UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended: March 31, 2017

 

or

 

[  ]       TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _____________ to _____________.

 

Commission File Number: 000-13789

 

MARINA BIOTECH, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   11-2658569
(State or other jurisdiction of   (IRS Employer
incorporation or organization)   Identification No.)

 

17870 Castleton Street, Suite 250

City of Industry, California

  91748
(Address of principal executive offices)   (Zip Code)

 

(626) 964-5788

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

[X]       YES      [  ]      NO

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

[X]       YES      [  ]      NO

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a small reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer [  ] Accelerated filer [  ]
       
Non-accelerated filer [  ] (Do not check if a smaller reporting company) Smaller reporting company [X]
       
    Emerging Growth Company [  ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act: [  ]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)

[  ]        YES       [X]       NO

 

As of May 15, 2017, there were 97,169,153 shares of registrant’s common stock outstanding.

 

 

 

 
 

 

MARINA BIOTECH, INC.

FORM 10-Q

FOR THE THREE MONTHS ENDED MARCH 31, 2017

 

TABLE OF CONTENTS

 

    Page
     
PART I - FINANCIAL INFORMATION 3
     
ITEM 1 Financial Statements (unaudited) 3
     
  Condensed Consolidated Balance Sheets as of March 31, 2017 and December 31, 2016 3
     
  Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2017 and 2016 4
     
  Condensed Consolidated Statement of Stockholders’ Deficit as of December 31, 2016 and March 31, 2017 5
     
  Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2017 and 2016 6
     
  Notes to Condensed Consolidated Financial Statements 7
     
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
     
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk 28
     
ITEM 4. Controls and Procedures 28
     
PART II - OTHER INFORMATION  
     
ITEM 1A. Risk Factors 29
     
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 29
     
ITEM 6. Exhibits 29
     
SIGNATURES 31

 

Items 1, 3, 4 and 5 have not been included as they are not applicable.

 

2
 

 

PART I – FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

MARINA BIOTECH, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

 

    March 31, 2017     December 31, 2016  
    (Unaudited)        
ASSETS                
                 
Current assets                
Cash   $ 216,441     $ 105,347  
Prepaid expenses and other assets     184,676       211,133  
Total current assets     401,117       316,480  
                 
Intangible asset, net     2,213,499       2,311,877  
Goodwill     3,502,829       3,558,076  
      5,716,328       5,869,953  
                 
Total assets   $ 6,117,445     $ 6,186,433  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                 
Current liabilities                
Accounts payable   $ 618,756     $ 663,261  
Accrued expenses     717,547       1,393,521  
Due to related party     200,333       83,166  
Notes payable     436,748       435,998  
Convertible note payable to related party     480,514       250,000  
Fair value of liabilities for price adjustable warrants     244,795       141,723  
Total current liabilities     2,698,693       2,967,669  
                 
Commitments and contingencies (Note 8)                
                 
Stockholders’ equity                
Preferred stock, $0.01 par value; 100,000 shares authorized                
                 

Series C convertible preferred stock, $0.01 par value; $5,100 liquidation preference; 1,200 shares authorized; 1,020 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively

    -       -  
                 
Series D convertible preferred stock, $0.01 par value; $300 liquidation preference; 220 shares authorized; 60 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively     -       -  
                 
Common stock, $0.006 par value; 180,000,000 shares authorized, 97,099,877 and 89,771,379 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively     582,599       538,628  
Additional paid-in capital     5,870,013       4,631,218  
Accumulated deficit     (3,033,860 )     (1,951,082 )
                 
Total stockholders’ equity     3,418,752       3,218,764  
                 
Total liabilities and stockholders’ equity   $ 6,117,445     $ 6,186,433  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

3
 

 

MARINA BIOTECH, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

 

    For the Three Months Ended March 31,  
    2017     2016  
             
Revenue                
                 
License and other revenues   $ -     $ -  
                 
Operating expenses                
                 
Personnel expenses     306,922       83,982  
Research and development     73,431       4,978  
Amortization     98,378       -  
General and administrative     488,522       25,231  
Total operating expenses     967,253       114,191  
                 
Loss from operations     (967,253 )     (114,191 )
                 
Other income (expense)                
                 
Interest expense     (11,653 )     -  
Change in fair value liability of warrants     (103,072 )     -  
      (114,725 )     -  
                 
Loss before provision for income taxes     (1,081,978 )     (114,191 )
                 
Provision for income taxes     800       -  
                 
Net loss   $ (1,082,778 )   $ (114,191 )
                 
Net loss per share – basic and diluted   $ (0.01 )   $ (0.00 )
                 
Weighted average shares outstanding     94,073,396       38,999,995  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4
 

 

MARINA BIOTECH, INC.

Condensed Consolidated Statements of Changes in Equity (Capital Deficiency)

(Unaudited)

 

                Additional              
    Common Stock     Paid-in     Accumulated        
    Number     Par Value     Capital     Deficit     Total  
                               
Balance, December 31, 2016     89,771,379     $ 538,628     $ 4,631,218     $ (1,951,082 )   $ 3,218,764  
                                         
Sale of common stock to related party     862,068       5,172       244,828             250,000  
                                         
Common stock issued for services     300,000       1,800     $ 52,200             54,000  
                                         
Common stock issued for accounts payable     6,153,684       36,923     $ 911,007             947,930  
                                         
Return of common stock for note receivable     (87,254 )     (524 )   $ (30,880 )           (31,404 )
                                         
Restricted stock issued to officer     100,000       600       17,400             18,000  
                                         
Stock option compensation                 44,240             44,240  
                                         
Net loss                       (1,082,778 )     (1,082,778 )
Balance, March 31, 2017     97,099,877     $ 582,599     $ 5,870,013     $ (3,033,860 )   $ 3,418,752  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

5
 

 

MARINA BIOTECH, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

    For the Three Months Ended March 31,  
    2017     2016  
             
Cash Flows Used in Operating Activities:                
                 
Net loss   $ (1,082,778 )   $ (114,191 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Share based compensation     62,240       -  
Common shares issued for third party services     54,000       -  
Warrants issued for services     -       36,470  
Amortization     98,378       -  
Goodwill adjustment     55,247       -  
Fair value liabilities for price adjustable warrants     103,072       -  
Changes in operating assets and liabilities:                
Prepaid expenses and other assets     (4,947 )     -  
Accounts payable     (44,505 )     11,130  
Accrued expenses     278,156       (59,166 )
Due to related party     117,167       (54,150 )
                 
Net Cash used in operating activities     (363,970 )     (179,907 )
                 
Cash Flows from Financing Activities:                
                 
Proceeds from sales of common stock to related party     250,000       -  
Proceed from convertible note, related party     225,064       -  
                 
Net cash provided by financing activities     475,064       -  
                 
Increase (decrease) in cash     111,094       (179,907 )
                 
Cash – Beginning of Period     105,347       261,848  
Cash - End of Period   $ 216,441     $ 81,941  
                 
Supplementary Cash Flow Information:                
Interest paid   $ -     $ -  
Income taxes paid   $ 800     $ -  
                 
Non-cash Investing and Financing Activities:      ,          
Issuance of warrants for services   $ -     $ 36,470  
Common stock issued for accounts payable   $ 947,930     $ -  
Return of common stock for note receivable   $ 31,404     $ -  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

6
 

 

MARINA BIOTECH, INC.

Notes to Condensed Consolidated Financial Statements

FOR THE THREE MONTHS ENDED MARCH 31, 2017

(Unaudited)

 

Note 1 – Nature of Operations, Basis of Presentation and Significant Accounting Policies

 

Reverse Merger with IThenaPharma

 

On November 15, 2016, Marina Biotech, Inc. and subsidiaries (“Marina” or the “Company”) entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among IThenaPharma Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Marina (“Merger Sub”), and Vuong Trieu as the IThena representative (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”). Upon completion of the Merger and subject to the applicable provisions of the Merger Agreement, Merger Sub has ceased to exist and IThena continues as the surviving corporation of the Merger and as a wholly-owned subsidiary of Marina. As consideration for the Merger, Marina issued to the former shareholders of IThena 58,392,828 shares of the Company’s common stock, representing approximately 65% of the issued and outstanding shares of Marina’s common stock following the completion of the Merger. Outstanding warrants to purchase 300,000 shares of common stock of IThena were converted into warrants to purchase common stock of Marina. In addition, Marina appointed Vuong Trieu, the president of IThena, as the Chairman of the Board of Directors of Marina, effective November 15, 2016. Dr. Trieu, in his capacity as the IThena representative, later appointed Philippe P. Calais, Ph.D., as a member of the Board of Directors of Marina effective December 8, 2016, pursuant to the rights granted to the former shareholders of IThena in the Merger Agreement.

 

As the former shareholders of IThena control greater than 50% of the Company subsequent to the Merger, for accounting purposes, the Merger was treated as a “reverse acquisition” and IThena is considered the accounting acquirer. Accordingly, IThena’s historical results of operations replace Marina’s historical results of operations for all periods prior to the Merger, and for all periods following the Merger, the results of operations of both companies are included. IThena accounted for the acquisition of Marina under the purchase accounting method following completion.

 

The purchase price of approximately $3.7 million represents the consideration in the reverse merger transaction and is calculated based on the number of shares of common stock of the combined company that Marina stockholders owned as of the closing of the transaction and the fair value of assets and liabilities assumed by IThena.

 

The number of shares of common stock Marina issued to IThena stockholders is calculated pursuant to the terms of the Merger Agreement based on Marina common stock outstanding as of November 15, 2016, as follows:

 

Shares of Marina common stock outstanding as of November 15, 2016     31,378,551  
Divided by the percentage of Marina ownership of combined company     35 %
Adjusted total shares of common stock of combined company     89,771,379  
Multiplied by the assumed percentage of IThena ownership of combined company     65 %
Shares of Marina common stock issued to IThena upon closing of transaction     58,392,828  

 

The application of the acquisition method of accounting is dependent upon certain valuations and other studies that have yet to be completed. The purchase price allocation will remain preliminary until IThena management determines the fair values of assets acquired and liabilities assumed. The final determination of the purchase price allocation is anticipated to be completed as soon as practicable after completion of the transaction and will be based on the fair values of the assets acquired and liabilities assumed as of the transaction closing date. The final amounts allocated to assets acquired and liabilities assumed could differ significantly from the amounts presented.

 

7
 

 

The purchase price as of March 31, 2017 has been allocated based on a preliminary estimate of the fair value of assets acquired and liabilities assumed:

 

Assets and Liabilities Acquired:        
Cash   $ 5,867  
Net current liabilities assumed (excluding cash)     (1,871,725 )
Identifiable intangible assets     2,361,066  
Debt     (326,037 )
Net assets acquired     169,170  
Goodwill     3,502,829  
Purchase price   $ 3,672,000  

 

The above estimated purchase allocation and goodwill valuation reflects changes in fair value determinations of $55,246 for the three months ended March 31, 2017 and approximately $1,238,000 since the merger date.

 

In connection with the Merger, Marina entered into a License Agreement with Autotelic LLC, a stockholder of IThena and an entity in which Dr. Trieu serves as Chief Executive Officer, pursuant to which (A) Marina licensed to Autotelic LLC certain patent rights, data and technology relating to Familial Adenomatous Polyposis and nasal insulin, for human therapeutics other than for oncology-related therapies and indications, and (B) Autotelic LLC licensed to Marina certain patent rights, data and know-how relating to IT-102 and IT-103, in connection with individualized therapy of pain using a non-steroidal anti-inflammatory drug and an anti-hypertensive without inducing intolerable edema, and treatment of certain aspects of proliferative disease, but not including rights to IT-102/IT-103 for Therapeutic Drug Monitoring (“TDM”) guided dosing for all indications using an Autotelic Inc. TDM Device. We also granted a right of first refusal to Autotelic LLC with respect to any license by us of the rights licensed by or to us under the License Agreement in any cancer indication outside of gastrointestinal cancers.

 

On November 15, 2016, simultaneously with the Merger, Autotelic Inc., a related party, acquired a technology asset (IT-101) from IThena, and IThena’s investment of $479 in a foreign entity from the Company. In exchange for the asset, Autotelic Inc. agreed to cancel its stock purchase warrant agreements (see below), received all of IThena’s then cash balance as payment against the liabilities and agreed to assume the remaining debts and liabilities of IThena, including accounts payable of $71,560, accrued expenses of $11,470, due to related party of $5,375, other liabilities of $118,759, convertible note of $50,000, and accrued interest payable of $567. IThena recognized contributed capital of $257,252 in connection with this transaction.

 

In connection with the Merger, Marina entered into a Line Letter dated November 15, 2016 with Dr. Trieu, our Chairman of the Board, for an unsecured line of credit to be used for current operating expenses in an amount not to exceed $540,000, of which $475,064 had been drawn at March 31, 2017 and $250,000 had been drawn at December 31, 2016. Dr. Trieu considered requests for advances under the Line Letter until April 30, 2017. Dr. Trieu has the right at any time for any reason in his sole and absolute discretion to terminate the line of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice; provided, that Dr. Trieu agreed that he shall not demand the repayment of any advances that are made under the Line Letter prior to the earlier of: (i) May 15, 2017; and (ii) the date on which (x) we make a general assignment for the benefit of our creditors, (y) we apply for or consent to the appointment of a receiver, a custodian, a trustee or liquidator of all or a substantial part of our assets or (z) we cease operations. Dr. Trieu has advanced an aggregate of $475,064 under the Line Letter. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by the Demand Promissory Note issued by us to Dr. Trieu, and are due and payable upon demand by Dr. Trieu.

 

Dr. Trieu has the right, exercisable by delivery of written notice thereof (the “Election Notice”), to either: (i) receive repayment for the entire unpaid principal amount advanced under the Line Letter and the accrued and unpaid interest thereon on the date of the delivery of the Election Notice (the “Outstanding Balance”) or (ii) convert the Outstanding Balance into such number of shares of our common stock as is equal to the quotient obtained by dividing (x) the Outstanding Balance by (y) $0.10 (such price, the “Conversion Price”); provided, that in no event shall the Conversion Price be lower than the lower of (x) $0.28 per share or (y) the lowest exercise price of any securities that have been issued by us in a capital raising transaction (and that would otherwise reduce the exercise price of any other outstanding warrants issued by us) during the period between November 15, 2016 and the date of the delivery of the Election Notice. No capital raising transactions have occurred through the date of this filing with securities at a price lower than $0.28 per share.

 

8
 

 

Further, we entered into a Master Services Agreement (“MSA”) with Autotelic Inc., a stockholder of IThena, pursuant to which Autotelic Inc. agreed to provide certain business functions and services from time to time during regular business hours at our request. See Note 3 for specific terms of the MSA.

 

On November 15, 2016, Marina agreed to issue to Novosom Verwaltungs GmbH (“Novosom”) 1.5 million shares of common stock upon the closing of the Merger in consideration of Novosom’s agreement that the consummation of the Merger would not constitute a “Liquidity Event” under that certain Asset Purchase Agreement dated as of July 27, 2010 between and among Marina, Novosom and Steffen Panzner, Ph.D., and thus that no additional consideration under such agreement would be due to Novosom as a result of the consummation of the Merger.

 

In July 2016, Marina pledged to issue common stock valued at approximately $15,000 to Novosom for the portion due under our July 2010 Asset Purchase Agreement with Novosom, related to Marina’s license agreement with an undisclosed licensee that grants such licensee rights to use Marina’s technology and intellectual property to develop and commercialize products combining certain molecules with Marina’s liposomal delivery technology known as NOV582. In November 2016, we issued 119,048 shares with a value of approximately $15,000 to Novosom as the equity component owed under our July 2016 license agreement.

 

Business Operations

 

IThenaPharma, Inc.

