(Mark One)
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|
þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended: September 30, 2013
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OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Florida
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58-2349413
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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification No.)
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Large accelerated filer
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o |
Accelerated filer
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o |
Non-accelerated filer
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o |
Smaller reporting company
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þ |
(Do not check if a smaller reporting company)
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PART I – FINANCIAL INFORMATION
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|||||
Item 1. | Financial Statements | 3 | |||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 23 | |||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 28 | |||
Item 4. | Controls and Procedures | 28 | |||
PART II – OTHER INFORMATION
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|||||
Item 1. | Legal Proceedings | 29 | |||
Item 1A. | Risk Factors | 29 | |||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 30 | |||
Item 3. | Defaults Upon Senior Securities | 30 | |||
Item 4. | Mine Safety Disclosures | 30 | |||
Item 5. | Other Information | 30 | |||
Item 6. | Exhibits | 30 |
September 30,
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December 31,
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|||||||
2013
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2012
|
|||||||
(Unaudited)
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||||||||
Assets
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||||||||
Current Assets
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||||||||
Cash and Cash Equivalents
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$ | 420,157 | $ | 260,357 | ||||
Accounts Receivable, net
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144,539 | 108,866 | ||||||
Due from Employees
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7,808 | 7,808 | ||||||
Inventories
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305,699 | 319,326 | ||||||
Prepaid Expenses
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77,234 | 185,839 | ||||||
Total Current Assets
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955,437 | 882,196 | ||||||
Property and Equipment, net
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1,685,928 | 1,915,179 | ||||||
Intangibles, net
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10,515,025 | 10,329,167 | ||||||
Goodwill
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425,969 | 425,969 | ||||||
Other Assets
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174,640 | 174,640 | ||||||
Total Assets
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$ | 13,756,999 | $ | 13,727,151 | ||||
Liabilities and Stockholders' Equity
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||||||||
Current Liabilities
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||||||||
Accounts Payable
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$ | 507,049 | $ | 613,141 | ||||
Accrued Expenses
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535,567 | 249,728 | ||||||
Payable for distribution rights
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400,000 | - | ||||||
Deferred Income
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39,000 | 39,000 | ||||||
Deferred Rent Payable
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1,338 | - | ||||||
Derivative Liability
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849,472 | 605,737 | ||||||
Total Current Liabilities
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2,332,426 | 1,507,606 | ||||||
Long-term Liabilities
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||||||||
Deferred Rent Payable
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28,718 | 24,891 | ||||||
Deferred Tax Obligation
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53,000 | 44,000 | ||||||
Total Liabilties
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2,414,144 | 1,576,497 | ||||||
Commitments and Contingencies
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||||||||
Stockholders' Equity
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||||||||
Preferred stock, par value $0.001; 1,000,000 shares authorized, no shares issued and outstanding
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- | - | ||||||
Common stock, par value $0.001 per share; 2,000,000,000 shares authorized; 310,850,165 shares issued and outstanding at
September 30, 2013 and 259,202,434 shares issued and outstanding at December 31, 2012
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310,850 | 259,204 | ||||||
Additional paid-in capital
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40,681,626 | 34,531,847 | ||||||
Shares to Be Issued
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- | - | ||||||
Subscription receivable
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- | (20,000 | ) | |||||
Accumulated deficit
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(29,649,621 | ) | (22,620,397 | ) | ||||
Total Stockholders' Equity
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11,342,855 | 12,150,654 | ||||||
Total Liabilities and Stockholders' Equity
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$ | 13,756,999 | $ | 13,727,151 | ||||
See notes to consolidated financial statements.
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For the Three Months Ended
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For the Nine Months Ended
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|||||||||||||||
September 30,
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September 30,
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|||||||||||||||
2013
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2012
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2013
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2012
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|||||||||||||
Revenue, net
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$ | 437,985 | $ | 373,790 | $ | 1,328,911 | $ | 828,260 | ||||||||
Cost of Sales
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586,719 | 451,076 | 1,544,569 | 1,347,693 | ||||||||||||
Gross Loss
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(148,734 | ) | (77,286 | ) | (215,658 | ) | (519,433 | ) | ||||||||
Operating Expenses
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||||||||||||||||
Selling, General and Administrative, (inclusive of stock based
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||||||||||||||||
compensation of $496,564 and $2,898,132 for the three and
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||||||||||||||||
nine month periods ended September 30, 2013, $278,904 and | ||||||||||||||||
972,453 for the three and nine months ended September 30, 2012 - see Note 8 )
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2,083,426 | 767,614 | 6,494,654 | 2,335,539 | ||||||||||||
Research and Product Development
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33,602 | 30,396 | 63,204 | 193,102 | ||||||||||||
Total Operating Expenses
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2,117,028 | 798,010 | 6,557,858 | 2,528,641 | ||||||||||||
Loss from operations
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(2,265,762 | ) | (875,296 | ) | (6,773,516 | ) | (3,048,074 | ) | ||||||||
Other Income (Expense)
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||||||||||||||||
Interest Expense
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(292 | ) | (1,103 | ) | (3,048 | ) | (2,538 | ) | ||||||||
Other Income
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- | 4,888 | - | 4,888 | ||||||||||||
Interest Income
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31 | 73 | 75 | 660 | ||||||||||||
Change in Value of Warrant Liability
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32,978 | - | (243,735 | ) | - | |||||||||||
Total Other Income (Expense)
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32,717 | 3,858 | (246,708 | ) | 3,010 | |||||||||||
Income Tax Provision
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3,000 | 3,000 | 9,000 | 9,000 | ||||||||||||
Net Loss
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(2,236,045 | ) | (874,438 | ) | (7,029,224 | ) | (3,054,064 | ) | ||||||||
Basic and Fully Diluted Loss per Share
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$ | (0.01 | ) | $ | (0.00 | ) | $ | (0.02 | ) | $ | (0.01 | ) | ||||
Weighted-Average Shares Outstanding -
basic and diluted
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310,850,165 | 237,346,999 | 282,290,443 | 230,247,429 |
Common Stock
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Additional
Paid-in
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Subscription
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Accumulated
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Total Stockholders'
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||||||||||||||||||||
Shares
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Amount
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Capital
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Receivable
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Deficit
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Equity
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|||||||||||||||||||
Balance, December 31, 2012
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259,202,434 | $ | 259,204 | $ | 34,531,847 | $ | (20,000 | ) | $ | (22,620,397 | ) | $ | 12,150,654 | |||||||||||
Issuance of common stock
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||||||||||||||||||||||||
for cash (net of issuance
costs of $186,132)
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42,684,262 | 42,683 | 3,228,610 | - | - | 3,271,293 | ||||||||||||||||||
Issuance of common stock
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||||||||||||||||||||||||
for services
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818,750 | 819 | 56,493 | - | - | 57,312 | ||||||||||||||||||
Issuance of common stock
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||||||||||||||||||||||||
to related party
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||||||||||||||||||||||||
for services, June 2013
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8,144,719 | 8,144 | 561,986 | - | - | 570,130 | ||||||||||||||||||
Receipt of subscription receivable
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- | - | - | 20,000 | - | 20,000 | ||||||||||||||||||
Share based compensation
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- | - | 2,270,690 | - | - | 2,270,690 | ||||||||||||||||||
Fair value of rent provided by
related party
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- | - | 32,000 | - | - | 32,000 | ||||||||||||||||||
Net loss
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- | - | - | - | (7,029,224 | ) | (7,029,224 | ) | ||||||||||||||||
Balance, September 30, 2013
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310,850,165 | $ | 310,850 | $ | 40,681,626 | $ | - | $ | (29,649,621 | ) | $ | 11,342,855 |
For the Nine Months Ended
September 30,
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||||||||
2013
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2012
|
|||||||
Cash Flows From Operating Activities
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||||||||
Net Loss
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$ | (7,029,224 | ) | $ | (3,054,064 | ) | ||
Adjustments to reconcile net loss to net cash
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||||||||
used in operating activities:
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||||||||
Depreciation and Amortization
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492,939 | 484,800 | ||||||
Reserve for Obsolete Inventory
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(4,363 | ) | 24,540 | |||||
Share Based Compensation
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2,270,690 | 687,953 | ||||||
Stock Issued for Services Rendered
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627,442 | 220,000 | ||||||
Stock Issued for Rent
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- | 64,500 | ||||||
Change in Value of Warrant Liability
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243,735 | - | ||||||
Fair Value of Rent Provided by related party
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32,000 | - | ||||||
Deferred Rent
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5,165 | 3,056 | ||||||
Changes in Operating Assets and Liabilities:
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||||||||
Accounts Receivable
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(35,673 | ) | (35,462 | ) | ||||
Inventory
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17,990 | (37,801 | ) | |||||
Deposits and Prepaid Expenses
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108,605 | (5,979 | ) | |||||
Accounts Payable and Accrued Expenses
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179,747 | 283,968 | ||||||
Deferred Tax Liability
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9,000 | 9,000 | ||||||
Deferred Revenue
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- | - | ||||||
Net Cash Used in Operating Activities
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(3,081,947 | ) | (1,355,489 | ) | ||||
Cash Flows from investing activities
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||||||||
Purchase of Distribution Rights
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(50,000 | ) | - | |||||
Proceeds (Purchases)of Property and Equipment
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454 | (84,366 | ) | |||||
Net Cash Used by Investing Activities
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(49,546 | ) | (84,366 | ) | ||||
Cash Flows From Financing Activities
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||||||||
Proceeds From Sale of Common Shares
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3,291,293 | 1,277,025 | ||||||
Net Cash Provided by Financing Activities
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3,291,293 | 1,277,025 | ||||||
Net Increase (Decrease) in Cash and Cash Equivalents
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159,800 | (162,830 | ) | |||||
Cash and Cash Equivalents
- Beginning of year
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260,357 | 260,111 | ||||||
Cash and Cash Equivalents
- End of year
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$ | 420,157 | 97,281 | |||||
Supplemental Disclosure of Cash Flows Information
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||||||||
Cash paid during the period for:
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||||||||
Interest
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$ | 3,048 | $ | 2,538 | ||||
Non-cash investing and financing activities
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||||||||
Common Stock issued to related party for rent
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$ | - | $ | 100,000 | ||||
Acquisition of Distribution Rights:
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||||||||
Cost of Distribution Rights
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$ | 450,000 | $ | - | ||||
Liability Incurred
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(400,000 | ) | - | |||||
Cash Paid
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$ | 50,000 | $ | - |
●
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AquaMed, which was incorporated in Delaware on January 13, 2009. Through AquaMed, the Company develops, manufactures and markets high water content, electron beam cross-linked, aqueous polymerhydrogels (“gels”) used for wound care, medical diagnostics, transdermal drug delivery and cosmetics.
