United States

Securities and Exchange Commission

Washington, DC 20549

 

FORM 10-Q

 

þ Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended March 31, 2014

 

¨ Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from ___________________ to __________________.

 

Commission file number 001-15070

 

RegeneRx Biopharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware 52-1253406
(State of Incorporation) (IRS Employer I.D. Number)

 

15245 Shady Grove Road

Suite 470

Rockville, Maryland 20850

(Address of Principal Executive Offices)

 

(301) 208-9191

(Registrant's Telephone Number, Including Area Code)

 

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

Yes þ   No ¨

 

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

Yes þ No ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “accelerated filer,” “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Securities Exchange Act of 1934. (Check one):

 

Large accelerated filer   ¨   Accelerated filer  ¨
Non-accelerated filer  ¨   Smaller reporting company  þ
(Do not check if a smaller reporting company)    

 

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

Yes ¨   No þ

 

92,983,247shares of common stock, par value $0.001 per share, were outstanding as of May 14, 2014.

 

 
 

 

RegeneRx Biopharmaceuticals, Inc.

Form 10-Q

Quarterly Period Ended March 31, 2014

 

Index

 

      Page No.
       
Part I. Financial Information  
       
  Item 1. Financial Statements  
       
    Balance Sheets at March 31, 2014 (unaudited) and December 31, 2013 3
       
    Statements of Operations for the three months ended March 31, 2014 and 2013 (unaudited) 4
       
    Statements of Cash Flows for the three months ended March 31, 2014 and 2013 (unaudited) 5
       
    Notes to Financial Statements (unaudited) 6-15
       
  Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 15
       
  Item 3. Quantitative and Qualitative Disclosures About Market Risk 26
       
  Item 4 Controls and Procedures 26
       
Part II. Other Information  
       
  Item 1. Legal Proceedings 26
       
  Item 1A. Risk Factors 26
       
  Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 43
       
  Item 3. Defaults Upon Senior Securities 43
       
  Item 4. Mine Safety Disclosures 43
       
  Item 5. Other Information 43
       
  Item 6. Exhibits 44-46
       
  Signatures 47

 

2
 

 

Part I – Financial Information

 

Item 1. Financial Statements

 

RegeneRx Biopharmaceuticals, Inc.

Balance Sheets

 

 

    March 31,     December 31,  
    2014     2013  
    (Unaudited)     (See Note 1)  
ASSETS                
Current assets                
Cash and cash equivalents   $ 1,299,928     $ 6,306  
Prepaid expenses and other current assets     49,394       26,299  
Total current assets     1,349,322       32,605  
Property and equipment, net of accumulated depreciation of  $122,643 and $121,727     3,457       4,373  
Other assets     5,752       5,752  
Total assets   $ 1,358,531     $ 42,730  
                 
LIABILITIES AND STOCKHOLDERS' DEFICIT                
Current liabilities                
Accounts payable   $ 549,847     $ 577,211  
Accrued expenses     119,489       39,049  
Convertible promisory note, net of discount of $7,513 and $10,854     292,487       289,146  
Total current liabilities     961,823       905,406  
                 
Long-Term liabilities                
Unearned revenue     400,000       400,000  
Convertible promisory notes, net of derivative liability     173,476       143,399  
Fair value of derivative liability     1,986,168       215,334  
Total liabilities     3,521,467       1,664,139  
                 
Commitments     -       -  
                 
Stockholders' deficit                
Preferred stock, $.001 par value per share, 1,000,000 shares authorized; no shares issued     -       -  
Common stock, par value $.001 per share, 200,000,000 shares authorized,  92,983,247 and 81,733,247  issued and outstanding     92,983       81,733  
Additional paid-in capital     96,919,888       95,347,571  
Accumulated deficit     (99,175,807 )     (97,050,713 )
Total stockholders' deficit     (2,162,936 )     (1,621,409 )
Total liabilities and stockholders' deficit   $ 1,358,531     $ 42,730  

 

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

 

3
 

 

RegeneRx Biopharmaceuticals, Inc.

