UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported):   September 15, 2014

 

  Marina Biotech, Inc.  
     
  (Exact name of registrant as specified in its charter)  

 

Delaware   000-13789   11-2658569
         
(State or other jurisdiction    (Commission    (I.R.S. Employer
of incorporation)   File Number)   Identification No.)
         
P.O. Box 1559, Bothell, WA       98041
         
(Address of principal executive offices)        (Zip Code)

 

Registrant’s telephone number, including area code:   425-892-4322

 

  N/A  
     
  Former name or former address, if changed since last report  

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 
 

 

Item 1.01 Entry Into a Material Definitive Agreement.

 

On September 15, 2014, Marina Biotech, Inc. (the “ Company ”) entered into an Amended and Restated Employment Agreement (the “ Employment Agreement ”) with J. Michael French, its President and Chief Executive Officer, pursuant to which Mr. French shall serve as the President and Chief Executive Officer of the Company until September 14, 2017.

 

Pursuant to the Employment Agreement, Mr. French is entitled to annual base compensation of $425,000 commencing as of April 1, 2014. He is also eligible to receive annual performance-based incentive cash compensation, with the targeted amount of such incentive cash compensation being 50% of his annual base compensation for the year, but with the actual amount to be determined by the Board or the Compensation Committee.

 

Under the Employment Agreement, the Company granted options to Mr. French to purchase up to 771,000 shares of the common stock, par value $0.006 per share, of the Company (“ Common Stock ”), at an exercise price of $1.07 per share, of which 257,000 options shall vest on the first anniversary of the grant date, 257,000 options shall vest monthly in equal installments commencing after the first anniversary of the grant date and shall be vested in full on the second anniversary of the grant date, and 257,000 options shall vest monthly commencing after the second anniversary of the grant date and shall be vested in full on the third anniversary of the grant date.

 

If Mr. French’s employment is terminated without cause or he chooses to terminate his employment for good reason, all of Mr. French’s options that are outstanding on the date of termination shall be fully vested and exercisable upon such termination and shall remain exercisable for the remainder of their terms. In addition, he will receive (i) base salary, (ii) incentive cash compensation determined on a pro-rated basis as to the year in which the termination occurs, (iii) pay for accrued but unused paid time off, and (iv) reimbursement for expenses through the date of termination, plus an amount equal to 12 months of his specified base salary at the rate in effect on the date of termination.

 

If Mr. French’s employment is terminated for cause or he chooses to terminate his employment other than for good reason, vesting of the options shall cease on the date of termination and any then unvested options shall terminate, however the then-vested options shall remain vested and exercisable for the remainder of their respective terms. He will also receive salary, pay for accrued but unused paid time off, and reimbursement of expenses through the date of termination.

 

If Mr. French’s employment is terminated due to death or disability, Mr. French or his estate, as applicable, is entitled to receive (i) salary, reimbursement of expenses, and pay for accrued but unused paid time off; (ii) incentive cash compensation determined on a pro-rated basis as to the year in which the termination occurs; and (iii) a lump sum equal to base salary at the rate in effect on the date of termination for the lesser of (A) twelve (12) months and (B) the remaining term of the Employment Agreement at the time of such termination. In addition, vesting of all of Mr. French’s options that are outstanding on the date of termination shall cease, and any then vested options shall remain exercisable as specified in the applicable grant agreements.

 

If Mr. French’s employment is terminated by the Company (other than for cause) or by Mr. French (for good reason), and in either case other than because of death or disability, during the one-year period following a change in control of the Company, then Mr. French will be entitled to receive as severance: (i) salary, expense reimbursement and pay for unused paid time off through the date of termination; and (ii) a lump-sum amount equal to twelve (12) months of base salary at the rate in effect on the date of termination. In addition, all of Mr. French’s outstanding stock options shall be fully vested and exercisable upon a change of control and shall remain exercisable as specified in the option grant agreements.

 

Pursuant to the Employment Agreement, a change in control generally means (i) the acquisition by any person or group of 40% or more of the voting securities of the Company, (ii) the reorganization, merger or consolidation of the Company, or sale of all or substantially all of the Company’s assets, following which the stockholders of the Company, prior to the consummation of such transaction hold 60% or less of the voting securities of the surviving or acquiring entity, as applicable, (iii) a turnover of the majority

 

 
 

 

of the Board as currently constituted, provided that under most circumstances any individual approved by a majority of the incumbent Board shall be considered as a member of the incumbent Board of Directors for this purpose, or (iv) a complete liquidation or dissolution of the Company.

 

The Employment Agreement also provides that the Company shall cause the nomination and recommendation of Mr. French for election as a director at the Company’s annual meetings of stockholders that occur during the employment term, and use all best efforts to cause Mr. French to be elected as a non-independent director.

 

In general, Mr. French has agreed not to compete with the Company during the employment term and for six months thereafter, to solicit the partners, consultants or employees of the Company for one year following the end of the employment term, or to solicit the Company’s clients during the employment term and for twelve months thereafter.

 

The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the Employment Agreement, a copy of which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

J. Michael French Employment Agreement

 

Please see Item 1.01 above for disclosure regarding the Amended and Restated Employment Agreement that the Company entered into with J. Michael French, its President and Chief Executive Officer, including the issuance of options to purchase shares of the Company’s Common Stock.

 

Expansion of Board of Directors

 

On September 15, 2014, the Board of Directors of the Company formally increased the size of the Board from four (4) members to five (5) members pursuant to Article II, Section 2 of the Amended and Restated By-Laws of the Company. As noted in Item 5.07 below, Donald A. Williams was elected by the stockholders of the Company at the 2014 Annual Meeting of Stockholders held on September 15, 2014 (the “ Annual Meeting ”) to fill such vacancy.

 

Adoption of 2014 Long-Term Incentive Plan

 

As noted in Item 5.07 below, at the Annual Meeting, the Company’s stockholders approved the adoption of the Company’s 2014 Long-Term Incentive Plan (the “ 2014 Plan ”). The 2014 Plan was previously adopted by the Company’s Board of Directors on August 6, 2014. A total of 5,000,000 shares of Common Stock are subject to the granting of awards under the 2014 Plan. A copy of the 2014 Plan is filed as Exhibit 10.2 hereto and is incorporated herein by reference.

 

Grant of Stock Options to Directors

 

On September 15, 2014, the Board approved the issuance to each of Stefan Loren, Ph.D., Joseph W. Ramelli, Philip C. Ranker and Donald A. Williams of options to purchase up to an aggregate of 62,000 shares of Common Stock at an exercise price of $1.07 per share, which represented the initial option grant to such non-employee directors, and 50% of the annual option grant for the 2014 calendar year (covering the third and fourth quarters, respectively, of the 2014 calendar year).

 

 
 

   

Item 5.07. Submission of Matters to a Vote of Security Holders.

 

The Company held its 2014 Annual Meeting of Stockholders on September 15, 2014. Proxies were solicited for each of the six (6) proposals set forth below. The voting results reported below are final.

 

PROPOSAL No. 1

 

The stockholders elected each of the Company’s five (5) nominees to serve as directors of the Company until the 2015 Annual Meeting based upon the following votes:

 

Nominee   Votes “FOR”   Votes WITHHELD   Broker Non-Votes
J. Michael French   9,612,717   151,845   11,432,489
Stefan Loren, Ph.D.   9,683,933   80,629   11,432,489
Joseph W. Ramelli   9,601,772   162,790   11,432,489
Philip C. Ranker   9,610,597   153,965   11,432,489
Donald A. Williams   9,609,879   154,683   11,432,489

 

PROPOSAL No. 2

 

The appointment of Wolf & Company, P.C. as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2014 was ratified based upon the following votes:

 

Votes “FOR”   Votes AGAINST   Votes ABSTAINED   Broker Non-Votes
21,114,943   1,037,264   44,844   -0-

 

PROPOSAL No. 3

 

The proposal to amend the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split, at any time within two (2) years following the Annual Meeting, and in such ratio between a one-for-two and one-for-ten reverse stock split, to be determined by the Board of Directors, to be in the best interest of the Company, was approved based upon the following votes:

 

Votes “FOR”   Votes AGAINST   Votes ABSTAINED   Broker Non-Votes
15,823,784   5,313,767   59,500   -0-

 

PROPOSAL No. 4

 

The adoption of the Company’s 2014 Long-Term Incentive Plan was approved based upon the following votes:

 

Votes “FOR”   Votes AGAINST   Votes ABSTAINED   Broker Non-Votes
9,240,059   263,457   261,046   11,432,489

 

PROPOSAL No. 5

 

The management proposal on the advisory vote to approve the compensation of the Company’s named executive officers was approved based upon the following votes:

 

Votes “FOR”   Votes AGAINST   Votes ABSTAINED   Broker Non-Votes
9,101,987   314,028   348,547   11,432,489

 

 
 

 

PROPOSAL No. 6

 

The management proposal on the advisory vote on the frequency of the advisory vote on the compensation of the Company’s named executive officers received the following votes:

 

3 Years   2 Years   1 Year   Votes ABSTAINED   Broker Non-Votes
922,329   29,614   8,767,130   45,489   11,432,489

 

On September 16, 2014, the Company issued a press release regarding the Annual Meeting, which is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Item 8.01 Other Events.

 

Board Compensation

 

On September 15, 2014, the Board approved the following compensation for non-employee directors:

 

Initial Option Grant: Options to purchase up to 43,000 shares of Common Stock, which options shall have a 5-year term and shall vest 50% immediately and 50% after one year.

 

Annual Option Grant: Options to purchase up to 38,000 shares of Common Stock, which options shall have a 5-year term and shall vest 50% immediately and 50% after one year.

 

Annual Cash Payment: $45,000 per year, payable quarterly in advance.

 

Investor Presentation

 

Attached to this Current Report on Form 8-K as Exhibit 99.2, and incorporated herein by reference, is a copy of a presentation about the Company that was used at the Annual Meeting.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits:

 

Exhibit No. Description
     
10.1**   Amended and Restated Employment Agreement, dated September 15, 2014, between Marina Biotech, Inc. and J. Michael French
     
10.2**   Marina Biotech, Inc. 2014 Long-Term Incentive Plan
     
99.1   Press release of Marina Biotech, Inc. dated September 16, 2014
     
99.2   Investor Presentation of Marina Biotech, Inc.

 

 

 

** Indicates management contract.

 

 
 

 

SIGNATURES

 

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

 

  Marina Biotech, Inc.  
       
September 19, 2014 By:  /s/ J. Michael French  

  Name: J. Michael French  
  Title: Chief Executive Officer  

 

 
 

 

EXHIBIT INDEX

 

Exhibit No.   Description
     
10.1**   Amended and Restated Employment Agreement, dated September 15, 2014, between Marina Biotech, Inc. and J. Michael French
     
10.2**   Marina Biotech, Inc. 2014 Long-Term Incentive Plan
     
99.1   Press release of Marina Biotech, Inc. dated September 16, 2014
     
99.2   Investor Presentation of Marina Biotech, Inc.

 

 

 

** Indicates management contract.

 

 

 

 

Exhibit 10.1

 

E XECUTION

 

AMENDED AND RESTATED

EMPLOYMENT AGREEMENT

 

This Amended and Restated Employment Agreement (this “Agreement”), is executed and entered into on the 15 th day of September, 2014, by and between Marina Biotech, Inc., a Delaware corporation (the “Company”), with offices c/o Pryor Cashman LLP, 7 Times Square, New York, NY 10036 and J. Michael French, an individual resident of the State of Florida and with a mailing address c/o Pryor Cashman LLP, 7 Times Square, New York, NY 10036 (the “Executive”), effective as of September 15, 2014 (the “Effective Date”),

 

W I T N E S S E T H :

 

WHEREAS, the Company and the Executive entered into that certain Employment Agreement dated June 10, 2008 ( as amended prior to the date hereof, the “Original Employment Agreement”); and

 

WHEREAS, the Company and the Executive wish to amend and restate the Original Employment Agreement in its entirety, as set forth in this Agreement, which shall set forth the Executive’s terms of employment as Chief Executive Officer and President of the Company;

 

NOW THEREFORE, in consideration of the mutual promises and agreements herein and for other good and valuable consideration the receipt and sufficiency of which are hereby mutually acknowledged, the Company and the Executive agree as follows:

 

1.           Application and Effectiveness of Agreements .   Effective as of the Effective Date, this Agreement shall govern (i) the employment relationship between the Company and the Executive and (ii) other matters as set forth herein.

 

2.           Employment; Responsibilities and Authority; Definitions .

 

(a)         Subject to the terms and conditions of this Agreement, the Company shall employ the Executive as its President and Chief Executive Officer during the Employment Period (as defined in Section 3, below) and the Executive shall perform such acts and duties and furnish such services to the Company and its Subsidiaries (as defined below) as the Board of Directors of the Company (the “Board”) shall from time to time direct.

 

(b)         Subject to the terms and conditions of this Agreement, the Executive hereby accepts such employment and agrees to devote his full time and continuous best efforts to the duties provided for herein.

 

(c)         For purposes of this Agreement: (1) the “Business of the Company” means the description of the Company’s business as is described in Part I, Item 1 of the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (provided, however, that for purposes of Sections 18(b) through (e) hereof, “Business of the Company” shall mean the Company’s business as of the date of termination of Executive’s employment, as the same may have changed since the Effective Date), and (2) the

 

1
 

 

term “Subsidiary” means a corporation or other entity that is at least majority owned, directly or indirectly, by the Company.