 

IThena is a developer of personalized therapies for combined pain/hypertension through its proprietary Fixed Dose Combination (“FDC”) technology and point of care TDM. Through the combination of these technologies, IThenaPharma is looking to deliver therapies with improved compliance and personalized dosing. IThena’s lead products are the celecoxib FDCs which include IT-102 and IT-103, fixed dose combinations of celecoxib and lisinopril and celecoxib and olmesartan, respectively. IT-102 and IT-103 are being developed as celecoxib without the drug induced edema associated with celecoxib alone. IT-102 and IT-103 are being developed initially for combined arthritis / hypertension and subsequently for treatment of pain, or cancer, or other indications requiring high doses of celecoxib.

 

Marina Biotech, Inc

 

Marina Biotech, Inc. (“Marina”) is a biopharmaceutical company engaged in the discovery, acquisition, development and commercialization of proprietary drug therapeutics for addressing significant unmet medical needs in the U.S., Europe and additional international markets. Marina’s primary therapeutic focus is the disease intersection of hypertension, arthritis, pain, and oncology allowing for innovative combination therapies of the plethora of already approved drugs and the proprietary novel oligotherapeutics of Marina.

 

Marina currently has three clinical development programs underway: (i) next generation celecoxib program drug candidates IT-102 and IT-103, each of which is a fixed dose combination of celecoxib and either lisinopril (IT-102) or olmesartan (IT-103); (ii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication of Familial Adenomatous Polyposis (“FAP”); and (iii) CEQ508 combined with IT-103 to treat Colorectal Cancer (“CRC”).

 

Summary of Significant Accounting Policies

 

Basis of Presentation

 

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP”) for complete financial statements. The accompanying unaudited financial information should be read in conjunction with the audited consolidated financial statements, including the notes thereto, as of and for the year ended December 31, 2016, included in our 2016 Annual Report on Form 10-K filed with the SEC. The information furnished in this report reflects all adjustments (consisting of normal recurring adjustments), which are, in the opinion of management, necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented. The results of operations for the three months ended March 31, 2017 are not necessarily indicative of the results for the year ending December 31, 2017 or for any future period.

 

9
 

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of IThenaPharma Inc. and Marina Biotech, Inc. and the wholly-owned subsidiaries, Cequent, MDRNA, and Atossa, and eliminate any inter-company balances and transactions.

 

Going Concern and Management’s Liquidity Plans

 

The accompanying condensed consolidated financial statements have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At March 31, 2017, we had an accumulated deficit of $3,033,860 and a negative working capital of $2,297,576. We anticipate that we will continue to incur operating losses as we execute our plan to raise additional funds and investigate strategic and business development initiatives. In addition, we have had and will continue to have negative cash flows from operations. We have previously funded our losses primarily through the sale of common and preferred stock and warrants, the sale of notes, revenue provided from our license agreements and, to a lesser extent, equipment financing facilities and secured loans. In 2016 and 2015, we funded operations with a combination of the issuance of notes and preferred stock, and license-related revenues. At March 31, 2017, we had a cash balance of $216,441. Our operating activities consume the majority of our cash resources.

 

There is substantial doubt about our ability to continue as a going concern, which may affect our ability to obtain future financing or engage in strategic transactions, and may require us to curtail our operations. We cannot predict, with certainty, the outcome of our actions to generate liquidity, including the availability of additional debt financing, or whether such actions would generate the expected liquidity as currently planned.

 

Use of Estimates

 

The preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Significant areas requiring the use of management estimates include valuation allowance for deferred income tax assets. Actual results could differ from such estimates under different assumptions or circumstances.

 

Fair Value of Financial Instruments

 

We consider the fair value of cash, accounts payable, due to related parties, notes payable, convertible notes payable and accrued liabilities not to be materially different from their carrying value. These financial instruments have short-term maturities. We follow authoritative guidance with respect to fair value reporting issued by the Financial Accounting Standards Board (“FASB”) for financial assets and liabilities, which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:

 

Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
   
Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
   
Level 3: Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use.

 

10
 

 

Our cash is subject to fair value measurement and is determined by Level 1 inputs. We measure the liability for committed stock issuances with a fixed share number using Level 1 inputs. We measure the liability for price adjustable warrants and certain features embedded in notes, using the probability adjusted Black-Scholes option pricing model (“Black-Scholes”), which management has determined approximates values using more complex methods, using Level 3 inputs. The following tables summarize our liabilities measured at fair value on a recurring basis as of December 31, 2016 and March 31, 2017:

 

   

Balance at

December 31, 2016

    Level 1
Quoted
prices in
active
markets for
identical
assets
    Level 2
Significant
other
observable
inputs
    Level 3
Significant
unobservable inputs
 
Liabilities:                                
Fair value liability for price adjustable warrants   $ 141,723     $ -     $ -     $ 141,723  
Total liabilities at fair value   $ 141,723     $ -     $ -     $ 141,723  

 

   

Balance at
March 31, 2017

    Level 1
Quoted
prices in
active
markets for
identical
assets
    Level 2
Significant
other
observable
inputs
   

Level 3
Significant
unobservable

inputs

 
Liabilities:                                
Fair value liability for price adjustable warrants   $ 244,795     $ -     $ -     $ 244,795  
Total liabilities at fair value   $ 244,795     $ -     $ -     $ 244,795  

 

The following presents activity of the fair value liability of price adjustable warrants determined by Level 3 inputs for the period ended March 31, 2017:

 

    Fair value
liability for
price
adjustable
warrants
 
       
Balance at December 31, 2016   $ 141,723  
Fair value of warrants issued     -  
Exercise of warrants     -  
Change in fair value included in condensed consolidated statement of operations     103,072  
Balance at March 31, 2017   $ 244,795  

 

The fair value liability of price adjustable warrants for the three months ended March 31, 2017 was determined using the probability adjusted Black-Scholes option pricing model using exercise prices of $0.28 to $0.75, stock price of $0.28, volatility of 123% to 184%, contractual lives of 2.5 to 6 years, and risk free rates of 0.62% to 1.93%.

 

11
 

 

Impairment of Long-Lived Assets

 

We review all of our long-lived assets for impairment indicators throughout the year and perform detailed testing whenever impairment indicators are present. In addition, we perform detailed impairment testing for indefinite-lived intangible assets at least annually at December 31. When necessary, we record charges for impairments. Specifically:

 

For finite-lived intangible assets, such as developed technology rights, and for other long-lived assets, we compare the undiscounted amount of the projected cash flows associated with the asset, or asset group, to the carrying amount. If the carrying amount is found to be greater, we record an impairment loss for the excess of book value over fair value. In addition, in all cases of an impairment review, we re-evaluate the remaining useful lives of the assets and modify them, as appropriate; and
   
For indefinite-lived intangible assets, such as acquired in-process R&D assets, each year and whenever impairment indicators are present, we determine the fair value of the asset and record an impairment loss for the excess of book value over fair value, if any.

 

Management determined that no impairment indicators were present and that no impairment charges were necessary as of March 31, 2017 or December 31, 2016.

 

Net Income (Loss) per Common Share

 

Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share includes the effect of common stock equivalents (stock options, unvested restricted stock, and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. Net income (loss) is adjusted for the dilutive effect of the change in fair value liability for price adjustable warrants, if applicable. The following number of shares have been excluded from diluted net income (loss) since such inclusion would be anti-dilutive:

 

    Three Months Ended March 31,  
    2017     2016  
             
Stock options outstanding     2,334,000       -  
Warrants     27,029,995       139,173  
Convertible Notes Payable     1,716,123       -  
Total     31,080,118       139,173  

 

Subsequent Events

 

Except for the event(s) discussed in Note 9, there were no subsequent events that required recognition or disclosure. The Company evaluated subsequent events through the date the financial statements were issued and filed with the Securities and Exchange Commission.

 

Note 2 – Intangible Assets

 

As part of the Merger, the Company allocated $3,502,829   to goodwill. Additionally, a substantial portion of the assets acquired were allocated to identifiable intangible assets. The fair value of the identifiable intangible asset is determined primarily using the “income approach,” which requires a forecast of all the expected future cash flows.

 

12
 

 

The following table summarizes the estimated fair value of the identifiable intangible asset acquired, their useful life, and method of amortization:

 

    Estimated
Fair Value
    Estimated
Useful Life
(Years)
    Annual
Amortization
Expense
 
Intangible asset   $ 2,361,066       6     $ 393,511  

 

The net intangible asset was $2,213,499, net of accumulated amortization of $147,567, as of March 31, 2017. Amortization expense was $98,378 and $0 for the three months ended March 31, 2017 and 2016, respectively.

 

Note 3 - Related Party Transactions

 

Due to Related Party

 

The Company and other related entities have a commonality of ownership and/or management control, and as a result, the reported operating results and /or financial position of the Company could significantly differ from what would have been obtained if such entities were autonomous.

 

The Company has a Master Services Agreement (“MSA”) with a related party, Autotelic Inc., effective January 1, 2015. Autotelic Inc. owns less than 10% of the Company. The MSA states that Autotelic Inc. will provide business functions and services to the Company and allows Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA includes personnel costs allocated based on amount of time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The MSA between Marina and Autotelic Inc. was effective on the reverse merger date of November 15, 2016.

 

During the period commencing January 1, 2015 (the “Effective Date”) and ending on the date that the Company has completed an equity offering of either common or preferred stock in which the gross proceeds therefrom is no less than $10,000,000 (the “Equity Financing Date”), the Company shall pay Autotelic the following compensation: cash in an amount equal to the actual labor cost (paid on a monthly basis), plus warrants for shares of the Company’s common stock with a strike price equal to the fair market value of the Company’s common stock at the time said warrants are issued. The Company shall also pay Autotelic for the services provided by third party contractors plus 20% mark up. The warrant price per share is calculated based on the Black-Scholes model.

 

After the Equity Financing Date, the Company shall pay Autotelic Inc. a cash amount equal to the actual labor cost plus 100% mark up of provided services and 20% mark up of provided services by third party contractors or material used in connection with the performance of the contracts, including but not limited to clinical trial, non-clinical trial, Contract Manufacturing Organizations (“CMO”), U.S. Food & Drug Administration (“FDA”) regulatory process, Contract Research Organizations (“CRO”) and Chemistry and Manufacturing Controls (“CMC”).

 

In accordance with the MSA, Autotelic Inc. billed the Company for personnel and service expenses Autotelic Inc. incurred on behalf of the Company. Personnel cost charged by Autotelic Inc. were $158,140 and $41,991 for the three months ended on March 31, 2017 and 2016, respectively. For the three months ended March 31, 2017 and 2016, Autotelic Inc. billed a total of $213,103 and $72,231, including personnel costs (above), respectively. The unpaid balance of $200,333 is recorded as due to related party in the accompanying balance as of March 31, 2017. The Company agreed to issue warrants at a future date for the remaining balance due of $178,572, which is included in accrued expenses as of March 31, 2017.

 

Convertible Notes Payable

 

In July 2016, IThena issued convertible promissory notes with an aggregate principal balance of $50,000 to related-party investors. Borrowings under each of these convertible notes bore interest at 3% per annum and these notes mature on June 30, 2018. Upon the completion of certain funding events, the Company has the right to convert the outstanding principal amount of these notes into shares of the Company’s common stock at $1.80 per share. The notes were assumed by Autotelic Inc. on November 15, 2016 as part of its acquisition of the technology asset (IT-101).

 

13
 

 

Convertible Notes Payable, Dr. Trieu

 

In connection with the Merger, Marina entered into the Line Letter dated November 15, 2016 with Dr. Trieu, our Chairman of the Board, for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses, as described in Note 1 above. Dr. Trieu has advanced an aggregate of $475,064     under the Line Letter as of March 31, 2017. Accrued interest on the Line Letter was $5,450 as of March 31, 2017 and is included in convertible notes payable to related parties on the accompanying balance sheets.

 

On April 4, 2017, the Company entered into a Line Letter with Autotelic Inc., a stockholder of IThenaPharma that became the holder of 5,255,354 shares of Marina common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board, for an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses. Autotelic Inc. will consider requests for advances under the Line Letter until September 1, 2017. Autotelic Inc. shall have the right at any time for any reason in its sole and absolute discretion to terminate the line of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice; provided, that Autotelic Inc. agreed that it shall not demand the repayment of any advances that are made under the Line Letter prior to the earlier of: (i) October 4, 2017; and (ii) the date on which (x) we make a general assignment for the benefit of our creditors, (y) we apply for or consents to the appointment of a receiver, a custodian, a trustee or liquidator of all or a substantial part of our assets or (z) we cease operations. Advances made under the Line Letter shall bear interest at the rate of five percent (5%) per annum, shall be evidenced by the Demand Promissory Note issued to Autotelic Inc., and shall be due and payable upon demand by Autotelic, Inc.

 

Note 4 – Notes Payable

 

Note Purchase Agreement

 

On June 20, 2016, Marina entered into a Note Purchase Agreement (the “Purchase Agreement”) with certain investors (the “Purchasers”), pursuant to which Marina issued to the Purchasers unsecured promissory notes in the aggregate principal amount of $300,000 (the “Notes”). Interest shall accrue on the unpaid principal balance of the Notes at the rate of 12% per annum beginning on September 20, 2016. The Notes will become due and payable on June 20, 2017, provided, that, upon the closing of a financing transaction that occurs while the Notes are outstanding, each Purchaser shall have the right to either: (i) accelerate the maturity date of the Note held by such Purchaser or (ii) convert the entire outstanding principal balance under the Note held by such Purchaser and accrued interest thereon into Marina’s securities that are issued and sold at the closing of such financing transaction.

 

Further, if we at any time while the Notes are outstanding receive any cash payments in the aggregate amount of not less than $250,000, as a result of the licensing, partnering or disposition of any of the technology held by us or any related product or asset, we shall pay to the holders of the Notes, on a pro rata basis, an amount equal to 25% of each payment actually received by us, which payments shall be applied against the outstanding principal balance of the Notes and the accrued and unpaid interest thereon, until such time as the Notes are repaid in full.

 

As of March 31, 2017, the accrued interest expense on the Notes amounted to $21,225, with a total balance of principal and interest of $321,225.

 

In the Purchase Agreement, Marina agreed: (x) to extend the termination date of all of the warrants to purchase shares of Marina common stock (such warrants, the “Prior Warrants”) that were delivered to the purchasers pursuant to that certain Note and Warrant Purchase Agreement, dated as of February 10, 2012 between Marina and the purchasers identified on the signature pages thereto, as it has been amended to date, to February 10, 2020 and (y) to extend the exercise price protection afforded of the Prior Warrants so that such protection would apply to any financing transaction effected on or prior to June 19, 2017 (with any such adjustment only applying to 80% of the Prior Warrants, and with such protection not resulting in the issuance of any additional shares of Marina common stock). As the Prior Warrants were already recorded at fair value as a result of price adjustable terms, the impacts of the modification of the terms is included in the change in fair value of price adjustable warrants in the statement of operations.

 

These notes were assumed by IThena in connection with the Merger.

 

14
 

 

Note Payable – Service Provider

 

On December 28, 2016, we entered into an Agreement and Promissory Note with a law firm for past services performed totaling $121,523. The note calls for monthly payments of $6,000 per month, beginning with an initial payment on March 31, 2017. The note is unsecured and non-interest bearing. The note will be considered paid in full if the Company pays $100,000 by December 31, 2017. The balance due on the note was $115,523 as of March 31, 2017.

 

Note 5 – Stockholders’ Equity

 

Preferred Stock

 

Marina designated 1,000 shares as Series B Preferred Stock (“Series B Preferred”) and 90,000 shares as Series A Junior Participating Preferred Stock (“Series A Preferred”). No shares of Series B Preferred or Series A Preferred are outstanding. In March 2014, Marina designated 1,200 shares as Series C Convertible Preferred Stock (“Series C Preferred”). In August 2015, Marina designated 220 shares as Series D Convertible Preferred Stock (“Series D Preferred”).

