Recipient’s dissolution or ceasing to do business.
8.3 Material Breach . Either party may terminate this Agreement upon sixty (60) days (thirty (30) days in the event of non-payment) prior written notice to the other party upon the material breach by the other party of any of its obligations under this Agreement; provided , however , that such termination shall become effective only if the other party shall fail to remedy or cure the breach within such sixty (60) day period (thirty (30) day period for non-payment).
8.4 Failure to Achieve Milestones . The Company may terminate this Agreement upon thirty (30) days notice if Recipient has failed to achieve a milestone pursuant to Section 3.1 or the Plan pursuant to Section 3.2.
8.5 Effect of Termination .
(a) Effect on License . Upon the expiration or earlier termination of this Agreement, the rights licensed under this Agreement shall be treated as follows:
(i) Upon the expiration of the term of this Agreement following the end of the Royalty Term, Recipient shall have a fully paid-up, perpetual, irrevocable, royalty-free, transferable, worldwide, non-exclusive right and license under the Company Intellectual Property, existing as of the date of such expiration, to develop, use, make, have made, market, offer to sell, sell, have sold and import or export for sale Products.
(ii) Upon termination by Company pursuant to Section 8.2, 8.3, 8.4 or any other provision under this Agreement that provides for termination prior to expiration, the license rights granted to Recipient pursuant to Section 2 shall terminate.
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(b) Ongoing Obligations .
(i) Except where explicitly provided elsewhere herein, expiration or termination of this Agreement for any reason will not affect: (1) obligations, including without limitation the payment of any Royalties or other sums which have accrued as of the date of termination or expiration, and (2) rights and obligations which, from the context thereof, are intended to survive termination or expiration of this Agreement.
(ii) Upon expiration or termination of this Agreement for any reason, each party shall immediately return to the other party, or destroy, any Confidential Information disclosed by the other party, except for one copy which may be retained by its legal counsel in its confidential files.
8.6 Inventory . Notwithstanding the foregoing, upon early termination of this Agreement pursuant to Section 8.2, 8.3 or 8.4, Recipient shall have the right to sell all remaining Products in its inventory within twelve (12) months after the date of termination, subject to the payment to Company of the amounts specified in Section 4. Thereafter, Recipient agrees to destroy any remaining supply of Products at Company’s request and direction.
9. INDEMNIFICATION.
9.1 Indemnification by Company . Company will indemnify and hold Recipient, its Affiliates and Sublicensees, and their employees, officers and directors harmless against any loss, damages, action, suit, claim, demand, liability, expense, bodily injury, death or property damage (a “ Loss ”), that may be brought, instituted or arise against or be incurred by such persons to the extent such Loss is based on or arises out of:
(a) claims that any Company Patent Rights or the use of any Company Patent Rights infringes the proprietary position of a third party; or
(b) the breach by Company of any of its covenants, representations or warranties set forth in this Agreement;
(c) provided , however , that the foregoing indemnification shall not apply to any Loss to the extent such Loss is caused by the gross negligence or willful misconduct of Recipient, its Affiliates or Sublicensees.
9.2 Indemnification by Recipient . Recipient will indemnify and hold Company and its Affiliates, and their employees, officers and directors harmless against any Loss that may be brought, instituted or arise against or be incurred by such persons to the extent such Loss is based on or arises out of:
(a) the development, commercialization, manufacture, use, sale, marketing, storage or handling of a Product (other than claims arising under Section 9.1(a)) by Recipient or its Affiliates or their Sublicensees, representatives, agents or subcontractors under this Agreement, or any actual or alleged violation of law resulting therefrom; or
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(b) the breach by Recipient of any of its covenants, representations or warranties set forth in this Agreement;
(c) provided , however , that the foregoing indemnification shall not apply to any Loss to the extent such Loss is caused by the gross negligence or willful misconduct of Company or its Affiliates.