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●
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Alliqua Biomedical, Inc. (“Alliqua Biomedical”), which was incorporated in Delaware on October 27, 2010. Through Alliqua Biomedical, the Company focuses on the development of proprietary products for wound care dressings and a core transdermal delivery technology platform designed to deliver drugs and other beneficial ingredients through the skin. The Company intends to market its own branded lines of prescription and over-the-counter (“OTC”) wound care products, as well as to supply products to developers and distributors of prescription and OTC wound healing products for redistribution to healthcare professionals and retailers through Alliqua Biomedical.
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●
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HepaLifeBiosystems, Inc. (“HepaLife”), which was incorporated in Nevada on April 17, 2007. Through HepaLife, the Company holds a technology called HepaMate™. Since May 2010, the Company has not allocated resources to HepaMate™ other than for the maintenance of patents and intellectual property related to the technology and instead has focused its resources on products being developed by AquaMed and Alliqua Biomedical. The Company continues, however, to explore various options to best realize value from its HepaMate™ technology, including selling it or partnering with another company to further develop it. If the Company is unsuccessful in its efforts to realize value from our HepaMate™ technology, the recorded value of the related intangibles will be subject to significant impairment.
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September 30,
|
||||||||
2013
|
2012
|
|||||||
Stock Options
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168,122,603 | 57,170,000 | ||||||
Warrants
|
88,913,719 | 27,234,000 | ||||||
Non-Vested Restricted Stock Units
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3,095,469 | - | ||||||
Total
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260,131,791 | 84,404,000 |
As of
|
||||||||
September 30,
2013
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December 31,
2012
|
|||||||
Raw materials
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$
|
190,191
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$
|
209,820
|
||||
Work in process
|
24,957
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25,119
|
||||||
Finished goods
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103,838
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102,037
|
||||||
Less: Inventory reserve
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(13,287
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)
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(17,650)
|
|||||
Total
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$
|
305,699
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$
|
319,326
|
Estimated
Useful Lives
|
Cost
|
Accumulated Amortization
|
Net
|
|||||||||||||
In process research and development
|
-
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$
|
8,100,000
|
$
|
-
|
$
|
8,100,000
|
|||||||||
Technology
|
10 years
|
3,000,000
|
(1,400,000
|
)
|
1,600,000
|
|||||||||||
Customer relationships
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12 years
|
600,000
|
(233,333
|
)
|
366,667
|
|||||||||||
Distribution rights and related customer information. (See Note 7.)
|
5.27 years
|
450,000
|
(1,642
|
)
|
448,358
|
|||||||||||
Total
|
$
|
12,150,000
|
$
|
(1,634,975
|
)
|
$
|
10,515,025
|
Calendar Year
|
Minimum Annual Purchase Amount
|
|
2014
|
500,000 Euros
|
|
2015
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1,000,000 Euros
|
|
2016
|
2,500,000 Euros
|
|
2017
|
4,000,000 Euros
|
Five-Year Warrants - $0.097 Exercise Price
|
||||||||||||||||||||
Common
|
Investor
|
Placement Agent
|
||||||||||||||||||
Issuance
|
Gross
|
Issuance
|
Stock
|
Warrants
|
Warrants
|
|||||||||||||||
Date
|
Proceeds
|
Costs
|
(Shares)
|
(Shares)
|
(Shares)
|
|||||||||||||||
2/22/2013
|
$ | 380,500 | $ | - | 4,697,532 | 4,697,532 | - | |||||||||||||
4/11/2013
|
236,000 | 37,100 | 2,913,580 | 2,913,580 | 291,358 | |||||||||||||||
4/22/2013
|
576,000 | 55,100 | 7,111,111 | 7,111,111 | 575,308 | |||||||||||||||
5/31/2013
|
288,000 | 31,300 | 3,555,557 | 3,555,557 | 355,556 | |||||||||||||||
6/28/2013
|
1,976,925 | 62,632 | 24,406,482 | 24,406,482 | 773,235 | |||||||||||||||
$ | 3,457,425 | $ | 186,132 | 42,684,262 | 42,684,262 | 1,995,457 |
For The
Three Months Ended
|
For The
Nine Months Ended
|
|||||||||||||||
2013
|
2012
|
2013
|
2012
|
|||||||||||||
Options
|
$ | 473,200 | $ | 258,904 | $ | 2,271,842 | $ | 684,176 | ||||||||
Warrants
|
7,447 | - | 7,447 | 3,777 | ||||||||||||
Restricted Stock Units
|
(34,395 | ) | - | (8,599 | ) | - | ||||||||||
Total Share Based Compensation
|
446,252 | 258,904 | 2,270,690 | 687,953 | ||||||||||||
Restricted Stock
|
50,312 | 20,000 | 57,312 | 284,500 | ||||||||||||
Restricted Stock - Related Party
|
- | - | 570,130 | - | ||||||||||||
Total Stock Issued for Services Rendered
|
50,312 | 20,000 | 627,442 | 284,500 | ||||||||||||
Total
|
$ | 496,564 | $ | 278,904 | $ | 2,898,132 | $ | 972,453 |
Issuance
|
Grantee
|
Shares
|
Vesting
|
Grant Date
|
|||||||
Date
|
Type
|
Issued
|
Term
|
Value
|
|||||||
5/24/2013
|
Consultant
|
100,000 |
Immediate
|
$ | 7,000 | ||||||
7/1/2013
|
Consultant
|
718,750 |
Immediate
|
50,312 | |||||||
818,750 | 57,312 | ||||||||||
6/28/2013
|
Fmr. President & Current Board Member
|
8,144,719 |
Immediate
|
570,130 | |||||||
8,963,469 | $ | 627,442 |
For The Three Months Ended
September 30,
|
For The Nine Months Ended
September 30,
|
|||||||||||||||
2013
|
2012
|
2013
|
2012
|
|||||||||||||
Risk free interest rate
|
1.40 | % | 0.74 | % | 1.15 | % | 0.84 | % | ||||||||
Expected term (years)
|
5.00 | 5.00 | 5.00 | 5.00 | ||||||||||||
Expected volatility
|
99.87 | % | 97.69 | % | 99.92 | % | 99.89 | % | ||||||||
Expected dividends
|
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
Weighted
|
||||||||||||||||
Weighted
|
Average
|
|||||||||||||||
Average
|
Remaining
|
|||||||||||||||
Number of
|
Exercise
|
Life
|
Intrinsic
|
|||||||||||||
Warrants
|
Price
|
In Years
|
Value
|
|||||||||||||
Outstanding, December 31, 2012
|
43,934,000 | $ | 0.09 | |||||||||||||
Issued
|
44,979,719 | 0.10 | ||||||||||||||
Exercised
|
- | - | ||||||||||||||
Forfeited
|
- | - | ||||||||||||||
Outstanding, September 30, 2013
|
88,913,719 | $ | 0.09 | 3.9 | $ | 403,610 | ||||||||||
Exercisable, September 30, 2013
|
88,663,719 | $ | 0.09 | 3.9 | $ | 403,610 |
Warrants Outstanding
|
Warrants Exercisable
|
|||||||||||||
Weighted
|
||||||||||||||
Outstanding
|
Average
|
Exercisable
|
||||||||||||
Exercise
|
Number of
|
Remaining Life
|
Number of
|
|||||||||||
Price
|
Warrants
|
In Years
|
Warrants
|
|||||||||||
$ | 0.050 | 19,600,000 | 4.1 | 19,600,000 | ||||||||||
0.069 | 11,609,500 | 3.4 | 11,609,500 | |||||||||||
0.080 | 100,000 | 3.6 | 100,000 | |||||||||||
0.097 | 44,679,719 | 4.7 | 44,679,719 | |||||||||||
0.100 | 300,000 | 4.8 | 50,000 | |||||||||||
0.160 | 6,156,000 | 1.6 | 6,156,000 | |||||||||||
0.200 | 6,468,500 | 1.7 | 6,468,500 | |||||||||||
88,913,719 | 3.9 | 88,663,719 |
Contractual
|
Vesting
|
|||||||||||||||||||||
Grant
|
Grantee
|
Options
|
Exercise
|
Term
|
Term
|
Grant Date
|
||||||||||||||||
Date
|
Type
|
Granted
|
Price
|
(Years)
|
(Years) [5]
|
Value
|
||||||||||||||||
2/4/2013
|
New CEO
|
12,216,195 | $ | 0.075 | 10.0 | 0.0 | $ | 684,107 | ||||||||||||||
4/9/2013
|
Consultant
|
2,500,000 | 0.100 | 5.0 | 0.0 | 142,000 | ||||||||||||||||
5/10/2013
|
Employee
|
7,500,000 | 0.100 - 0.200 | 10.0 | 0.0 - 2.0 | 292,406 | ||||||||||||||||
5/10/2013
|
Employee
|
12,000,000 | 0.100 - 0.250 | 10.0 | 0.0 - 4.0 | 476,794 | ||||||||||||||||
5/10/2013
|
Employee
|
4,000,000 | 0.100 - 0.200 | 10.0 | 0.0 - 3.0 | 159,558 | ||||||||||||||||
5/10/2013
|
Consultant
|
150,000 | 0.100 | 10.0 | 0.0 | 7,793 | ||||||||||||||||
5/10/2013
|
Consultant
|
3,000,000 | 0.100 | 10.0 | 0.0 - 0.6 | 155,863 | ||||||||||||||||
5/10/2013
|
Consultant
|
250,000 | 0.100 | 10.0 | 1.0 - 4.0 | 12,989 | ||||||||||||||||
5/10/2013
|
Employee
|
1,000,000 | 0.100 | 10.0 | 0.0 - 0.1 | 37,258 | ||||||||||||||||
5/10/2013
|
Director
|
5,000,000 | 0.100 | 10.0 | [2 | ] | 212,386 | |||||||||||||||
5/10/2013
|
Consultant
|
750,000 | 0.100 - 0.200 | 10.0 | 0.0 - 1.6 | 37,877 | ||||||||||||||||
5/10/2013
|
Employee
|
1,000,000 | 0.100 | 10.0 | 0.0 - 2.6 | 42,489 | ||||||||||||||||
5/10/2013
|
Consultant
|
100,000 | 0.100 | 10.0 | 1.0 - 3.0 | 5,195 | ||||||||||||||||
5/10/2013
|
Consultant
|
4,666,666 | 0.150 - 0.210 | 1.1 | 0.0 | 9,155 | ||||||||||||||||
7/22/2013
|
Director
|
27,220,000 | 0.150 - 0.250 | 9.5 | [3 | ] | 1,556,984 | |||||||||||||||
8/15/2013
|
Consultant
|
500,000 | 0.100 | 10.0 | 0.0 - 3.0 | 35,363 | ||||||||||||||||
9/3/2013
|
New CFO
|
8,100,000 | 0.100 - 0.200 | 10.0 | 0.0 - 2.0 | 384,210 | ||||||||||||||||
9/3/2013
|
Fmr. CFO
|
5,000,000 | 0.100 | 3.3 | 0.0 | 202,000 | ||||||||||||||||
94,952,861 | $ | 0.148 | $ | 4,454,427 |
[1]
|
Granted pursuant to the 2011 Plan.