 

In August 2015, Marina entered into a Securities Purchase Agreement with certain investors pursuant to which Marina sold 220 shares of Series D Preferred, and warrants to purchase up to 3.44 million shares of Marina’s common stock at an initial exercise price of $0.40 per share before August 2021, for an aggregate purchase price of $1.1 million. Marina incurred $0.01 million of stock issuance costs in conjunction with the Series D Preferred, which were netted against the proceeds. The warrants issued in connection with Series D Preferred contain an exercise price protection provision whereby the exercise price per share to purchase common stock covered by these warrants is subject to reduction in the event of certain dilutive stock issuances at any time within two years of the issuance date, but not to be reduced below $0.28 per share. Any such adjustment will not result in the issuance of any additional shares of Marina’s common stock. Each share of Series D Preferred has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $0.40 per share. The Series D Preferred is initially convertible into an aggregate of 2,750,000 shares of Marina’s common stock, subject to certain limitations and adjustments, has a 5% stated dividend rate, is not redeemable and has voting rights on an as-converted basis.

 

To account for the issuance of the Series D Preferred and warrants, Marina first assessed the terms of the warrants and determined that, due to the exercise price protection provision, they should be recorded as derivative liabilities. Marina determined the fair value of the warrants on the issuance date and recorded a liability and a discount of $0.6 million on the Series D Preferred resulting from the allocation of proceeds to the warrants. Marina then determined the effective conversion price of the Series D Preferred which resulted in a beneficial conversion feature of $0.7 million. The beneficial conversion feature was recorded as both a debit and a credit to additional paid-in capital and as a deemed dividend on the Series D Preferred in determining net income applicable to common stock holders in the consolidated statements of operations.

 

Each share of Series C Preferred has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $0.75 per share. In June 2015, an investor converted 90 shares of Series C Preferred into 600,000 shares of common stock with a value of $0.54 per share. In November 2015, an investor converted an additional 90 shares of Series C Preferred into 600,000 shares of common stock with a value of $0.31 per share. Also in November 2015, an investor converted 50 shares of Series D Preferred into 625,000 shares of common stock with a value of $0.28 per share.  

 

In February 2016, an investor converted 110 shares of Series D Preferred into 1,375,000 shares of common stock with a value of $0.15 per share.

 

15
 

 

Common Stock

 

Holders of our common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the holders of our common stock. Subject to the rights of the holders of any class of our capital stock having any preference or priority over our common stock, the holders of our common stock are entitled to receive dividends that are declared by our board of directors out of legally available funds. In the event of our liquidation, dissolution or winding-up, the holders of common stock are entitled to share ratably in our net assets remaining after payment of liabilities, subject to prior rights of preferred stock, if any, then outstanding. Our common stock has no preemptive rights, conversion rights, redemption rights or sinking fund provisions, and there are no dividends in arrears or default. All shares of our common stock have equal distribution, liquidation and voting rights, and have no preferences or exchange rights. Our common stock currently trades on the OTCQB tier of the OTC Markets.

 

In February 2017, we entered into two privately negotiated transactions pursuant to which we issued an aggregate of 6,153,684 shares of our common stock for an effective price per share of $0.29 to settle aggregate liability of approximately $948,000, which is reflected in accrued expenses as of December 31, 2016.

 

In February 2017, we issued 300,000 shares of our common stock with a fair value of $0.18 per share to a consultant providing investment advisory services.

 

In February 2017, we issued 100,000 restricted shares of our common stock with a fair value of $0.14 per share to our CEO for services.

 

On February 6, 2017, we entered into a Stock Purchase Agreement with LipoMedics, a related party, pursuant to which we issued to LipoMedics an aggregate of 862,068 shares of our common stock for a total purchase price of $250,000.

 

On March 31, 2017, we entered into a Settlement Agreement, whereby a note receivable for $45,000 was settled with a cash payment by the note holder to the Company of $14,049, the surrender of 60,000 warrants, and the surrender of 87,254 shares of common stock held by the noteholder, which were cancelled effective March 31, 2017.

 

Warrants

 

As of March 31, 2017, there were 27,029,995   warrants outstanding, with a weighted average exercise price of $0.43 per share, and annual expirations as follows:

 

Expiring in 2017     2,100,545  
Expiring in 2018     113,831  
Expiring in 2019     6,000,000  
Expiring in 2020     11,890,792  
Expiring in 2021     3,437,500  
Expiring thereafter     3,487,327  
      27,029,995  

 

Note 6 — Stock Incentive Plans

 

Stock Options

 

Stock option activity was as follows:

 

    Options Outstanding  
    Shares     Weighted
Average
Exercise Price
 
Outstanding, December 31, 2016     1,688,106     $ 3.68  
Options granted     646,000       0.17  
Options expired     (106 )     526.40  
Outstanding, March 31, 2017     2,334,000       2.69  
Exercisable, March 31, 2017     1,931,000     $ 3.21  

 

16
 

 

The following table summarizes additional information on Marina’s stock options outstanding at March 31, 2017:

 

      Options Outstanding     Options Exercisable  

Range of

Exercise
Prices

    Number
Outstanding
    Weighted-
Average
Remaining
Contractual
Life (Years)
    Weighted
Average
Exercise
Price
    Number
Exercisable
    Weighted
Average
Exercise Price
 
$ 0.10       140,000       4.63     $ 0.10       140,000     $ 0.10  
$ 0.17 - .018       646,000       4.80       0.17       243,000       0.17  
$ 0.26 - 0.82       484,000       3.24       0.46       484,000       0.46  
$ 1.07 - $2.20       1,021,500       6.24       1.07       1,021,500       1.07  
$ 47.60 - $87.60       21,000       1.19       67.60       21,000       67.60  
$ 127.60 - $207.60       21,500       1.19       158.30       21,500       158.30  
  Totals       2,334,000       5.03     $ 3.68       1,931,000     $ 3.21  

 

Weighted-Average Exercisable Remaining Contractual Life (Years) 5.08

 

In January 2017, the Company granted a total of 486,000 stock options to directors and officers for services. One-half of the options vest immediately and one-half of the options vest on the one year anniversary of the grant date. The options have an exercise price of $0.17 and a five-year term.

 

In February 2017, the Company granted a total of 160,000 stock options to key employees for services. The options vest on the one year anniversary of the grant date, have an exercise price of $0.18, and have a five-year term.

 

At March 31, 2017, we had $51,901 of total unrecognized compensation expense related to unvested stock options. Total expense related to stock options was $44,240 for the three months ended March 31, 2017.

 

At March 31, 2017, the intrinsic value of options outstanding or exercisable was $99,300 as there were 1,018,000 options outstanding with an exercise price less than $0.28, the per share closing market price of our common stock at that date.

 

Note 7 — Intellectual Property and Collaborative Agreements

 

Novosom Agreements

 

In July 2010, Marina entered into an agreement pursuant to which Marina acquired intellectual property for Novosom’s SMARTICLES-based liposomal delivery system. In February 2016, Marina issued Novosom 0.21 million shares of common stock valued at $0.06 million.

 

In March 2016, Marina entered into a license agreement covering certain of Marina’s platforms for the delivery of an undisclosed genome editing technology. Under the terms of the agreement, Marina received an upfront license fee of $0.25 million and could receive up to $40 million in success-based milestones. In April 2016, Marina issued Novosom 0.47 million shares of common stock valued at $0.075 million for amounts due under this agreement.

 

In July 2016, Marina entered into a license agreement with an undisclosed licensee that grants such licensee rights to use Marina’s technology and intellectual property to develop and commercialize products combining certain molecules with Marina’s liposomal delivery technology known as NOV582. Under the terms of this agreement, the licensee agreed to pay to us an upfront license fee in the amount of $0.35 million (to be paid in installments through the end of 2017), along with milestone payments on a per-licensed-product basis and royalty payments in the low single digit percentages. As of September 30, 2016, Marina had received $0.05 million per the terms of this license agreement. In November 2016, we issued 0.12 million shares with a value of $0.015 million to Novosom as the equity component owed under Marina’s July 2016 license agreement.

 

17
 

 

Arrangements with LipoMedics

 

On February 6, 2017, we entered into a License Agreement (the “License Agreement”) with LipoMedics, Inc., a related party (“LipoMedics”), pursuant to which, among other things, we provided to LipoMedics a license to our SMARTICLES platform for further development of Lipomedics’s proprietary phospholipid nanoparticles that can deliver protein, small molecule drugs, and peptides. These are not currently being developed at Marina Biotech and Marina Biotech has no IP around these products. On the same date, we also entered into a Stock Purchase Agreement with LipoMedics pursuant to which we issued to LipoMedics an aggregate of 862,068 shares of our common stock for a total purchase price of $250,000.

 

Under the terms of the License Agreement, we could receive up to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if LipoMedics determines to pursue further development and commercialization of products under the License Agreement, LipoMedics agreed, in connection therewith, to purchase shares of our common stock for an aggregate purchase price of $500,000, with the purchase price for each share of common stock being the greater of $0.29 or the volume weighted average price of our common stock for the thirty (30) trading days immediately preceding the date on which LipoMedics notifies us that it intends to pursue further development or commercialization of a licensed product.

 

If LipoMedics breaches the License Agreement, we shall have the right to terminate the License Agreement effective sixty (60) days following delivery of written notice to LipoMedics specifying the breach, if LipoMedics fails to cure such material breach within such sixty (60) day period. LipoMedics may terminate the License Agreement by giving thirty (30) days’ prior written notice to us.

 

Vuong Trieu, Ph.D., the Chairman of the Board of Directors of the Company (the “Board”), is the Chairman of the Board and Chief Operating Officer of LipoMedics.

 

In consideration Lipomedics agreed to the following fee schedule: 1) Evaluations License Fee. Simultaneous with the execution and delivery of this Agreement, Lipomedics shall enter into a Stock Purchase Agreement in form and substance reasonably acceptable to Marina and Lipomedics, pursuant to which Marina will sell to Lipomedics shares of the common stock of Marina for an aggregate purchase price of $250,000, with the purchase price for each share of Marina common stock being $0.29. 2) Commercial License Fee. Unless this Agreement is earlier terminated, within thirty (30) days following Lipomedics’s delivery of an Evaluation Notice advising that it intends to pursue, or cause to be pursued, further development and commercialization of Licensed Products. 3) For up to and including three Licensed Products, Lipomedics shall pay to Marina a milestone (collectively the “Sales Milestones”) of Ten Million Dollars ($10,000,000) upon reaching Commercial Sales in the Territory in any given twelve month period equal to or greater than Five Hundred Million Dollars ($500,000,000) for a given Licensed Product and of Twenty Million Dollars ($20,000,000) upon reaching Commercial Sales in any given twelve month period equal to or greater than One Billion Dollars ($1,000,000,000) for such Licensed Product, such payments to be made within thirty (30) days following the month in which such Commercial Sale targets are met.

 

Note 8 – Commitments and Contingencies

 

Litigation

 

Because of the nature of the Company’s activities, the Company is subject to claims and/or threatened legal actions, which arise out of the normal course of business. Management is currently not aware of any pending lawsuits.

 

Note 9 - Subsequent Events   

 

On April 13, 2017, the Company entered into a Compromise and Release Agreement to settle $36,047 due to a service provider for $15,957 in cash and $20,090 of the Company’s common stock at $0.29 per share (for a total issuance of 69,276 shares). The Company issued 69,276 shares to the service provider in May 2017.

 

18
 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Forward-Looking Statements

 

This report contains forward-looking statements. The following discussion should be read in conjunction with the financial statements and related notes contained in our Annual Report on Form 10-K, as filed with the Securities & Exchange Commission on March 31, 2017. Certain statements made in this discussion are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are projections in respect of future events or financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements made in a quarterly report on Form 10-Q may include statements about:

 

our ability to obtain additional and substantial funding for our company on an immediate basis, whether pursuant to a capital raising transaction arising from the sale of our securities, a strategic transaction or otherwise;
   
our ability to attract and/or maintain research, development, commercialization and manufacturing partners;
   
the ability of our company and/or a partner to successfully complete product research and development, including pre-clinical and clinical studies and commercialization;
   
the ability of our company and/or a partner to obtain required governmental approvals, including product and patent approvals;
   
the ability of our company and/or a partner to develop and commercialize products that can compete favorably with those of our competitors;
   
the timing of costs and expenses related to the research and development programs of our company and/or our partners;
   
the timing and recognition of revenue from milestone payments and other sources not related to product sales;
   
our ability to obtain suitable facilities in which to conduct our planned business operations on acceptable terms and on a timely basis;
   
our ability to satisfy our disclosure obligations under the Securities Exchange Act of 1934, as amended, and to maintain the registration of our common stock thereunder;
   
our ability to attract and retain qualified officers, employees and consultants as necessary; and
   
the costs associated with any product liability claims, patent prosecution, patent infringement lawsuits and other lawsuits.

 

These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled “Risk Factors” set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities & Exchange Commission on March 31, 2017, any of which may cause our company’s or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks may cause the Company’s or its industry’s actual results, levels of activity or performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements.

 

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity or performance. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The Company is under no duty to update any forward-looking statements after the date of this report to conform these statements to actual results.

 

As used in this quarterly report and unless otherwise indicated, the terms “we,” “us,” “our” or the “Company” refer to Marina Biotech, Inc., a Delaware corporation. Unless otherwise specified, all dollar amounts are expressed in United States dollars. Our common stock is currently listed on the OTC Market, OTCQB tier, under the symbol “MRNA”.

 

19
 

 

Corporate Overview

 

We are a biopharmaceutical company engaged in the discovery, acquisition, development and commercialization of proprietary drug therapeutics for addressing significant unmet medical needs in the U.S., Europe and international markets. Our primary therapeutic focus is the disease intersection of hypertension, arthritis, pain, and oncology allowing for the innovative combination therapies from already approved drugs and the proprietary novel oligotherapeutics of Marina Biotech, Inc. (“Marina”). Our approach is meant to reduce the risk associated with developing a new drug and to also accelerate the time to commercialization by shortening the clinical development program through leveraging what is already known or can be learned in our proprietary Patient Level Database (“PLD”).

 

We currently have three clinical development programs underway including (i) our next generation celecoxib program drug candidates IT-102 and IT-103, each of which is a fixed dose combination of celecoxib and either lisinopril (IT-102) or olmesartan (IT-103), (ii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication of Familial Adenomatous Polyposis (“FAP”); and (iii) CEQ508 combined with IT-103 to treat Colorectal Cancer (“CRC”).

 

Our preclinical pipeline also includes oligotherapeutics for bladder cancer, Inflammatory Bowel Disease (“IBD”), and Duchenne Muscular Dystrophy. Preclinical proof of concept studies have been completed with respect to bladder cancer and IBD.

 

Although we intend to retain ownership and control of product candidates by advancing their development, we will also consider partnerships with pharmaceutical or biopharmaceutical companies in order to reduce time to market and to balance the risks associated with drug discovery and development, thereby maximizing our stockholders’ value. Our partnering objectives include generating revenue through license fees, milestone-related development fees and royalties by licensing rights to our product candidates, which would be a source of non-dilutive capital.

 

We may engage in licensing activities associated with our delivery platforms (SMARTICLES and tk RNAi). However, since our strategy is to be a late-stage biopharmaceutical company with the goal of a commercial product launch and profitability within the next several years, the development and licensing of these platforms for the therapeutic assets of third parties will not be the primary focus of our company.