Statements of Operations

 

    Three Months ended March 31,  
    2014     2013  
    (Unaudited)     (Unaudited)  
Sponsored research revenue   $ -     $ 29,484  
                 
Operating expenses                
Research and development     74,700       91,489  
General and administrative     288,857       263,369  
Total operating expenses     363,557       354,858  
Loss from operations     (363,557 )     (325,374 )
Interest and other income     3       8  
Interest expense     (45,706 )     (7,040 )
Change in fair value of derivative     (1,715,834 )     -  
Net loss   $ (2,125,094 )   $ (332,406 )
                 
Basic and diluted net loss per common share   $ (0.03 )   $ (0.00 )
Weighted average number of common shares outstanding     82,233,247       81,733,247  

 

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

 

4
 

 

RegeneRx Biopharmaceuticals, Inc.

Statements of Cash Flows

 

    For the Three months ended March 31,  
    2014     2013  
    (Unaudited)     (Unaudited)  
             
Operating activities:                
Net loss   $ (2,125,094 )   $ (332,406 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization     916       1,431  
Share-based compensation     83,567       19,919  
Non-cash interest expense     33,418       3,341  
Change in fair value of derivative     1,715,834       -  
Changes in operating assets and liabilities:                
Grant receivable     -       177,350  
Prepaid expenses and other current assets     (23,095 )     8,289  
Other assets     -       -  
Accounts payable     (27,364 )     9,476  
Accrued expenses     80,440       (19,347 )
Net cash used in operating activities     (261,378 )     (131,947 )
                 
Financing activities:                
Proceeds from sale of common stock and issuance of warrants     1,500,000       -  
Proceeds from issuance of debt     55,000       225,000  
Cash provided by financing activities     1,555,000       225,000  
                 
Net increase in cash and cash equivalents     1,293,622       93,053  
                 
Cash and cash equivalents at beginning of period     6,306       141,905  
Cash and cash equivalents at end of period   $ 1,299,928     $ 234,958  
                 
Supplemental Disclosure of Non-Cash Operating and Financing Activities                
Fair value of derivative liability at issuance   $ 55,000     $ 225,000  

 

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

 

5
 

 

RegeneRx Biopharmaceuticals, Inc.

Notes to Financial Statements

For the three months ended March 31, 2014 and 2013 (Unaudited)

 

1. organization, business overview and basis of presentation

 

Organization and Nature of Operations.

 

RegeneRx Biopharmaceuticals, Inc. (“RegeneRx”, the “Company”, “We”, “Us”, “Our”), a Delaware corporation, was incorporated in 1982. We are focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Our operations are confined to one business segment: the development and marketing of product candidates based on Thymosin Beta 4 (“Tβ4”), an amino acid peptide.

 

Management Plans.

 

On March 28, 2014 we received the proceeds from the first equity purchase in the amount of $1,350,000 from G-treeBNT Co., Ltd. (“G-treeBNT”) formerly known as Digital Aria Co., Ltd., pursuant to the March 2014 execution of two licensing agreements and an associated common stock purchase agreement with G-treeBNT (see Note 7). We had previously received $150,000 earlier in the quarter in connection with these agreements. As of March 31, 2014 we had cash on hand of approximately $1,300,000. With this capital we have resources to continue operations. The operations include the development of RGN-259 for certain ophthalmic indications, including pursuing clinical development for the treatment of dry eye syndrome and neurotrophic keratopathy (NK), for which we received orphan designation at the end of 2013. We believe that we will be able to extend these activities for the next twelve months with the cash on hand plus the proceeds from the second common stock purchase closing with G-treeBNT that is scheduled to occur on or before August 31, 2014. This estimate may change if we are able to accelerate our development efforts or if we discover that we need to undertake additional efforts to support our objectives in which case we would need additional capital in less than 12 months. In addition to the RGN-259 development activities we intend to continue to pursue additional partnering activities, particularly for RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications.

 

We anticipate incurring additional losses in the future as we continue our RGN-259 development activities while seeking partners to explore the potential clinical benefits of Tβ4-based product candidates over multiple indications. We will need additional funds in order to pursue our current operating objectives substantially beyond the second quarter of 2015. Accordingly, we are in the process of exploring various funding alternatives, including, without limitation, a public or private placement of our securities, debt financing, corporate collaboration and additional licensing arrangements.

 

Although we intend to continue to seek additional financing or a strategic partner, we may not be able to complete a financing or corporate transaction, either on favorable terms or at all. If we are unable to complete a financing or strategic transaction, we may not be able to continue as a going concern after our funds have been exhausted, and we could be required to significantly curtail or cease operations, file for bankruptcy or liquidate and dissolve. There can be no assurance that we will be able to obtain any sources of funding. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be forced to take any such actions.