 

3.           Term; Employment Period .   The “Employment Period” under this Agreement shall commence on the Effective Date and shall terminate at the close of business on September 14, 2017 unless it is (a) extended by written agreement between the parties or by continuing employment of the Executive by the Company as provided in the following sentence or (b) earlier terminated pursuant to Section 11 hereof. If the Executive shall remain in full-time employment by the Company beyond what would otherwise be the end of the Employment Period without any written agreement between the parties, this Agreement and the Employment Period shall be deemed to continue on a quarter-to-quarter basis and either party shall have the right to terminate the Executive’s employment hereunder at the end of any ensuing fiscal quarter on written notice of at least ninety (90) days.

 

4.           Salary .             For services rendered to the Company during the Employment Period, the Company shall compensate the Executive with a base salary, payable in semi-monthly installments, which initially shall be four hundred twenty-five thousand dollars ($425,000) per annum commencing as of April 1, 2014 (the “Base Salary”). The Company shall pay Executive a lump sum within thirty (30) days following full execution of this Agreement, with such amount being the excess of Executive’s Salary Base Salary hereunder from April 1, 2014 through the date hereof, over whatever compensation the Company has paid Executive through the date hereof.

 

5.           Incentive Cash Compensation .

 

(a)         For the Company’s fiscal year that began on January 1, 2014, and for each subsequent fiscal year or portion thereof during the Employment Period, the Executive shall also be eligible to receive incentive cash compensation based on the Executive’s performance in relation to the performance areas and performance targets which the Board or Compensation Committee shall determine and communicate to the Executive as described below (the “Annual Bonus Plan”). The targeted amount of such Annual Bonus Plan shall be fifty percent (50%) of the Executive’s Base Salary for such year; provided, however, that the Executive and the Company acknowledge that the amount actually paid to the Executive pursuant to this Section 5 for any fiscal year or portion thereof may be nil, or may be more or less than said targeted amount.

 

(b)         The Board shall establish performance criteria for determination of the incentive cash compensation that will be payable to the Executive with respect to each fiscal year of the Company. To the extent possible, such criteria shall be established, as to each fiscal year, prior to the end of the second month of such fiscal year. As an example, such performance criteria may be comprised of several designated performance areas and one or more performance targets in each area. The Company acknowledges that the business objectives used in determining the Executive’s incentive cash compensation, and the performance areas and performance targets referred to herein, shall be based on the input and recommendations of the Company’s Chair and that, in exercising its review and supervisory role with respect to the determination and adoption of those performance areas and performance targets, the Board or the Compensation Committee, as the case may be, shall act reasonably and in consultation and cooperation with the Chair and consistently with past practice.

 

(c)         As soon as practical, and absent unforeseen circumstances no later than sixty (60) days following the end of each fiscal year of the Company, the Board shall determine, reasonably and in good faith, the extent to which the applicable performance criteria for such fiscal year shall have been achieved and, accordingly,

 

 
 

 

shall cause the appropriate amount of incentive cash compensation to be paid to the Executive no later than the 15 th day of the third month following the end of the fiscal year to which such incentive cash compensation relates. If unforeseen developments occur that in the opinion of the Board make the performance areas and/or targets previously determined unachievable, infeasible, or inadvisable — and therefore inappropriate as a measure of the performance of the Executive — the Board shall consider in good faith the extent to which the actual performance of the Executive nevertheless warrants payment of the amounts that would have been payable if the performance criteria had been achieved; and, to such extent, payment shall be made to the Executive.

 

6.           Stock Options .   The Company and the Executive hereby acknowledge that the Board of Directors has granted, or shall grant, to the Executive options to purchase shares of common stock of the Company, as more fully set forth in this Section 6 (the “Outstanding Options”). The terms of the grant agreements granting such Outstanding Options shall govern the rights and obligations of the Executive with respect thereto, subject, however, to the provisions of Sections 12 and 21 of this Agreement, if and as applicable. On September 15, 2014, the Company granted to the Executive options to purchase up to 771,000 shares of common stock at an exercise price of $1.07 per share. One-third of such options shall vest on the first anniversary of the grant date, one-third of such options shall vest monthly in equal installments commencing after the first anniversary of the grant date and shall be vested in full on the second anniversary of the grant date, and one-third of the options shall vest monthly commencing after the second anniversary of the grant date and shall be vested in full on the third anniversary of the grant date.

 

It is intended that all of these Outstanding Options qualify as incentive stock options under Section 422 of the Internal Revenue Code of 1986, and the remaining Outstanding Options shall be treated as non-qualified options. It is further intended that the incentive stock options shall vest such that, as nearly as possible, the aggregate fair market value prices of those incentive stock options which first become exercisable in each of calendar years 2014 through 2017 shall be $100,000 in each such year.

 

7.           Board .   During the Employment Period, the Company shall cause the nomination and recommendation of the Executive for election as a director at the annual shareholders’ meetings that may occur during the Employment Period, and use all best efforts to cause Executive to be elected as a non-independent director. Upon termination of Executive’s employment for any reason, Executive shall immediately resign from the Board and shall be deemed to have immediately for all purposes to have resigned from the Board and from all other positions with the Company and Subsidiaries, unless the Executive and Board otherwise agree. Executive’s failure to be appointed and/or re-elected to the Board shall constitute a material breach of this Agreement by the Company.

 

8.          Intentionally Omitted.

 

9.           Benefits .   During the Employment Period, the Company shall provide or cause to be provided to the Executive at least such employee benefits as are generally provided to other executive officers of the Company.

 

10.         Paid Time Off .   The Executive shall be entitled to paid time off in accordance with the Company’s policies in effect from time to time for executive officers of the Company.

 

 
 

 

11.          Termination .

 

(a)         Executive’s employment by the Company shall be “at will.” Either the Company or the Executive may terminate Executive’s employment by the Company at any time, with or without Cause or Good Reason (as such terms are defined below), in its or his sole discretion. In addition, the Executive’s employment by the Company shall be terminated by his death or “Disability” (as defined below). Termination of the Executive’s employment as provided for herein shall terminate the Employment Period.

 

(b)         For purposes of this Agreement, in the case of a termination of the Executive’s employment hereunder by the Executive, the term “Good Reason” shall have the meaning set forth for it below; in the case of a termination of the Executive’s employment hereunder by the Company, the term “Cause” shall have the meaning set forth for it below; and the other terms set out below in this Section 11 shall have the meanings provided for them respectively:

 

(i)          “Good Reason” shall mean (i) any material diminution in the Executive’s authority, duties, or responsibilities; (ii) any material diminution of the Executive’s Base Salary; or (iii) any other action or inaction that constitutes a material breach by the Company of the Agreement (including the Executive’s failure to be appointed and/or re-elected to the Board as provided in Section 7); provided that , the Executive must notify the Company in writing of the existence of a Good Reason within 90 days of the initial event giving rise to such Good Reason, the Company must fail to cure said Good Reason within sixty (60) days of Executive’s written notification, and Executive must terminate his employment with the Company for Good Reason by the end of the year following the year in which such Good Reason condition arose.

 

(ii)         “Cause” shall mean (i) the Executive’s willful and repeated failure to perform his duties hereunder or to comply with any reasonable and proper direction given by the Board, which failure continues for a period of thirty (30) days following receipt by the Executive of written notice from the Company containing a specific description of any such alleged failure(s) and a demand for immediate cure thereof; (ii) Executive’s indictment of or being charged for a felony or criminal offense involving moral turpitude; (iii) the Executive’s commission of an act of fraud or theft against the Company; or (iv) the Executive’s material violation of any of the terms, covenants, representations or warranties contained in this Agreement provided that , in the case of this clause “iv,” if such violation is subject to cure and effective remediation by the Executive, such violation is not so cured and remediated by the Executive within thirty (30) days following receipt by the Executive of written notice from the Company containing a reference to the violation and a demand for immediate cure thereof.

 

(c)         “Disability” shall mean that the Executive is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous  period of not less than twelve (12) months, as determined by an independent physician chosen jointly by the Executive and the Company.

 

(d)         “Termination Date” shall mean (i) if this Agreement is terminated on account of death, the date of death; (ii) if this Agreement is terminated for Disability, the date that such Disability is established; (iii) if this Agreement is terminated by the Company or by the Executive, the effective date of the termination as

 

 
 

 

provided in Section 11(a) hereof; or (iv) if this Agreement expires by its terms, September 14, 2017 or, if later, the expiration of the Employment Period.

 

12.           Severance .

 

(a)          Subject to Section 21 hereof, if (i) the Company terminates the employment of the Executive during any Employment Period and without Cause, or (ii) the Executive terminates his employment during any Employment Period for Good Reason, then (A) Executive shall be entitled to receive accrued but unpaid Base Salary (the “Accrued Salary Payment”), incentive cash compensation (determined on a pro-rated basis by multiplying the incentive cash compensation the Company determines Executive has earned for the fiscal year of termination by a fraction, the numerator of which is the number of days elapsed in the fiscal year as of the Termination Date and the denominator of which is 365) (the “Bonus Payment”), pay for accrued but unused paid time off (the “Vacation Payment”), and reimbursement for expenses (the “Reimbursement Payment”) pursuant to Section 13 hereof through the Termination Date, and an amount equal to twelve (12) months of the Executive’s specified Base Salary hereunder (the “Severance Payment”); and (B) notwithstanding the vesting and exercisability provisions otherwise applicable to Outstanding Options, all of such options shall be fully vested and exercisable upon such termination and shall remain exercisable as specified in the option grant agreements. Executive must satisfy the release requirement (“ Release Requirement ”) described below in order to receive the Severance Payment and Bonus Payment. The Company shall pay the Accrued Salary Payment, the Vacation Payment, and the Reimbursement Payment to Executive within thirty (30) days after the date of such termination. The Company shall pay the Bonus Payment to the Executive at the time provided in Section 5(c), provided the Release Requirement is satisfied. The Company shall pay the Executive the Severance Payment in semi-monthly installments, with the first payment being made on the Company’s first payroll date following the date the Release Requirement is satisfied, with the first payment being a “catch-up” for missed payments retroactive to the Termination Date, provided , however , that any such payments that would jeopardize the ability of the Company to continue as a going concern will be delayed and not paid to the Executive until such time as such payments would no longer have such effect and provided , further , that any such payments also are subject to the restrictions contained within Section 30, if applicable. Notwithstanding the foregoing, the Company shall not be required to pay any part of the Bonus Payment or Severance Payment for any period following the Termination Date if it shall have been determined in writing by a court of competent jurisdiction or by any arbitrator appointed pursuant to Section 27 that the Executive has materially violated the provisions of Section 18, 19, or 20 of this Agreement and such violation has not been cured within thirty (30) days following receipt of written notice from the Company containing a description of the violation and a demand for immediate cure. The Company also may withhold any such payments while it pursues such determination.

 

(b)          Subject to Section 21 hereof, if (A) the Executive voluntarily terminates his employment during any Employment Period other than for Good Reason or (B) the Executive’s employment is terminated by the Company during any Employment Period for Cause, then the Executive shall be entitled to receive only the Accrued Salary Payment, the Vacation Payment, and the Reimbursement Payment; vesting of Outstanding Options shall cease on such Termination Date; any then un-vested Outstanding Options shall terminate (with the then-vested Outstanding Options remaining vested and exercisable as specified in the option grant agreements). The Company shall pay the Accrued Salary Payment, the Vacation Payment, and the Reimbursement Payment to Executive within thirty (30) days after the date of such termination.

 

 
 

 

(c)          Subject to Section 21 hereof, if the Executive’s employment is terminated during any Employment Period due to death or Disability, the Executive (or his estate or legal representative as the case may be) shall be entitled to receive the Accrued Salary Payment, the Vacation Payment, the Reimbursement Payment; the Bonus Payment; and a lump sum equal to Base Salary at the rate in effect on the date of such termination for the lesser of (i) twelve (12) months and (ii) the remaining term of this Agreement at the time of such termination (the “Disability/Death Payment”). In such case, vesting of the Outstanding Options shall cease on such Termination Date, and any then un-vested Outstanding Options shall terminate (with the then-vested Outstanding Options remaining vested and exercisable as specified in the option grant agreements). The Company shall pay the Accrued Salary Payment, the Vacation Payment, and the Reimbursement Payment to Executive (or his estate or legal representative as the case may be) within thirty (30) days after the date of such termination. The Company shall pay the Bonus Payment to the Executive (or his estate or legal representative as the case may be) at the time provided in Section 5(c). The Company shall pay the Executive (or his estate or legal representative as the case may be) the Disability/Death Payment in a lump sum within thirty (30) days after the date of such termination, provided , however , that if such payment would jeopardize the ability of the Company to continue as a going concern, it will be delayed and not paid to the Executive (or his estate or legal representative as the case may be) until such time as such payment would no longer have such effect.

 

(d)          In addition to the provisions of Section 12(a), 12(b), or 12(c), hereof, as the case may be, to the extent COBRA shall be applicable or as provided by law, the Executive and/or his dependents shall be entitled to continuation of group health plan benefits for the periods provided by law following the Termination Date if the Executive (or his survivors) makes the appropriate election and payments; provided, further, that if the Executive and/or his survivors are entitled to severance under Section 12(a) or 12(c) hereof, and the Executive and/or his survivors elect COBRA coverage under a group health plan maintained by the Company (“COBRA Coverage”), the Company shall pay to the Executive (or his estate or legal representative as the case may be) each month for the twelve (12) month period following his Termination Date, an amount which is equal to the excess of the cost of COBRA Coverage which corresponds to the group health plan coverage he maintained for himself and his dependents immediately prior to the termination of his employment over what the Company employees pay for such coverage.

 

(e)          Subject to Section 21 hereof, the Executive acknowledges that, upon termination of his employment, he is entitled to no other compensation, severance or other benefits other than those specifically set forth or referred to in this Agreement.