 

Background and Corporate Developments

 

Merger with IThenaPharma

 

On November 15, 2016, Marina entered into an Agreement and Plan of Merger with IThenaPharma, Inc., a Delaware corporation (“IThena” or “IThenaPharma”), IThena Acquisition Corporation, a Delaware corporation and a wholly-owned subsidiary of IThena (“Merger Sub”), and Vuong Trieu, Ph.D. as the IThena Representative (the “Merger Agreement”), pursuant to which, among other things, Merger Sub merged with and into IThena, with IThena surviving as a wholly owned subsidiary of Marina (such transaction, the “Merger”). Pursuant to the Merger Agreement, at the effective time of the Merger, without any action on the part of any shareholder, each issued and outstanding share of IThenaPharma’s common stock, other than shares to be cancelled pursuant to the Merger Agreement, was converted into the right to receive 10.510708 shares of Marina common stock (the “Exchange Ratio”). IThenaPharma shareholders were not entitled to receive fractional shares in the Merger. Instead, a holder of IThenaPharma’s common stock that would otherwise have been entitled to receive a fractional share of Marina common stock in the Merger received one full additional share of Marina common stock. In addition, in connection with the Merger, each outstanding IThenaPharma warrant was assumed by Marina and converted into a warrant representing the right to purchase shares of Marina common stock, with the number of shares underlying such warrant and the exercise price thereof being adjusted by the Exchange Ratio, with any fractional shares rounded down to the next lowest number of whole shares. As a result of the Merger, the former holders of IThenaPharma common stock immediately prior to the completion of the Merger owned approximately 65% of the issued and outstanding shares of Marina common stock immediately following the completion of the Merger.

 

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Marina was incorporated under the laws of the State of Delaware under the name Nastech Pharmaceutical Company on September 23, 1983, and IThena was incorporated under the laws of the State of Delaware on September 3, 2014. IThena is deemed to be the accounting acquirer in the Merger, and thus the historical financial statements of IThena are treated as the historical financial statements of our company and are reflected in our quarterly and annual reports for periods ending after the effective time of the Merger, or November 15, 2016. Accordingly, beginning with our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as filed with the Securities & Exchange Commission on March 31, 2017, we reported the results of IThena and Marina and their respective subsidiaries on a consolidated basis.

  

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Autotelic LLC License Agreement

 

In connection with the Merger Agreement and the closing of the Merger, on November 15, 2016, Marina entered into a License Agreement with Autotelic LLC (the “License Agreement”), a stockholder of IThenaPharma that became the holder of 23,123,558 shares of Marina common stock as a result of the Merger, and an entity of which Dr. Trieu, the Chairman of our Board of Directors (the “Board) serves as Chief Executive Officer, pursuant to which (i) Marina licensed to Autotelic LLC certain patent rights, data and know-how relating to FAP and nasal insulin, for human therapeutics other than for oncology-related therapies and indications, and (ii) Autotelic LLC licensed to Marina certain patent rights, data and know-how relating to IT-102 and IT-103, in connection with individualized therapy for pain using a non-steroidal anti-inflammatory drug and an anti-hypertensive without inducing intolerable edema, and treatment of certain aspects of proliferative disease, but not including rights to IT-102/IT-103 for TDM guided dosing for all indications using an Autotelic LLC TDM Device. Marina also granted a right of first refusal to Autotelic LLC with respect to any license by Marina of the rights licensed by or to Marina under the License Agreement in any cancer indication outside of gastrointestinal cancers.

 

The License Agreement shall immediately terminate, all rights granted by a licensor under the License Agreement shall immediately revert forthwith to the applicable licensor, all benefits which have accrued under the License Agreement shall automatically be transferred to the applicable licensor, and all rights, title and interest in the licensed intellectual property shall immediately revert back to the applicable licensor if: (i) the applicable licensee makes a general assignment for the benefit of its creditors prior to the two (2) year anniversary of the date of the License Agreement; (ii) the applicable licensee applies for or consents to the appointment of a receiver, a custodian, a trustee or liquidator of all or a substantial part of its intellectual property prior to the two (2) year anniversary of the date of the License Agreement; (iii) prior to the two (2) year anniversary of the date of the License Agreement, and without the consent of the applicable licensor, the applicable licensee effects a Change of Control Transaction (as defined in the License Agreement); (iv) the applicable licensee ceases operations; or (v) the applicable licensee fails to take any material steps, as reasonably determined by the applicable licensor, to develop the licensed intellectual property prior to the one (1) year anniversary of the date of the License Agreement (each of the foregoing items (i) through (v), a “Termination Event”). Upon the occurrence of any Termination Event, the applicable licensee shall immediately discontinue all use of the licensed intellectual property.

 

Master Services Agreement

 

In connection with the Merger Agreement and the closing of the Merger, on November 15, 2016, Marina entered into a Master Services Agreement with Autotelic Inc. (“Autotelic”), a stockholder of IThenaPharma that became the holder of 5,255,354 shares of Marina common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board, pursuant to which Autotelic agreed to provide certain business functions and services from time to time during regular business hours at Marina’s request (the “Master Services Agreement”). The Master Services Agreement has a term of ten years, though either party can terminate it by giving to the other party ninety (90) days’ prior written notice of such termination (provided that the final day of the term shall be on the last day of the calendar month in which the noticed termination date falls). The resources available to Marina through Autotelic include, without limitation, regulatory, clinical, preclinical, manufacturing, formulation, legal, accounting and information technology.

 

As partial consideration for the services to be performed by Autotelic under the Master Services Agreement, during the period prior to the date on which we have completed an equity offering of either common or preferred stock in which the gross proceeds therefrom is no less than $10 million, we shall issue to Autotelic warrants to purchase shares of our common stock (the “MSA Warrants”), with the number of shares of common stock for which such MSA Warrants are exercisable, and the exercise price for such MSA Warrants, being based on the closing price of our common stock; provided, that in no event shall such price be lower than the lower of (x) $0.28 per share or (y) the lowest exercise price of any warrants that have been issued by us in a capital raising transaction (and that would otherwise reduce the exercise price of any other outstanding warrants issued by us) during the period beginning on November 15, 2016 and ending on the date of the issuance of the MSA Warrants.

 

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Line Letter with Dr. Trieu

 

In connection with the Merger, Marina entered into a line of credit dated November 15, 2016 with Dr. Trieu, our Chairman of the Board, for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses (“Line Letter”). Dr. Trieu will consider requests for advances under the Line Letter until April 30, 2017. As of March 31, 2017, Dr. Trieu has advanced an aggregate of $475,064 under the Line Letter. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by a demand promissory note issued to Dr. Trieu, and are due and payable upon demand by Dr. Trieu.

 

Recent Developments During the Three Months Ended March 31, 2017

 

Clinical and IP Developments

 

On January 3, 2017, we announced that the Company was granted a patent for Bacteria Mediated Gene Silencing (EP 08768475.9, European Patent 2173875) claims by the European Patent Office. The granted claims relate to the Company’s tk RNAi technology that is being utilized in its CEQ508 program for the treatment of FAP.

 

Our clinical data from our CEQ508 Phase 1 trial for the treatment of FAP met its primary and secondary endpoints of safety and efficacy for CEQ508. The data demonstrated “safety and statistically significant Catenin Knockdown for Cohort 2 along the Duodenum and Ileum.” We intend to continue clinical development of CEQ508 in combination with IT-102, which was acquired in the recent merger with IthenaPharma.

 

Officer Appointments and Employment Agreements

 

On February 2, 2017, we entered into an employment letter (the “Employment Letter”) with Joseph W. Ramelli, the Chief Executive Officer of the Company. Pursuant to the Employment Letter, Mr. Ramelli shall continue to serve as the Chief Executive Officer of the Company pursuant to the terms and conditions set forth therein. He shall receive a monthly base salary of $10,000, and he also will be entitled to receive a discretionary bonus as determined by the Board of Directors of the Company in its sole discretion. In connection with the Employment Letter, we granted to Mr. Ramelli 100,000 restricted shares of common stock under our 2014 Long-Term Incentive Plan, which shares vested upon our entry into a License Agreement with Lipomedics Inc.

 

On February 10, 2017, our Board of Directors approved the appointment of Larn Hwang, Ph.D. to serve as our Chief Scientific Officer, effective February 13, 2017. In connection with such appointment, we entered into an employment letter (the “Hwang Letter”) with Dr. Hwang pursuant to which, as compensation for such service, Dr. Hwang will receive an annual base salary of $85,000, and she also will be entitled to receive a discretionary bonus as determined by the Board in its sole discretion. We also granted to Dr. Hwang options to purchase up to 60,000 shares of our common stock under our 2014 Long-Term Incentive Plan at an exercise price of $0.18 per share, with all of such options to vest on the one year anniversary of the Hwang Letter.

 

On February 10, 2017, our Board of Directors approved the appointment of Mihir Munsif to serve as our Chief Operating Officer, effective February 13, 2017. In connection with such appointment, we entered into an employment letter (the “Munsif Letter”) with Mr. Munsif pursuant to which, as compensation for such service, Mr. Munsif will receive an annual base salary of $65,000, and he also will be entitled to receive a discretionary bonus as determined by the Board in its sole discretion. We also granted to Mr. Munsif options to purchase up to 60,000 shares of our common stock under our 2014 Long-Term Incentive Plan at an exercise price of $0.18 per share, with all of such options to vest on the one year anniversary of the Munsif Letter.

 

On February 21, 2017, we appointed Seymour Fein MD as our Chief Medical Officer. Having taken more than twenty drugs from development on through FDA approval, Dr. Fein is in a unique position to lead the regulatory and clinical development of our pipeline.

 

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Lipomedics License Agreement

 

On February 6, 2017, the Company entered into a License Agreement (the “License Agreement”) with LipoMedics, Inc., a related party (“LipoMedics”), pursuant to which, among other things, the Company provided to LipoMedics a license to the Company’s SMARTICLES platform for further development of Lipomedics’s proprietary phospholipid nanoparticles that can deliver protein, small molecule drugs, and peptides. These are not currently being developed at Marina Biotech and Marina Biotech has no IP around these products.

 

Under the terms of the License Agreement, the Company could receive up to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if LipoMedics determines to pursue further development and commercialization of products under the License Agreement, LipoMedics agreed, in connection therewith, to purchase shares of the Company’s common stock for an aggregate purchase price of $500,000, with the purchase price for each share of common stock being the greater of $0.29 or the volume weighted average price of the common stock for the thirty (30) trading days immediately preceding the date on which LipoMedics notifies the Company that it intends to pursue further development or commercialization of a licensed product.

 

If LipoMedics breaches the License Agreement, the Company shall have the right to terminate the License Agreement effective sixty (60) days following delivery of written notice to LipoMedics specifying the breach, if LipoMedics fails to cure such material breach within such sixty (60) day period. LipoMedics may terminate the License Agreement by giving thirty (30) days’ prior written notice to the Company.

 

Vuong Trieu, Ph.D., the Chairman of our Board of Directors, is the Chairman of the Board and Chief Operating Officer of LipoMedics.

 

Issuances of Equity Securities and Autotelic Line Letter    

 

On February 6, 2017, the Company entered into a Stock Purchase Agreement (the “Purchase Agreement”) with LipoMedics, pursuant to which the Company issued to LipoMedics an aggregate of 862,068 shares of the common stock of the Company for a total purchase price of $250,000 ($0.29 per share).

 

On February 6, 2017 and February 8, 2017, the Company entered into two privately negotiated transactions pursuant to which it committed to issue an aggregate of approximately 6.15 million shares of its common stock for an effective price per share of $0.29 per share. As a result of such transactions, the Company reduced the aggregate amount of its outstanding payables to certain service providers by approximately $1.78 million.

 

On April 4, 2017, the Company entered into an agreement with Autotelic Inc., pursuant to which Autotelic Inc. offered to the Company an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses of the Company (the “Line Letter”). Autotelic Inc. will consider requests for advances under the Line Letter until September 1, 2017. Autotelic Inc. shall have the right at any time for any reason in its sole and absolute discretion to terminate the line of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice to the Company or any other person; provided, that Autotelic Inc. agreed that it shall not demand the repayment of any advances that are made to the Company under the Line Letter prior to the earlier of: (i) October 1, 2017; and (ii) the date on which (x) the Company makes a general assignment for the benefit of its creditors, (y) the Company applies for or consents to the appointment of a receiver, a custodian, a trustee or liquidator of all or a substantial part of its assets or (z) the Company ceases operations. Advances made under the Line Letter shall bear interest at the rate of five percent (5%) per annum, shall be evidenced by a demand promissory note issued by the Company to Autotelic Inc., and shall be due and payable upon demand by Autotelic Inc. Autotelic Inc. is a stockholder of the Company, and an entity of which Dr. Trieu, the Chairman of the Board of the Company, serves as Chairman of the Board.

 

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Results of Operations

 

Comparison of the Three Months Ended March 31, 2017 to the Three Months Ended March 31, 2016

 

Our loss before income taxes for the three months ended March 31, 2017 is summarized as follows in comparison to the three months ended March 31, 2016:

 

    Three Months Ended  
    March 31, 2017     March 31, 2016  
Revenues   $ -     $ -  
Personnel expenses     306,922       83,982  
Research and development     73,431       4,978  
Amortization     98,378       -  
General and administrative expenses     488,522       25,231  
Other income (expense), net     (114,725 )     -  
Loss before provision for income taxes   $ (1,082,778 )   $ (114,191 )

 

Revenues

 

We had no in revenue in the three months ended March 31, 2017 or 2016. The majority of our licensing deals provide for clinical and regulatory milestones, so significant revenues could result from the existing licenses, but are uncertain as to timing or probability. We will continue to seek research and development collaborations as well as licensing transactions to fund business operations.

 

Expenses

 

Our expenses for the three months ended March 31, 2017 are summarized as follows in comparison to our expenses for the three months ended March 31, 2016:

 

Personnel Expenses

 

Personnel expenses consists primarily of costs related to the Master Services Agreement with Autotelic Inc., a stockholder of IThenaPharma, that became the holder of 5,255,354 shares of Marina common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board, pursuant to which Autotelic Inc. agreed to provide certain business functions and services from time to time during regular business hours at Marina’s request. We pay Autotelic Inc. for their services with both cash and through the issuance of warrants. Personnel expenses increased $229,940 for the three months ended March 31, 2107, as compared to the three months ended March 31, 2016 due to increased use of Autotelic Inc.’s services.

 

Research and Development

 

Research and development (“R&D”) expense consists primarily of costs of sublicensing fees, clinical development and pre-clinical studies, consulting and other outside services, and other costs. R&D expense increased $68,453 primarily due to the use of additional R&D consulting during the three months ended March 31, 2017, as compared to the three months ended March 31, 2016.

 

Amortization Expense

 

Amortization expenses relates to amortization of intangible assets acquired in the November 15, 2016 merger, with an estimated fair value of $2,361,066 amortized over its estimated useful life of six years.

 

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General and Administrative Expenses

 

    Three Months Ended  
    March 31, 2017     March 31, 2016  
Directors’ fees   $ 56,250     $ -  
Accounting and audit fees     69,874       -  
Legal fees     244,808       -  
Insurance     30,100       -  
Other general and administrative expenses     87,491       25,231  
Total   $ 488,522     $ 23,231  

 

General and administrative (“G&A”) expense consists primarily of salaries and other personnel-related expenses to support our R&D activities, stock-based compensation for G&A personnel and non-employee members of our Board, professional fees, such as accounting and legal, and corporate insurance costs. G&A costs increased $463,291 primarily since the results of the three months ended March 31, 2017 include the operating expenses of Marina and IThena as a result of the November 15, 2017 merger, while the results for the three months ended March 31, 2016 include only the G&A expenses of IThena.

 

Other Income (Expense)

 

    Three Months Ended  
    March 31, 2017     March 31, 2016  
Interest expense   $ (11,653 )   $ -  
Change in fair value liability of warrants     (103,072 )     -  
Total other expense, net   $ (114,725 )   $ -  

 

Total net other expense for the three months ended March 31, 2017 increased $114,725 compared to the three months ended March 31, 2016. The increase is primarily attributable to interest expense on notes payable acquired in the November 15, 2016 merger, and an increase in the estimated fair value of price adjustable warrants, partially offset by a gain on the settlement of accounts payable with a service provider.