9.3 Indemnification Claims . To the extent that the provisions of Section 5 may conflict with the provisions of this Section 9.3 the provisions of Section 5 shall govern those aspects of the claims pertaining to intellectual property. Each party shall give the other party prompt notice of any claim for which indemnification under this Section 9 is or may be applicable and will cooperate with the indemnifying party in the defense or settlement of such claim at the indemnifying party’s expense. The indemnifying party shall be required to provide at its sole expense, and be entitled to control, the defense of any claim covered hereunder with counsel reasonably satisfactory to the other party, which may, at its own expense, participate in the defense of any claim after the indemnifying party assumes control of the defense thereof. The indemnification obligations in this Section 9 shall not apply to amounts paid in settlement of such claim if such settlement is effected without the consent of the indemnifying party, which consent shall not be unreasonably withheld or delayed. The indemnifying party shall have the right to settle any claim covered hereunder at its sole discretion, provided , however , that the indemnified party’s consent to such settlement is required if such settlement would require the indemnified party to be subject to an injunction or to make a monetary payment or would otherwise adversely affect the indemnified party’s rights under this Agreement. The failure of the indemnified party to deliver notice to the indemnifying party promptly after the commencement of any such action, if and to the extent prejudicial to the indemnifying party’s ability to defend such action, shall relieve the indemnifying party of any liability to the indemnified party under this Section 9, but the failure to promptly deliver notice to the indemnifying party will not relieve it of any liability that it may have to the indemnified party other than under this Section 9.
9.4 Limitation of Liability . EXCEPT WITH RESPECT TO A BREACH OF SECTION 7 (“CONFIDENTIALITY”) OR SECTION 9 (“INDEMNIFICATION”), IN NO EVENT SHALL EITHER PARTY HERETO BE LIABLE TO THE OTHER FOR LOST PROFITS OR ANY CONSEQUENTIAL, SPECIAL, INCIDENTAL OR INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE OR STRICT LIABILITY), ARISING OUT OF THIS AGREEMENT. EACH PARTY AGREES THAT THESE LIMITATIONS SHALL APPLY EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
9.5 Compliance . The parties shall comply fully with all applicable laws and regulations in connection with their respective activities under this Agreement.
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9.6 Insurance. Prior to the first clinical trials of any Product, Recipient shall, or if such Product is being commercialized by an Affiliate or a Sublicensee, such Affiliate or Sublicensee shall, at its sole expense, procure and maintain commercial general liability insurance, including product liability and errors and omissions insurance, in such amounts and having such limits and terms as are consistent with sound business practices of other companies in the industry having comparable products. Recipient shall furnish Company with certificates of insurance evidencing compliance with the requirements of this Section, when requested. Recipient will require its Affiliates and Sublicensees to comply with this Section to the same extent that it applies to Recipient. The requirements of this Section shall survive termination or expiration of this Agreement.
10. MISCELLANEOUS.
10.1 Dispute Resolution . Any dispute arising out of or relating to this Agreement will be referred to the President of the Company and the President of Recipient for resolution. If the President of the Company and the President of Recipient are unable to resolve such dispute within thirty (30) days of such dispute being referred to such individuals, then, except as set forth in Section 10.3, upon the written request of either party to the other party, the dispute shall be subject to arbitration, as provided in Section 10.2.
10.2 Arbitration .
(a) Claims . Subject to Section 10.3 below, any claim, dispute, or controversy of whatever nature arising out of or relating to this Agreement that is not resolved pursuant to Section 10.1, including, without limitation, any action or claim based on tort, contract or statute, or concerning the interpretation, effect, termination, validity, performance and/or breach of this Agreement, shall be resolved by final and binding arbitration before a neutral expert with relevant industry experience. The arbitration proceeding shall be administered by the International Chamber of Commerce (the “ ICC ”) in accordance with its then existing arbitration rules or procedures regarding commercial or business disputes, and the arbitrator shall be selected in accordance with such rules. Arbitration shall take place in London, England. The parties agree that they are bound to the arbitration award. Except to the extent necessary to confirm an award or as may be required by law, neither a party nor an arbitrator may disclose the existence, content or results of arbitration without the prior written consent of both parties.
(b) Arbitrators’ Award . The arbitrators shall, within fifteen (15) days after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The decision or award rendered by the arbitrators shall be final and non appealable, and judgment may be entered upon it in any court of competent jurisdiction. Either party may apply for interim injunctive relief with the arbitrators until the arbitration award is rendered or the controversy is otherwise resolved. The arbitrators shall be authorized to award compensatory damages, but shall NOT be authorized (i) to award non-economic damages, (ii) to award punitive damages or (iii) to reform, modify or materially change this Agreement or any other agreements contemplated hereunder; provided , however , that the damage limitations described in parts (i) and (ii) of this sentence will not apply if such damages are statutorily imposed.
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(c) Costs . Each party shall bear its own attorneys’ fees, costs and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators; provided , however , the arbitrators shall be authorized to determine whether a party is the prevailing party, and at their discretion, to award to that prevailing party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs of the ICC and the arbitrators.