 

(f)          In order to satisfy the Release Requirement, Executive must (i) execute a full general release in form and substance acceptable to the Company, releasing all claims, known or unknown, that Executive may have against Company or its affiliates arising out of or in any way related to Executive’s employment or termination of employment with Company, and such release must become effective and irrevocable in accordance with its terms on or before the 60 th day following the termination of Executive’s employment and (ii) continue to comply with the terms of this Agreement. In the event that Executive does not satisfy the Release Requirement, Executive shall forfeit all payments subject to the requirements of the Release Requirement. If the period of time Executive has to consider and/or revoke such release falls into two calendar years, the Company will begin paying the Severance Payment as soon as practicable in the later calendar year, but in no event later than March 15 of such later year.

 

 
 

 

13.          Expenses .   The Company shall pay or reimburse the Executive for all expenses that are reasonably incurred by him in furtherance of his duties hereunder and such further expenses as may be authorized and approved by the Company from time to time. In addition, the Company shall reimburse the Executive for the costs of his legal counsel incurred in connection with the review and negotiation of this Agreement, in an amount not to exceed $2,000.

 

14.          Facilities and Services .   The Company shall furnish the Executive with office space, secretarial and support staff, and such other facilities and services as shall be reasonably necessary for the performance of his duties under this Agreement.

 

15.          Mitigation Not Required .   In the event this Agreement is terminated, the Executive shall not be required to mitigate his losses or the amounts otherwise payable hereunder by seeking other employment or otherwise. The Executive’s acceptance of any other employment shall not diminish or impair the amounts otherwise payable to the Executive hereunder.

 

16.          Place of Performance .   The Executive shall perform his duties at the main offices of the Company, or such other location from time to time as the Board shall reasonably permit, subject to reasonable travel requirements which may be authorized and directed from time to time by the Board.

 

17.          Insurance and Indemnity .   With respect to his service hereunder, the Company shall maintain, at its expense, customary directors’ and officers’ liability and errors and omissions insurance covering the Executive and, if such coverage is available at reasonable cost, for all other executive officers and directors of the Company, in an amount both deemed appropriate by the Company and available in the marketplace. To the extent such defense and indemnification are not fully and irrevocably provided by Company-supplied insurance, the Company shall defend and indemnify the Executive, to the fullest extent permitted by law, from and against any liability asserted against or incurred by the Executive (a) by reason of the fact that the Executive is or was an officer, director, employee, or consultant of the Company or any affiliate or related party or is or was serving in any capacity at the request of the Company for any other corporation, partnership, joint venture, trust, employment benefit plan or other entity or enterprise or (b) in connection with any action(s), omission(s), or occurrence(s) during the course of such service or such status as an officer, director, employee, or consultant of or to any of the foregoing. The Company’s obligations under this Section 17 shall survive the termination of the Executive’s employment hereunder and any termination of this Agreement.

 

18.          Non-Competition .

 

(a)         The Executive agrees that, except in accordance with his duties under this Agreement on behalf of the Company, he will not during the Employment Period: participate in, be employed in any capacity by, serve as director, consultant, agent or representative for, or have an interest, directly or indirectly in, any enterprise which is engaged in the business of developing, licensing, or selling technology, products or services which are directly competitive with the Business of the Company or any of its Subsidiaries or with any technology, products or services being actively developed, with the bona fide intent to market same, by the Company or any of its Subsidiaries at the time in question; provided, however, that interests in publicly-traded entities that constitute less than a five percent (5%) interest in such entities, and do not otherwise constitute control either directly or indirectly of such entities, which interests were acquired or are held for investment purposes, shall not be deemed to be a violation of this paragraph.

 

 
 

 

(b)          In addition, the Executive agrees that, for a period of six (6) months after the end of the Executive’s employment by the Company (unless such employment is terminated by the Company without Cause, or by the Executive for Good Reason, in which event the following shall be inapplicable), the Executive shall not (1) own, either directly or indirectly or through or in conjunction with one or more members of his or his spouse’s family or through any trust or other contractual arrangement, a greater than five percent (5%) interest in, or otherwise control either directly or indirectly, or (2) participate in, be employed in any capacity by, or serve as director, consultant, agent or representative for, any partnership, corporation, or other entity which is engaged in the business of developing, licensing, or selling technology, products or services which are directly competitive with the Business of the Company or any of its Subsidiaries as of the termination of the Executive’s employment with the Company or which are directly competitive with any technology, products, or services being actively developed by the Company or any of its Subsidiaries, with the bona fide intent to market same, as of the termination of the Executive’s employment at the Company.

 

(c)          Executive further agrees, for twelve (12) months following the end of the Executive’s employment by the Company (unless such employment is terminated by the Company without Cause, or by the Executive for Good Reason, in which event the following shall be inapplicable), to refrain from directly or indirectly soliciting or hiring the Company’s collaborative partners, consultants, certified research organizations, principal vendors, licensees or employees except any such solicitation in connection with activities that would not be directly competitive with and/or adverse to the Business of the Company or any of its Subsidiaries or with and to any products or services being offered by the Company or any of its Subsidiaries at the date such employment terminated or then being actively developed, with the bona fide intent to market same, by the Company or any of its Subsidiaries.

 

(d)          Executive further agrees, while employed by the Company and for twelve (12) months following the end of the Executive’s employment by the Company (unless such employment is terminated by the Company without Cause, or by the Executive for Good Reason, in which event the following shall be inapplicable), that he will not, directly or indirectly, as a sole proprietor, member of a partnership or as a stockholder, investor, officer or director of a corporation, or as an employee, agent, associate or consultant of any person, firm or corporation, other than for the exclusive benefit of the Company or any of its Subsidiaries, solicit or accept business from, or perform or supervise the performance of any services related to such business for, (i) any client of the Company or any of its Subsidiaries who was a client during the Executive’s employment with the Company, (ii) any clients or prospective clients of the Company or any of its Subsidiaries who were solicited or serviced, directly or indirectly, by the Executive, in whole or in part, or (iii) any former client of the Company or any of its Subsidiaries who was a client within one (1) year prior to the Executive’s termination of employment and who was solicited or serviced, directly or indirectly, by the Executive, or by those supervised, directly or indirectly, by the Executive, in whole or in part, in connection with activities that would be directly competitive with and/or adverse to the Business of the Company or any of its Subsidiaries or with and to any products or services being offered by the Company or any of its Subsidiaries at the date such employment terminated or then being actively developed, with the bona fide intent to market same, by the Company or any of its Subsidiaries.

 

(e)          The Executive hereby agrees that damages and any other remedy available at law would be inadequate to redress or remedy any loss or damage suffered by the Company upon any breach of the terms of this Section 18 by the Executive, and the Executive therefore agrees that the Company, in addition to recovering

 

 
 

 

on any claim for damages or obtaining any other remedy available at law, also may enforce the terms of this Section 18 by injunction or specific performance, and may obtain any other appropriate remedy available in equity.

 

(f)          The time periods (if applicable) of the covenants contained in this Section 18 shall be extended by any and all periods during which Executive is in breach of such covenants.

 

19.          Assignment of Patents .   Executive shall disclose fully to the Company any and all discoveries he shall make and any and all ideas, concepts or inventions he shall conceive or make that are related or applicable to the Business of the Company or of any of its Subsidiaries or to any other products, services, or technology in medicine or the health sciences in which the Company shall during the Employment Period undertake, or actively and in good faith consider, research or commercial involvement; provided, however, that either (a) such discovery(ies), idea(s), concept(s) and/or invention(s) are made by the Executive during the Employment Period or (b) such discovery(ies), idea(s), concept(s) and/or invention(s) are made by the Executive during the period of six (6) months after his employment terminates and are in whole or in part the result of his work with the Company. Such disclosure is to be made promptly after each such discovery or conception, and each such discovery, idea, concept or invention will become and remain the property of the Company, whether or not patent applications are filed thereon. Upon the request and at the expense of the Company, the Executive shall (i) make application through the patent solicitors of the Company for letters patent of the United States and any and all other countries at the discretion of the Company on such discoveries, ideas and inventions, and (ii) assign all such applications to the Company, or at its order, without additional payment by the Company except as otherwise agreed by the Company and the Executive. The Executive shall give the Company, its attorneys and solicitors, reasonable assistance in preparing and prosecuting such applications and, on request of the Company, execute such papers and do such things as shall be reasonably necessary to protect the rights of the Company and vest in it or its assigns the discoveries, ideas or inventions, applications and letters patent herein contemplated. Said cooperation shall also include such actions as are reasonably necessary to aid the Company in the defense of its rights in the event of litigation. This Section 19 shall not apply to any invention for which no equipment, supplies, facilities, or trade secret information of the Company or its Subsidiaries was used, and which was developed entirely on the Executive’s own time, unless (i) the invention relates directly to the Business of the Company or of any of its Subsidiaries or to the actual or demonstrably anticipated research or development of the Company or of any of its Subsidiaries, or (ii) the invention results from any work performed by the Executive for the Company.

 

20.          Trade Secrets .

 

(a)          In the course of the term of this Agreement, it is anticipated that the Executive shall have access to secret or confidential technical, scientific and commercial information, records, data, formulations, specifications, systems, methods, plans, policies, inventions, material and other knowledge that is (are) specifically related or applicable to the Business of the Company or of any of its Subsidiaries or to any other products, services, or technology in medicine or the health sciences in which the Company shall during the Employment Period undertake, or actively and in good faith consider, research or commercial involvement and that is/are owned by the Company or its Subsidiaries (“Confidential Material”). The Executive recognizes and acknowledges that included within the Confidential Material are the following as they may specifically relate or be applicable to the Company’s Business or technology, or to current or specifically contemplated future Company products or services: the Company’s confidential commercial information, technology, formulations and know-how, methods of manufacture, chemical formulations, device designs, pending patent

 

 
 

 

applications, clinical data, pre-clinical data and any related materials, all as they may exist from time to time, and that such material is or may be valuable special, and unique aspects of the Company’s business. All such Confidential Material shall be and remain the property of the Company. Except as required by his duties to the Company, the Executive shall not, directly or indirectly, either during the term of his employment or at any time thereafter, disclose or disseminate to anyone or make use of, for any purpose whatsoever, any Confidential Material. Upon termination of his employment, the Executive shall promptly deliver to the Company all Confidential Material (including all copies thereof, whether prepared by the Executive or others) which are in the possession or under the control of the Executive. The Executive shall not be deemed to have breached this Section 20 if the Executive is compelled by legal process or order of any judicial, legislative, or administrative authority or body to disclose any Confidential Material; provided that Executive shall give prompt notice of such process or order to the Company, and the Executive shall in good faith use reasonable efforts to provide the Company the opportunity to intervene in the event Executive may be compelled to disclose Confidential Information of the Company pursuant to such process or order.

 

(b)          The Executive hereby agrees that damages and any other remedy available at law would be inadequate to redress or remedy any loss or damage suffered by the Company upon any breach of the terms of this Section 20 by the Executive, and the Executive therefore agrees that the Company, in addition to recovering on any claim for damages or obtaining any other remedy available at law, also may enforce the terms of this Section 20 by injunction or specific performance, and may obtain any other appropriate remedy available in equity.

 

21.          Payment and Other Provisions After Change of Control .

 

(a)          In the event the Executive’s employment with the Company is terminated either by the Company or by the Executive (other than because of the Executive’s death or Disability) following the occurrence of a Change of Control, and such termination is without Cause if by the Company, or for Good Reason if by Executive, and the date of such termination is within one (1) year following the occurrence of such Change of Control, then the Executive shall be entitled to receive from the Company the Accrued Salary Payment, Vacation Payment, Reimbursement Payment, and, in lieu of the Severance Payment or Disability/Death Payment otherwise payable pursuant to Section 12 hereof, the following:

 

(i)           Additional Amount Based on Base Salary .   A lump-sum amount equal to twelve (12) months of Executive’s specified Base Salary hereunder (the “Change of Control Payment”); and

 

(ii)           Other Benefits .   Notwithstanding the vesting and/or exercisability provisions otherwise applicable to Outstanding Options, all such stock options shall be fully vested and exercisable upon a Change of Control and shall remain exercisable as specified in the applicable option plan(s) and option grant agreements.

 

The Company shall pay the Accrued Salary Payment, the Vacation Payment, and the Reimbursement Payment to Executive within thirty (30) days after the date of such termination. The Company shall pay the Change of Control Payment in a lump sum within thirty (30) days after the date of such termination, provided , however , that if such payment would jeopardize the ability of the Company to continue as a going concern, it will be delayed and not paid to the Executive until such time as such payment would no longer have such effect, that such payment is subject to the restrictions contained within Section 30, if applicable, and that if the Change of

 

 
 

 

Control does not satisfy the definitions of "change in the ownership of a corporation", "change in the effective control of a corporation" or "change in the ownership of a substantial potion of the assets of a corporation" as such terms are defined in Code Section 409A and any regulations or other authority promulgated thereunder (“Section 409A”), then the Change of Control Payment will be paid at the time and in the manner provided for the Severance Payment in Section 12(a) (in semi-monthly installments).