 

The fair value liability is revalued each balance sheet date utilizing probability-weighted Black-Scholes computations, with the decrease or increase in fair value being reported in the statement of operations as other income or expense, respectively.

 

Liquidity & Capital Resources

 

Working Capital Deficiency

 

    March 31, 2017     December 31, 2016  
Current assets   $ 401,117     $ 316,480  
Current liabilities     (2,698,693 )     (2,967,669 )
Working capital deficiency   $ (2,297,576 )   $ (2,651,189 )

 

Current assets increased by $84,637, which was primarily attributable to an increase in cash of $111,094.

 

Current liabilities decreased by $268,976, which was primarily attributable to a decrease of $675,674 in accrued expenses, which is primarily attributable to a reduction in approximately $947,000 in accrued legal fees through the issuance of 6,153,684 shares of the Company’s common stock during the three months ended March 31, 2017.

 

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Cash Flows

 

    Three Months Ended  
    March 31, 2017     March 31, 2016  
Net cash used in operating activities   $ (369,420 )   $ (179,907 )
Net cash used in investing activities     -       -  
Net cash provided by financing activities     480,514       -  
Increase (decrease) in cash and cash equivalents   $ 111,094     $ (179,907 )

 

The increase in net cash used in operating activities for the three months ended March 31, 2017, compared to 2016, was mainly due to increased operating expenses as a result of the November 15, 2016 merger. Operating expenses for the three months ended March 31, 2017 includes the expenses of both Marina and IThena, while the operating expenses for the three months ended March 31, 2016 reflect only the operating expenses of IThena.

 

The Company used no cash in investing activities for the three months ended March 31, 2017 or 2016.

 

The $480,514 increase in net cash provided by financing activities for the three months ended March 31, 2017, compared to 2016, is attributable to proceeds of $250,000 from the sale of stock, and $230,514 from additional borrowings on the convertible note to related party during the three months ended March 31, 2017.

 

We will need to raise additional operating capital in calendar year 2017 in order to maintain our operations and to realize our business plan. Without additional sources of cash and/or the deferral, reduction, or elimination of significant planned expenditures, we may not have the cash resources to continue as a going concern thereafter.

 

Going Concern

 

The condensed consolidated financial statements contained in this report have been prepared assuming that the Company will continue as a going concern. We have net losses for the period from inception through March 31, 2017 of approximately $3 million, as well as negative cash flows from operating activities. Management estimates that the cash balance as of March 31, 2017 of $216,441, along with the $500,000 Line Letter from Autotelic Inc., will allow the Company to continue its operations and activities through the third or fourth quarter of 2017 without additional funding. Presently, the Company does not have sufficient cash resources to meet its plans in the twelve months following December 31, 2016. These factors raise substantial doubt about our ability to continue as a going concern. Management is in the process of evaluating various financing alternatives for operations, as we will need to finance future research and development activities and general and administrative expenses through fund raising in the public or private equity markets.

 

The interim condensed consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern. Our continuation as a going concern is dependent on our ability to obtain additional financing as may be required and ultimately to attain profitability. If we raise additional funds through the issuance of equity or equity-linked securities, the percentage ownership of current shareholders could be reduced, and such securities might have rights, preferences or privileges senior to our common stock. Additional financing may not be available upon acceptable terms, or at all. If adequate funds are not available or are not available on acceptable terms, we may not be able to take advantage of prospective business endeavors or opportunities, which could significantly and materially restrict our future plans for developing our business and achieving commercial revenues. If we are unable to obtain the necessary capital when needed, we may have to cease operations.

 

During 2016, we have funded our losses primarily through the sale of common and preferred stock and warrants, revenue provided from our license agreements and loans provided by Dr. Trieu pursuant to the Line Letter and, to a lesser extent, equipment financing facilities and secured loans. During the first quarter of 2017, we raised $250,000 from the private placement of our equity securities and borrowed $230,514 under the Line Letter. In addition, in April 2017, we entered into an additional credit agreement with Autotelic Inc., pursuant to which Autotelic Inc. offered to the Company an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses of the Company.

 

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Future Financing

 

We will require additional funds to implement our growth strategy for our business. As mentioned above, we raised additional capital to both supplement our clinical developments that are not covered by any grant funding and to cover our operational expenses. We may raise the additional funds required through equity financing, debt financing, or other sources, which may result in further dilution in the equity ownership of our shares. There can be no assurance that additional financing will be available when needed or, if available, that can be obtained on commercially reasonable terms. If we will not be able to obtain the additional financing on a timely basis as required, or generate significant material revenues from operations, we will not be able to meet our other obligations as they become due and will be forced to scale down or perhaps even cease our operations.

 

Off-Balance Sheet Arrangements

 

As of March 31, 2017, we did not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.

 

Critical Accounting Policies and Estimates

 

Our significant accounting policies are more fully described in the notes to our financial statements included herein for the quarter ended March 31, 2017 and in the notes to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2016.

 

Recently Adopted Accounting Pronouncements

 

Our recently adopted accounting pronouncements are more fully described in Note 1 to our financial statements included herein for the quarter ended March 31, 2017.

 

ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4 CONTROLS AND PROCEDURES

 

a)        Disclosure Controls and Procedures . As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our senior management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Management identified material weaknesses in internal control over financial reporting as described under the heading “Management Report on Internal Control” contained in Item 9A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (the “2016 Form 10-K”), which have not been remediated, and therefore our principal executive officer and our principal financial officer concluded that, as of March 31, 2017, our disclosure controls and procedures were not effective.

 

(b)        Internal Control Over Financial Reporting . Management has reported to the Board of Directors and the Audit Committee thereof material weaknesses described under the heading “Management Report on Internal Control” contained in Item 9A of the 2016 Form 10-K. The material weaknesses discussed therein have not been remediated. There have been no changes in our internal control over financial reporting or in other factors during the fiscal quarter ended March 31, 2017 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. To remediate the material weakness identified in the 2016 Form 10-K, we plan to hire additional experienced accounting and other personnel to assist with filings and financial record keeping, and to take additional steps to improve our financial reporting systems and enhance our existing policies, procedures and controls, as resources allow.

 

Because of its inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

 

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PART II – OTHER INFORMATION

 

ITEM 1A. RISK FACTORS

 

An investment in our common stock involves a number of very significant risks. You should carefully consider the risk factors included in the “Risk Factors” section of the Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities & Exchange Commission on March 31, 2017, in addition to other information contained in those reports and in this quarterly report in evaluating the Company and its business before purchasing shares of our common stock. Our business, operating results and financial condition could be adversely affected due to any of those risks.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

On March 31, 2017, we entered into a Settlement Agreement with a debtor to, and shareholder of, our company, pursuant to which we agreed that indebtedness owed to our company by such debtor in the principal amount of $45,000, plus accrued and unpaid interest thereon, would be settled through: (i) the payment by such debtor to our company of $14,059 in cash; (ii) the surrender by such debtor of 87,254 shares of our common stock for cancellation; and (iii) the surrender by such debtor of warrants to purchase up to 60,000 shares of our common stock at exercise prices ranging from $0.63 to $1.05 for cancellation.

 

In April 2017, we entered into a Compromise and Release Agreement to settle $36,047 due to a service provider for $15,957 in cash and the issuance to the service provider of 69,276 shares of our common stock. The shares were issued in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder.

 

Item 6. Exhibits

 

Exhibit    
Number   Description
     
(10)   Material Contracts
     
10.1#   Employment Letter dated February 2, 2017 between the Registrant and Joseph W. Ramelli (filed as Exhibit 10.1 to our Current Report on Form 8-K dated February 2, 2017, and incorporated herein by reference).
     
10.2   Stock Purchase Agreement dated as of February 6, 2017 by and between the Registrant and Lipomedics Inc. (filed as Exhibit 10.1 to our Current Report on Form 8-K dated February 6, 2017, and incorporated by reference herein).
     
10.3#   Employment Letter dated February 13, 2017 between the Registrant and Larn Hwang, Ph.D. (filed as Exhibit 10.1 to our Current Report on Form 8-K dated February 8, 2017, and incorporated by reference herein).
     
10.4#   Employment Letter dated February 13, 2017 between the Registrant and Mihir Munsif (filed as Exhibit 10.2 to our Current Report on Form 8-K dated February 8, 2017, and incorporated by reference herein).
     
10.5*   License Agreement dated February 6, 2017 between the Registrant and Lipomedics, Inc. (1)
     
(31)   Rule 13a-14(a)/15d-14(a) Certification
     
31.1*   Certification of our Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. (1)
     
(32)   Section 1350 Certification
     
32.1*   Certification of our Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (2)
     
(99)   Additional Exhibits
     
99.1   Press release announcing the grant of a patent for Bacteria Mediated Gene Silencing (EP 08768475.9, European Patent 2173875) claims by the European Patent Office relating to the Company’s tkRNAi technology being utilized in its CEQ508 program that is being developed to treat familial adenomatous polyposis (FAP) (filed as Exhibit 99.1 to our Current Report on Form 8-K dated January 3, 2017, and incorporated by reference herein).
     
99.2   Audited Financial Statements of IThenaPhama, Inc. as of and for the years ended December 31, 2014 and 2015 and unaudited financial statements of IThenaPharma Inc as of and for the nine months ended September 30, 2015 and 2016 (filed as Exhibit 99.1 to our Current Report on Form 8-K/A dated November 15, 2016, as filed on January 26, 2017, and incorporated by reference herein).

 

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99.3   Unaudited Pro Forma Condensed Combined Financial Statements of Marina Biotech, Inc. and Subsidiaries (filed as Exhibit 99.1 to our Current Report on Form 8-K/A dated November 15, 2016, as filed on January 26, 2017, and incorporated by reference herein).
     
(101)**   Interactive Data Files
     
101.INS   XBRL Instance Document
     
101.SCH   XBRL Taxonomy Extension Schema Document
     
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document
     
101.DEF   XBRL Taxonomy Extension Definition Linkbase Document
     
101.LAB   XBRL Taxonomy Extension Label Linkbase Document
     
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document

 

* Filed herewith.
   
** Furnished herewith.
   
# Indicates management contract or compensatory arrangement.
   

(1)

Portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and the omitted material has been filed separately with the SEC.

 

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SIGNATURES

 

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

 

 

MARINA BIOTECH, INC.

   
Date: May 15, 2017 /s/ Joseph W. Ramelli
  Joseph W. Ramelli
  Chief Executive Officer
  (Principal Executive Officer, Principal Financial Officer
  and Principal Accounting Officer)

 

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LICENSE AGREEMENT

 

This LICENSE AGREEMENT (this “ Agreement ”) is made and entered into this 6th day of February, 2017 (the “ Effective Date ”) by and between Marina Biotech, Inc. (formerly known as MDRNA, Inc.), a Delaware corporation having a principal business address of 17870 Castleton Street, Suite 250 City of Industry, CA 91748 (“ Marina ”), and Lipomedics, Inc., a Delaware corporation, having a principal business address of 3400 Camp Bowie Boulevard, CBH-214, Fort Worth, TX 76107 (“ Lipomedics ”).

 

WHEREAS, Marina is the owner of NOV340 and other lipid nanoparticle delivery technologies collectively referred to as the SMARTICLES™ technology (as further defined below, the “ SMARTICLES™ Technology ”, or the “ Delivery Technologies ”);

 

WHEREAS, Lipomedics has expertise in and owns or controls proprietary technology in the nanotechnology area (as further defined below, the “ Lipomedics Technology ”) that may be used by Lipomedics or its licensees to, among other things, develop therapeutics; and

 

WHEREAS , Lipomedics desires to license the Marina Technology (as defined below) to ascertain whether the Delivery Technologies would improve the delivery of therapeutics produced by Lipomedics or its licensees using the Lipomedics Technology and, if so, to commercialize such products.

 

NOW THEREFORE, in consideration of the promises and of the mutual covenants and agreements contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties intend to be legally bound as follows:

 

1. Definitions. For purposes of this Agreement, the following terms shall have the meanings set forth below:

 

  1.1 Affiliates ” means, as to any party, any corporation or business entity controlled by, controlling, or under common control with such party. For this purpose, “control” shall mean direct or indirect beneficial ownership of at least fifty percent (50%) of the voting stock or income interest in such corporation or other business entity, or such other relationship as, in fact, constitutes actual control.
     
  1.2 API ” means a moiety utilizing the Lipomedics Technology, but not including moieties utilizing macromolecules consisting of a specific nucleic acid encoding a nuclease produced in accordance with the [***] Technology. “[***] Technology” means the [***] technology based on [***] that is owned or Controlled by [***] (“[***]”), as of the Effective Date, or that comes to be owned or Controlled by [***] at any time during the term of the [***] Agreement, including [***]. To be clear, API is meant to include solely small molecules, peptides, or proteins that are not restricted by the [***] Agreement.

 

 
 

 

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  1.3 Commercial Sale ” means, with respect to a Licensed Product in any jurisdiction in the Territory, a commercial transfer, lease or disposition for value of such Licensed Product in such jurisdiction to a third party in a bona fide arm’s length transaction after marketing approval from the relevant regulatory authority in such jurisdiction has been obtained.
     
  1.4 Control ” or “ Controlled ” means, with respect to any know-how, patent rights or other intellectual property rights, that a party has the legal authority or right (whether by ownership, license or otherwise) to grant a license, sublicense, access or right to use (as applicable) under such know-how, patent rights, or other intellectual property rights, including to the other party on the terms and conditions set forth herein, as applicable, in each case without breaching the terms of any agreement with a third party.
     
  1.5 Delivery Technologies ” means the SMARTICLES™ Technology and such other technologies as may be added to this Agreement by agreement of the parties hereto.
     
  1.6 Field ” means all therapeutic, diagnostic, prophylactic and palliative uses in mammals (including humans).
     
  1.7 First Commercial Sale ” with respect a Licensed Product means the first Commercial Sale (without regard to approved indication) in any jurisdiction in the Territory in a bona fide arm’s length transaction after marketing approval from the relevant regulatory authority in such jurisdiction has been obtained.
     
  1.8 IND ” means an ‘investigational new drug application’ as such term is used under the United States Federal Food, Drug and Cosmetic Act, as amended from time to time, and all regulations promulgated thereunder, or any equivalent application to the relevant regulatory authority in any jurisdiction in the Territory other than the United States.
     
  1.9 Licensed Product ” means a therapeutic, diagnostic, prophylactic and palliative product comprised of an API which is delivered to a cell of therapeutic interest or used for diagnostic, prophylactic and palliative purposes using either of the Delivery Technologies or any combination of the Delivery Technologies. For clarity, (i) Licensed Products which incorporate different APIs shall be considered different Licensed Products, and (ii) regardless of which Delivery Technology or combination thereof is used, Licensed Products which incorporate the same API even if approved for different uses or indications or in multiple jurisdictions or countries in the Territory, shall be considered the same Licensed Product.

 

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  1.10 Lipomedics Technology ” means the nanotechnology, emulsion, nanoemulsion, micelles, reverse micelles, suspension, nanosuspension, therapeutic drug monitoring, nanoparticle process technology, nanoemulsion evaporation technology that is owned or Controlled by Lipomedics as of the Effective Date, or that comes to be owned or Controlled by Lipomedics at any time during the term of this Agreement, as applied to small molecules (being low molecular weight (i.e. less than 1000 daltons), organic compounds, peptides (being short chains of 50 or fewer amino acid monomers linked by peptide (amide) bonds), proteins including enzymes and antibodies, and biologics (being genetically-engineered proteins derived from human genes).
     