|
[2]
|
The options vest and become exercisable as follows: (i) 1,666,666 immediately on the grant date; (ii) 1,666,667 options upon the Company becoming listed on a registered national securities exchange provided it occurs before June 30, 2014; and (iii) 1,666,667 options on the last day of the first fiscal quarter the Company has achieved a positive cash-flow provided it occurs before June 30, 2015.
|
[3]
|
The options vest and become exercisable as follows: (i) 9,073,333 options with an exercise price of $0.15 per share will vest and become exercisable provided the Company files a Form 10-K with annual revenues greater than $10 million by April 15, 2016; (ii) 9,073,333 options with an exercise price of $0.20 per share will vest and become exercisable provided the Company files a Form 10-K with annual revenues greater than $20 million by April 17, 2017; and (iii) 9,073,334 options with an exercise price of $0.25 per share will vest and become exercisable provided the Company files a Form 10-K with annual revenues greater than $25 million by April 17, 2018.
|
[4]
|
Pursuant to the terms of the award, the following prior option grants to the same non-employee director were cancelled; (a) 4,640,000 ten-year non-qualified stock options with an exercise price of $0.15 per share that were granted on May 17, 2012 and were scheduled to vest if certain performance criteria were met by November 17, 2013; (b) 5,000,000 ten-year non-qualified stock options with an exercise price of $0.20 per share that were granted on November 27, 2012 and were scheduled to vest if certain performance criteria were met by September 30, 2013; and (c) 2,500,000 ten-year non-qualified stock options with an exercise price of $0.20 per share that were granted on November 27, 2012 and were scheduled to vest if certain performance criteria were met by December 31, 2013.
|
[5]
|
Vesting term range represents the number of years from the grant date until the first vesting date through the final vesting date, with "0.0" representing an award that has a portion of shares that vest immediately.
|
For The Three Months Ended
September 30,
|
For The Nine Months Ended
September 30,
|
|||||||||||||||
2013
|
2012
|
2013
|
2012
|
|||||||||||||
Risk free interest rate
|
1.69 | % | 0.49 | % | 1.26 | % | 0.73 | % | ||||||||
Expected term (years)
|
6.04 | 3.86 | 5.63 | 5.51 | ||||||||||||
Expected volatility
|
99.87 | % | 97.57 | % | 99.17 | % | 98.75 | % | ||||||||
Expected dividends
|
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
Weighted
|
||||||||||||||||
Weighted
|
Average
|
|||||||||||||||
Average
|
Remaining
|
|||||||||||||||
Number of
|
Exercise
|
Life
|
Intrinsic
|
|||||||||||||
Options
|
Price
|
In Years
|
Value
|
|||||||||||||
Outstanding, December 31, 2012
|
102,104,742 | $ | 0.15 | |||||||||||||
Granted
|
94,952,861 | 0.15 | ||||||||||||||
Exercised
|
- | - | ||||||||||||||
Forfeited
|
(28,935,000 | ) | 0.16 | |||||||||||||
Outstanding, September 30, 2013
|
168,122,603 | $ | 0.15 | 8.2 | $ | - | ||||||||||
Exercisable, September 30, 2013
|
85,117,078 | $ | 0.13 | 7.2 | $ | - |
Options Outstanding
|
Options Exercisable
|
|||||||||||||
Weighted
|
||||||||||||||
Outstanding
|
Average
|
Exercisable
|
||||||||||||
Exercise
|
Number of
|
Remaining Life
|
Number of
|
|||||||||||
Price
|
Options
|
In Years
|
Options
|
|||||||||||
$ | 0.075 | 12,216,195 | 9.4 | 12,216,195 | ||||||||||
0.100 | 53,731,408 | 6.7 | 36,372,551 | |||||||||||
0.125 | 5,275,000 | 9.6 | 1,355,000 | |||||||||||
0.135 | 750,000 | 7.3 | 750,000 | |||||||||||
0.145 | 12,540,000 | 6.7 | 12,540,000 | |||||||||||
0.150 | 23,688,333 | 4.5 | 5,155,000 | |||||||||||
0.200 | 43,388,333 | 8.9 | 11,188,332 | |||||||||||
0.210 | 5,000,000 | 5.2 | 5,000,000 | |||||||||||
0.250 | 11,473,334 | 9.6 | 480,000 | |||||||||||
0.260 | 50,000 | 5.0 | 50,000 | |||||||||||
0.610 | 10,000 | 4.7 | 10,000 | |||||||||||
168,122,603 | 7.2 | 85,117,078 |
Beginning balance as of January 1, 2013
|
$ | 605,737 | ||
Change in fair value of warrant liability
|
243,735 | |||
Ending balance as of September 30, 2013
|
$ | 849,472 |
Level
|
Level
|
Level
|
||||||||||
1 | 2 | 3 | ||||||||||
Recurring:
|
||||||||||||
Derivative liabilities
|
N/A | N/A | $ | 849,472 |
●
|
The uncertainty of our ability to continue as a going concern;
|
●
|
the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives;
|
●
|
inadequate capital;
|
●
|
loss or retirement of key executives;
|
●
|
adverse economic conditions and/or intense competition;
|
●
|
loss of a key customer or supplier;
|
●
|
entry of new competitors and products;
|
●
|
adverse federal, state and local government regulation;
|
●
|
technological obsolescence of our products;
|
●
|
technical problems with our research and our products;
|
●
|
price increases for supplies and components; and
|
●
|
the inability to carry out research, development and commercialization plans.
|
Calendar Year
|
Minimum Annual Purchase Amount
|
|
2014
|
500,000 Euros
|
|
2015
|
1,000,000 Euros
|
|
2016
|
2,500,000 Euros
|
|
2017
|
4,000,000 Euros
|
●
|
incur more than $100,000 of indebtedness or a security interest on any of our assets or the assets of our subsidiaries, other than in connection with ordinary course equipment financings;
|
●
|
authorize additional shares of Series A Convertible Preferred Stock;
|
●
|
amend our Articles of Incorporation or Bylaws in any manner that would impair or reduce the rights of ourSeries A Convertible Preferred Stock;
|
●
|
liquidate or dissolve; or
|
●
|
issue any class or series of equity security senior to ourSeries A Convertible Preferred Stock.
|
ALLIQUA, INC.
|
|||
Date: November 12, 2013
|
By:
|
/s/
David I. Johnson
|
|
Name:
|
David I. Johnson
|
||
Title:
|
Chief Executive Office
|
||
(Principal Executive Officer)
|
|||
By:
|
/s/
Brian M. Posner
|
||
Name:
|
Brian M. Posner
|
||
Title:
|
Chief Financial Officer
|
||
(Principal Financial Officer)
|
Exhibit No.
|
Description
|
|
3.1
|
Composite Articles of Incorporation of Alliqua, Inc. (incorporated by reference to Exhibit 3.1 to Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on May 16, 2013)
|
|
3.2
|
Amended and Revised Bylaws(incorporated by reference to Exhibit 3.2 to Form 8-K filed with the Securities and Exchange Commission on June 10, 2010)
|
|
3.3 | Articles of Amendment to Articles of Incorporation of Alliqua, Inc. (incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the Securities and Exchange Commison on September 27, 2013) | |
3.4 | Certificate of Designation of the Relative Rights and Preferences of the Series A Convertible Preferred Stock of Alliqua, Inc. (incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on October 28, 2013) | |
10.1
|
Offer Letter, dated July 19, 2013 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on September 9, 2013)
|
|
10.2
|
Nonqualified Stock Option Agreement, dated September 3, 2013, between Brian Posner and Alliqua, Inc. (incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on September 9, 2013)
|
|
10.3
|
Transition Agreement and Release, dated September 3, 2013, between Steven Berger and Alliqua, Inc. (incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed with the Securities and Exchange Commission on September 9, 2013)
|
|
10.4
|
Nonqualified Stock Option Agreement, dated September 3, 2013, between Steven Berger and Alliqua, Inc. (incorporated by reference to Exhibit 10.4 to Current Report on Form 8-K filed with the Securities and Exchange Commission on September 9, 2013)
|
|
10.5*+
|
Distributor Agreement, dated September 23, 2013, by and between Sorbion GmbH & Co KG and Alliqua Biomedical, Inc.
|
|
10.6*
|
Agreement, dated September 23, 2013, by and between Carolon Company and Alliqua Biomedical, Inc.
|
|
10.7* | Separation and General Release Agreement, dated as of November 11, 2013, by and between Alliqua, Inc. and David Stefansky | |
10.8* | Consulting Agreement, dated as of November 11, 2013, by and between Alliqua, Inc. and David Stefansky | |
31.1
*
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
|
|
31.2
*
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
|
|
32.1
*
|
Certification of Chief Executive Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2
*
|
Certification of Chief Financial Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS**
|
XBRL Instance Document.
|
|
101.CAL**
|
XBRL Taxonomy Calculation Linkbase Document.
|
|
101.DEF**
|
XBRL Taxonomy Definition Linkbase Document.
|
|
101.LAB**
|
XBRL Taxonomy Label Linkbase Document.
|
|
101.PRE**
|
XBRL Taxonomy Presentation Linkbase Document.
|
|
101.SCH**
|
XBRL Taxonomy Extension Schema Document.