 

(b)           For purposes of this Agreement, the term “Change of Control” shall mean:

 

(i)          The acquisition by any individual, entity or group (within the meaning of Rule 13d-3 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or any successor provision) (any of the foregoing hereafter a “Person”) of forty percent (40%) or more of either (a) the then outstanding shares of Capital Stock of the Company (the “Outstanding Capital Stock”) or (b) the combined voting power of the then outstanding voting securities of the Company entitled to vote generally in the election of directors (the “Voting Securities”), provided, however, that such an acquisition by one of the following shall not constitute a change of control: (1) the Company or any of its Subsidiaries, or any employee benefit plan (or related trust) sponsored or maintained by the Company or any of its Subsidiaries or (2) any Person that is eligible, pursuant to Rule 13d-1(b) under the Exchange Act, to file a statement on Schedule 13G with respect to its beneficial ownership of Voting Securities, whether or not such Person shall have filed a statement on Schedule 13G, unless such Person shall have filed a statement on Schedule 13D with respect to beneficial ownership of forty percent (40%) or more of the Voting Securities or (3) any corporation with respect to which, following such acquisition, more than sixty percent (60%) of both the then outstanding shares of common stock of such corporation and the combined voting power of the then outstanding voting securities of such corporation entitled to vote generally in the election of directors is then beneficially owned, directly or indirectly, by all or substantially all of the individuals and entities who were the beneficial owners, respectively, of the Outstanding Capital Stock or Voting Securities immediately prior to such acquisition in substantially the same proportions as their ownership, immediately prior to such acquisition, of the Outstanding Capital Stock or Voting Securities, as the case may be; or

 

(ii)          Individuals who, as of the Effective Date, constitute the Board (the “Incumbent Board”) cease for any reason to constitute at least a majority of the Board, provided that any individual becoming a director subsequent to the Effective Date whose election or nomination for election by the Company’s shareholders was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the Directors of the Company (as such terms are used in Rule 14a-11 of Regulation 14A, or any successor section, promulgated under the Exchange Act); or

 

(iii)          Approval by the shareholders of the Company of a reorganization, merger or consolidation (a “Business Combination”), in each case, with respect to which all or substantially all holders of the Outstanding Capital Stock and Voting Securities immediately prior to such Business Combination do not, following such Business Combination, beneficially own, directly of indirectly, in substantially the same proportions, more than sixty percent (60%) of, respectively, the then outstanding shares of common stock and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors, as the case may be, of the corporation resulting from the Business Combination; or

 

 
 

 

(iv)        A complete liquidation or dissolution of the Company; or

 

(v)         A sale or other disposition of all or substantially all of the assets of the Company other than to a corporation with respect to which, following such sale or disposition, more than sixty percent (60%) of the then outstanding shares of common stock and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors are then owned beneficially, directly or indirectly, by all or substantially all of the individuals and entities who were the beneficial owners, respectively, of the Outstanding Capital Stock or Voting Securities Immediately prior to such sale or disposition in substantially the same proportions as their ownership of the Outstanding Capital Stock and Voting Securities, as the case may be, immediately prior to such sale or disposition.

 

22.          Notices .   Any notice required or permitted to be given under this Agreement shall be sufficient if in writing and personally delivered (including by regular messenger service, signature required) or sent by registered or certified mail, return receipt requested, to both his office and his residence, in the case of notices directed to the Executive, or to its principal office, Attn.: Chief Financial Officer, in the case of notices directed to the Company, or to such other address and/or addressee as the party to whom such notice is directed shall have designated for this purpose by notice to the other in accordance with this Section. Such notices shall be effective upon personal delivery or three (3) days after mailing.

 

23.          Entire Agreement; Waiver .   This Agreement contains the entire understanding of the parties with respect to the subject matter hereof (it being acknowledged, however, that the Company and the Executive may enter into certain grant agreements relating to Outstanding Options which shall be effective in accordance with the terms thereof). This Agreement may not be changed orally but only by an instrument in writing, signed by the party against whom enforcement of any waiver, change, modification or discharge is sought; provided that should the Executive be appointed by the Board to an additional executive office of the Company during the Employment Period, the terms of this Agreement shall apply, the references to “President and Chief Executive Officer” shall be deemed to read “President, Chief Executive Officer and [insert office]”, and the compensation provisions hereof shall continue unamended. Waiver of or failure to exercise any rights provided by this Agreement in any respect shall not be deemed a waiver of any further or future rights.

 

24.         Original Employment Agreement .     Executive represents that he has received all amounts of compensation due to him pursuant to the Original Employment Agreement, including any bonuses and awards of stocks or options. The Company and Executive acknowledge that paid time off for Executive shall commence to accrue as of January 1, 2014. The Company and Executive agree and acknowledge that paid time off shall be waived and not due and payable upon the bankruptcy or insolvency of the Company.

 

25.          Binding Effect; Assignment .   The rights and obligations of this Agreement shall bind and inure to the benefit of any successor of the Company by reorganization, merger or consolidation, or any transferee of all or substantially all of the Company’s business or properties. The Executive’s rights hereunder are personal to and shall not be transferable nor assignable by the Executive.

 

26.          Headings .   The headings contained in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this Agreement.

 

 
 

 

27.          Governing Law; Arbitration .   This agreement shall be construed in accordance with and governed for all purposes by the laws of the State of New York applicable to contracts made and to be performed wholly within such state. Except as otherwise provided in Sections 18(e) and 20(b) of this Agreement, any dispute or controversy arising out of or relating to this Agreement shall be settled by arbitration in accordance with the rules of the American Arbitration Association, and judgment upon the award may be entered in any court having jurisdiction thereover. The arbitration shall be held in New York, New York or in such other place as the parties hereto may agree.

 

28.          Further Assurances .   Each of the parties agrees to execute, acknowledge, deliver and perform, and cause to be executed, acknowledged, delivered and performed, at any time and from time to time, all such further acts, deeds, assignments, transfers, conveyances, powers of attorney and/or assurances as may be necessary or proper to carry out the provisions or intent of this Agreement.

 

29.          Severability .   The parties agree that if any one or more of the terms, provisions, covenants or restrictions of this Agreement shall be determined by a court of competent jurisdiction to be invalid, void, or unenforceable, the remainder of the terms, provisions, covenants and restrictions of this Agreement shall remain in full force and effect and shall in no way be affected, impaired or invalidated.

 

30.          Section 409A .   The Executive and the Company intend that any compensation under this Agreement shall be paid in compliance with Section 409A of the Internal Revenue Code such that there are no adverse tax consequences, interest, or penalties as a result of the payments, and the parties hereby agree to amend this Agreement as and when necessary or desirable to conform to or otherwise properly reflect any guidance issued under Section 409A after the date hereof without violating Section 409A. In the case any one or more provisions of this Agreement fails to comply with the provisions of Section 409A, the remaining provisions of this Agreement shall remain in effect, and this Agreement shall be administered and applied as if the non-complying provisions were not part of this Agreement. The parties in that event shall endeavor to agree upon a reasonable substitute for the non-complying provisions, to the extent that a substituted provision would not cause this Agreement to fail to comply with Section 409A, and, upon so agreeing, shall incorporate such substituted provisions in this Agreement. A termination of the Executive’s employment hereunder shall not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amount or benefit constituting “deferred compensation” under Section 409A upon or following a termination of employment unless such termination is also a “separation from service” within the meaning of Section 409A and, for purposes of any such provision of this Agreement, references to a “termination,” “termination of employment” or like terms shall mean “separation from service.” In the event that any payment or benefit made hereunder or under any compensation plan, program, or arrangement of the Company would constitute payments or benefits pursuant to a non-qualified deferred compensation plan within the meaning of Section 409A and, at the time of the Executive’s “separation from service,” the Executive is a “specified employee” within the meaning of Section 409A, then any such payments or benefits shall be delayed and payment shall be made, or commence to be made, as the case may be, on the date that is six months and one day after the Executive’s separation from service. Each payment made under this Agreement shall be designated as a “separate payment” within the meaning of Section 409A. All reimbursements and in-kind benefits provided under this Agreement shall be made or provided in accordance with the requirements of Section 409A to the extent that such reimbursements or in-kind benefits are subject to Section 409A. All reimbursements for expenses paid pursuant hereto that constitute taxable income to Executive shall in no event be paid later than the end of the calendar year

 

 
 

 

next following the calendar year in which Executive incurs such expense or pays such related tax. Unless otherwise permitted by Section 409A, the right to reimbursement or in-kind benefits under this Agreement shall not be subject to liquidation or exchange for another benefit and the amount of expenses eligible for reimbursement, or in-kind benefits, provided during any taxable year shall not affect the expenses eligible for reimbursement, or in-kind benefits to be provided, respectively, in any other taxable year.

 

31.         Counterparts .   This Agreement may be executed in several counterparts, and all counterparts so executed shall constitute one agreement, binding on the parties hereto, notwithstanding that both parties are not signatory to the original or the same counterpart.

 

32.         Withholding .   The Company shall be entitled to withhold from payment any amount of withholding required by law.

 

33.         Survivorship .   The respective rights and obligations of the parties hereunder shall survive any termination of this Agreement to the extent necessary to the intended preservation of such rights and obligations.

 

[ remainder of page intentionally left blank; signature page follows ]

 

 
 

 

IN WITNESS WHEREOF, Marina Biotech, Inc. has caused this instrument to be signed by a duly authorized signatory and the Executive has hereunto set his hand as of the day and year first above written.

 

  THE COMPANY:  
       
  MARINA BIOTECH, INC.  
       
  By: /s/ Stefan Loren  

  Name:   Stefan Loren  
  Title: Director  

  THE EXECUTIVE:  
     
  /s/ J. Michael French  
  J. Michael French  

 

 

 

 

Exhibit 10.2

 

 

MARINA BIOTECH, INC.

 

2014 LONG-TERM INCENTIVE PLAN

 

* * * * *

 

1. Purpose.    The purpose of the Marina Biotech, Inc. 2014 Long-Term Incentive Plan (the “Plan”) is to further and promote the interests of Marina Biotech, Inc. (the “Company”), its Subsidiaries and its stockholders by enabling the Company and its Subsidiaries to attract, retain and motivate employees, directors and consultants, or those who will become employees directors or consultants, and to align the interests of those individuals and the Company’s stockholders. To do this, the Plan offers performance-based incentive awards and equity-based opportunities providing such employees, directors and consultants with a proprietary interest in maximizing the growth, profitability and overall success of the Company and its Subsidiaries.

 

2. Definitions .    For purposes of the Plan, the following terms shall have the meanings set forth below:

 

 2.1 “Award” means an award or grant made to a Participant under Sections 6, 7, 8 and/or 9 of the Plan.

 

 2.2 “Award Agreement” means the agreement executed by a Participant pursuant to Sections 3.2 and 15.7 of the Plan in connection with the granting of an Award.

 

 2.3 “Board” means the Board of Directors of the Company, as constituted from time to time.

 

 2.4 “Code” means the Internal Revenue Code of 1986, as in effect and as amended from time to time, or any successor statute thereto, together with any rules, regulations and interpretations promulgated thereunder or with respect thereto.

 

 2.5 “Committee” means the committee of the Board established to administer the Plan, as described in Section 3 of the Plan, or if no such committee has been appointed or established, the Board.

 

 2.6 “Common Stock” means the Common Stock, par value $0.006 per share, of the Company, or any security of the Company issued by the Company in substitution or exchange therefor.

 

 2.7 “Company” means Marina Biotech, Inc., a Delaware corporation, or any successor entity to Marina Biotech, Inc.

 

 2.8 “Exchange Act” means the Securities Exchange Act of 1934, as in effect and as amended from time to time, or any successor statute thereto, together with any rules, regulations and interpretations promulgated thereunder or with respect thereto.

 

 2.9 “Fair Market Value” means on, or with respect to, any given date(s), the average of the highest and lowest market prices of the Common Stock, as reported on a public exchange for such date(s) or, if the Common Stock was not traded on such date(s), on the next preceding day or days on which the Common Stock was traded. If at any time the Common Stock is not traded on an exchange, the Fair Market Value of a share of the Common Stock shall be determined in good faith by the Board.

 

 2.10 “Incentive Stock Option” means any stock option granted pursuant to the provisions of Section 6 of the Plan (and the relevant Award Agreement) that is intended to be (and is specifically designated as) an “incentive stock option” within the meaning of Section 422 of the Code.

 

 2.11 “Non-Qualified Stock Option” means any stock option granted pursuant to the provisions of Section 6 of the Plan (and the relevant Award Agreement) that is not (and is specifically designated as not being) an Incentive Stock Option.

 

 2.12 “Participant” means any individual who is selected from time to time under Section 5 to receive an Award under the Plan.

 

 2.13 “Performance Units” means the monetary units granted under Section 9 of the Plan and the relevant Award Agreement.

 

1
 

 

 2.14 “Plan” means the Marina Biotech, Inc. 2014 Long-Term Incentive Plan, as set forth herein and as in effect and as amended from time to time (together with any rules and regulations promulgated by the Committee with respect thereto).

 

 2.15 “Restricted Shares” means the restricted shares of Common Stock granted pursuant to the provisions of Section 8 of the Plan and the relevant Award Agreement.

 

 2.16 “Stock Appreciation Right” means an Award described in Section 7.2 of the Plan and granted pursuant to the provisions of Section 7 of the Plan.

 

 2.17 “Subsidiary(ies)” means any corporation (other than the Company), trust, partnership or limited liability company in an unbroken chain of entities, including and beginning with the Company, if each of such entities, other than the last entity in the unbroken chain, owns, directly or indirectly, more than fifty percent (50%) of the voting shares, partnership, beneficial or membership interests in one of the other entities in such chain.

 

3. Administration .

 

 3.1 The Committee .    The Plan shall be administered by the Committee. Subject to the last sentence of this Section 3.1, the Committee shall be appointed from time to time by the Board and shall be comprised of not less than two (2) of the then members of the Board who are Non-Employee Directors (within the meaning of SEC Rule 16b-3(b)(3)) of the Company and Outside Directors (within the meaning of Section 162(m) of the Code). Consistent with the Bylaws of the Company, members of the Committee shall serve at the pleasure of the Board and the Board, subject to the immediately preceding sentence, may at any time and from time to time remove members from, or add members to, the Committee. In the event that the Board has not appointed the Committee, then the Board shall have all the powers of the Committee under the Plan.