  1.11 Marina Patents ” means (i) the patents and patent applications identified on Schedule A, (ii) any other patents and patent applications owned or Controlled by Marina as of the Effective Date that have claims covering either of the Delivery Technologies, and (iii) any other patents and patent applications that are owned solely or Controlled by Marina at any time during the New Technology Period and that have claims covering either of the Delivery Technologies or any modifications or improvements to any inventions and or technology that is the subject of the patents and patent applications described in clauses (i) and (ii) of this definition. For clarity, Marina Patents will include any such applications for patents pending at any time during the New Technology Period (and patents issued in respect thereto regardless of when issued), including, without limitation, provisional applications, continuations, continuations-in-part, divisional and substitute applications.
     
  1.12 Marina Technology ” has the meaning set forth in Section 5.1.
     
  1.13 New Technology Period ” means the three (3) year period following the Effective Date except that the New Technology Period means the term of this Agreement in respect of (i) any Innovations developed by Lipomedics as contemplated by Section 5.1.1(ii) and Section 5.1.2 or (ii) any patents and patent applications that have claims covering any such Innovations.
     
  1.14 [***] ” means [***], which has obtained certain expertise in developing and manufacturing delivery technologies and formulations using the Delivery Technologies.
     
  1.15 [***] Agreement ” means the License Agreement between [***] and Marina dated as of [***], as the same may be amended, modified or extended from time to time.
     
  1.16 SMARTICLES™ Technology ” means Marina’s NOV340 and other related lipid nanoparticle delivery technology and lipids owned or Controlled by Marina as of the Effective Date, or that comes to be owned or Controlled by Marina at any time during the New Technology Period, based on fully charge-reversible particles allowing delivery of active substance (siRNA, single-stranded oligonucleotides, etc.) inside a cell either by local or systemic administration.
     
  1.17 Stock Purchase Agreement ” means that Stock Purchase Agreement entered into as of the Effective Date among Marina and those Purchasers named therein.
     
  1.18 Territory ” means worldwide.

 

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2. Grant of License. Subject to the terms of this Agreement, Marina hereby grants to Lipomedics a [***], sublicensable through multiple tiers (subject to Section 7) license (the “License”) under the Marina Technology and the Marina Intellectual Property (i) to research, develop, make, have made, import, use, offer for sale or sell Licensed Products in the Field in the Territory, and (ii) practice any method, process or procedure included in the Marina Technology or the Marina Intellectual Property in connection with its exercise of the activities described in clause (i) throughout the world (the “Agreed Purpose”), all in accordance with the terms and conditions of this Agreement.

 

  2.1 The parties acknowledge that Marina has previously granted an exclusive license under the Marina Patents and the Marina Technology for “all fields of use other than therapeutic, diagnostic, prophylactic and palliative uses in mammals (including humans) (the “ Prior Granted Fields ”). In the event that any right to practice the Marina Patents or the Marina Technology in the Prior Granted Fields reverts to Marina during the term of this Agreement (as defined in Section 15.1.1), Marina shall notify Lipomedics within thirty (30) days thereafter, which notice shall contain Marina’s offer to amend the definition of Field in this Agreement (without further consideration from Lipomedics) to include such reverted Prior Granted Field (the “ Reverted Field ”). Upon acceptance in writing by Lipomedics of such offer, the same rights previously granted to Lipomedics with regard to the original Field shall be extended to the Reverted Field automatically, and without further action by the parties, provided that Lipomedics complies with all of the terms and conditions of this Agreement with respect to any Licensed Product made, used or sold in the Reverted Field. Lipomedics shall be responsible and shall reimburse Marina upon demand for all costs and expenses incurred by Marina to maintain such rights extended to the Reverted Field.
     
  2.2 Lipomedics (or its sublicensees) shall be responsible at their own expense for manufacturing or having manufactured the Licensed Products, providing the staff, animals, tools and equipment, materials and laboratory space necessary to research, develop, and clinically evaluate Licensed Products (including reporting of the data generated from such evaluation procedures).
     
  2.3 This Agreement does not preclude Marina from granting other licenses of the Marina Technology or the Marina Patents to third parties for manufacturing or any other purposes.
     
  2.4 Each party acknowledges that the rights and licenses granted under this Article 2 and elsewhere in this Agreement are limited to the scope expressly granted. Accordingly, except for the rights and licenses expressly granted in this Agreement, neither party is granted any right or license under or to any technology, patents or other intellectual property rights of the other party, nor shall any such right or license be implied or imputed, by estoppel or otherwise. All rights with respect to the technology, patents or other intellectual property of a party that are not specifically granted herein are reserved to the owner thereof.

 

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3. Technology Transfer; Evaluation of Delivery Technologies.

 

  3.1 Lipomedics represents and warrants that it has the expertise necessary to appreciate the significance of all Marina Technology provided to it by Marina and to handle any related physical materials with care and without danger to Lipomedics, its employees, Marina or the public. Lipomedics acknowledges and agrees that it has requested and received from Marina all information and advice which it reasonably believes is necessary to ensure that it is capable of handling the physical materials in a safe and prudent manner. Lipomedics shall not expose to or use in humans any of the physical materials except as permitted by applicable law and Lipomedics will in any event conduct its activities with such physical materials in compliance with all applicable laws.
     
  3.2 Marina will be responsible for making available to Lipomedics or (subject to Section 9.2) to [***] or other contract manufacturer identified to Marina, upon written request and without charge (except as set forth in Section 3.3), all Marina Know-How relevant to the Agreed Purpose.
     
  3.3 On Lipomedics’s reasonable request, Marina agrees to provide, without charge, up to sixty (60) hours of consulting and advisory services to or on behalf of Lipomedics regarding the use and technical transfer of the Marina Technology. If Lipomedics requests more than sixty (60) hours of such services Marina shall use commercially reasonable efforts to provide such services and shall be entitled to compensation of $150 for each hour provided in excess of sixty (60) hours.
     
  3.4 Lipomedics shall use commercially reasonable efforts to determine whether it believes the Delivery Technologies may improve the delivery of APIs and to keep Marina reasonably informed regarding the progress of its evaluation program. No later than (i) any filing by Lipomedics or any of its sublicensees of an IND in respect of a Licensed Product or (ii) three (3) years following the Effective Date, whichever is earlier, Lipomedics shall provide written notice to Marina including a summary of the results of Lipomedics’s evaluation program and whether it intends to pursue, or cause to be pursued, further development and commercialization of Licensed Products (the “ Evaluation Notice ”).

 

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4. Representations and Warranties.

 

  4.1 General Representations and Warranties . Each party hereby represents and warrants to the other party that such party:

 

    4.1.1 is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated;
       
    4.1.2 has the full corporate or organizational power and authority, and has obtained all approvals, permits and consents necessary, to enter into this Agreement and to perform its obligations hereunder; and
       
    4.1.3 this Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms.

 

  4.2 Marina . Marina hereby covenants, represents and warrants to Lipomedics that:

 

    4.2.1 Marina is the owner of record of the Marina Technology and the Marina Intellectual Property, and Marina has all rights necessary to grant the rights and licenses under the Marina Technology and the Marina Intellectual Property which are granted to Lipomedics under this Agreement;
       
    4.2.2 Marina knows of no reason why the Marina Patents should not be valid and enforceable, or why any pending patent applications within the Marina Patents should not, if resulting in issued Marina Patents, be valid and enforceable, and no third party has alleged in writing that any of the Marina Patents is invalid or unenforceable;
       
    4.2.3 Marina is not bound by, and none of the Marina Intellectual Property is subject to, any contract that in any way limits or restricts the ability of Marina to use, exploit, assert, or enforce any such Marina Intellectual Property asset anywhere in the world;
       
    4.2.4 Marina has not granted, and will not grant, any rights in the Delivery Technologies that are inconsistent with the licenses and rights granted to Lipomedics under this Agreement;
       
    4.2.5 the Marina Patents are not subject to any pending re-examination, opposition, interference or litigation proceedings;
       
    4.2.6 no claims of infringement, misappropriation or other conflict with any intellectual property rights or other rights of any third party were pending in the twelve (12) months preceding the Effective Date, are pending or, to Marina’s knowledge, are threatened with respect to the Marina Technology or the Marina Intellectual Property;
       
    4.2.7 Marina believes its commercial relationship with [***] is in good legal standing. [***] has not given Marina notice (written or oral) terminating, canceling, reducing the volume under, or renegotiating the pricing terms or any other material terms of any contract or relationship with Marina and Marina has no reason to believe that [***] intends to take any of such actions; and
       
    4.2.8 Based on Marina’s preclinical studies and clinical experience disclosed to Marina by licensees through the Effective Date, Marina is not aware of any undesirable experiences associated with the use of a medical product in a patient or any other facts or circumstances, in each case related to or involving the use of a Delivery Technology, that could reasonably be expected to cause any regulatory agency or other governmental authority to question the suitability, safety, or efficacy of such Delivery Technology for delivery of therapeutics inside a cell or used for diagnostic, prophylactic and palliative purposes.

 

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5. Intellectual Property.

 

  5.1 Marina Intellectual Property .

 

    5.1.1 As between the parties, Marina shall be the exclusive owner of, and shall have all right, title and interest in (a) all technology (including the Delivery Technologies), discoveries, innovations, or improvements, know-how, documentation, reports, information, records, processes, procedures, raw data, specimens and/or other work product owned or Controlled by Marina (all of the foregoing collectively, the “ Marina Know-How ”), which Marina Know-How either (i) predates the Effective Date or does not exist at the Effective Date and is independently developed after the Effective Date by or on behalf of Marina without reference to or in reliance on the Lipomedics Technology or (ii), subject to Section 5.1.2, does not exist at the Effective Date, is developed by Lipomedics by reference to or in reliance on the Delivery Technology, and is generally applicable to the delivery using a Delivery Technology of both APIs and macromolecules other than APIs (all of the foregoing, including the Marina Know-How, collectively, the “ Marina Technology ”), and (b) all Marina Patents, and any other patents and other intellectual property rights related to or based solely upon the Marina Know-How (collectively, the “ Marina Intellectual Property ”). Except as provided herein, no license, express or implied, by estoppel or otherwise, to any Marina Technology or Marina Intellectual Property is granted herein. For clarity, Marina Technology and Marina Intellectual Property shall not include any technology, discoveries, innovations, or improvements discovered or reduced to practice by or on behalf of either party that are specifically applicable to the delivery using a Delivery Technology of APIs but are not generally applicable to the delivery using a Delivery Technology of macromolecules other than APIs.

 

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    5.1.2 If at any time Lipomedics determines that it may develop any technology, discoveries, innovations, or improvements (“ Innovation ”) which would be considered Marina Technology under Section 5.1.1(ii), then Lipomedics shall notify Marina in writing thereof, generally describing the proposed Innovation and the development plan for realizing such Innovation, together with a term sheet outlining the proposed terms for a license of such Innovation from Marina. Marina shall have the perpetual, royalty free right, with a right to sublicense, to practice in the Territory all Innovation outside the Field hereunder, and upon the termination of this Agreement Marina shall have the perpetual, royalty free right to practice in the Territory all Innovation.
       
    (a) Any such description and term sheet shall be deemed confidential information of Lipomedics hereunder unless and until the parties enter into a definitive license agreement with respect to such Innovation, in which case the treatment of such description and terms shall be addressed in such definitive agreement.
       
    (b) Within a reasonable time following receipt of such notice, the parties shall enter into negotiations regarding Lipomedics’s proposal. All such negotiations shall be conducted by the parties in good faith. If, despite such good faith negotiations, Marina and Lipomedics do not reach agreement on the terms of such an agreement within three (3) months (or such longer period as agreed by the parties in writing) from the notification in writing by Lipomedics to Marina, then Lipomedics may proceed with such Innovation at its own risk, with the understanding that it will have no right to practice such Innovation outside the Field without the written agreement of Marina and will be obligated under Section 5.3 to assign all of its right, title and interest in such Innovation to Marina; provided , that if, after such assignment, Marina offers licensing conditions for such Innovation to a Third Party for any country in the Territory that are financially and/or commercially more favorable than those that were last proposed by Lipomedics in writing in the parties’ negotiations, Marina shall propose those new terms in writing to Lipomedics, which shall have forty-five (45) days after receipt of such new terms to exercise the right to negotiate in good faith and execute with Marina an agreement on the same terms and conditions as those offered by Marina to such Third Party. After expiration of such forty-five (45) days, Marina shall be free to enter into an agreement with such Third Party on such terms.

 

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    (c) Notwithstanding the foregoing, Marina agrees that it will not license (or disclose any non-public information regarding) any Innovation to any Third Party seeking to utilize either or both of the Delivery Technologies in conjunction with any gene-editing technology, provided , that Marina shall have no liability to Lipomedics if another licensee of one or both of the Delivery Technologies, without any breach by Marina of the foregoing, independently develops (as evidenced by such licensee’s contemporaneous records) technology, discoveries, innovations, or improvements substantially similar to an Innovation.

 

  5.2 Lipomedics Intellectual Property . As between the parties, Lipomedics shall be the exclusive owner of and shall have all rights, title and interest in (a) all technology (including the Lipomedics Technology), discoveries, innovations, or improvements, know-how, documentation, reports, information, records, processes, procedures, raw data, specimens and/or other work product owned or Controlled by Lipomedics (all of the foregoing collectively, the “ Lipomedics Know-How ”) which Lipomedics Know-How either (i) predates the Effective Date or does not exist at the Effective Date and is independently generated by or on behalf of Lipomedics without reference to or in reliance on any Delivery Technology, or (ii) does not exist at the Effective Date, is developed by either party by reference to or in reliance on any Delivery Technology, and is (x) only applicable to the delivery using a Delivery Technology of APIs and (y) not generally applicable to the delivery using a Delivery Technology of both APIs and macromolecules other than APIs (all of the foregoing, including the Lipomedics Know-How, collectively, the “ Lipomedics Technology ”) and (b) all patent and other intellectual property rights related to or based solely upon Lipomedics Know-How (all of the foregoing collectively, the “ Lipomedics Intellectual Property ”). For clarity, Lipomedics Technology and Lipomedics Intellectual Property shall not include any technology, discoveries, innovations, or improvements discovered or reduced to practice by or on behalf of Lipomedics that are generally applicable to the delivery using a Delivery Technology of macromolecules other than APIs.
     
  5.3 Assignments of Intellectual Property Rights . To the extent any intellectual property rights in any technology do not vest by operation of law or otherwise in the correct party consistent with the parties’ intention reflected in Sections 5.1 and 5.1.2(b), each of Lipomedics or Marina, as the case may be, agrees to assign and does hereby assign to the other party all of its rights, title, and interest, including intellectual property rights, in any such technology that the other party is entitled to own pursuant to Sections 5.1 or 5.1.2(b), as the case may be. The assignee party under this Section 5.3 shall have the sole and exclusive right to file, prosecute, maintain and enforce all intellectual property rights in all such technology. The assigning party under this Section 5.3 shall provide reasonable assistance at no extra cost to the assignee party to carry out this provision.

 

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  5.4 Maintenance of Patents. Marina agrees to use commercially reasonable efforts (a) to maintain each of the issued Marina Patents and (b) to pursue issuance of patents in respect of any patent applications included in the Marina Patents. If Marina determines to abandon or cease pursuing issuance of any Marina Patent in any particular jurisdiction, Marina will provide prior written notice to Lipomedics of such intention to abandon or decline responsibility not less than thirty (30) days prior to the last allowable date for filing or taking any other action required with respect to such Marina Patent.