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Alliqua, 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(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
a.
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b.
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c.
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d.
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a.
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b.
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
November 12, 2013
|
By: |
/s/
David Johnson
|
|
David Johnson
|
|||
Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Alliqua, 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(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
a.
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b.
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c.
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d.
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a.
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b.
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
November 12, 2013
|
By: |
/s/
Brian M. Posner
|
|
Brian M. Posner
|
|||
Chief Financial Officer
(Principal Financial Officer)
|
(1)
|
The Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered in this report.
|
Date: November 12, 2013
|
By:
|
/s/
David
Johnson
|
|
Name:
|
David Johnson
|
||
Title:
|
Chief Executive Officer
(Principal Executive Officer)
|
(1)
|
The Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered in this report.
|
Date: November 12, 2013
|
By:
|
/s/ Brian M. Posner
|
|
Name:
|
Brian M. Posner
|
||
Title:
|
Chief Financial Officer
(Principal Financial Officer)
|
(1)
|
SORBION hereby appoints ALLIQUA as its distributor for the sale of the products listed in
Exhibit B
(including Annex 1, Annex 2 and Annex 3 to
Exhibit B
) and – subject to para (2) below – all product line extensions of any of the foregoing (hereinafter referred to as “
PRODUCTS
”) within the TERRITORY. ALLIQUA accepts such appointments. The specifications of the PRODUCTS are described in
Exhibit B
(
Annex 1
,
Annex 2
and
Annex 3
). SORBION represents and warrants that the grant of rights to ALLIQUA under this AGREEMENT does not conflict with any agreement that SORBION has with any third party.
|
|
(a)
|
ALLIQUA’s rights to distribute the PRODUCTS listed in
Exhibit B, Annex 1
and – subject to para (2) below – all product line extensions of any of the foregoing (collectively, the “
ANNEX 1 PRODUCTS
”) shall be exclusive (even as to SORBION) in the TERRITORY;
provided
,
however
, that notwithstanding such exclusivity, a certain third party distributor of SORBION, Systagenix Wound Management (“
SYSTAGENIX
”), shall have the right to distribute the ANNEX 1 PRODUCTS in the TERRITORY on a private-label basis under SYSTAGENIX’s brand pursuant to an agreement between SYSTAGENIX and SORBION that exists as of the date of this AGREEMENT. If SYSTAGENIX’s right to distribute the ANNEX 1 PRODUCTS in the TERRITORY expires or is terminated, then ALLIQUA’s rights to distribute the ANNEX 1 PRODUCTS shall automatically become exclusive in all respects.
|
|
(b)
|
As of the date of this AGREEMENT, ALLIQUA’s rights to distribute the PRODUCTS listed in
Exhibit B, Annex 2
and – subject to para (2) below – all product line extensions of any of the foregoing (collectively, the “
ANNEX 2 PRODUCTS
”) shall be exclusive (even as to SORBION) in the TERRITORY;
provided
,
however
, that notwithstanding such exclusivity, a certain third party distributor of SORBION, Carolon Company (“
CAROLON
”), shall have the right to distribute the ANNEX 2 PRODUCTS in the TERRITORY (in addition to ALLIQUA’s right to distribute the ANNEX 2 PRODUCTS in the TERRITORY) pursuant to an agreement between CAROLON and SORBION that exists as of the date of this AGREEMENT. If CAROLON’s right to distribute the ANNEX 2 PRODUCTS in the TERRITORY expires or is terminated (or is assigned to ALLIQUA), then ALLIQUA’s rights to distribute the ANNEX 2 PRODUCTS shall automatically become exclusive in all respects.
|
|
(c)
|
ALLIQUA’s rights to distribute the PRODUCTS listed in
Exhibit B, Annex 3
and – subject to para (2) below – all product line extensions of any of the foregoing (collectively, the “
ANNEX 3 PRODUCTS
”) shall be exclusive (even as to SORBION) in the TERRITORY at all times during the term of this AGREEMENT.
|
(2)
|
The Parties upon mutual agreement may modify
Exhibit B
(
Annex 1
,
Annex 2
and
Annex 3
). For the avoidance of doubt, SORBION has the sole discretion which product line extension may be distributed in the TERRITORY. Therefore, if a product line extension is distributed outside the TERRITORY but Sorbion decides not to distribute this product line extension in the TERRITORY, ALLIQUA may not sell the respective product line extension in the TERRITORY.
|
(3)
|
The basis of the legal relationship between the PARTIES, in relation to all processes connected with this AGREEMENT, is exclusively this AGREEMENT as well as the General Terms and Conditions of Sale and Transfer of SORBION that are attached as
Exhibit C
, which shall be applicable to the individual purchase contracts still to be concluded (see below section 2). Conflicting, deviating or additional agreements do not exist, except as attached as exhibits to this AGREEMENT or except with respect to the design, packaging and labeling agreement referenced below in section 1(4). SORBION does not acknowledge any general terms and conditions of ALLIQUA. Even if a purchase contract is performed without reservation in the knowledge of conflicting or deviating terms and conditions of ALLIQUA, this shall not constitute a consent of SORBION to their application.
|
(4)
|
ALLIQUA shall buy the PRODUCTS directly from SORBION in its own name and on its own account, and then shall sell them under the respective trademark (e. g. “SORBION”, “SORBION sachet”, “SORBION sachet S” or “SORBION sana”) with the design, packaging and labeling as agreed by the PARTIES (such agreement not to be unreasonably withheld or delayed), to third parties domiciling within the TERRITORY in its own name and on its own account. ALLIQUA is free in determining its selling prices.
|
(5)
|
Nothing in this AGREEMENT shall constitute the right of ALLIQUA to act as an agent of SORBION to represent SORBION in any way whatsoever. ALLIQUA is not entitled to conclude legal transaction on behalf of SORBION. For the avoidance of doubt, ALLIQUA is an independent enterprise and not an employee of SORBION.
|
(6)
|
ALLIQUA is in a position to assess the financial chances and risks of the activity hereby contractually assumed. SORBION is therefore not responsible for the profitability of the business of ALLIQUA.
|
(7)
|
ALLIQUA shall not be entitled to engage subcontractors or any third party as its subagent or the alike with respect to marketing of the PRODUCTS without having obtained SORBION´s prior written approval to do so, such approval not to be unreasonably withheld;
provided
,
however
, that for the avoidance of doubt, SORBION’s approval will not be required for ALLIQUA to: (i) sell PRODUCTS through wholesalers, Group Purchasing Organizations (“
GPOs
”) and other third parties as are customarily involved in the distribution and sale of medical device products in the TERRITORY or (ii) use contract sales organizations or other independent sales representatives in connection with the marketing of the PRODUCTS.
|
(8)
|
ALLIQUA acknowledges SORBION's policy of working with local partners and granting them exclusivity for certain countries and regions outside the TERRITORY: ALLIQUA agrees not to interfere with this policy. ALLIQUA is not allowed to actively initiate, support and accomplish soliciting any sales of the PRODUCTS outside the TERRITORY. ALLIQUA shall limit its efforts to advertise and solicit sales of the PRODUCTS to activities executed within the TERRITORY, unless customers from outside the TERRITORY have solicited for quotations and/or deliveries without prior inducement by ALLIQUA (passive distribution). ALLIQUA will not ship or sell any customer outside the TERRITORY without the expressed written approval of SORBION. Sale and distribution in the European Union, Switzerland, Turkey and Australia explicitly is reserved to SORBION and its other distributors. ALLIQUA will inform its customers that the PRODUCTS are for sale in the TERRITORY only. Should ALLIQUA determine that PRODUCTS are being sold outside the TERRITORY by a customer from within the TERRITORY, ALLIQUA will notify SORBION so that appropriate action may be taken.
|
(1)
|
ALLIQUA will undertake commercially reasonable efforts to enhance the sale of the PRODUCTS. ALLIQUA will undertake commercially reasonable efforts to achieve a regular flow of orders and take-offs of the PRODUCTS during each calendar year. ALLIQUA is obliged to protect the interests and reputation of SORBION and not to do anything which would endanger the reputation, market position or creditworthiness of SORBION or otherwise damage SORBION. ALLIQUA undertakes to discuss with SORBION at regular intervals the objectives and strategies for the sale of PRODUCTS in the TERRITORY.
|
(2)
|
SORBION sells the PRODUCTS on the basis of its General Terms and Conditions of Sale and Transfer attached as
Exhibit C
and which can be amended from time to time upon the mutual, written agreement of the PARTIES. The provisions of this AGREEMENT shall have in case of contradiction priority over the General Terms and Conditions of Sale and Transfer. For the avoidance of doubt, and without limiting the foregoing, the PARTIES agree that the following provisions set forth in the General Terms and Conditions of Sale and Transfer shall have no effect, as such provisions address matters that are covered in the main body of this AGREEMENT: Section II(1), Section III, Section IV(1). For the avoidance of doubt, the sale of PRODUCTS are on basis of Section XIII of the General Terms and Conditions of Sale and Transfer.
|
(3)
|
Except as provided below as well as in Section 2(3) and Section 2(5) below, SORBION will accept all Product orders that are issued by ALLIQUA and that are consistent with the valid price list (see para. (6) below). However, the individual purchase contract shall come into effect only on acceptance of the order of ALLIQUA by SORBION. SORBION shall send an order confirmation. SORBION is entitled to stop accepting orders for the PRODUCTS, only to the extent SORBION decides to do so generally for all markets worldwide, after informing ALLIQUA in writing with a notice period of six months. Orders of ALLIQUA accepted by SORBION before the end of such notice period shall remain unaffected. Further, SORBION may decide to not to accept orders if the respective Products are – pursuant SORBION’s sole discretion – not marketable or defective or if there is the risk or suspicion that the respective Products do not comply with the requirements set out in Section 4(1) below.
|
(4)
|
SORBION will deliver PRODUCTS to ALLIQUA by the delivery date set forth on ALLIQUA’s order, provided that such delivery date is no sooner than 30 days after the date of such order.
|
(5)
|
Events of force majeure hindering the Parties in fulfilling their contractual obligations in part or in total, shall exempt and free the relevant Party from its obligation to fulfill this contract until the events of force majeure do not exist anymore. The following shall be regarded as events of force majeure: fire, natural disaster, war, revolution, riots, acts of terrorism, shortage of raw materials, strike, lockouts, disturbances in seller’s business or business of suppliers, acts of government or authority. The other Party may terminate the contract if the event of force majeure lasts for more than six months or if the party terminating the contract can reasonably demonstrate that it would be unreasonable for the party to continuously be bound by the contract.