 

In addition to our current operational requirements, we expect to continue to expend substantial funds to complete our planned product development efforts. Additionally, we continually refine our operating strategy and will continue to evaluate potential orphan indication clinical uses of Tβ4. However, substantial additional resources will be needed before we will be able to achieve sustained profitability.

 

To achieve profitability we, and/or a partner, must successfully conduct pre-clinical studies and clinical trials, obtain required regulatory approvals and successfully manufacture and market those pharmaceuticals we wish to commercialize. The time required to reach profitability is highly uncertain, and there can be no assurance that we will be able to achieve sustained profitability, if at all.

 

6
 

 

These factors could significantly limit the ability to continue as a going concern. The accompanying financial do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.

 

Basis of Presentation.

 

The accompanying unaudited interim financial statements reflect, in the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented. These statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and with the rules and regulations of the SEC, for interim financial statements. Accordingly, they do not include all of the information and footnotes required by GAAP. The accounting policies underlying our unaudited interim financial statements are consistent with those underlying our audited annual financial statements. These unaudited interim financial statements should be read in conjunction with the audited annual financial statements as of and for the year ended December 31, 2013, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2013 (the “Annual Report”).

 

The accompanying December 31, 2013 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three-month period ended March 31, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014 or any other future period.

 

References in this Quarterly Report on Form 10-Q to “authoritative guidance” are to the Accounting Standards Codification issued by the Financial Accounting Standards Board (“FASB”).

 

Use of Estimates.

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Critical accounting policies involved in applying our accounting policies are those that require management to make assumptions about matters that are highly uncertain at the time the accounting estimate was made and those for which different estimates reasonably could have been used for the current period. Critical accounting estimates are also those which are reasonably likely to change from period to period, and would have a material impact on the presentation of our financial condition, changes in financial condition or results of operations. Our most critical accounting estimates relate to accounting policies for fair value measurements in connection with derivative liabilities, clinical trial accruals and share-based arrangements. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results could differ from those estimates.

 

Convertible Notes with Detachable Warrants.

 

In accordance with Accounting Standards Codification (ASC) 470-20, Debt with Conversion and Other Options , the proceeds received from convertible notes are allocated between the convertible notes and the detachable warrants based on the relative fair value of the convertible notes without the warrants and the relative fair value of the warrants. The portion of the proceeds allocated to the warrants is recognized as additional paid-in capital and a debt discount. The debt discount related to warrants is accreted into interest expense through maturity of the notes.

 

Derivative Financial Instruments

 

Derivative financial instruments consist of financial instruments or other contracts that contain a notional amount and one or more underlying variables (e.g. interest rate, security price or other variable), which require no initial net investment and permit net settlement. Derivative financial instruments may be free-standing or embedded in other financial instruments. Further, derivative financial instruments are initially, and subsequently, measured at fair value and recorded as liabilities or, in rare instances, assets.

 

7
 

 

The Company does not use derivative financial instruments to hedge exposures to cash-flow, market or foreign-currency risks. However, the Company has issued financial instruments including warrants that are either (i) not afforded equity classification, (ii) embody risks not clearly and closely related to host contracts, or (iii) may be net-cash settled by the counterparty. In certain instances, these instruments are required to be carried as derivative liabilities, at fair value, in the Company’s financial statements. In other instances these instruments are classified as equity instruments in the Company’s financial statements.

 

The Company estimates the fair values of its derivative financial instrument using the Black-Scholes option pricing model because it embodies all of the requisite assumptions (including trading volatility, estimated terms and risk free rates) necessary to fair value these instruments. Estimating fair values of derivative financial instruments requires the development of significant and subjective estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the trading market price of the Company’s common stock, which has a high-historical volatility. Since derivative financial instruments are initially and subsequently carried at fair values, the Company’s operating results reflect the volatility in these estimate and assumption changes in each reporting period.

 

Revenue Recognition.

 

We recognize revenue in accordance with the authoritative guidance for revenue recognition. We recognize revenue when all of the following criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery (or passage of title) has occurred or services have been rendered, (iii) the seller's price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured. We also comply with the authoritative guidance for revenue recognition regarding arrangements with multiple deliverables. Multiple-element arrangements are analyzed to determine whether the deliverables, which may include a license together with performance obligations such as providing a clinical supply of product and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting. Revenue associated with licensing agreements consists of non-refundable upfront license fees and milestone payments. Non-refundable upfront license fees received under license agreements, whereby continued performance or future obligations are considered inconsequential to the relevant license technology, are recognized as revenue upon delivery of the technology.