 

 3.2 Plan Administration and Plan Rules .    The Committee is authorized to construe and interpret the Plan and to promulgate, amend and rescind rules and regulations relating to the implementation, administration and maintenance of the Plan. Subject to the terms and conditions of the Plan, the Committee shall make all determinations necessary or advisable for the implementation, administration and maintenance of the Plan including, without limitation, (a) selecting the Plan’s Participants, (b) making Awards in such amounts and form as the Committee shall determine, (c) imposing such restrictions, terms and conditions upon such Awards as the Committee shall deem appropriate, and (d) correcting any technical defect(s) or technical omission(s), or reconciling any technical inconsistency(ies), in the Plan and/or any Award Agreement. The Committee may designate persons other than members of the Committee to carry out the day-to-day ministerial administration of the Plan under such conditions and limitations as it may prescribe, except that the Committee shall not delegate its authority with regard to the selection for participation in the Plan and/or the granting of any Awards to Participants. The Committee’s determinations under the Plan need not be uniform and may be made selectively among Participants, whether or not such Participants are similarly situated. Any determination, decision or action of the Committee in connection with the construction, interpretation, administration, implementation or maintenance of the Plan shall be final, conclusive and binding upon all Participants and any person(s) claiming under or through any Participants. The Company shall effect the granting of Awards under the Plan, in accordance with the determinations made by the Committee, by execution of written agreements and/or other instruments in such form as is approved by the Committee. The Committee may, in its sole discretion, delegate its authority to one or more senior executive officers for the purpose of making Awards to Participants who are not subject to Section 16 of the Exchange Act.

 

 3.3 Liability Limitation .    Neither the Board nor the Committee, nor any member of either, shall be liable for any act, omission, interpretation, construction or determination made in good faith in connection with the Plan (or any Award Agreement), and the members of the Board and the Committee shall be entitled to indemnification and reimbursement by the Company in respect of any claim, loss, damage or expense (including, without limitation, attorneys’ fees) arising or resulting therefrom to the fullest extent permitted by law and/or under any directors and officers liability insurance coverage which may be in effect from time to time.

 

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4. Term of Plan/Common Stock Subject to Plan .

 

 4.1 Term .    Unless terminated earlier by the Board, the Plan shall terminate on August 6, 2024, except with respect to Awards then outstanding. After such date no further Awards shall be granted under the Plan.

 

 4.2 Common Stock .    The maximum number of shares of Common Stock in respect of which Awards may be granted or paid out under the Plan, subject to adjustment as provided in Section 13.2 of the Plan, shall not exceed 5,000,000 shares. In the event of a change in the Common Stock of the Company that is limited to a change in the designation thereof to “Capital Stock” or other similar designation, or to a change in the par value thereof, or from par value to no par value, without increase or decrease in the number of issued shares, the shares resulting from any such change shall be deemed to be the Common Stock for purposes of the Plan. Common Stock which may be issued under the Plan may be either authorized and unissued shares or issued shares which have been reacquired by the Company (in the open-market or in private transactions) and which are being held as treasury shares. No fractional shares of Common Stock shall be issued under the Plan.

 

 4.3 Computation of Available Shares.    For the purpose of computing the total number of shares of Common Stock available for Awards under the Plan, there shall be counted against the limitations set forth in Section 4.2 of the Plan the maximum number of shares of Common Stock potentially subject to issuance upon exercise or settlement of Awards granted under Sections 6 and 7 of the Plan, the number of shares of Common Stock issued under grants of Restricted Shares pursuant to Section 8 of the Plan and the maximum number of shares of Common Stock potentially issuable under grants or payments of Performance Units pursuant to Section 9 of the Plan, in each case determined as of the date on which such Awards are granted. If any Awards expire unexercised or are forfeited, surrendered, cancelled, terminated or settled in cash in lieu of Common Stock, the shares of Common Stock which were theretofore subject (or potentially subject) to such Awards shall again be available for Awards under the Plan to the extent of such expiration, forfeiture, surrender, cancellation, termination or settlement of such Awards.

 

5. Eligibility .    Individuals eligible for Awards under the Plan shall consist of employees, directors and consultants, or those who will become employees, directors or consultants, of the Company and/or its Subsidiaries whose performance or contribution, in the sole discretion of the Committee, benefits or will benefit the Company or any Subsidiary.

 

6. Stock Options .

 

 6.1 Terms and Conditions .    Stock options granted under the Plan shall be in respect of Common Stock and may be in the form of Incentive Stock Options or Non-Qualified Stock Options (sometimes referred to collectively herein as the “Stock Option(s)”). Such Stock Options shall be subject to the terms and conditions set forth in this Section 6 and any additional terms and conditions, not inconsistent with the express terms and provisions of the Plan, as the Committee shall set forth in the relevant Award Agreement.

 

 6.2 Grant .    Stock Options may be granted under the Plan in such form as the Committee may from time to time approve. Stock Options may be granted alone or in addition to other Awards under the Plan or in tandem with Stock Appreciation Rights. Special provisions shall apply to Incentive Stock Options granted to any employee who owns (within the meaning of Section 422(b)(6) of the Code) more than ten percent (10%) of the total combined voting power of all classes of stock of the Company or its parent corporation or any subsidiary of the Company, within the meaning of Sections 424(e) and (f) of the Code (a “10% Shareholder”).

 

 6.3 Exercise Price .    The exercise price per share of Common Stock subject to a Stock Option shall be determined by the Committee; provided , however , that the exercise price of a Stock Option shall not be less than one hundred percent (100%) of the Fair Market Value of the Common Stock on the date of the grant of such Stock Option; provided , further , however , that, in the case of a 10% Shareholder, the exercise price of an Incentive Stock Option shall not be less than one hundred ten percent (110%) of the Fair Market Value of the Common Stock on the date of grant.

 

 6.4 Term .    The term of each Stock Option shall be such period of time as is fixed by the Committee; provided, however , that the term of any Incentive Stock Option shall not exceed ten (10) years (five (5) years, in the case of a 10% Shareholder) after the date immediately preceding the date on which the Incentive Stock Option is granted.

 

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 6.5 Method of Exercise .    A Stock Option may be exercised, in whole or in part, by giving written notice of exercise to the Secretary of the Company, or the Secretary’s designee, specifying the number of shares to be purchased. Such notice shall be accompanied by payment in full of the exercise price (and applicable tax withholding) in cash, by certified check, bank draft, or money order payable to the order of the Company, or, if permitted by the Committee in its sole discretion, by delivery of shares of Common Stock satisfying such requirements as the Committee shall establish, or through such other mechanism as the Committee shall permit, in its sole discretion. Payment instruments shall be received by the Company subject to collection. The proceeds received by the Company upon exercise of any Stock Option may be used by the Company for general corporate purposes. Any portion of a Stock Option that is exercised may not be exercised again.

 

 6.6 Tandem Grants .    If Non-Qualified Stock Options and Stock Appreciation Rights are granted in tandem, as designated in the relevant Award Agreements, the right of a Participant to exercise any such tandem Stock Option shall terminate to the extent that the shares of Common Stock subject to such Stock Option are used to calculate amounts or shares receivable upon the exercise of the related tandem Stock Appreciation Right.

 

7. Stock Appreciation Rights .

 

 7.1 Terms and Conditions .    The grant of Stock Appreciation Rights under the Plan shall be subject to the terms and conditions set forth in this Section 7 and any additional terms and conditions, not inconsistent with the express terms and provisions of the Plan, as the Committee shall set forth in the relevant Award Agreement.

 

 7.2 Stock Appreciation Rights .    A Stock Appreciation Right is an Award granted with respect to a specified number of shares of Common Stock entitling a Participant to receive an amount equal to the excess of the Fair Market Value of a share of Common Stock on the date of exercise over the Fair Market Value of a share of Common Stock on the date of grant of the Stock Appreciation Right, multiplied by the number of shares of Common Stock with respect to which the Stock Appreciation Right shall have been exercised.

 

 7.3 Grant .    A Stock Appreciation Right may be granted in addition to any other Award under the Plan or in tandem with or independent of a Non-Qualified Stock Option.

 

 7.4 Date of Exercisability .    In respect of any Stock Appreciation Right granted under the Plan, unless otherwise (a) determined by the Committee (in its sole discretion) at any time and from time to time in respect of any such Stock Appreciation Right, or (b) provided in the Award Agreement, a Stock Appreciation Right may be exercised by a Participant, in accordance with and subject to all of the procedures established by the Committee, in whole or in part at any time and from time to time during its specified term. The Committee may also provide, as set forth in the relevant Award Agreement and without limitation, that some Stock Appreciation Rights shall be automatically exercised and settled on one or more fixed dates specified therein by the Committee.

 

 7.5 Form of Payment .    Upon exercise of a Stock Appreciation Right, payment may be made in cash, in Restricted Shares or in shares of unrestricted Common Stock, or in any combination thereof, as the Committee, in its sole discretion, shall determine and provide in the relevant Award Agreement.

 

 7.6 Tandem Grant .    The right of a Participant to exercise a tandem Stock Appreciation Right shall terminate to the extent such Participant exercises the Non-Qualified Stock Option to which such Stock Appreciation Right is related.

 

8. Restricted Shares .

 

 8.1 Terms and Conditions .    Grants of Restricted Shares shall be subject to the terms and conditions set forth in this Section 8 and any additional terms and conditions, not inconsistent with the express terms and provisions of the Plan, as the Committee shall set forth in the relevant Award Agreement. Restricted Shares may be granted alone or in addition to any other Awards under the Plan. Subject to the terms of the Plan, the Committee shall determine the number of Restricted Shares to be granted to a Participant and the Committee may provide or impose different terms and conditions on any particular Restricted Share grant made to any Participant. With respect to each Participant receiving an Award of Restricted Shares, there shall be issued a stock certificate (or certificates) in respect of such Restricted Shares. Such stock

 

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certificate(s) shall be registered in the name of such Participant, shall be accompanied by a stock power duly executed by such Participant, and shall bear, among other required legends, the following legend:

 

“The transferability of this certificate and the shares of stock represented hereby are subject to the terms and conditions (including, without limitation, forfeiture events) contained in the Marina Biotech, Inc. 2014 Long-Term Incentive Plan and an Award Agreement entered into between the registered owner hereof and Marina Biotech, Inc. Copies of such Plan and Award Agreement are on file in the office of the Secretary of Marina Biotech, Inc. Marina Biotech, Inc. will furnish to the recordholder of the certificate, without charge and upon written request at its principal place of business, a copy of such Plan and Award Agreement. Marina Biotech, Inc. reserves the right to refuse to record the transfer of this certificate until all such restrictions are satisfied, all such terms are complied with and all such conditions are satisfied.”

 

Such stock certificate evidencing such shares shall, in the sole discretion of the Committee, be deposited with and held in custody by the Company until the restrictions thereon shall have lapsed and all of the terms and conditions applicable to such grant shall have been satisfied.

 

 8.2 Restricted Share Grants .    A grant of Restricted Shares is an Award of shares of Common Stock granted to a Participant, subject to such restrictions, terms and conditions as the Committee deems appropriate, including, without limitation, (a) restrictions on the sale, assignment, transfer, hypothecation or other disposition of such shares, (b) the requirement that the Participant deposit such shares with the Company while such shares are subject to such restrictions, and (c) the requirement that such shares be forfeited upon termination of employment for specified reasons within a specified period of time or for other reasons (including, without limitation, the failure to achieve designated performance goals).

 

 8.3 Restriction Period.    In accordance with Sections 8.1 and 8.2 of the Plan and unless otherwise determined by the Committee (in its sole discretion) at any time and from time to time, Restricted Shares shall only become unrestricted and vested in the Participant in accordance with such vesting schedule relating to such Restricted Shares, if any, as the Committee may establish in the relevant Award Agreement (the “ Restriction Period ”). During the Restriction Period, such stock shall be and remain unvested and a Participant may not sell, assign, transfer, pledge, encumber or otherwise dispose of or hypothecate such Award. Upon satisfaction of the vesting schedule and any other applicable restrictions, terms and conditions, the Participant shall be entitled to receive payment of the Restricted Shares or a portion thereof, as the case may be, as provided in Section 8.4 of the Plan.

 

 8.4 Payment of Restricted Share Grants .    After the satisfaction and/or lapse of the restrictions, terms and conditions established by the Committee in respect of a grant of Restricted Shares, a new certificate, without the legend set forth in Section 8.1 of the Plan, for the number of shares of Common Stock which are no longer subject to such restrictions, terms and conditions shall, as soon as practicable thereafter, be delivered to the Participant, provided that the removal of such legend is permitted by applicable federal and state securities laws.

  

 8.5 Shareholder Rights .    A Participant shall have, with respect to the shares of Common Stock underlying a grant of Restricted Shares, all of the rights of a shareholder of such stock (except as such rights are limited or restricted under the Plan or in the relevant Award Agreement). Any stock dividends paid in respect of unvested Restricted Shares shall be treated as additional Restricted Shares and shall be subject to the same restrictions and other terms and conditions that apply to the unvested Restricted Shares in respect of which such stock dividends are issued.

 

9. Performance Units .

 

 9.1 Terms and Conditions .    Performance Units shall be subject to the terms and conditions set forth in this Section 9 and any additional terms and conditions, not inconsistent with the express provisions of the Plan, as the Committee shall set forth in the relevant Award Agreement.

 

 9.2 Performance Unit Grants .    A Performance Unit is an Award of units (with each unit representing such monetary amount as is designated by the Committee in the Award Agreement) granted to a Participant, subject to such terms and conditions as the Committee deems appropriate, including, without limitation, the requirement that the Participant forfeit such units (or a portion thereof) in the event certain performance criteria or other conditions are not met within a designated period of time.

 

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 9.3 Grants .    Performance Units may be granted alone or in addition to any other Awards under the Plan. Subject to the terms of the Plan, the Committee shall determine the number of Performance Units to be granted to a Participant and the Committee may impose different terms and conditions on any particular Performance Units granted to any Participant.