|
(6)
|
SORBION is free to determine its prices and conditions. At least 30 days before the beginning of each calendar year starting with 2015, SORBION shall send ALLIQUA the valid price list which shall remain in effect for the duration of such calendar year. The currently valid price list which shall remain in effect for calendar years 2013 and 2014 is attached to this AGREEMENT as
Exhibit D
. The prices according to
Exhibit D
are ex works and have to be paid within 30 days after date of invoice with 3% deduction or 45 days after date of invoice without deduction. SORBION will invoice ALLIQUA for each PRODUCT order upon shipment of the PRODUCTS covered by the order to ALLIQUA. For the avoidance of doubt, prices do not include any import taxes, sales taxes, duty or other governmental fees which have to be paid by ALLIQUA. Notwithstanding anything to the contrary: (i) Sorbion will pay for fifty percent (50%) of Shipment Costs (as defined below) with respect to PRODUCT orders that are for less than 50.000,00 € and (ii) Sorbion will pay for one hundred percent (100%) of Shipment Costs with respect to PRODUCT orders that are equal or above 50.000,00 €. “
Shipment Costs
” means the following costs associated with an order of PRODUCTS: (i) shipping costs (via a mutually agreed upon means of shipping), (ii) other logistics costs, including customs clearance costs and (iii) import taxes, sales taxes, duties and other governmental fees.
|
(7)
|
In cases of late payment for PRODUCTS that conform to the requirements of this AGREEMENT, SORBION is entitled to claim interest in the amount of 8 % p. a. Further claims for damages remain unaffected.
|
section 3
|
Exclusivity
|
(1)
|
ALLIQUA shall act as SORBION´s exclusive distributor for the PRODUCTS within the TERRITORY for the term of this AGREEMENT (subject to the limited exceptions provided for in Sections 1(1)(a) and (b) and also subject to ppara. (3) and (4) below). As long as exclusivity is granted to ALLIQUA, SORBION will not itself sell any PRODUCTS into the TERRITORY or appoint any third party to sell PRODUCTS into the TERRITORY (other than the existing appointments of SYSTAGENIX and CAROLON as distributors of ANNEX 1 PRODUCTS and ANNEX 2 PRODUCTS, respectively, as provided in Sections 1(1)(a) and (b)) without ALLIQUA’s approval. In addition, SORBION agrees that it will use its best efforts to insure that the PRODUCTS are not sold from another territory into the TERRITORY.
|
(2)
|
The exclusivity granted to ALLIQUA under this AGREEMENT is conditioned on ALLIQUA purchasing from SORBION, during calendar year 2014 and each calendar year thereafter during the term of this AGREEMENT, PRODUCTS for an aggregate purchase price that equals or exceeds the minimum purchase amount that is set forth for such calendar year on
Exhibit E
(the “
MINIMUM ANNUAL PURCHASE AMOUNT
”). If ALLIQUA fails to make PRODUCT purchases for payments that, in the aggregate, equal or exceed the MINIMUM ANNUAL PURCHASE AMOUNT for a given calendar year, then ALLIQUA may, at its sole discretion, cure such failure by paying SORBION, within 45 days after the end of such calendar year, an amount equal to such MINIMUM ANNUAL PURCHASE AMOUNT minus the aggregate payments made by ALLIQUA for PRODUCT purchases for such year. SORBION’s sole and exclusive remedy for any failure by ALLIQUA to pay the MINIMUM ANNUAL PURCHASE AMOUNT for a given calendar year shall be as set forth below in Section 3(3), Section 3(4) and Section 3(5).
|
(3)
|
If ALLIQUA fails to pay the applicable MINIMUM ANNUAL PURCHASE AMOUNT for a given calendar year in accordance with para. (2) above, SORBION is entitled to terminate the exclusivity right of ALLIQUA immediately and convert ALLIQUA’s rights under this AGREEMENT to non-exclusive rights. In addition, if ALLIQUA fails to pay the MINIMUM ANNUAL PURCHASE AMOUNT in accordance with para. (2) above for two subsequent calendar years, SORBION shall have the right to terminate this AGREEMENT in its entirety upon ninety (90) days prior, written notice to ALLIQUA.
|
(4)
|
Notwithstanding anything to the contrary, ALLIQUA shall not be required to purchase the MINIMUM ANNUAL PURCHASE AMOUNT in order to retain the exclusivity granted to ALLIQUA under this AGREEMENT, and SORBION shall have no termination right under Section 3(3) above, if SORBION fails to supply PRODUCTS to ALLIQUA that meet the requirements of this AGREEMENT, whether on account of an Event of Force Majeure, on account of SORBION no longer accepting orders pursuant to Section 2(3) with regard to any PRODUCT or a cessation of sales pursuant to Section 4(6) with regard to any PRODUCT, or otherwise. Further, ALLIQUA shall not be required to purchase the MINIMUM ANNUAL PURCHASE AMOUNT regarding the calendar year 2014 in order to retain the exclusivity granted to ALLIQUA under this AGREEMENT, and SORBION shall have no termination right under Section 3(3) above, if ALLIQUA acquires CAROLON’s rights to distribute the ANNEX 2 PRODUCTS in the TERRITORY.
|
(5)
|
Further, any material breach of this AGREEMENT by ALLIQUA will entitle SORBION to terminate the exclusivity by providing ALLIQUA with thirty (30) days prior, written notice of such termination;
provided
,
however
, that such exclusivity will not terminate if ALLIQUA cures such breach by the end of such thirty (30) day period. This shall not affect any other rights or remedies of SORBION arising from such failure, especially the right to terminate the whole AGREEMENT in accordance with section 10.
|
(1)
|
SORBION declares conformity with the essential requirements as stated in Annex I of the European medical device directive 93/42/EEC and confirms to maintain a complete quality management system as required by Annex II of 93/42/EEC. SORBION represents, warrants and covenants that the PRODUCTS at all times shall be: (i) labeled internationally, including English language and English language instructions for use, and in compliance with all applicable laws and regulations in the TERRITORY and (ii) the PRODUCTS at all times shall meet all applicable laws and regulations pertaining to the sale of the PRODUCTS in the TERRITORY. If legal provisions or authority directives in the TERRITORY require a change in the PRODUCTS ALLIQUA is obliged to inform SORBION.
|
(2)
|
ALLIQUA is obliged to ensure that its marketing practices with respect to the PRODUCTS complies with local or other laws. ALLIQUA is liable for any damages, financial or of any other kind, which are caused by failure to meet the foregoing requirement.
|
(3)
|
ALLIQUA will comply with all statutory and/or official regulations, laws, instructions, decisions and/or statutes which affect ALLIQUA and its enterprise as well as the possibility of the sale of the PRODUCTS in the TERRITORY. ALLIQUA will pay all taxes, license fees, permit fees or registration fees and other costs and charges incurred by ALLIQUA connected with the establishment and/or the operation of ALLIQUA’s business as well as the sale of the PRODUCTS, insofar as such exist.
|
(4)
|
SORBION will be responsible, at its expense, for (i) obtaining and maintaining any required regulatory approvals and clearances with respect to the PRODUCTS in the TERRITORY, (ii) responding to requests from regulatory authorities in the TERRITORY with respect to the PRODUCTS, (iii) reporting any adverse events with respect to the PRODUCTS to applicable regulatory authorities in accordance with applicable laws and regulations, (iv) conducting any clinical studies with respect to the PRODUCTS and (v) obtaining reimbursement approvals for the PRODUCTS in the TERRITORY.
|
(5)
|
ALLIQUA will promptly report to SORBION any adverse events of which ALLIQUA becomes aware with regard to the PRODUCTS. ALLIQUA will conduct its distribution activities (including but not restricted to the keeping of distribution records, complaint handling, and problem reporting to SORBION and recall procedures) in accordance with applicable laws and regulations in the TERRITORY. ALLIQUA will provide for adequate insurance with regard to its distribution activities. ALLIQUA undertakes reasonable efforts to market the SORBION brand in the TERRITORY.
|
(6)
|
SORBION has the right to instruct ALLIQUA to immediately cease sales of the PRODUCTS in the event such sales would violate any applicable law, or would expose SORBION to product defect liability in the event of non-conformity. Such right of SORBION is in addition to its rights under section 2(3) of this AGREEMENT.
|
(7)
|
All marketing materials such as brochures, internet marketing and any kind of advertising must be in conformity of the PRODUCT’s respective instructions for use and have to be agreed upon with SORBION before launch. SORBION will not unreasonably withhold its approval of any such marketing materials. Changes in the PRODUCTS, the packaging and design are only allowed with prior written consent of SORBION. SORBION may provide for marketing, branding, corporate identity- and compliance-schemes and materials, which ALLIQUA must use commercially reasonable efforts to comply with and use. ALLIQUA must inform SORBION if ALLIQUA becomes aware of that such schemes and materials violate or interfere with applicable law in the TERRITORY, in which event the PARTIES will adjust such schemes and/or materials to accomplish the directive of SORBION at the best.
|
(8)
|
ALLIQUA will provide user support for local customers and be responsible for post-market surveillance in the TERRITORY (provided that SORBION shall be responsible for any reporting obligations to applicable regulatory authorities). ALLIQUA will establish procedures for complaint handling and will inform SORBION without undue delay of any problems relating to the PRODUCTS.
|
(9)
|
ALLIQUA will introduce and maintain a system for keeping distribution records, which enables ALLIQUA to perform a product recall, if such recall should become necessary. ALLIQUA will establish procedures to perform such a recall procedure. The distribution records will be kept for five years after the PRODUCTS “use-by”-date, even if the exclusivity and/ or the AGREEMENT have expired. In the event that a recall of the PRODUCTS becomes necessary, SORBION will provide to ALLIQUA instructions on recall procedures which shall be followed by ALLIQUA to the extent commercially reasonable. Costs of any recalls shall be borne by SORBION, unless recall necessity is solely as a result of ALLIQUA’s negligence.
|
(10)
|
ALLIQUA will follow the applicable regulations for marketing medical devices and the applicable regulations on fair competition and fair dealing. Even if there are no local restrictions in the TERRITORY, ALLIQUA will not use fraudulent or misleading advertising or marketing.