 

Whenever we determine that an arrangement should be accounted for as a single unit of accounting, we must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. We recognize revenue using the relative performance method provided that the we can reasonably estimate the level of effort required to complete our performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period.

 

If we cannot reasonably estimate the level of effort required to complete our performance obligations under an arrangement, the performance obligations are provided on a best-efforts basis and we can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period we expect to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date.

 

If we cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until we can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance.

 

8
 

 

We recognize consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria:

 

· The consideration is commensurate with either the entity's performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity's performance to achieve the milestone;

 

· The consideration relates solely to past performance; and

 

· The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement .

 

A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity's performance or on the occurrence of a specific outcome resulting from the entity's performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us.

 

We account for non-refundable grants as “Sponsored research revenues” in the accompanying statements of operations. Revenue from non-refundable grants is recognized when the following criteria are met; persuasive evidence of an arrangement exists, services have been rendered and the underlying costs incurred, the contract price is fixed or determinable, and collectability is reasonably assured. For the quarter ended March 31, 2014 we did not record any grant revenues and for the year ended December 31, 2013, all of our revenues were received from one NIH grant which was substantially completed during the quarter ended March 31, 2013. No future revenues are expected to be earned from this grant.

 

Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in our accompanying balance sheets.

 

Research and Development .

 

Research and development (“R&D”) costs are expensed as incurred and include all of the wholly-allocable costs associated with our various clinical programs passed through to us by our outsourced vendors. Those costs include: manufacturing Tβ4; formulation of Tβ4 into the various product candidates; stability for both Tβ4 and the various formulations; pre-clinical toxicology; safety and pharmacokinetic studies; clinical trial management; medical oversight; laboratory evaluations; statistical data analysis; regulatory compliance; quality assurance; and other related activities. R&D includes cash and non-cash compensation, payroll taxes, travel and other miscellaneous costs of our internal R&D personnel, four persons in total, who are part-time hourly employees dedicated to R&D efforts. R&D also includes a pro-ration of our common infrastructure costs for office space and communications.

 

Cost of Preclinical Studies and Clinical Trials .

 

We accrue estimated costs for preclinical studies based on estimates of work performed. We estimate expenses incurred for clinical trials that are in process based on patient enrollment and based on clinical data collection and management. Costs based on clinical data collection and management are recognized based on estimates of unbilled goods and services received in the reporting period. We monitor the progress of the trials and their related activities and adjust the accruals accordingly. Adjustments to accruals are charged to expense in the period in which the facts that give rise to the adjustment become known. In the event of early termination of a clinical trial, we would accrue an amount based on estimates of the remaining non-cancelable obligations associated with winding down the clinical trial.

 

9
 

 

Recent Accounting Pronouncements.

 

We did not adopt any new accounting pronouncements during the three months ended March 31, 2014 that had or are expected to have a material impact on our financial statements.

 

2. Net Loss per Common Share

 

Net loss per common share for the three-month periods ended March 31, 2014 and 2013, respectively, is based on the weighted-average number of shares of common stock outstanding during the periods. Basic and diluted loss per share are identical for all periods presented as potentially dilutive securities have been excluded from the calculation of the diluted net loss per common share because the inclusion of such securities would be antidilutive. The potentially dilutive securities include 45,641,175 shares and 23,238,500 shares in 2014 and 2013, respectively, reserved for the conversion of convertible debt or exercise of outstanding options, warrants, including 13,833,333 related to G-treeBNT’s second equity purchase and purchase option (see Note 7).

 

3. Stock-Based Compensation

 

We measure stock-based compensation expense based on the grant date fair value of the awards, which is then recognized over the period which service is required to be provided. We estimate the value of our stock option awards on the date of grant using the Black-Scholes option pricing model and amortize that cost over the expected term of the grant. We recognized $83,567 and $19,919 in stock-based compensation expense for the three months ended March 31, 2014 and 2013, respectively. We expect to recognize the compensation cost related to non-vested options as of March 31, 2014 of $162,131 over the weighted average remaining recognition period of 1.80 years.