10.3 Court Actions . Nothing contained in this Agreement shall deny either party the right to seek, upon good cause, injunctive or other equitable relief from a court of competent jurisdiction in the context of an emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any ongoing dispute resolution discussions or arbitration proceedings. In addition, either party may bring an action in any court of competent jurisdiction to resolve disputes pertaining to the validity, construction, scope, enforceability, infringement or other violations of intellectual property rights, except for disputes concerning the ownership of intellectual property, and no such matter shall be subject to arbitration pursuant to Section 10.2.
10.4 Governing Law; Jurisdiction . This Agreement shall be construed and the respective rights of the parties determined according to the substantive laws of England and Wales, without regard to provisions governing conflicts of law, except matters of intellectual property law which shall be determined in accordance with the intellectual property laws relevant to the intellectual property in question. The parties consent to personal jurisdiction and agree to venue in the courts of England and Wales for purposes of any dispute filed in court.
10.5 Waiver . The failure on the part of Recipient or Company to exercise or enforce any rights conferred upon it hereunder shall not be deemed to be a waiver of any such rights nor operate to bar the exercise or enforcement thereof at any time or times thereafter. The observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) by the party entitled to enforce such term, but any such waiver shall be effective only if in writing signed by the party against whom such waiver is to be asserted.
10.6 Force Majeure . Neither party shall be held liable or responsible to the other party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from fire, floods, embargoes, government regulations, prohibitions or interventions, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts, acts of God, or any other cause beyond the reasonable control of the affected party.
10.7 Severability . Each party hereby agrees that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association of countries. Should one or more provisions of this Agreement be or become invalid, the parties hereto shall substitute, by mutual consent, valid provisions for such invalid provisions which valid provisions in their economic effect are sufficiently similar to the invalid provisions that it can be reasonably assumed that the parties would have entered into this Agreement with such valid provisions. In case such valid provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the parties would not have entered into this Agreement without the invalid provisions.
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10.8 Assignment . This Agreement may not be assigned or otherwise transferred by either party without the prior written consent of the other party; provided , however , that either party may assign this Agreement, without the consent of the other party, (i) to any of its Affiliates, if the assigning party guarantees the full performance of its Affiliates’ obligations hereunder, or (ii) in connection with the transfer or sale of all or substantially all of its assets or business or in the event of its merger or consolidation with another company. In all cases the assigning party shall provide the other party with prompt notice of any such assignment. Any purported assignment in contravention of this Section shall, at the option of the nonassigning party, be null and void and of no effect. No assignment shall release either party from responsibility for the performance of any accrued obligation of such party hereunder.
10.9 No Agency . Nothing herein contained shall be deemed to create an agency, joint venture, amalgamation, partnership or similar relationship between Company and Recipient. Notwithstanding any of the provisions of this Agreement, neither party shall at any time enter into, incur or hold itself out to third parties as having authority to enter into or incur, on behalf of the other party, any commitment, expense or liability whatsoever, and all contracts, expenses and liabilities undertaken or incurred by one party in connection with or relating to the development, manufacture or sale of Products shall be undertaken, incurred or paid exclusively by that party, and not as an agent or representative of the other party.
10.10 Notice . Any formal notices, requests, deliveries, approvals or consents required or permitted to be given under this Agreement between the parties shall be in writing and shall be deemed to have been sufficiently given when it is received, whether delivered in person, transmitted by facsimile or electronic mail with contemporaneous confirmation, delivered by certified mail (or its equivalent) or delivered by overnight courier service (receipt required) to the party to which it is directed at its address shown below or such other address as such party shall have last given by notice to the other party.
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If to Company, at: | with a copy to: |
Senesco, Inc. | Emilio Ragosa, Esq. |
721 Route 202/206, Suite 130 | Morgan, Lewis & Bockius LLP |
Bridgewater, NJ 08807 | 502 Carnegie Center |
Fax: 908.864.4440 | Princeton, NJ 08540 |
Attn: Leslie J. Browne, Ph. D., President & CEO | Fax: 609.919.6701 |
Email: lbrowne@senesco.com | Email: eragosa@morganlewis.com |
If to Recipient, at: | with a copy to: |
Rahan Meristem (1998) Ltd. | Rahan Meristem (1998) Ltd. |
Kibbutz Rosh Hanikra | Kibbutz Rosh Hanikra |
Western Galilee, 22825 Israel | Western Galilee, 22825 Israel |
Fax: 972.4.982.4333 | Fax: 972.4.982.4333 |
Attn: Eli Khayat | Attn: Maya Levy |
Email: ekhayat@rahan.co.il | Email: maya@rahan.co.il |
10.11 Headings . The paragraph headings are for convenience only and will not be deemed to affect in any way the language of the provisions to which they refer.