 

6. Initial License Period. Notwithstanding Article 2 above, for a period commencing on the Effective Date and ending on the date that Lipomedics pays the Commercial License Fee (as defined in Section 8.2) (such period, the “Initial License Period”), Lipomedics and its sublicensees shall not sell or have sold any Licensed Product to any third parties for use in the Field anywhere in the Territory; provided, however, the prohibition in this Article ‎6 shall not restrict in any manner the purchase or sale of any quantities of Licensed Product intended for use in research and development activities, in clinical trials, in connection with regulatory submissions for marketing approvals, in compassionate use cases, or similar non-commercial activities. Additionally, during the Initial License Period, Lipomedics and its sublicensees shall not make any application for a patent or other intellectual property protection in any country of the world related to technology, discoveries, innovations, or improvements discovered or reduced to practice that refers to or relies on any Delivery Technology and that is specifically applicable to the delivery using a Delivery Technology of APIs, without prior notification to Marina. Lipomedics shall include in each sublicense entered into during the Initial License Period an express acknowledgement by such sublicensee that it is subject to the restrictions set forth in this Section and that Marina shall be deemed a third party beneficiary of such restrictions. Any breach of such restrictions by such sublicensee shall be deemed a breach of this Agreement by Lipomedics.
   
7. Sublicenses. The License includes the right to grant sublicenses within the scope thereof. Lipomedics and any sublicensee (with respect to any lower tier sublicense) shall include in any sublicense agreement with its sublicensees (a) an explicit reference to this Agreement and (b) a requirement that such sublicensees pay directly to Marina any unpaid relevant Candidate-Specific License Fee as a result of such sublicensee’s exercise of the rights granted in Article ‎2, provided, however, that notwithstanding any such assumption of Lipomedics’s obligations by any sublicensee, Lipomedics shall continue to be primarily liable for payment and performance of all of its obligations due to Marina under this Agreement and the relevant Candidate-Specific License Fee. Notwithstanding anything in this Agreement to the contrary, to the extent a sublicensee pays directly to Marina the Candidate-Specific License Fee as a result of such sublicensee’s exercise of the rights granted in Article ‎2, Lipomedics shall have no obligation to make such payment to Marina hereunder. All sublicense agreements with sublicensees shall be consistent with the terms and conditions hereunder. Lipomedics shall notify Marina in writing within thirty (30) days of any sublicense granted, including without limitation the identity of the sublicensee, the term, and the general scope of the rights granted. All such information regarding a sublicense shall be deemed Confidential Information of Lipomedics.

 

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8. Payments  In consideration of the execution by Marina of this Agreement, Lipomedics shall make the following payments to Marina:

 

  8.1 Evaluations License Fee . Simultaneous with the execution and delivery of this Agreement, Lipomedics shall enter into a Stock Purchase Agreement in form and substance reasonably acceptable to Marina and Lipomedics, pursuant to which Marina will sell to Lipomedics shares of the common stock of Marina for an aggregate purchase price of $250,000, with the purchase price for each share of Marina common stock being $0.29.
     
  8.2 Commercial License Fee . Unless this Agreement is earlier terminated, within thirty (30) days following Lipomedics’s delivery of an Evaluation Notice advising that it intends to pursue, or cause to be pursued, further development and commercialization of Licensed Products, Lipomedics shall, in connection therewith (and as a condition thereto), enter into a Stock Purchase Agreement in form and substance reasonably acceptable to Marina and Lipomedics, pursuant to which Marina will sell to Lipomedics shares of the common stock of Marina for an aggregate purchase price of $500,000, with the purchase price for each share of Marina common stock being the greater of $0.29 or the volume weighted average price of the Marina common stock for the thirty (30) trading days immediately preceding the date on which Lipomedics delivers the Evaluation Notice to Marina.
     
  8.3 For up to and including three Licensed Products, Lipomedics shall pay to Marina a milestone (collectively the “ Sales Milestones ”) of Ten Million Dollars ($10,000,000) upon reaching Commercial Sales in the Territory in any given twelve month period equal to or greater than [***] Million Dollars ($[***]) for a given Licensed Product and of Twenty Million Dollars ($20,000,000) upon reaching Commercial Sales in any given twelve month period equal to or greater than [***] Dollars ($[***]) for such Licensed Product, such payments to be made within thirty (30) days following the month in which such Commercial Sale targets are met. For clarity’s sake, the aggregate amount of Sales Milestones paid hereunder may not exceed in any event Ninety Million Dollars ($90,000,000). There is no milestone payments for Licensed Products for fourth or beyond.

 

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9. Confidentiality.

 

  9.1 Definition . “Confidential Information” as used in this Agreement will include all non-public oral and written information and material, in tangible or intangible form (including but not limited to Marina Intellectual Property and Lipomedics Intellectual Property) which one party furnishes (“ Disclosing Party ”), directly or indirectly, to the other party (“ Receiving Party ”). Confidential Information expressly does not include:

 

(a)       information that was already known to the Receiving Party without obligation of confidentiality prior to disclosure of it to the Receiving Party by the Disclosing Party;

 

(b)       information that is disclosed to the Receiving Party without obligation or confidentiality by a third party who has the right to make such disclosure;

 

(c)       information that is in the public domain or hereafter enters the public domain through no fault of the Receiving Party; and

 

(d)       information that was independently developed by the Receiving Party without any reliance on Confidential Information of the Disclosing Party.

 

  9.2 Non-Disclosure . The Receiving Party shall (i) keep the Disclosing Party’s Confidential Information in strict confidence; (ii) protect it with the same degree of care as the Receiving Party treats its own confidential information, but with no less than reasonable care; (iii) not, without the prior written consent of the Disclosing Party, disclose or permit it to be disclosed to anyone other than (A) the Receiving Party’s actual or prospective sublicensees, directors, officers, employees, agents, independent contractors or consultants who have a legitimate need to know the Confidential Information in connection with the Agreed Purpose, or (B) regulatory authorities in connection with regulatory submissions or other communications related to any Licensed Product; and (iv) will not use and will not permit its sublicensees, directors, officers, employees, agents, independent contractors or consultants to use the Disclosing Party’s Confidential Information for any reason other than the Agreed Purpose. The Receiving Party shall only make disclosure to its actual or prospective sublicensees, directors, officers, employees, agents, independent contractors or consultants who are bound by the confidentiality obligations at least as restrictive as those set forth in this Agreement.
     
  9.3 Compelled Disclosure . In the event the Receiving Party is required by any court or legislative or administrative body (by oral questions, interrogatories, requests for information or documents, subpoena, civil investigation demand or similar process) to disclose any Confidential Information of the Disclosing Party, the Receiving Party shall provide the Disclosing Party with prompt notice of such requirement in order to afford the Disclosing Party an opportunity to seek an appropriate protective order or to legally contest such disclosure. The Receiving Party shall cooperate, at the Disclosing Party’s expense, with all reasonable requests of the Disclosing Party for assistance in seeking such order or contesting such disclosure. However, if the Disclosing Party is unable to obtain or does not seek such protective order and the Receiving Party is, in the opinion of its counsel, compelled to disclose such Confidential Information under pain or liability for contempt or other censure or penalty, disclosure of such information may be made without liability.

 

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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

  9.4 Return of Confidential Information . Upon demand by the Disclosing Party, the Receiving Party shall return and deliver all Confidential Information of the Disclosing Party which was disclosed to it, and the Receiving Party shall destroy all copies, summaries, compilations or analyses thereof, in whatever form maintained or derived and a senior officer of the Receiving Party shall, upon request, certify as to such return and destruction. Notwithstanding the foregoing, (a) during the term of this Agreement, Lipomedics and its sublicensees may retain any Marina Know-How licensed under Article 2, and (b) following any such demand, the Receiving Party (i) may retain one copy of the Confidential Information for legal purposes by the Receiving Party’s legal division, including for the purpose of certifying the scope and nature of the documents received under this Agreement, and (ii) will not be required to destroy any computer files stored securely by the Receiving Party that are created during automatic system back-up.
     
  9.5 Publicity; Terms of Agreement . The parties shall treat the existence and material terms of this Agreement as Confidential Information and shall not disclose such Confidential Information to third parties without the prior written consent of the other party or except as provided in this Section 9.5.

 

    9.5.1 The parties agree that upon execution of this Agreement or shortly thereafter, Marina may issue a press release substantially and materially in the form attached hereto as Exhibit B . Except for such press release or as otherwise required by applicable law or applicable stock exchange requirements, neither Marina nor Lipomedics shall issue or cause the publication of any other press release or public announcement with respect to the transactions contemplated by this Agreement without the express prior approval of the other party, which approval shall not be unreasonably withheld or delayed; provided that, each of Marina and Lipomedics may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases, so long as any such public statement or press release is not inconsistent with prior public disclosures or public statements approved by the other party pursuant to this Section 9.5.1 and which do not reveal non-public information about the other party. With respect to complying with the disclosure requirements of the Securities and Exchange Commission or other regulatory agencies, in connection with any required filing of this Agreement with such agency, the parties shall consult with one another concerning which terms of this Agreement shall be requested to be redacted in any public disclosure of the Agreement by the agency, and each party shall seek confidential treatment by the agency in public disclosure of the Agreement by the agency for all sensitive commercial, financial and technical information.

 

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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

    9.5.2 Each party may disclose Confidential Information with respect to the existence and material terms of this Agreement and the transactions contemplated by this Agreement (i) to Affiliates and potential commercial partners who need to know such information for the development, manufacture and commercialization of Licensed Products, (ii) to bankers, lawyers, accountants, agents or other third parties in connection with due diligence or similar investigations, and (iii) to potential third party investors in confidential financing documents or potential acquirers or merger partners in confidence pursuant to due diligence; provided in each case that any such party or person receiving such Confidential Information is bound by obligations of confidentiality and non-use at least as restrictive as those set forth herein.

 

10. Return of Property.

 

  10.1 Return of Marina’s Property . Lipomedics acknowledges that Marina’s sole and exclusive property includes all materials and information provided by Marina to Lipomedics, whether or not constituting Marina Intellectual Property or Confidential Information and whether or not related to the Agreed Purpose. Lipomedics agrees to promptly deliver or destroy Marina’s property that is then in Lipomedics’s possession, including but not limited to, Marina Intellectual Property, upon the earlier of Marina’s request or the termination of this Agreement. Notwithstanding the foregoing, during the term of this Agreement, Lipomedics and its sublicensees may retain any Marina Know-How licensed under Article 2. Lipomedics shall not make or retain any copies of Marina Intellectual Property or any other materials supplied by Marina, except as provided in Section 9.4.
     
  10.2 Return of Lipomedics’s Property . Marina acknowledges that Lipomedics’s sole and exclusive property includes all materials and information provided by Lipomedics to Marina, whether or not constituting Lipomedics Intellectual Property or Confidential Information of Lipomedics and whether or not related to the performance of the Agreed Purpose. Marina agrees to promptly deliver Lipomedics’s property that is then in Marina’s possession to Lipomedics, including but not limited to, Lipomedics Intellectual Property, upon the earlier of Lipomedics’s request or the termination of this Agreement. Marina shall not make or retain any copies of Lipomedics Intellectual Property or any other materials supplied by Lipomedics, except as provided in Section 9.4.

 

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11. Indemnification.

 

  11.1 By Lipomedics. Lipomedics shall defend, indemnify, and hold harmless Marina, its Affiliates (other than Lipomedics) and their respective directors, officers, shareholders, employees and agents (“ Marina Indemnitees ”), from and against any and all liabilities, claims, damages, losses, penalties, fines, costs, expenses (including reasonable attorneys’ fees), judgments or settlements (collectively, “ Liabilities ”) arising from or occurring as a result of any investigation, claim, action, suit, or other proceeding by any Person other than the parties (each, a “ Third Party Claim ”) against a Marina Indemnitee, which Third Party Claim is due to or based upon: (a) any breach of a representation, warranty, covenant or agreement made or undertaken by Lipomedics under this Agreement; (b) any negligent or more culpable act of Lipomedics, or any of its Affiliates or sublicensees under this Agreement; or (c) the development, manufacture, use, offer for sale, sale, importation or marketing of any Licensed Product by Lipomedics, or any of its Affiliates or sublicensees. However, Lipomedics shall not indemnify or hold harmless any Marina Indemnitee from any Liabilities to the extent that such Liabilities were the direct result of the acts or omissions of a Marina Indemnitee, or any breach of any term or warranty of this Agreement by Marina.
     
  11.2 By Marina . Marina shall defend, indemnify, and hold harmless Lipomedics, its Affiliates (other than Marina) and their respective directors, officers, shareholders, employees and agents (“ Lipomedics Indemnitees ”), from and against any and all Liabilities arising from or occurring as a result of a Third Party Claim against a Lipomedics Indemnitee, which Third Party Claim is due to or based upon: (a) any breach of a representation, warranty, covenant or agreement made or undertaken by Marina under this Agreement; (b) any negligent or more culpable act of Marina or its Affiliates under this Agreement, or (c) based on a claim that use of Marina Technology or Marina Intellectual Property in connection with the manufacture, use or sale of a Licensed Product infringes or misappropriates any third party intellectual property rights, except that Marina shall not have any liability to Lipomedics to the extent that the challenged use of Marina Technology or Marina Intellectual Property in combination with macromolecules other than APIs or other methods or technologies for producing macromolecules (including other gene-editing technologies) would not itself be infringing. However, Marina shall not indemnify or hold harmless any Lipomedics Indemnitee from any Liabilities to the extent that such Liabilities were the direct result of the acts or omissions of a Lipomedics Indemnitee or any breach of any term or warranty of this Agreement by Lipomedics.

 

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  11.3 Indemnification Procedures . In the event an Indemnitee (either a Lipomedics Indemnitee or a Marina Indemnitee) intends to claim indemnification under this Article 11, such Indemnitee shall provide the indemnifying party with prompt notice of the Third Party Claim. The indemnifying party shall have the right to control, with counsel of its choice, the defense thereof or to settle any such Third Party Claim; provided, however, that the indemnifying party shall not enter into any settlement that admits fault, wrongdoing or damages or restricts the Indemnitee’s business in any way without the affected Indemnitee’s written consent, such consent not to be unreasonably withheld or delayed. The affected Indemnitee shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any Third Party Claim that has been assumed by the indemnifying party. The affected Indemnitee shall cooperate with all reasonable requests of the indemnifying party and its legal representatives in the investigation and defense of any Third Party Claim covered by this Article 11. An Indemnitee shall not, except at its own cost, voluntarily make any payment or incur any expense with respect to any claim or suit without the prior written consent of the indemnifying party, which such party shall not be required to give.

 

12. Use of Names. Nothing contained in this Agreement shall be construed as conferring any right to use in advertising, publicity, or other promotional activities any name, trade name, trademark, trade dress or other designation of either party hereto (including any contraction, abbreviation or simulation of any of the foregoing), save as expressly stated herein. Each party hereto agrees not to use or refer to this Agreement or any provision hereof in any promotional activity without the express written approval of the other party, such approval not to be unreasonably withheld, conditioned or delayed.
   
13. Warranty Disclaimer. EXCEPT AS EXPRESSLY SET FORTH HEREIN, (I) MARINA MAKES NO WARRANTIES WITH RESPECT TO THE MARINA TECHNOLOGY OR THE MARINA INTELLECTUAL PROPERTY, EITHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND (II) THE MARINA TECHNOLOGY IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND AND USE BY LIPOMEDICS OF THE MARINA TECHNOLOGY IS AT LIPOMEDICS’S OWN RISK; AND (III) LIPOMEDICS MAKES NO WARRANTIES WITH RESPECT TO THE LIPOMEDICS TECHNOLOGY OR THE LIPOMEDICS INTELLECTUAL PROPERTY, EITHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND (IV) THE LIPOMEDICS TECHNOLOGY IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND AND USE BY MARINA OF THE LIPOMEDICS TECHNOLOGY IS AT MARINA’S OWN RISK.
   
14. Limitation on Liability. EXCEPT FOR BREACHES OF A PARTY’S CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9 OR A PARTY’S INDEMNIFICATION OBLIGATIONS IN RESPECT OF THIRD PARTY CLAIMS UNDER ARTICLE ‎11, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES, EVEN IF SUCH PARTY HAD NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

 

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15. Term and Termination.