|
(1)
|
SORBION grants to ALLIQUA the right to use the trademarks SORBION, SORBION Sachet S, SORBION Sana for the sale and distribution of the PRODUCTS delivered by SORBION to customers in the TERRITORY and for marketing activities in the TERRITORY under the terms and for the duration of this AGREEMENT as long as it is clearly indicated that the Product is manufactured by SORBION and imported and distributed by ALLIQUA.
|
(2)
|
ALLIQUA will market, sell and deliver the PRODUCTS as provided by SORBION only under the SORBION SORBION Sachet S, SORBION Sana trademark and Logo with the original package and directions for use. SORBION will add a reference identifying ALLIQUA as responsible importer /vendor and/or local contact. The design requires the prior written consent of both PARTIES.
|
(3)
|
ALLIQUA agrees not to use any name or trademark similar to, confusingly or deceptively similar with the trademarks of SORBION and to assist SORBION, at SORBION’s request and expense, in taking all reasonable steps to defend or to protect its trademarks relating to the PRODUCTS in the TERRITORY.
|
(4)
|
From the marketing, sale, distribution, or other use of the PRODUCTS, ALLIQUA generally does not derive any right regarding the trademark, Logo, symbols or part thereof of SORBION. If local law grants any such rights to ALLIQUA, ALLIQUA is obliged and guarantees to return the right to SORBION immediately after the end of exclusivity and/or the AGREEMENT without costs to SORBION.
|
(5)
|
ALLIQUA undertakes to use intellectual property (i.e. trademarks, patents, know-how, copyright) belonging to SORBION only in the manner and to the extent expressly permitted by this AGREEMENT or in writing by SORBION. ALLIQUA will provide all possible co-operation and assistance, at SORBION’s request and expense, in SORBION’s efforts to protect its intellectual property in the TERRITORY.
|
section 6
Sales Forecast / Market Analysis
|
(1)
|
ALLIQUA shall provide SORBION with a first market analysis for 2014 on or before 30.11.2013.
|
(2)
|
In each quarter ALLIQUA shall provide SORBION with a marketing- and activity-report, relating to its own activities and the general market development with respect to the PRODUCTS.
|
(3)
|
Not later than thirty (30) days prior to first day of each calendar quarter during the term of this AGREEMENT, ALLIQUA shall also provide to SORBION: (i) its non-binding written forecast of ALLIQUA’s good faith written estimate of expected requirements for PRODUCTS during the following 12 months, and (ii) its binding written forecast of ALLIQUA’s requirements for PRODUCTS, during such calendar quarter (for example, the forecast for the first calendar quarter of each year shall be provided not later than 30 days prior to the first day of the first calendar quarter of such year). Each such binding forecast shall be broken down on a month-by-month basis for the applicable calendar quarter.
|
(4)
|
SORBION shall provide ALLIQUA with any information regarding SORBION’s sales activity outside the TERRITORY, including for new products and special marketing activities, except regarding confidential information as determined by SORBION.
|
(1)
|
ALLIQUA shall examine the PRODUCTS promptly after collection/delivery of the PRODUCTS for any damage that is obvious from a visual inspection (“
Obvious Defects
”). Obvious defects shall be notified to SORBION in writing immediately, in any event not later than seven days after receipt. Defects that are not Obvious Defects have to be notified promptly after discovery. If SORBION is not notified in time, all claims are excluded.
|
(2)
|
If the delivered PRODUCTS are not conforming to the specifications agreed between the PARTIES or the other requirements of this AGREEMENT (hereinafter referred to as “
DEFECTIVE PRODUCTS
” or “
DEFECT
”) SORBION at its choice will either render substitutive delivery or repair, promptly and at no additional cost to ALLIQUA. DEFECTIVE PRODUCTS shall, on demand of SORBION and at its costs, be returned or be demolished. If SORBION fails to fill the order at issue with PRODUCTS that are not DEFECTIVE PRODUCTS within 30 days after ALLIQUA’s original requested delivery date, then ALLIQUA has the right to rescind the relevant portion of the order upon notice to SORBION, in which event SORBION will refund to ALLIQUA any amounts previously paid by ALLIQUA with respect to such order.
|
(3)
|
THE WARRANTY AND LIABILITY OF SORBION IS EXCLUDED, IF THE DEFECT IS BASED ON A USE OUTSIDE THE TERRITORY, IMPROPER TRANSPORT OR STORAGE BY ALLIQUA, OR BECAUSE ALLIQUA HAS DISREGARDED WRITTEN INSTRUCTIONS OF SORBION WITH RESPECT TO THE STORAGE OR HANDLING OF PRODUCTS.
|
(4)
|
To the best knowledge of SORBION the use of the trademarks and use or sale of the PRODUCTS does not infringe any rights of third parties. HOWEVER NO WARRANTY ABOUT THE ABSENCE OF AN INFRINGEMENT OF THIRD PARTIES’ INTELLECTUAL PROPERTY RIGHTS IN THE TERRITORY IS GIVEN AND ABOUT THE FACT OF THE CONTINUANCE OF THE TRADEMARKS AND THE UNDERLYING INTELLECTUAL PROPERTY CONCERNING THE PRODUCTS.
|
(5)
|
SUBJECT TO SECTION 7 (6) BELOW, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES ARISING FROM OR IN CONNECTION WITH THIS AGREEMENT OR THE PRODUCTS (INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS OR REVENUES OR BUSINESS) WHETHER ARISING OUT OF WARRANTY, INDEMNITY, CONTRACT, NEGLIGENCE OR OTHER TORT, OR OTHERWISE.
|
(6)
|
Notwithstanding anything to the contrary, the liability exclusions set forth in section 7 (5) will not apply to: (i) any damages arising from a PARTY’s gross negligence, fraud or willful misconduct or (ii) the PARTIES’ respective indemnity obligations under section 8.
|
section 8
|
(1)
|
SORBION shall indemnify, defend and hold ALLIQUA and its affiliates and its and their respective officers, directors, employees and agents harmless against any claims, actions, lawsuits and investigations brought by a third party (“
THIRD PARTY CLAIMS
”) and will pay any settlements, awards, fines and reasonable attorney’s fees and expenses and court costs associated with such THIRD PARTY CLAIMS (collectively, “
LOSSES
”), in each case to the extent arising from or relating to any assertion that any Product contains a defect, such as faulty design, materials or workmanship, unless caused by ALLIQUA’s negligence, fraud or willful misconduct; provided, however, that ALLIQUA provide proper notice of the potential THIRD PARTY CLAIM in accordance with section 8(2) below, and provided that SORBION shall have the exclusive right, subject to its own indemnity insurance agreements, to select counsel and to accept or reject any offers of settlement with adverse parties. SORBION’S right to select counsel and to have exclusive right to accept or reject any offers of settlement shall be a precondition for any indemnification. This clause shall not apply to any THIRD PARTY CLAIM related solely to unauthorized sales made in contravention of a cessation instruction under section 4(6) of this AGREEMENT.
|
(2)
|
ALLIQUA shall immediately notify SORBION in writing of any notice or claim for which ALLIQUA seeks indemnity pursuant to section 8(1) and of the commencement of any suit or action with respect to any such claim, but in no event more than five (5) business days following the first day ALLIQUA becomes aware of the suit or action;
provided
,
however
, that the failure to give timely notice hereunder will not affect rights to indemnification hereunder if Alliqua has committed this failure neither deliberately nor carelessly. ALLIQUA shall permit SORBION to become informed of and to follow any such proceedings.
|
(3)
|
ALLIQUA shall indemnify, defend and hold SORBION and its affiliates and its and their respective officers, directors, employees and agents harmless against any THIRD PARTY CLAIMS, and will pay any associated LOSSES, in each case to the extent arising from or relating to ALLIQUA’s negligence, fraud or willful misconduct.
|
(4)
|
In the event one PARTY is liable to indemnify the other hereunder, the indemnity shall include any and all liability as against third parties, as well as reasonable legal and any other costs incurred in defending or settling such claims.
|
(5)
|
The provisions of this section 8 shall not be affected by the completion, termination or cancellation of this AGREEMENT or any part thereof, and shall apply notwithstanding any other provisions of this AGREEMENT.
|
section 9
|
(1)
|
ALLIQUA shall purchase the PRODUCTS only from SORBION.
|
(2)
|
ALLIQUA shall not during the term of the AGREEMENT without the prior written consent of SORBION, whether directly or indirectly, itself or through third parties, distribute, sell, advertise or otherwise market any wound dressing containing alginate nor any superabsorbent products that compete with any of the PRODUCTS.
|
(1)
|
The initial term of this AGREEMENT begins on the date appearing on the signature page below and ends on December 31, 2018.
|
(2)
|
In September 2014, the PARTIES will agree on Minimum Annual Purchase Amount to be met in 2018. If these Minimum Annual Purchase Amount is met, the Distributor AGREEMENT shall be renewed automatically for another year after the initial term. If the PARTIES cannot agree on the Minimum Annual Purchase Amount for 2018 until 31 September 2014 or until a mutually agreed extension date, the AGREEMENT will end automatically on December 31, 2018. Likewise, the PARTIES will agree within September 2015, September 2016, September 2017 and – as the case may be – September 2018 on Minimum Annual Purchase Amounts to be met in 2019, 2020, 2021 and 2022, and if the Minimum Annual Purchase Amount for any such year is met, then the AGREEMENT will be renewed automatically, each time for another year. Therefore, if the agreed Minimum Annual Purchase Amounts are met by ALLIQUA each year, the total duration of AGREEMENT will be extended until December 31, 2023. The PARTIES will negotiate on any further extension mutually.
|
(3)
|
ALLIQUA may terminate this AGREEMENT at any time upon six (6) months prior, written notice to SORBION.
|
(4)
|
Each PARTY’s right to terminate this AGREEMENT for good cause remains unaffected. Good cause for termination by Sorbion shall be limited to the following:
|
|
|
a change in the ownership of ALLIQUA unless interference with the legitimate interests of SORBION is not thereby to be anticipated;
|
|
|
a material breach of obligations out of sales contracts concluded in the framework of this AGREEMENT (above all, the failure to settle outstanding purchase-price receivables), which breach is not cured within sixty (60) days after receiving written notice of such breach from SORBION;
|
·
|
ALLIQUA’s material breach of any of its obligations under this AGREEMENT, which breach is not cured within sixty (60) days after receiving written notice of such breach from SORBION;
|
·
|
in case ALLIQUA at any time challenges any intellectual property of SORBION;
|
·
|
ALLIQUA’s application for opening of insolvency proceedings as well as the refusal to open insolvency proceedings for lack of assets, or any similar proceeding; or
|
·
|
full closure of business (other than on account of any PRODUCT or market issues or for other reasons outside of ALLIQUA’s reasonable control), with an actual or anticipated duration of more than ninety (90) days.