10.12 Entire Agreement . This Agreement and the schedules and exhibits attached hereto contain the entire understanding of the parties relating to the matters referred to herein, and may only be amended by a written document, duly executed on behalf of the respective parties.
10.13 Counterparts . This Agreement may be executed in duplicate, both of which shall be deemed to be originals, and both of which shall constitute one and the same Agreement.
[Signature Page Follows]
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IN WITNESS WHEREOF , the parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the day and year first above written.
SENESCO, INC. | ||
By: | /s/ Leslie J. Browne | |
Name: Leslie J. Browne, Ph.D. | ||
Title: President and Chief Executive Officer | ||
SENESCO TECHNOLOGIES, INC. | ||
By: | /s/ Leslie J. Browne | |
Name: Leslie J. Browne, Ph.D. | ||
Title: President and Chief Executive Officer | ||
RAHAN MERISTEM (1998) LTD. | ||
By: | /s/ Onn Barzilay | |
Name: Dr. Onn Barzilay | ||
Title: Chief Executive Officer |
- 19 - |
SCHEDULE A
Company Patent Right
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- 2 - |
SCHEDULE B
Recipient Patent Rights
***
SCHEDULE C
Development, Commercialization and Sales Milestones
Schedule C outlines the plan to product validation and approval. The duration of this phase will be *** to *** . A Commercialization Plan will be developed and added before final product approval.
1. The process
i. | Constructs preparation: *** | |
ii. | Agrobacterium transformation and embryo generation: *** | |
iii. | Embryo germination and plant regeneration: *** | |
iv. | Hardening *** | |
v. | Nursery stage *** |
2. Transformation lines
All the transformations that were performed from March 2011 are in stable lines that have been pre-tested in the field for stability.
3. Promoters
The constructs contain one of the following promoters:
i. | Banana Osmotin | |
ii. | Maize PPDK | |
iii. | Banana Elicited I | |
iv. | Banana Elicited II | |
v. | 35S, from Cauliflower Mosaic Virus |
4. Field trials with approximate duration to achieve product validation.
i. | Field growth until plants are ready for resistance analysis. (indexing) *** . | |
ii. | Final validation *** after the first fruit set |
5. New Product Application Patents will be filed as soon as we see proof of concept prior to regulation. Plant patents in the US are normally granted *** after application.
6. Preparation and submission of documents to regulatory agency, ***
7. Deregulation: will start soon after proof of resistance, estimated duration *** after validation.
8. Commercialization: Transgenic lines will be propagated ( *** ) and subsequently commercialized, soon after approval of the FDA, EPA and USDA in the US and/or the regulatory agencies in Europe.
- 2 - |
CERTIFICATION PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Leslie J. Browne, Ph.D., certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q of Senesco Technologies, 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 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): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: February 14, 2012 | /s/ Leslie J. Browne |
Leslie J. Browne, Ph.D. | |
President and Chief Executive Officer | |
(principal executive officer) |
CERTIFICATION PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Joel Brooks, certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q of Senesco Technologies, 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 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): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: February 14, 2012 | /s/ Joel Brooks |
Joel Brooks | |
Chief Financial Officer, Secretary and | |
Treasurer | |
(principal financial and accounting officer) |
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Senesco Technologies, Inc. for the period ended December 31, 2011 as filed with the Securities and Exchange Commission on the date hereof, the undersigned, Leslie J. Browne, Ph.D. , President and Chief Executive Officer, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:
(1) The Quarterly Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of Senesco Technologies, Inc.
Dated: February 14, 2012 | /s/ Leslie J. Browne * |
Leslie J. Browne, Ph.D. | |
President and Chief Executive Officer | |
(principal executive officer) |
* A signed original of this written statement required by Section 906 has been provided to us and will be retained by us and furnished to the Securities and Exchange Commission or its staff upon request.
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Senesco Technologies, Inc. for the period ended December 31, 2011 as filed with the Securities and Exchange Commission on the date hereof, the undersigned, Joel Brooks, Chief Financial Officer, Secretary and Treasurer, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:
(1) The Quarterly Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of Senesco Technologies, Inc.
Dated: February 14, 2012 | /s/ Joel Brooks * |
Joel Brooks | |
Chief Financial Officer, Secretary and Treasurer | |
(principal financial and accounting officer) |
* A signed original of this written statement required by Section 906 has been provided to us and will be retained by us and furnished to the Securities and Exchange Commission or its staff upon request.