 

  15.1 Term .

 

    15.1.1 This Agreement shall commence on the Effective Date and shall continue, unless terminated earlier as provided in this Article 15, in full force and effect as to each Licensed Product on a country-by-country basis until the last to expire Marina Patent in such country covering such Licensed Product. Upon the expiration (but not the earlier termination) of this Agreement in a given country in accordance with this Section 15.1.1, the licenses and rights granted by Marina to Lipomedics under this Agreement will continue on a fully paid-up, royalty-free and irrevocable basis in such country.
       
    15.1.2 Notwithstanding anything in this Agreement to the contrary, in the event that Lipomedics fails (i) to timely deliver the Evaluation Notice or (ii) to timely pay the Commercial License Fee, this Agreement shall automatically and without further action by Marina terminate in its entirety.

 

  15.2 Termination

 

    15.2.1 By Marina . In the event Lipomedics breaches this Agreement, Marina shall have the right to terminate this Agreement effective sixty (60) days following delivery of written notice to Lipomedics referencing this Section 15.2.1 and specifying the breach, if Lipomedics fails to cure such material breach within such sixty (60) day period; provided , that if Lipomedics advises Marina in writing within such sixty (60) day period that such breach cannot reasonably be cured within such sixty (60) day period, and if in the reasonable judgment of Marina, Lipomedics is diligently seeking to cure such breach during such sixty (60) day period, then such sixty (60) day period shall be extended an additional sixty (60) days for an aggregate of 120 days after written notice of termination, and if Lipomedics fails to cure such material breach by the end of such 120-day period this Agreement shall automatically and without further action by Marina terminate in its entirety.
       
    15.2.2 By Lipomedics . Any provision herein notwithstanding, Lipomedics shall have the right to terminate this Agreement by giving Marina thirty (30) days prior written notice referencing this Section 15.2.2.

 

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  15.3 Effect of Termination/Expiration .

 

    15.3.1 Reversion of Rights . As of the effective date of a termination pursuant to Section 15.2 and except as provided in this Section 15.3, the rights and licenses granted by Marina to Lipomedics under Article 2 shall terminate and all rights in the Marina Technology and the Marina Intellectual Property shall revert to Marina.
       
    15.3.2 No Release . Termination of this Agreement shall not release either party hereto from any liability which at the time of such termination has already accrued to the other party.
       
    15.3.3 Stock on Hand . In the event this Agreement is terminated for any reason, Lipomedics shall deliver to Marina, as soon as practicable after termination, a report indicating the quantity and description of Licensed Products on hand, on order, or in the course of manufacture as of the date of expiration or termination. Marina shall have the right to conduct a physical inventory of Lipomedics’s premises (and those of its sublicensees) to ascertain or verify such final report. In the event Lipomedics or such sublicensee refuses to permit Marina to conduct such physical inventory, Marina shall retain all legal and equitable rights that it may have in the premises. If such termination occurs after payment of the Commercial License Fee, Lipomedics and its sublicensees shall have the right, for a period of six (6) months following termination, to sell or otherwise dispose of all such Licensed Products.
       
    15.3.4 Return of Information. Lipomedics shall forthwith deliver to Marina (and, unless a sublicensee has entered agreements with Marina pursuant to Section 15.3.5, shall cause such sublicensee to deliver) (a) a right of reference to any regulatory filings made by Lipomedics (or such sublicensee) with respect to Licensed Products (provided that Marina shall reimburse Lipomedics or such sublicensee for any costs or expenses incurred to provide any such rights of reference) and (b) all reports, memoranda, drawings, data, flow sheets and other documents and all copies thereof which contain or describe any research performed utilizing the Marina Technology or containing any Confidential Information of Marina.
       
    15.3.5 Rights of Sublicensees . If this Agreement terminates for any reason (a) prior to payment by Lipomedics of the Commercial License Fee, then all sublicenses granted by Lipomedics shall automatically terminate and (b) after payment by Lipomedics of the Commercial License Fee, then each of Lipomedics’s sublicensees will, from the effective date of such termination, be deemed to have become a direct licensee of Marina with respect to the rights originally sublicensed to the sublicensee by Lipomedics, and Marina agrees that it will confirm the foregoing in writing at the request and for the benefit of Lipomedics and/or the sublicensee; provided, that (i) such sublicensee is not in breach of its sublicense agreement, (ii) such sublicensee promptly agrees to comply with all of the terms of this Agreement to the extent applicable with respect to the rights originally sublicensed to it by Lipomedics, (iii) such sublicensee promptly agrees to pay directly to Marina such sublicensee’s payments under such sublicense to the extent applicable to the rights sublicensed to it by Lipomedics and (iv) Marina shall have no obligations under such sublicense that are different from or greater than its obligations to Lipomedics under this Agreement; provided , further, that any such sublicensee shall only be responsible for any payments that become due as a result solely of such sublicensee’s activities after the effective date of any such termination and such sublicensee will be credited for any license payments already paid prior to the effective date of any such termination as if such payment had been made by such sublicensee.

 

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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

16. Bankruptcy Code. All rights and licenses granted under this Agreement will be deemed licenses of rights to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code for purposes of Section 365(n) of the U.S. Bankruptcy Code and Lipomedics will retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. In addition, in the event that during the term of this Agreement, Marina files a voluntary petition in bankruptcy, is adjudicated a bankrupt, makes a general assignment for the benefit of creditors, admits in writing that it is insolvent or fails to discharge within sixty (60) days an involuntary petition in bankruptcy filed against it, then (i) Lipomedics will have a right of access to the information, patents and technology of Marina licensed under this Agreement consistent with the terms of this Agreement for purposes of 11 U.S.C. Section 365(n), (ii) Lipomedics as a licensee of intellectual property under this Agreement, shall retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code, subject to its ongoing payment obligations as provided in U.S.C. 365(n) and (iii) Lipomedics shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such information, intellectual property and all embodiments of such intellectual property, which, if not already in Lipomedics’s possession, shall be promptly delivered to Lipomedics (A) upon any such commencement of a bankruptcy proceeding upon Lipomedics’s written request therefor unless Marina continues to perform all of its obligations under this Agreement, or (B) if not delivered under clause (A) above, following the rejection of this Agreement by or on behalf of Marina, upon written request therefor by Lipomedics.

 

17. Miscellaneous.

 

  17.1 Force Majeure . Neither Lipomedics nor Marina shall be responsible for failure or delay in performance of its obligations related to the Agreed Purpose due to causes beyond its reasonable control, including but not limited to, acts of God, governmental actions, fire, earthquake, labor difficulty, shortages, civil disturbances, transportation problems, interruptions of power or communications, failure of suppliers or subcontractors, or natural disasters.

 

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  17.2 Relationship of the Parties . The relationship of the parties is that of independent contractors, and nothing herein shall be construed as establishing one party, its Affiliates, or any of its or their employees as the agent, legal representative, partner, employee, or servant of the other party or its Affiliates. Neither party shall have any right, power or authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other party or its Affiliates.
     
  17.3 Waiver and Severability . No waiver by either party of any breach of any provision hereof shall constitute a waiver of any other breach of that or any other provision hereof. If any part, term or provision herein is determined to be invalid or unenforceable, the remainder of the terms and conditions herein shall not be affected, and shall otherwise remain in full force and effect.
     
  17.4 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflicts of law rules, provided that those matters pertaining to the validity or enforceability of patent rights shall be interpreted and enforced in accordance with the laws of the territory in which such patent rights exist.
     
  17.5 Assignment . Neither party shall assign this Agreement without the prior written consent of the other party. Notwithstanding the foregoing, either party may assign or transfer this Agreement to an Affiliate or to a successor to the party’s business by merger, consolidation, or similar business combination transaction, sale of stock, or sale of substantially all assets to which this Agreement relates, provided that, in the case of any assignment or transfer of this Agreement to an Affiliate, the assigning or transferring party shall remain fully liable for all of its obligations hereunder. As a condition to the effectiveness of any permitted assignment hereunder, any permitted successor or assignee of rights and/or obligations hereunder shall, in writing to the non-assigning party, expressly assume performance of all rights and/or obligations of the assigning party under this Agreement. This Agreement shall be binding upon and shall inure to the benefit of each party’s permitted successors-in-interest and permitted assigns. Any assignment or attempted assignment by either party in violation of the terms of this Section 17.5 shall be null and void and of no legal effect.
     
  17.6 Entire Agreement . This Agreement constitutes the entire, full, and complete agreement of the parties concerning the subject matter hereof, and supersedes all prior agreements, negotiations, representations, and discussions, written or oral, express or implied, between the parties in relation thereto. This Agreement may only be amended or modified by a writing signed by both parties hereto.
     
  17.7 Notices . Any consent, notice or report required or permitted to be given or made under this Agreement by one of the parties to the other shall be in writing, (a) delivered personally, (b) sent by registered or certified mail, return receipt requested, or (c) sent by reputable overnight business courier, in each case to such other party at its address indicated above, or to such other address as the addressee shall have last furnished in writing to the addressor, and shall be effective upon receipt by the addressee.

 

[signature page follows]

 

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[Signature Page to License Agreement]

 

IN WITNESS WHEREOF , the parties have caused this License Agreement to be executed as of the date first written above.

 

MARINA BIOTECH, INC.   LIPOMEDICS, INC.
         
By: /s/ Joseph W. Ramelli   By: /s/ Tapas K. De
  Joseph W. Ramelli, CEO     Tapas K De, CEO
         
Date: February 6, 2017   Date: February 6, 2017

 

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Exhibit A

 

Marina Patents

 

Patents Covering SMARTICLE™ Technology

 

No.   Serial No.   Title   Country   Status
                 
1   International Application No. PCT/EP2006/009013   IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES   WIPO   National Stage
                 
2   Australia Patent No.   IMPROVEMENTS IN OR RELATING TO   Australia   Issued
    2006291429   AMPHOTERIC LIPOSOMES        
                 
3   Canada Patent No. 2,622,584   IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES   Canada   Issued
                 
4   Canada Appl. No. 2,889,540   IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES   Canada   Pending
                 
5   Japan Patent No. 5,571,308   IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES   Japan   Issued
                 
6   European Patent Application No. 06254821.9   IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES   European Pat Office   Pending
                 
7   US Patent No. 9,066,867   IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES   U.S.   Issued
                 
8   US Application No. 14/538,809   IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES   U.S.   Pending
                 
9   International Application No. PCT/EP2002/001880   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   WIPO   National Stage
                 
10   European Patent No. 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   European Pat Office   Issued
                 
11   EP 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Austria   Issued

 

 
 

 

[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

12   EP 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Belgium   Issued
                 
13   EP 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Switzerland   Issued
                 
14   DE 50210271.3   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Germany   Issued
                 
15   ES 02701290.5   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Spain   Issued
                 
16   EP 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   France   Issued
                 
17   EP 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Great  Britain   Issued
                 
18   EP 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Ireland   Issued
                 
19   EP 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Italy   Issued
                 
20   EP 1,363,601   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Netherlands   Issued
                 
21   Australia Patent No.   AMPHOTERIC LIPOSOMES AND THE   Australia   Issued
    2002234643   USE THEREOF        
                 
22   Brazil Patent No. PI0207775.2   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Brazil   Issued
                 
23   Canada Patent No. 2,438,116   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Canada   Issued
                 
24   China Patent No. 1,241,549   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   China   Issued
                 
25   Japan Patent No. 5,480,764   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Japan   Issued
                 
26   Japan Appl. No. 2014-165961   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Japan   Pending
                 
27   Japan Appl. No. 2016-001813   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   Japan   Pending

 

 
 

 

[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

28   US Patent No. 7,371,404   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   U.S.   Issued
                 
29   US Patent No. 7,780,983   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   U.S.   Issued
                 
30   US Patent No. 7,858,117   AMPHOTERIC LIPOSOMES AND THE USE THEREOF   U.S.   Issued
                 
31   International Application No. PCT/EP2007/002349   EFFICIENT METHOD FOR LOADING AMPHOTERIC LIPOSOMES WITH NUCLEIC ACID ACTIVE SUBSTANCES   WIPO   National Stage
                 
32   European Application No. 07723327.8   EFFICIENT METHOD FOR LOADING AMPHOTERIC LIPOSOMES WITH NUCLEIC ACID ACTIVE SUBSTANCES   European Pat Office   Pending
                 
33   US Application No. 14/066,616   EFFICIENT METHOD FOR LOADING AMPHOTERIC LIPOSOMES WITH NUCLEIC ACID ACTIVE SUBSTANCES   U.S.   Pending

 

 
 

 

[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

EXHIBIT B

 

Press Release

 

News Release

 

Marina Biotech Announces a License Agreement to SMARTICLES

 

City of Industry, CA January [  ], 2017 – Marina Biotech, Inc. (OTCQB: MRNA) a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension, and cancer, today announced that they have entered into a license agreement regarding the Company’s SMARTICLES platform for the delivery of nanoparticles including small molecules, peptides, proteins and biologics. This represents the first time that the Company’s SMARTICLES technologies have been licensed in connection with nanoparticles delivering small molecules, peptides, proteins and biologics. Under terms of the agreement, Marina could receive up to $90MM in success based milestones. Further details of the agreement were not disclosed.

 

“With the execution of this license agreement, the company extends its runway and enters into new areas medicine,” stated Joseph W. Ramelli, CEO of Marina Biotech. “We are now beginning to see our delivery technologies used with various types of molecules and entities. We hope our delivery technologies continue to provide new therapeutic opportunities to the patient community.”

 

About Marina Biotech, Inc.

 

Marina Biotech is a biotechnology company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension, and cancer. Our pipeline includes combination therapies of oligonucleotide-based therapeutics and small molecules. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome). By its merger with IthenaPharma, Marina Biotech recently acquired IT-102/IT-103- next generation celecoxib- which will be developed together with CEQ508 as a therapeutic enhancer for therapies against FAP and CRC. IT-102/IT-103 are also being developed for the treatment of combined arthritis/ hypertension and treatment of pain requiring high dose of celecoxib. Additional information about Marina Biotech is available at http://www.marinabio.com .

 

 
 

 

[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

Marina Biotech Forward-Looking Statements

 

Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Marina Biotech to successfully integrate its business operations with those of IthenaPharma; (ii) the ability of Marina Biotech to obtain funding to support its clinical development; (iii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iv) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (v) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (vi) the ability of Marina Biotech and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ 2 materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech’s most recent filings with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update or supplement forward-looking statements because of subsequent events.

 

For Marina inquires: Joseph Ramelli CEO Marina Biotech, Inc. (626) 964-5753

 

 
 

 

 

Exhibit 31.1

 

MARINA BIOTECH, INC.

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Joseph W. Ramelli, being the Chief Executive Officer of Marina Biotech, Inc., certify that:

 

1. I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2017 for Marina Biotech, 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. I am 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 my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me 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 my 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 my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. I have disclosed, based on my 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.

 

Dated: May 15, 2017 /s/ Joseph W. Ramelli
  Joseph W. Ramelli
  Chief Executive Officer
  (Principal Executive Officer &
  Principal Financial Officer)
  Marina Biotech, Inc.

 

 
 

 

 

Exhibit 32.1

 

MARINA BIOTECH, INC.

CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Joseph W. Ramelli, the Chief Executive Officer of Marina Biotech, Inc. (“Marina Biotech”), certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of Marina Biotech on Form 10-Q for the quarter ended March 31, 2017 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and that information contained in the Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of Marina Biotech.

 

Dated: May 15, 2017 /s/ Joseph W. Ramelli
  Joseph W. Ramelli
  Chief Executive Officer
  (Principal Executive Officer &
  Principal Financial Officer)
  Marina Biotech, Inc.

 

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

 

This certification accompanies each periodic report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed by Marina Biotech for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.