 

 9.4 Performance Goals and Performance Periods .    Participants receiving a grant of Performance Units shall only earn into and be entitled to payment in respect of such Awards if the Company and/or the Participant achieves certain performance goals (the “ Performance Goals ”) during and in respect of a designated performance period (the “ Performance Period ”). The Performance Goals and the Performance Period shall be established by the Committee, in its sole discretion. The Committee shall establish Performance Goals for each Performance Period prior to, or as soon as practicable after, the commencement of such Performance Period. The Committee shall also establish a schedule or schedules for Performance Units setting forth the portion of the Award which will be earned or forfeited based on the degree of achievement, or lack thereof, of the Performance Goals at the end of the relevant Performance Period. In setting Performance Goals, the Committee may use, but shall not be limited to, such measures as total shareholder return, return on equity, net earnings growth, sales or revenue growth, cash flow, comparisons to peer companies, individual or aggregate Participant performance or such other measure or measures of performance as the Committee, in its sole discretion, may deem appropriate. Such performance measures shall be defined as to their respective components and meaning by the Committee (in its sole discretion). During any Performance Period, the Committee shall have the authority to adjust the Performance Goals and/or the Performance Period in such manner as the Committee, in its sole discretion, deems appropriate at any time and from time to time.

 

 9.5 Payment of Units .    With respect to each Performance Unit, the Participant shall, if the applicable Performance Goals have been achieved, or partially achieved, as determined by the Committee in its sole discretion, by the Company and/or the Participant during the relevant Performance Period, be entitled to receive payment in an amount equal to the designated value of each Performance Unit times the number of such units so earned. Payment in settlement of earned Performance Units shall be made as soon as practicable following the conclusion of the respective Performance Period in cash, in unrestricted Common Stock, or in Restricted Shares, or in any combination thereof, as the Committee, in its sole discretion, shall determine and provide in the relevant Award Agreement.

 

10. Other Provisions .

 

 10.1 Performance-Based Awards .    Performance Units, Restricted Shares, and other Awards subject to performance criteria that are intended to be “qualified performance-based compensation” within the meaning of section 162(m) of the Code shall be paid solely on account of the attainment of one or more pre-established, objective performance goals within the meaning of section 162(m) and the regulations thereunder. Until otherwise determined by the Committee, the performance goals shall be the attainment of pre-established levels of any of net income, market price per share, earnings per share, return on equity, return on capital employed and/or cash flow, regulatory approval of products, strategic alliances and joint ventures and patent issuances. The payout of any such Award to a Covered Employee may be reduced, but not increased, based on the degree of attainment of other performance criteria or otherwise at the discretion of the Committee. For purposes of the Plan, “Covered Employee” has the same meaning as set forth in Section 162(m) of the Code.

 

 10.2 Maximum Yearly Awards .    The maximum annual Common Stock amounts in this Section 10.2 are subject to adjustment under Section 13.2 and are subject to the Plan maximum under Section 4.2.

 

 10.2.1 Performance-Based Awards .    The maximum amount payable in respect of Performance Units, performance-based Restricted Shares and other Awards in any calendar year may not exceed 1,000,000 shares of Common Stock (or the then equivalent Fair Market Value thereof) in the case of any individual Participant.

 

 10.2.2   Stock Options and SARs .    Each individual Participant may not receive in any calendar year Awards of Options or Stock Appreciation Rights exceeding 1,000,000 underlying shares of Common Stock.

 

11. Dividend Equivalents .    In addition to the provisions of Section 8.5 of the Plan, Awards of Stock Options, and/or Stock Appreciation Rights, may, in the sole discretion of the Committee and if provided

 

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for in the relevant Award Agreement, earn dividend equivalents. In respect of any such Award which is outstanding on a dividend record date for Common Stock, the Participant shall be credited with an amount equal to the amount of cash or stock dividends that would have been paid on the shares of Common Stock covered by such Award had such covered shares been issued and outstanding on such dividend record date. The Committee shall establish such rules and procedures governing the crediting of such dividend equivalents, including, without limitation, the amount, timing, form of payment and payment contingencies and/or restrictions of such dividend equivalents, as it deems appropriate or necessary.

 

12. Non-transferability of Awards .    Unless otherwise provided in the Award Agreement, no Award under the Plan or any Award Agreement, and no rights or interests herein or therein, shall or may be assigned, transferred, sold, exchanged, encumbered, pledged, or otherwise hypothecated or disposed of by a Participant or any beneficiary(ies) of any Participant, except by testamentary disposition by the Participant or the laws of intestate succession. No such interest shall be subject to execution, attachment or similar legal process, including, without limitation, seizure for the payment of the Participant’s debts, judgments, alimony, or separate maintenance. Unless otherwise provided in the Award Agreement, during the lifetime of a Participant, Stock Options and Stock Appreciation Rights are exercisable only by the Participant.

 

13. Changes in Capitalization and Other Matters .   

 

 13.1 No Corporate Action Restriction .    The existence of the Plan, any Award Agreement and/or the Awards granted hereunder shall not limit, affect or restrict in any way the right or power of the Board or the stockholders of the Company to make or authorize (a) any adjustment, recapitalization, reorganization or other change in the Company’s or any Subsidiary’s capital structure or its business, (b) any merger, consolidation or change in the ownership of the Company or any Subsidiary, (c) any issue of bonds, debentures, capital, preferred or prior preference stocks ahead of or affecting the Company’s or any Subsidiary’s capital stock or the rights thereof, (d) any dissolution or liquidation of the Company or any Subsidiary, (e) any sale or transfer of all or any part of the Company’s or any Subsidiary’s assets or business, or (f) any other corporate act or proceeding by the Company or any Subsidiary. No Participant, beneficiary or any other person shall have any claim against any member of the Board or the Committee, the Company or any Subsidiary, or any employees, officers, shareholders or agents of the Company or any subsidiary, as a result of any such action.

 

 13.2 Recapitalization Adjustments .    In the event that the Board determines that any dividend or other distribution (whether in the form of cash, Common Stock, other securities, or other property), recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase, or exchange of Common Stock or other securities of the Company, or other corporate transaction or event affects the Common Stock such that an adjustment is determined by the Board, in its sole discretion, to be necessary or appropriate in order to prevent dilution or enlargement of benefits or potential benefits intended to be made available under the Plan, the Board may, in such manner as it in good faith deems equitable, adjust any or all of (i) the number of shares of Common Stock or other securities of the Company (or number and kind of other securities or property) with respect to which Awards may be granted, (ii) the number of shares of Common Stock or other securities of the Company (or number and kind of other securities or property) subject to outstanding Awards, and (iii) the exercise price with respect to any Stock Option, or make provision for an immediate cash payment to the holder of an outstanding Award in consideration for the cancellation of such Award.

 

 13.3 Mergers .    If the Company enters into or is involved in any merger, reorganization, recapitalization, sale of all or substantially all of the Company’s assets, liquidation, or business combination with any person or entity (such merger, reorganization, recapitalization, sale of all or substantially all of the Company’s assets, liquidation, or business combination to be referred to herein as a “ Merger Event ”), the Board may take such action as it deems appropriate, including, but not limited to, replacing such Stock Options with substitute stock options and/or stock appreciation rights in respect of the shares, other securities or other property of the surviving corporation or any affiliate of the surviving corporation on such terms and conditions, as to the number of shares, pricing and otherwise, which shall substantially preserve the value, rights and benefits of any affected Stock Options or Stock Appreciation Rights granted hereunder as of the date of the consummation of the Merger Event. Notwithstanding anything to the contrary in the Plan, if any Merger Event occurs, the Company shall have the right, but not the obligation, to cancel each Participant’s Stock Options and/or Stock Appreciation Rights and to pay to each affected

 

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Participant in connection with the cancellation of such Participant’s Stock Options and/or Stock Appreciation Rights, an amount equal to the excess of the Fair Market Value, as determined by the Board, of the Common Stock underlying any unexercised Stock Options or Stock Appreciation Rights (whether then exercisable or not) over the aggregate exercise price of such unexercised Stock Options and/or Stock Appreciation Rights.

 

Upon receipt by any affected Participant of any such substitute stock options, stock appreciation rights (or payment) as a result of any such Merger Event, such Participant’s affected Stock Options and/or Stock Appreciation Rights for which such substitute options and/or stock appreciation rights (or payment) were received shall be thereupon cancelled without the need for obtaining the consent of any such affected Participant.

 

14. Amendment, Suspension and Termination .    

 

 14.1 In General .    The Board may suspend or terminate the Plan (or any portion thereof) at any time and may amend the Plan at any time and from time to time in such respects as the Board may deem advisable to insure that any and all Awards conform to or otherwise reflect any change in applicable laws or regulations, or to permit the Company or the Participants to benefit from any change in applicable laws or regulations, or in any other respect the Board may deem to be in the best interests of the Company or any Subsidiary. No such amendment, suspension or termination shall (x) materially adversely affect the rights of any Participant under any outstanding Stock Options, Stock Appreciation Rights, Performance Units, or Restricted Share grants, without the consent of such Participant, or (y) increase the number of shares available for Awards pursuant to Section 4.2 or increase the Maximum Yearly Awards under Section 10.2 or change the performance criteria listed in Section 10.1, without shareholder approval; provided , however , that the Board may amend the Plan, without the consent of any Participants, in any way it deems appropriate to satisfy Code Section 409A and any regulations or other authority promulgated thereunder, including any amendment to the Plan to cause certain Awards not to be subject to Code Section 409A.

 

 14.2 Award Agreement Modifications .    The Committee may (in its sole discretion) amend or modify at any time and from time to time the terms and provisions of any outstanding Stock Options, Stock Appreciation Rights, Performance Units, or Restricted Share grants, in any manner to the extent that the Committee under the Plan or any Award Agreement could have initially determined the restrictions, terms and provisions of such Stock Options, Stock Appreciation Rights, Performance Units, and/or Restricted Share grants, including, without limitation, changing or accelerating (a) the date or dates as of which such Stock Options or Stock Appreciation Rights shall become exercisable, (b) the date or dates as of which such Restricted Share grants shall become vested, or (c) the performance period or goals in respect of any Performance Units. No such amendment or modification shall, however, materially adversely affect the rights of any Participant under any such Award without the consent of such Participant; provided, however, that the Committee may amend an Award without the consent of the Participant, in any way it deems appropriate to satisfy Code Section 409A and any regulations or other authority promulgated thereunder, including any amendment to or modification of such Award to cause such Award not to be subject to Code Section 409A.

 

15. Miscellaneous .    

 

 15.1 Tax Withholding .    The Company shall have the right to deduct from any payment or settlement under the Plan, including, without limitation, the exercise of any Stock Option or Stock Appreciation Right, or the delivery, transfer or vesting of any Common Stock or Restricted Shares, any federal, state, local or other taxes of any kind which the Committee, in its sole discretion, deems necessary to be withheld to comply with the Code and/or any other applicable law, rule or regulation. Shares of Common Stock may be used to satisfy any such tax withholding. Such Common Stock shall be valued based on the Fair Market Value of such stock as of the date the tax withholding is required to be made, such date to be determined by the Committee. In addition, the Company shall have the right to require payment from a Participant to cover any applicable withholding or other employment taxes due upon any payment or settlement under the Plan.

 

 15.2 No Right to Employment .    Neither the adoption of the Plan, the granting of any Award, nor the execution of any Award Agreement, shall confer upon any employee of the Company or any Subsidiary any right to continued employment with the Company or any Subsidiary, as the case may be, nor shall it

 

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interfere in any way with the right, if any, of the Company or any Subsidiary to terminate the employment of any employee at any time for any reason.

 

 15.3 Unfunded Plan .    The Plan shall be unfunded and the Company shall not be required to segregate any assets in connection with any Awards under the Plan. Any liability of the Company to any person with respect to any Award under the Plan or any Award Agreement shall be based solely upon the contractual obligations that may be created as a result of the Plan or any such award or agreement. No such obligation of the Company shall be deemed to be secured by any pledge of, encumbrance on, or other interest in, any property or asset of the Company or any Subsidiary. Nothing contained in the Plan or any Award Agreement shall be construed as creating in respect of any Participant (or beneficiary thereof or any other person) any equity or other interest of any kind in any assets of the Company or any Subsidiary or creating a trust of any kind or a fiduciary relationship of any kind between the Company, any Subsidiary and/or any such Participant, any beneficiary thereof or any other person.

 

 15.4 Payments to a Trust .    The Committee is authorized to cause to be established a trust agreement or several trust agreements or similar arrangements from which the Committee may make payments of amounts due or to become due to any Participants under the Plan.

 

 15.5 Other Company Benefit and Compensation Programs .    Payments and other benefits received by a Participant under an Award made pursuant to the Plan shall not be deemed a part of a Participant’s compensation for purposes of the determination of benefits under any other employee welfare or benefit plans or arrangements, if any, provided by the Company or any Subsidiary unless expressly provided in such other plans or arrangements, or except where the Board expressly determines in writing that inclusion of an Award or portion of an Award should be included to accurately reflect competitive compensation practices or to recognize that an Award has been made in lieu of a portion of competitive annual base salary or other cash compensation. Awards under the Plan may be made in addition to, in combination with, or as alternatives to, grants, awards or payments under any other plans or arrangements of the Company or its Subsidiaries. The existence of the Plan notwithstanding, the Company or any Subsidiary may adopt such other compensation plans or programs and additional compensation arrangements as it deems necessary to attract, retain and motivate employees.