|
(5)
|
The termination requires written form. It may be sent by fax, first-class mail or email using the notice address in Section 12 below.
|
(6)
|
The termination and ending of this AGREEMENT shall not affect the purchase contracts concluded in the course of its performance. In the event of any termination, SORBION will continue to supply ALLIQUA so that the latter can perform the transactions entered into with third parties in the normal course of business prior to expiry of the AGREEMENT.
|
(7)
|
Documents provided to ALLIQUA may no longer be used from the ending of the AGREEMENT and are to be returned, unless consumed as intended.
|
(8)
|
The use of intellectual property rights and designations in the sense of this AGREEMENT shall be ceased at the ending of the AGREEMENT; provided, however, that ALLIQUA shall be entitled to market and sell any PRODUCTS that are in inventory or on order as of the effective date of any expiration or termination of this AGREEMENT for a period of six (6) months after the effective date of such expiration or termination.
|
(9)
|
ALLIQUA will, at the ending of the AGREEMENT, cooperate in smoothly transferring the customer relations.
|
(10)
|
Termination of this AGREEMENT shall not give rise to a right of either PARTY hereto for compensation of any losses or damages incurred by the termination of this AGREEMENT only, which shall not affect either PARTY’s rights or remedies for any other reason, including any reason to terminate this AGREEMENT. ALLIQUA especially shall have no claim against SORBION for compensation for loss of distribution rights, loss of goodwill or any similar loss.
|
(11)
|
The following provisions will survive any expiration or termination of this AGREEMENT: section 4 (“Agreement of Quality Assurance”), section 7 (“Warranty and liability”), section 8 (“Product liability”), section 10 (“Duration and Termination of the AGREEMENT”), section 11 (“Confidentiality”) and section 12 (“Miscellaneous”).
|
|
Each PARTY hereby undertakes:
|
(a)
|
at all times during the continuance of this AGREEMENT and for five (5) years after its termination not to disclose or divulge the contents of this AGREEMENT to any third party, whether in whole or in part, without the prior written consent of the other PARTY, unless (i) the same is required in terms of any statutory or regulatory obligation or requirement or exchange rules or (ii) on a confidential basis to any prospective financing source or acquirer and their advisors;
|
(b)
|
at all times during the continuance of this AGREEMENT and for five (5) years after its termination to maintain confidentiality of information which is marked “confidential” or “secret” or which might fairly be considered to be of a confidential nature, supplied by the other PARTY and including, but not limited to, trade secrets, know-how, procedures, formulas, statistics, marketing and sales plans, costs and pricing concepts not publicly released by the other PARTY;
|
(c)
|
on the expiry or termination of this AGREEMENT, or upon the request of the other PARTY made at any time, to deliver immediately to such other PARTY all documents and other materials in the possession, care, custody and/or control of the first PARTY that bear or incorporate the confidential information of the other PARTY whether in whole or in part; provided, however, such first PARTY will not be required to deliver any copies of documents or other materials necessary for its performance under this AGREEMENT or that are maintained in such PARTY’s backup or archival systems.
|
(1)
|
Neither PARTY is entitled to transfer any rights or obligations under this AGREEMENT to third parties without the other PARTY’s prior, written consent
. However, notwithstanding the foregoing (but subject to SORBION’s termination right under
clause 10(4)
to the extent applicable), either PARTY may, without any requirement to obtain the other PARTY’s consent,
transfer and assign its rights and obligations under this AGREEMENT to (i) an affiliated company of such PARTY or (ii) in connection with any merger, sale of equity interests, sale of all or substantially all assets or other change of control transaction relating to such PARTY or such PARTY’s line of business to which this AGREEMENT relates.
|
(2)
|
This AGREEMENT shall not be altered or modified, unless in writing and signed by both PARTIES hereto. The same applies for any modification of this requirement of the written form. The Exhibits are an integral part of this AGREEMENT.
|
(3)
|
NOTICES: All notices, requests, demands and other communications provided for in this AGREEMENT shall: (a) be in writing; (b) be sent by hand delivery, first class mail, overnight courier, email or facsimile transmission and (c) be addressed to the PARTIES hereto as indicated below unless otherwise specified in writing by any such PARTY.
|
(4)
|
This AGREEMENT shall to the greatest extent possible be interpreted in such a manner as to comply with the applicable laws. However, if any provision hereof is, notwithstanding such interpretation, determined to be or become invalid or unenforceable, or if there is an omission, the remaining provisions of this AGREEMENT shall remain to be binding upon the PARTIES. The PARTIES agree to replace any such invalid or unenforceable provision by a valid and enforceable one which comes as close as possible to the original purpose and intention of the invalid or unenforceable provision. In the event of an omission, a provision which corresponds with the intention and purpose of what would have been agreed between the PARTIES if the matter had been considered at the outset shall be deemed to have been agreed.
|
(5)
|
In the event of any controversy or claim arising out of or relating to any provision of this AGREEMENT or the breach thereof, the PARTIES shall try to settle the problem amicably between themselves. Should they fail to agree, any controversy or claim arising out of or relating to this contract, or the breach thereof, shall be determined by confidential arbitration administered by the American Arbitration Association in accordance with its International Arbitration Rules. The number of arbitrators shall be one. The place of arbitration shall be New York, New York. The language of the arbitration shall be English. The Parties agree to keep the substance of the arbitration confidential except to the extent commercially necessary. The Parties agree not to make any public statements, written or verbal, or cause or encourage others to make any public statements, written or verbal, that defame, disparage or in any way criticize the personal or business reputation, practices, or conduct of each other, its employees, directors, and officers. The Parties acknowledge and agree that this prohibition extends to statements, written or verbal, made to anyone, including but not limited to, the news media, investors, potential investors, any board of directors or advisory board or directors, industry analysts, competitors, strategic partners, vendors, employees (past and present), and clients. The Parties understand and agree that this Paragraph is a material provision of this Agreement and that any breach of this Paragraph shall be a material breach of this Agreement, and that each Party would be irreparably harmed by violation of this provision. For the avoidance of doubt, any sale of PRODUCTS are on basis of Section XIII of the General Terms and Conditions of Sale and Transfer and not subject to the sentences stated before.
|
(6)
|
This AGREEMENT, and any disputes directly or indirectly arising from or relating to this AGREEMENT, will be construed and controlled by the laws of the State of New York, U.S.A. (without reference to the choice of law rules thereof).
|
(7)
|
This AGREEMENT (including the Exhibits attached hereto) constitutes the final, complete and exclusive agreement of the PARTIES concerning the subject matter hereof, and supersedes any other communication related hereto.
|
(8)
|
This AGREEMENT may be executed in multiple counterparts (which may be exchanged by facsimile or via email by .pdf copies), each of which will be deemed an original and all of which together will constitute one instrument.
|
Product Name
|
VE
|
SAP-Nr.
|
Artikei-Nr.
|
sorbion sachet S 10 x 10 cm US
|
10
|
10012
|
22143004-10
|
sorbion sachet S 20 x 10 cm US
|
10
|
10022
|
22143009-10
|
sorbion sachet S 20 x 20 cm US
|
10
|
20033
|
22143006-10
|
sorbion sachet S 30 x 20 cm US
|
10
|
20039
|
22143007-10
|
Product Name
|
VE
|
SAP-Nr.
|
Artikei-Nr.
|
sorbion sachet S 7,5 x 7,5 cm US
|
10
|
10002
|
22143002-10
|
sorbion sachet S 12,5x10 cm US
|
10
|
10046
|
22143018-10
|
sorbion sachet S Drainage 10 x 10 em US
|
10
|
10048
|
22143008-10
|
sorbion sachet multi star ø 8 cm US
|
10
|
10222
|
22143019-10
|
sorbion sachet multi star ø 14 cm US
|
10
|
10223
|
22143020-10
|
sorbion sachet border 10 x 10 cm
|
10
|
10107
|
22663011-10
|
sorbion sachet border 15 x 15 cm US
|
10
|
10189
|
22663004-10
|
sorbion sachet border 25 x 15 cm US
|
10
|
10188
|
22663009-10
|
sorbion sachet border 25 x 25 cm US
|
10
|
10190
|
22663006-10
|
Product Name
|
VE
|
SAP-Nr.
|
Artikei-Nr.
|
sorbion sana gentle 8,5 x 8,5cm US
|
10
|
10224
|
25523002-10
|
sorbion sana gentle 12 x 12cm US
|
10
|
20225
|
25523004-10
|
sorbion sana gentle 22 x 12cm US
|
10
|
10226
|
25523009-10
|
sorbion sana gentle 22 x 22cm US
|
10
|
10227
|
25523006-10
|
sorbion sana gentle 32 x 22cm US
|
10
|
10228
|
25523007-10
|
sorbion sana multi star iii 11em
|
10
|
10214
|
25143019-10
|
sorbion sana multi star iii 17 em
|
10
|
10217
|
25143020-10
|
Product Name
|
VE
|
SAP-Nr.
|
Article-Nr.