 

 15.6 Listing, Registration and Other Legal Compliance .    No Awards or shares of the Common Stock shall be required to be issued or granted under the Plan unless legal counsel for the Company shall be satisfied that such issuance or grant will be in compliance with all applicable federal and state securities laws and regulations and any other applicable laws or regulations. The Committee may require, as a condition of any payment or share issuance, that certain agreements, undertakings, representations, certificates, and/or information, as the Committee may deem necessary or advisable, be executed or provided to the Company to assure compliance with all such applicable laws or regulations. Certificates for shares of the Restricted Shares and/or Common Stock delivered under the Plan may be subject to such stock-transfer orders and such other restrictions as the Committee may deem advisable under the rules, regulations, or other requirements of the Securities and Exchange Commission, any stock exchange upon which the Common Stock is then listed, and any applicable federal or state securities law. In addition, if, at any time specified herein (or in any Award Agreement or otherwise) for (a) the making of any Award, or the making of any determination, (b) the issuance or other distribution of Restricted Shares and/or Common Stock, or (c) the payment of amounts to or through a Participant with respect to any Award, any law, rule, regulation or other requirement of any governmental authority or agency shall require either the Company, any Subsidiary or any Participant (or any estate, designated beneficiary or other legal representative thereof) to take any action in connection with any such determination, any such shares to be issued or distributed, any such payment, or the making of any such determination, as the case may be, shall be deferred until such required action is taken. With respect to persons subject to Section 16 of the Exchange Act, transactions under the Plan are intended to comply with all applicable conditions of Rule 16b-3 promulgated under the Exchange Act.

 

 15.7 Award Agreements .    Each Participant receiving an Award under the Plan shall enter into an Award Agreement with the Company in a form specified by the Committee. Each such Participant shall agree to the restrictions, terms and conditions of the Award set forth therein and in the Plan.

 

 15.8 Designation of Beneficiary .    Each Participant to whom an Award has been made under the Plan may designate a beneficiary or beneficiaries to exercise any option or to receive any payment which

 

9
 

 

under the terms of the Plan and the relevant Award Agreement may become exercisable or payable on or after the Participant’s death. At any time, and from time to time, any such designation may be changed or cancelled by the Participant without the consent of any such beneficiary. Any such designation, change or cancellation must be on a form provided for that purpose by the Committee and shall not be effective until received by the Committee. If no beneficiary has been designated by a deceased Participant, or if the designated beneficiaries have predeceased the Participant, the beneficiary shall be the Participant’s estate. If the Participant designates more than one beneficiary, any payments under the Plan to such beneficiaries shall be made in equal shares unless the Participant has expressly designated otherwise, in which case the payments shall be made in the shares designated by the Participant.

 

 15.9 Leaves of Absence/Transfers .    The Committee shall have the power to promulgate rules and regulations and to make determinations, as it deems appropriate, under the Plan in respect of any leave of absence from the Company or any Subsidiary granted to a Participant. Without limiting the generality of the foregoing, the Committee may determine whether any such leave of absence shall be treated as if the Participant has terminated employment with the Company or any such Subsidiary. If a Participant transfers within the Company, or to or from any Subsidiary, such Participant shall not be deemed to have terminated employment as a result of such transfers.

 

 15.10 Code Section 409A .    This Plan and all Awards hereunder are intended to comply with the requirements of Code Section 409A and any regulations or other authority promulgated thereunder. Notwithstanding any provision of the Plan or any Award Agreement to the contrary, the Board and the Committee reserve the right (without the consent of any Participant and without any obligation to do so or to indemnify any Participant or the beneficiaries of any Participant for any failure to do so) to amend this Plan and/or any Award Agreement as and when necessary or desirable to conform to or otherwise properly reflect any guidance issued under Code Section 409A after the date hereof without violating Code Section 409A. In the event that any payment or benefit made hereunder would constitute payments or benefits pursuant to a non-qualified deferred compensation plan within the meaning of Code Section 409A and, at the time of a Participant’s “separation from service”, such Participant is a “specified employee” within the meaning of Code Section 409A, then any such payments or benefits shall be delayed until the six-month anniversary of the date of such Participant’s “separation from service”. Each payment made under this Plan shall be designated as a “separate payment” within the meaning of Code Section 409A.

 

 15.11 Governing Law .    The Plan and all actions taken thereunder shall be governed by and construed in accordance with the laws of the State of Delaware, without reference to the principles of conflict of laws thereof. Any titles and headings herein are for reference purposes only, and shall in no way limit, define or otherwise affect the meaning, construction or interpretation of any provisions of the Plan.

 

 15.12 Effective Date .    The Plan shall be effective upon its approval by the Board and adoption by the Company, subject to the approval of the Plan by the Company’s stockholders in accordance with Sections 162(m) and 422 of the Code.

 

[ remainder of page intentionally left blank ]

 

 

 

 

 

 

 

 

 

 

 

10
 

 

IN WITNESS WHEREOF, this Plan is adopted by the Company on this 6​ th day of August, 2014.

 

 

  MARINA BIOTECH, INC.
   
  By: /s/ J. Michael French
  Name: 
Title:
J. Michael French
President & CEO

 

 

 

 

 

 

11

 

Exhibit 99.1

 

 

News Release

 

Marina Biotech Announces the Election of Donald A. Williams to its Board of Directors

 

Stockholders Approved All Proposals in the 2014 Proxy

 

BOSTON, MA – (Marketwired – Sep 16, 2014) Marina Biotech, Inc. (PINKSHEETS: MRNA), a leading nucleic acid-based drug discovery and development company focused on rare diseases, announced today that all five of the director nominees submitted to the company's stockholders for election at Marina Biotech's 2014 Annual Meeting of Stockholders held on September 15, 2014 in San Diego, CA were elected to serve as members of the company's board of directors. The director nominees included four incumbent directors — J. Michael French, Stefan Loren, Ph.D., Joseph W. Ramelli and Philip C. Ranker — as well as new board member Donald A. Williams. In addition to the election of all of the director nominees, the recommendations of the Board with respect to all five of the other items that were described in the proxy statement for consideration at the Annual Meeting also received sufficient stockholder support.

 

"I am pleased to welcome Don Williams to Marina Biotech's Board of Directors," stated J. Michael French, President and CEO of Marina Biotech. "Don's extensive finance experience including strong expertise in developing and funding growth companies will be instrumental as we continue Marina's turn-around and rebuild shareholder value. I look forward to working with Don and the rest of the board of directors through this effort."

 

Mr. Williams is a 35-year veteran of the public accounting industry, retiring in 2014. Mr. Williams spent 18 years as an Ernst & Young (E&Y) Partner and the last seven years as a Partner with Grant Thornton (GT). Mr. Williams' career focused on private and public companies in the technology and life sciences sectors. During the last seven years at Grant Thornton, he served as the National Leader of Grant Thornton's Life Sciences Practice and the Managing Partner of the San Diego Office. He was the lead partner for both E&Y and GT on multiple initial public offerings; secondary offerings; private and public debt financings; as well as numerous mergers and acquisitions. From 2001 to 2014, Mr. Williams served on the Board of Directors and is past President and Chairman of the San Diego Venture Group and has served on the Board of Directors of various charitable organizations in the communities in which he has lived. Mr. Williams is a graduate of Southern Illinois University with a B.S. degree.

 

About Marina Biotech, Inc.

 

Marina Biotech is an oligonucleotide therapeutics company with broad drug discovery technologies providing the ability to develop proprietary single and double-stranded nucleic acid therapeutics including siRNAs, microRNA mimics, antagomirs, and antisense compounds, including messengerRNA therapeutics. These technologies were built via a roll-up strategy to discover and develop different types of nucleic acid therapeutics in order to modulate (up or down) a specific protein(s) which is either being produced too much or too little thereby causing a particular disease. We believe that the Marina Biotech technologies have unique strengths as a drug discovery engine for the development of nucleic acid-based therapeutics for rare and orphan diseases. Further, we believe Marina Biotech is the only company in the sector that has a delivery technology in human clinical trials with differentiated classes of payloads, through licensees ProNAi Therapeutics and Mirna Therapeutics, delivering single-stranded and double-stranded nucleic acid payloads, respectively. Our novel chemistries and other delivery technologies have been validated through license agreements with Roche, Novartis, Monsanto, and Tekmira. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome) and a preclinical program in myotonic dystrophy. Marina Biotech's goal is to improve human health through the development of RNAi- and oligonucleotide-based compounds and drug delivery technologies that

 

 
 

  

together provide superior therapeutic options for patients. Additional information about Marina Biotech is available at www.marinabio.com .

 

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 obtain additional funding; (ii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (v) 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 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.

 

Contact:

 

For media inquiries:
Ryan Ferrell
ryan.ferrell@hdmz.com
Desk/Mobile: (312) 506-5202

For partnership inquires:
J. Michael French
President and CEO
Marina Biotech, Inc.
admin@marinabio.com
(425) 892-4322

 

2

 

 

Exhibit 99.2

 

 

Nucleic Acid Therapeutics

and

Rare Diseases

Annual Meeting

San Diego, CA

15 September 2014

 

 
 

 

Forward Looking Statement

Statements made in this presentation 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 forwardlooking

statements include, but are not limited to: (i) the ability of Marina Biotech to obtain

additional funding; (ii) the ability of Marina Biotech to attract and/or maintain manufacturing,

research, development and commercialization partners; (iii) the ability of Marina Biotech

and/or a partner to successfully complete product research and development, including

preclinical and clinical studies and commercialization; (iv) the ability of Marina Biotech

and/or a partner to obtain required governmental approvals; and (v) 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 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.

 
 

 

2012-2013 Achievements

» Advanced Clinical Pipeline

» Completed Cohort 2 dosing in the dose escalating segment of Phase 1b Study

» Validated Technologies Through the Following License Agreements:

» SMARTICLES to Mirna Therapeutics for the development of microRNA-based therapeutics

» SMARTICLES to ProNAi for the development of DNAi therapeutics

» Nucleic acid drug discovery platform to Monsanto for the development of agriculture

products

» CRN chemistry to Novartis for the development of nucleic acid-based therapeutics

» UNA chemistry to Tekmira for the development of nucleic acid-based therapeutics

» Expanded Worldwide Intellectual Property Portfolio Through the Following

Issuances and Allowances:

» Two patents covering UNA chemistry (New Zealand & U.S.)

» Seventeen patents covering lipid-based delivery (Australia, Europe, Japan & U.S.)

» Two patents covering tk RNAi (Canada & Japan)

» Three patents covering peptides and lipo-peptides (China, Europe, & U.S.)

» Regains Intellectual Property Rights to its tk RNAi™ Technology for Agriculture and

Veterinary Uses

» Created a Strategic Alliance

» Alliance with Girindus (now Nitto Denko Avecia) to develop and manufacture CRN

chemistries

 
 

 

Increase Efforts and Focus on Rare Disease

Clinical Pipeline

» Nucleic Acid Therapeutics Have Demonstrated Good Clinical Safety

» Numerous constructs (siRNA, antisense, antagomirs, microRNA mimics, etc.)

utilizing multiple mechanisms of action (RNAi, mRNA inhibition, exonskipping,

steric blocking, microRNA modulation) have reached human clinical

development and have been established as safe and well tolerated

» Marina’s Delivery Technology Has Demonstrated Unequaled Clinical

Versatility

» SMARTICLES delivery technology is in Phase 1 and Phase 2 human trials

delivering double- AND single-stranded nucleic acid therapeutics, respectively

» Marina’s Broad Drug Discovery Platform Can Best Support Robust

Clinical Programs in Rare Diseases

» Specific mechanisms of action will be inadequate in eliciting a therapeutic

effect depending on target and indication

» Robust development programs will require more than one nucleic acid

modality (i.e. lead and back-ups) as part of a clinical package

Marina’s nucleic acid drug discovery platform is unmatched in the sector

 

 
 

 

Capability Comparison

(FTO Against Competition)

Nucleic Acid Constructs Delivery

siRNA ASO MicroRNA

mimics Antagomirs Lipid Polymer Peptide Bacterial

Marina X X X X X X X

Alnylam X X X

Arrowhead X X X

Dicerna X X

Rxi X X

Silence X X

Tekmira X X

Isis X

Prosensa X

Sarepta X

Regulus X X

Santaris X

PhaseRx X

 
 

 

Biochemistry Technologies

» Unlocked nucleobase monomers (UNA) – non-nucleotide, acyclic

monomers

6

» Conformationally restricted nucleotides (CRN) – nucleotide analogs

with a “bridge” connecting the C2’ and C4’ carbons of ribose

RNA CRN LNA

 
 

 

Delivery Technologies

» SMARTICLES – Amphoteric liposomes composed of unique

combinations of anionic and cationic lipids which enable cell uptake

and pH-triggered endosomal escape

» DiLA2 – Liposomes composed of unique combinations of head

groups, linkers and alkyl chains where the head group is an amino

acid (naturally occurring or man-made)

» tkRNA i – Non-pathogenic bacteria engineered to produce, deliver and

release interfering RNA mediators (shRNA) to targeted tissue

» Trp Cage Phage Display Library – Library Trp Cage possesses 207

unique peptides in a high copy number phage library; trp cage motif is

the smallest known peptide that folds into a stabile 3-D structure

» Breadth of delivery technologies allows for possibility of I.V.,

subQ, Local, Topical and Oral administration

 Marina is ONLY company delivering single & double-stranded NAs – both in the clinic

 

 
 

 

Delivery Capability Is Unparalleled

Within the Sector

» Two separate and distinct delivery technologies in clinical

development

» SMARTICLES (lipid nanoparticle)

» tkRNAi (engineered, non-pathogenic bacteria)

» Most versatile delivery technology (SMARTICLES) in clinical

development

» Delivering both a single-stranded and double-stranded nucleic acid

» Delivering to both the cell nucleus and cell cytoplasm

» Nucleus: ProNAi – single-stranded DNA decoy

» Cytoplasm: Mirna Therapeutics – double-stranded microRNA mimic

» Delivering a lipid nanoparticle outside the liver, (i.e. tumors)

» ProNAi: Refractory solid tumors

» Mirna: Unresectable primary liver cancer/solid cancers with liver involvement

» Only Orally administered RNAi-based therapeutic in clinical

development (tk RNAi )

 
 

 

SMARTICLES Clinical Status

» ProNAi Therapeutics (PNT2258) – Advanced Solid Tumors & Lymphomas

» Phase 1 Completed in November 2012

» 30 patients (dose range 1-150 mg/m2); (J Clin Oncol 30, 2012 (suppl; abstr

TPS3110))

» Reported interim Phase 2 data at American Society of Hematology in December 2013

» 82% of patients had tumor shrinkage when receiving single-agent therapy with

PNT2258

» Overall response rate in patients with follicular lymphoma is 40% and in patients

with diffuse large B-cell lymphoma is 50%

» Mirna Therapeutics (MRX34) – Liver-Based Cancers

» Initiated Phase 1 clinical testing in April 2013

» Reported interim Phase 1 data at American Association for Cancer Research in April

2014

» To date, manageable safety profile in patients with advanced cancer and liver

involvement

» Maximum Tolerated Dose not reached; dose escalation phase ongoing

» Non-linear PK, half-life > 1 day

To date, SMARTICLES has been administered to ~50 people

 

 
 

 

SMARTICLES Potential Mechanisms

of Delivery

» Exosomal repackaging (Cell-to-Cell Communication):

» SMARTICLES may promote cellular repackaging of oligonucleotides into exosomes

providing sustained functional delivery to certain vascularized tissues

» Payload “tells” exosome what tissue to target

10

» Delivery directly to nucleus1:

» Small RNAs can silence nuclear RNA and guide sitespecific

cleavage of the targeted RNA, demonstrating that

RNAi can function in the human nucleus

» Ability to target multiple non-coding RNAs in the nucleus

1Gagnon et al., RNAi Factors Are Present and Active in Human Cell Nuclei,

Cell Reports (2014), http://dx.doi.org/ 10.1016/j.celrep.2013.12.013

In either case the potential delivery “opportunity” is tremendous

 

 
 

 

Broad, Young and Issuing

Intellectual Property Estate

Technology US

Issued

Foreign

Issued

Worldwide

Pending

Biochemistry

Unlocked Nucleobase Monomers (UNA) 1 5 23

Conformationally Restricted Nucleotides

(CRN) 5 -- 10

Delivery

Liposome Systems 12 53 43

Liposome Manufacturing Methods -- 2 20

Bacterial Systems -- 9 7

Phage Display Library 6 -- --

Targeting, conjugating & condensing

peptides 1 14 17

Over 100 issued patents and over 90 pending U.S. and foreign applications

 
 

 

Ability to Utilize Multiple Mechanisms of

Action to Achieve Therapeutic Effect

Chemistry Delivery

UNA CRN SMARTICLES DiLA2 Lipopeptide

tkRNAi TrpCage

RNAi X X X X X X X

mRNA Translational

Inhibition X X X X X X

Exon Skipping X X X X X

Alternative Splicing X X X X

Steric Blocking X X

microRNA replacement X X X X X X

microRNA inhibition X X X X X X X

mRNA replacement X X

CRN- and UNA-substituted constructs span entire therapeutic spectrum

 
 

 

Strategic Alliances

» Nitto Denko Avecia – CRN Chemistry

» Avecia:

» Process development for CRN synthesis

» CRN “reagent” sales to academic and research laboratories

» CRN GLP manufacturing

» Marina:

» Dedicated research and manufacturing (i.e. off Marina’s bench)

» Rosetta Genomics – microRNA Targets/Biomarkers in Dystrophies

» Rosetta:

» Identify microRNA biomarkers as part of Marina’s clinical development efforts and

determine which biomarkers may be causative versus correlative, i.e. novel

microRNA therapeutic targets

» Develop, manufacture and sell microRNA diagnostics for patient identification and

stratification

» Marina:

» Develop, manufacture and sell microRNA-based therapeutics against targets

identified by Rosetta

 
 

 

Rare Disease Drug Development

 
 

 

Familial Adenomatous Polyposis (FAP)

» Rare hereditary disease

» Mutation in Adenomatous Polyposis Coli (APC) gene

» Causes dysregulation and accumulation of β-catenin

» Results in numerous colon polyps appearing in early

adolescence with potential for rapid disease progression

» Clinical drug product, CEQ508, targets β-catenin oncogene

» Unmet medical need

» ~100,000 worldwide (orphan status)

» Near 100% risk of colon cancer if untreated

» Treatment options:

» Surgical intervention (colectomy) is the only available treatment

to prevent colon cancer progression

» No generally accepted pharmaceutical approach is available

» Currently, no other significant pharmaceutical advancements in clinical development

» Opportunities to expand into sporadic CRC, other polyposis syndromes and

other GI cancers

Potential peak year U.S. sales of $195 MM

 
 

 

TransKingdom RNAi (tk RNAi™)

Compound is taken orally by

the patient

Invasin receptor

Invasin

Receptor-mediated

cell entry

Bacterial lysis in endosome

Endosome lysis and

shRNA release into

cytoplasm

to Dicer for

processing

shRNA

ONLY orally available RNAi clinical candidate

 
 

 

FAP Clinical/Regulatory Strategy

» Accelerated Clinical Development Plan

» Approval on single pivotal trial – ~60 patients treated for six months

» Based on Pfizer’s Celecoxib accelerated FDA approval

» Double-blind, placebo controlled, randomized, multi-center, parallel group study of

single daily doses of CEQ508

» Endpoint of “reduction of polyp burden” (measure of number and size of polyps)

» Pursue accelerated development program with FDA

» Fast-Track designation and/or “Breakthrough Therapy” designation

» Open Label Safety Trial

» Assumes FDA will require a additional patients for a safety database

» Roll in all patients from the pivotal trial once treatment is completed and would

include new patients

» Pediatric Trial

» Planned as a phase IV trial – 30 patients treated for one month

» May conduct as phase I trial with similar design to adult phase 1 trial

Pfizer approved on polyp reduction of 28% vs. 5% with placebo

 
 

 

FAP Value Drivers

» Near Term

» 4Q 2014 – Complete Cohort 1 and 2 sample analysis

» 1Q 2015 – Dose Cohort 3 patients

» 3Q 2015 – Complete Escalating Dose Phase

» Notable Mid- to Long-Term

» 1H 2016 – Submit "Breakthrough Therapy“ and complete Stable

Dose Phase

» 2H 2016 – Initiate Pivotal Phase 2 and file EU Orphan Status

Application

» 2017 – Submit NDA

» 2018 – NDA approval and commercial launch

Potential for first RNAi drug to market

 
 

 

Myotonic Dystrophy Type 1 (DM1) – A

Muscle Disease with Systemic Effects

» Myotonia

» Skeletal muscle wasting

» Cardiac arrythmias

» Smooth muscle dysfunction

» Radial cataracts

» Cognitive dysfunction

• Weakness and

wasting of voluntary

muscles in the face,

neck and lower arms

and legs

• Muscles between the

ribs and those of the

diaphragm can be

weakened

• The heart is also

Affected

• The digestive tract and

uterus are often

affected

• Abnormalities in the

brain can lead to

excessive sleepiness or

apathy

 
 

 

DM1 - Devastating Impact on Entire

Families

» Myotonic Dystrophy type 1 (DM1) accounts for >95% cases

» Expansion of CTG repeats in 3’ UTR of the DMPK (dystrophia myotonicaprotein

kinase) gene

» Severity of disease

can be progressive

within families

 
 

 

Nucleic Acid-based Strategies for

Therapeutic Intervention

Accumulation of

altered DMPK mRNA

in nucleus sequesters

Muscleblind (MBNL1)

protein resulting in

loss-of-function

» Displace/Disrupt the MNBL-CUGn+x interaction

» (CAG) oligonucleotide to compete with MNBL1

» Cleave nuclear DMPK mRNA

» Initiate nuclease-mediated degradation

» Modulate CUGn+x via altered splicing of DMPK gene

» Target spice sites to reduce/skip CUGn+x

 
 

 

Matching the Nucleic Acid Construct to

the Most Effective Mechanism of Action

RNAi-dependent

Translational Blocker

DMPK mRNA to

increase degradation and elimination

Targeting the CUG-repeat for

degradation/elimination or compete with

proteins for binding sites

Targeting intron-exon splice to

bias for less-toxic or non-toxic variants

RNase H-dependent

Translational Blocker

Steric Blocker

RNase H-dependent

Translational Blocker

Splice Junction Inhibitor

CRN = UNA

Marina’s compounds span the entire spectrum of RNA-based MOAs

 
 

 

mRNA Translational Inhibition: Dose-response for

CRN- and LNA-Substituted Oligo1

LNA-substituted Translational Block Oligo

CRN-substituted Translational Block Oligo

1Data produced by undisclosed academic laboratory

In vitro Myotonic Dystrophy assay measuring CUG repeat blocking (lower % is better)

 
 

  

DM1 Pre-clinical/Clinical Strategy

» Efficacy Studies

» Tolerability and efficacy in transgenic mouse model of DM1

» mRNA expression/protein conformation and function

» Muscle cell histopathology/immunohistochemistry

» Physiological signs (muscle strength, gait, etc.)

» Safety Studies

» Standard in vitro/in vivo studies for IND

» Evaluate potential routes of administration (I.V. and Subq)

» Phase I Trial

» ~24 healthy volunteers

» Primary endpoints of safety and tolerability

» Phase 2a Trial (Proof-of-Concept)

» ~60 DM1 patients treated for six months

» Primary endpoint demonstrating improvement in 6 minute walk test

 
 

  

Duchenne Muscular Dystrophy (DMD)

» Muscle weakness can begin as early as age 3

» First affecting the muscles of the hips, pelvic area, thighs and shoulders

» Later affecting skeletal (voluntary) muscles

in the arms, legs and trunk

» By the early teens, heart and respiratory

muscles also are affected

» DMD is caused by an absence of

functional dystrophin, a protein

essential for muscle cell

survival and function

» Disease primarily affects boys,

but in rare cases girls

 
 

 

Nucleic Acid-based Strategy for

Therapeutic Intervention – Exon Skipping

26

» “Exon Skipping” restores a functional form of the dystrophin

protein and improves muscle cell survival

Modified

Full disease

Profile

disease

profile

Images adapted from Aartsma-Rus and Van Ommen,

RNA (2007), 13:1609–1624.

 
 

 

DMD Competitive Landscape

» In Development

» Sarepta and Prosensa oligonucleotides

» Exon skipping

» Sarepta’s eteplirsen: AVI 4658 skipping exon 51

» Prosensa’s drisapersen: PRO 051 skipping exon 51

» Announced that NDAs would be filed prior to end of 2014

» Exon 51 mutation represents ~15% of patient population

» PTC Therapeutics – Atalauren, “post translational control” small molecule

» Nonsense mutations (~13% of DMD patients – 2-2500 patients)

» Currently limited information on genetic makeup of

subpopulations

 
 

 

DMD Strategy

» Monitor DMD sector progress while conducting research in DM1

» DM1 in vivo POC will demonstrate potential effectiveness of

SMARTICLES delivery technology to muscle, etc.

» FDA expected to respond to NDA applications by 1Q 2015

» Develop construct targeting Exon 51 skipping

» Propriety chemistry (i.e., CRN)

» Proprietary delivery (i.e., SMARTICLES)

» Potential for greater efficacy compared to competitors

» Develop combination therapies targeting multiple Exons

» Multiple “Exon skippers” in single formulation, i.e. SMARTICLES

» Identify potential non-coding RNA approaches to DMD treatment

» Expand efforts with Rosetta Genomics (4Q 2014) to identify disease

modifying microRNA targets.

 
 

 

DMD Pre-clinical/Clinical Strategy

» Efficacy Studies

» Tolerability and efficacy in transgenic mouse model of DMD

» mRNA expression/protein conformation and function

» Muscle cell histopathology/immunohistochemistry

» Physiological signs (muscle strength, gait, etc.)

» Safety Studies

» Standard in vitro/in vivo studies for IND

» Evaluate potential routes of administration (I.V. and Subq)

» Phase I Trial

» ~20 healthy volunteers

» Primary endpoints of safety and tolerability

» Phase 2a Trial (Proof-of-Concept)

» ~12 DMD patients treated for twelve months

» Group A: >18 years old; Group B: 5-18 years old

» Primary endpoint demonstrating improvement in 6 minute walk test

 
 

 

DM1 and DMD Value Drivers

» Near Term

» 4Q 2014 – Demonstrate in vivo proof-of-concept

» 2Q 2015 – Lead identification and selection

» Notable Mid- to Long-Term

» DM1:

» 1H 2016 – File IND, submit Orphan Drug application and initiate

Phase 1

» 2017 – Submit “Breakthrough Therapy”

» 2018 – Initiate Phase 2a

» DMD:

» 2017 – File IND, submit Orphan Drug application, initiate Phase 1

and submit “Breakthrough Therapy”

» 2018 – Initiate Phase 2a

 
 

 

Partnering Goals

» Rare Disease “Fast Follower” (i.e. ALS, Cystic Fibrosis, Hemophilia,

Spinal Muscular Atrophy) Research Collaboration

» Marina:

» Identify novel nucleic acid compounds

» Conducts in vitro as well as in vivo safety, tolerability and, possibly, efficacy studies

» Partner

» Conducts in vivo POC, IND enabling studies, regulatory and clinical development

» Therapeutic Indication-Specific Research Collaboration

» Marina:

» Identify novel nucleic acid compounds

» Conducts in vitro as well as in vivo safety, tolerability and, possibly, efficacy studies

» Partner

» Conducts in vivo POC, IND enabling studies, regulatory and clinical development

» License Agreements

» Target-specific licensing of SMARTICLES and other delivery technologies

Leverage platform for non-dilutive capital and expanded capability

 
 

 

Thank You