|
price in
€
|
sorbion sachet S 7,5 x 7,5 cm US
|
10
|
10002
|
22143002-
10
|
*****
€
|
sorbion sachet S 10 x 10 cm US
|
10
|
10012
|
22143004-
10
|
*****
€
|
sorbion sachet S 12,5x10cm US
|
10
|
10046
|
22143018-
10
|
*****
€
|
sorbion sachet S 20 x 10 cm US
|
10
|
10022
|
22143009-
10
|
*****
€
|
sorbion sachet S 20 x 20 cm US
|
10
|
10033
|
22143006-
10
|
*****
€
|
sorbion sachet S 30 x 20 cm US
|
10
|
10039
|
22143007-
10
|
*****
€
|
sorbion sachet S Drainage 10 x 10 cm US
|
10
|
10048
|
22143008-
10
|
*****
€
|
sorbion sachet multi star
0
8 cm US
|
10
|
10222
|
22143019-
10
|
*****
€
|
sorbion sachet multi star
0
14 cm US
|
10
|
10223
|
22143020-
10
|
*****
€
|
sorbion sachet border 10 x 10 cm
|
10
|
10107
|
22663011-
10
|
*****
€
|
sorbion sachet border 15 x 15 cm US
|
10
|
10189
|
22663004-
10
|
*****
€
|
sorbion sachet border 25 x 15 cm US
|
10
|
10188
|
22663009-
10
|
*****
€
|
sorbion sachet border 25 x 25 cm US
|
10
|
10190
|
22663006-
10
|
*****
€
|
sorbion sana gentle 8,5 x 8,5cm US
|
10
|
10224
|
25523002-
10
|
*****
€
|
sorbion sana gentle 12 x 12cm US
|
10
|
20225
|
25523004-
10
|
*****
€
|
sorbion sana gentle 22 x 12cm US
|
10
|
10226
|
25523009-
10
|
*****
€
|
sorbion sana gentle 22 x 22cm US
|
10
|
10227
|
25523006-
10
|
*****
€
|
sorbion sana gentle 32 x 22cm US
|
10
|
10228
|
25523007-
10
|
*****
€
|
sorbion sana multi star 0 11 cm
|
10
|
10214
|
25143019-
10
|
*****
€
|
sorbion sana multi star 0 17 cm
|
10
|
10217
|
25143020-
10
|
*****
€
|
2014
|
2015
|
2016
|
2017
|
500.000,00
|
1.000.000,00
|
2.500.000,00
|
4.000.000,00
|
(a)
|
relinquishes, in favor of Alliqua’s rights under the Alliqua-Sorbion Agreement, any and all rights of the Carolon Parties under the Carolon-Sorbion Agreement or otherwise relating to the distribution of Sorbion Products in the Territory (including, but not limited to, any rights to use any trademarks of Sorbion) (collectively, the “
Distribution Rights
”);
|
(b)
|
transfers and assigns to Alliqua all right, title and interest in and to the Transferred Assets; and
|
(c)
|
transfers and assigns to Alliqua all right, title and interest in and to any saleable inventory of the Sorbion Products that are in the possession or control of any of the Carolon Parties (the “
Inventory
”).
|
(a)
|
in consideration of Carolon’s relinquishment of the Distribution Rights and delivery of the Sorbion Termination Agreement, Alliqua agrees to pay the sum of $400,000.00 to Carolon, payments to be made in equal payments of $33,333.33 each over a 12 month period beginning with November 2013; and
|
(b)
|
in consideration of the Transferred Assets,
Alliqua agrees to pay Carolon as follows: (i) $50,000.00 to be paid within two (2) business days after Carolon provides the fully-executed Sorbion Termination Agreement to Alliqua in accordance with
Section 2
above and (ii) $50,000.00 to be paid in January 2015, provided that Alliqua will have no obligation to make such payment to Carolon if Alliqua’s sales of the Sorbion Products that are listed on
Appendix A
are less than $600,000.00 for calendar year 2014.
|
(a)
|
Carolon agrees to assist Alliqua in transferring all Sorbion business to Alliqua.
|
(b)
|
Promptly after the Effective Date, Carolon will provide Alliqua with the following:
|
|
(i)
|
customer information relating to the Sorbion Products, based on Carolon’s marketing, tracking and accounting system (the “
Customer Information
”). This will include (A) all sales information covering date of transaction, customers, products sold, pricing, and territory and (B) information listing all samples shipped.
|
|
(ii)
|
all relevant literature and sales materials relating to the Sorbion Products (the “
Sales Materials
”); and
|
|
(iii)
|
sales training and training materials, including Power Point presentations, relating to the Sorbion Products (the “
Training Materials
”).
|
(c)
|
Carolon agrees to work with Alliqua to transfer to Alliqua information and to provide assistance regarding all sales representatives and other subdistributors that were representing the Sorbion Products on behalf of Carolon immediately prior to the Effective Date (the “
Third Party Sales Force
”).
|
|
(i)
|
The parties will mutually agree on the communications to Third Party Sales Force with regard to the transition of distribution rights for the Sorbion Products from Carolon to Alliqua.
|
|
(ii)
|
Effective as of the Effective Date, Carolon will terminate any agreements between Carolon and the Third Party Sales Force with regard to the distribution of any Sorbion Products in the Territory.
|
|
(iii)
|
The selection of which members of the Sales Force will continue to represent the Sorbion Products for Alliqua will be made with the mutual consent of Carolon, Alliqua and the applicable Sales Force members. If Alliqua and a member of the Sales Force agree that such member will continue to represent the Sorbion Products for Alliqua, Alliqua will negotiate with the Sales Force representative as to the terms of their agreement. Should Alliqua choose not to continue to use a Sales Force currently representing the products for Carolon, Alliqua agrees to pay the Sales Force a monthly commission of 10% for existing business within the territory for 6 months after the Effective Date for facilitating a smooth transition to the new Sales Force.
|
(d)
|
Carolon will transfer any pending orders for Sorbion Products placed by customers prior to the Effective Date (the “
Customer Orders
”) to Alliqua.
|
|
(i)
|
Alliqua will notify Carolon that they are prepared to service a customer or customers.
|
|
(ii)
|
Carolon will maintain an adequate inventory to facilitate the transfer.
|
|
(iii)
|
Carolon will notify Alliqua of any orders it receives after the transfer and will assist Alliqua in directing the customer to Alliqua.
|
(e)
|
Upon request of Alliqua, at any time and from time to time, Carolon will do, execute, acknowledge and deliver, or will cause to be done, executed, acknowledged and delivered, all such further acts, deeds, assignments, transfers, conveyances, and assurances as may be reasonably required to evidence further the relinquishment of the Distribution Rights and the sale, assignment, transfer, conveyance and delivery of the Assets and Inventory to Alliqua.
|
(a)
|
Carolon will defend, indemnify and hold harmless Alliqua and its affiliates and its and their respective officers, directors, employees and agents (collectively, the “
Alliqua Indemnified Parties
”) from and against any and all claims, actions, lawsuits and investigations brought by a third party (“
Third Party Claims
”) and will pay any settlements, awards, fines and reasonable attorney’s fees and expenses and court costs (collectively, “
Losses
”) associated with such Third Party Claims, in each case to the extent arising from or relating to: (i) an actual or alleged breach of this Agreement by Carolon, (ii) the distribution of Sorbion Products by any of the Carolon Parties prior to the Effective Date or (iii) any of the Retained Liabilities.
|
(b)
|
Alliqua will defend, indemnify and hold harmless Carolon and its affiliates and its and their respective officers, directors, employees and agents (collectively, the “
Carolon Indemnified Parties
”) from and against any and all Third Party Claims and will pay any Losses associated with such Third Party Claims, in each case to the extent arising from or relating to: (i) an actual or alleged breach of this Agreement by Alliqua or (ii) the distribution of Sorbion Products by Alliqua after the Effective Date.
|
ALLIQUA BIOMEDICAL, INC.
By:
/s/ James Sapirstein
Print Name: James Sapirstein
Title: CEO-Alliqua Therapeutics
|
CAROLON COMPANY
By:
/s/ L. G. Reid
Print Name: L. G. Reid
Title: President
|
Product Name
|
sorbion sachet S 7,5 x 7,5 cm US
|
sorbion sachet S 12,5x10 cm US
|
sorbion sachet S Drainage 10 x 10 em US
|
sorbion sachet multi star ø 8 cm US
|
sorbion sachet multi star ø 14 cm US
|
sorbion sachet border 10 x 10 cm
|
sorbion sachet border 15 x 15 cm US
|
sorbion sachet border 25 x 15 cm US
|
sorbion sachet border 25 x 25 cm US
|
(v)
|
the good will of the business relating to the distribution of the Sorbion Products; and
|
(vi)
|
any other rights and assets of Carolon that solely relate to the distribution of the Sorbion Products in the Territory.
|
Alliqua, Inc.
|
|||||||||
Outstanding Stock Options
|
|||||||||
At December 31 2012
|
|||||||||
Number of
|
Grant
|
Number of
|
Number of
|
Vesting
|
Expiration
|
Exercise
|
|||
Name
|
Options Granted
|
date
|
Options Vested
|
Options Unvested
|
Date
|
date
|
price
|
LTIP?
|
Notes
|
David Stefansky
|
1,000,000
|
12/09/10
|
1,000,000
|
-
|
12/09/10
|
12/09/20
|
$0.145
|
||
David Stefansky
|
1,000,000
|
12/09/10
|
1,000,000
|
-
|
01/04/11
|
12/09/20
|
$0.145
|
18
|
|
David Stefansky
|
3,000,000
|
12/09/10
|
3,000,000
|
-
|
05/31/12
|
12/09/20
|
$0.145
|
19
|
|
David Stefansky
|
1,666,667
|
03/01/11
|
1,666,667
|
-
|
03/01/11
|
03/01/21
|
$0.210
|
25
|
|
David Stefansky
|
1,666,666
|
05/31/12
|
-
|
1,666,666
|
05/31/13
|
05/31/22
|
$0.200
|
Yes
|
29
|
David Stefansky
|
1,666,667
|
05/31/12
|
-
|
1,666,667
|
05/31/14
|
05/31/22
|
$0.200
|
Yes
|
29
|
David Stefansky
|
1,666,667
|
05/31/12
|
-
|
1,666,667
|
05/31/15
|
05/31/22
|
$0.200
|
Yes
|
29
|
David Stefansky
|
166,666
|
05/31/12
|
-
|
166,666
|
05/31/13
|
05/31/22
|
$0.200
|
No
|
29
|
David Stefansky
|
166,667
|
05/31/12
|
-
|
166,667
|
05/31/14
|
05/31/22
|
$0.200
|
No
|
29
|
David Stefansky
|
166,667
|
05/31/12
|
-
|
166,667
|
05/31/15
|
05/31/22
|
$0.200
|
No
|
29
|
Note 18: all 1,000,000 options vest upon completion of a strategic transaction: creation of Board that fully complies with NYSE Amex Rules (occurred 1/4/11)
|
|||||||||
Note 19: all 3,000,000 options vest upon completion of a strategic transaction: Upon listing of Company on national security exchange (one year estimate)
|
|||||||||
Note 25: all 1,666,667 options vest immediately on grant date
|
|||||||||
Note 29: ISO options issued to David Stefansky pursuant to Employment Agreement - vest in equal 1/3 amounts over the four (4) years in equal 33 1/3% tranches.
|