 

We did not grant any stock options during the three months ended March 31, 2013. We used the following forward-looking range of assumptions to value the 2,025,000 stock options granted to employees, consultants and directors during the three months ended March 31, 2014:

 

Dividend yield     0.0 %
Risk-free rate of return     1.76 %
Expected life in years     4 - 5  
Volatility     91-98 %
Forfeiture rate     2.6 %

 

4. Income Taxes

 

As of March 31, 2014, there have been no material changes to our uncertain tax positions disclosures as provided in Note 9 of the Annual Report. The tax returns for all years in the Company’s major tax jurisdictions are not settled as of January 1, 2014; no changes in settled tax years have occurred through March 31, 2014. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes.

 

5. Fair Value Measurements

 

The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance describes a fair value hierarchy based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following:

 

10
 

 

Level 1 — Quoted prices in active markets for identical assets and liabilities.

 

Level 2 — Observable inputs other than quoted prices in active markets for identical assets and liabilities.

 

Level 3 — Unobservable inputs.

 

March 31, 2014 and 2013, our only qualifying assets that required measurement under the foregoing fair value hierarchy were money market funds included in Cash and Cash Equivalents valued at $1,300,000 and $235,000, respectively, using Level 1 inputs. Our March 31, 2014 balance sheet reflects qualifying liabilities resulting from the price protection provision in the convertible promissory notes issued in March, July and September of 2013 and January 2014 (see Note 6). We evaluated the derivative liability embedded in the series of convertible notes to determine if an adjustment to the carrying value of the liability was required at March 31, 2014 using the following assumptions.

 

    March 2013     July 2013     Sept 2013     Jan 2014  
                         
Dividend yield     0.00 %     0.00 %     0.00 %     0.00 %
Risk-free rate of return     1.73 %     1.73 %     1.73 %     1.73 %
Expected life in years     4       4.25       4.45       4.75  
Volatility     97.6 %     94.7 %     93.1 %     88.2 %

 

Given the conditions surrounding the trading of the Company’s equity securities, the Company values its derivative instruments related to embedded conversion features from the issuance of convertible debentures in accordance with the Level 3 guidelines.  For the period ended March 31, 2014, the following table reconciles the beginning and ending balances for financial instruments that are recognized at fair value in these financial statements.

 

    Balance at                 Balance at  
    December 31,     New     Change in     March 31,  
    2013     Issuances     Fair Values     2014  
                         
Level 3 -                                
Derivative liabilities from:                                
Conversion features                                
March 2013   $ 75,000     $ -     $ 562,500     $ 637,500  
July 2013     33,334       -       250,000       283,334  
September 2013     107,000       -       802,500       909,500  
January 2014     -       55,000       100,834       155,834  
Derivative instruments   $ 215,334     $ 55,000     $ 1,715,834     $ 1,986,168  

 

6. Convertible Notes

 

2012 Convertible Note

 

On October 19, 2012 we completed a private placement of convertible notes (the “2012 Notes”) raising an aggregate of $300,000 in gross proceeds. The 2012 Notes bear interest at a rate of five percent (5%) per annum, mature twenty-four (24) months after their date of issuance and are convertible into shares of our common stock at a conversion price of fifteen cents ($0.15) per share (subject to adjustment as described in the 2012 Notes) at any time prior to repayment, at the election of the Investors. In the aggregate, the 2012 Notes are initially convertible into up to 2,000,000 shares of our common stock if held to maturity, excluding interest.

 

11
 

 

At any time prior to maturity of the 2012 Notes, with the consent of the holders of a majority in interest of the 2012 Notes, we may prepay the outstanding principal amount of the 2012 Notes plus unpaid accrued interest without penalty. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of ninety (90) days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the 2012 Notes will accelerate and automatically become immediately due and payable.

 

In connection with the issuance of the 2012 Notes we also issued warrants to each Investor. The warrants are exercisable for an aggregate of 400,000 shares of common stock with an exercise price of fifteen cents ($0.15) per share for a period of five years. The relative fair value of the warrants issued is $27,097, calculated using the Black-Scholes-Merton valuation model value of $0.07 with an expected and contractual life of 5 years, an assumed volatility of 74.36%, and a risk-free interest rate of 0.77%. The warrants were recorded as additional paid-in-capital and a discount on the 2012 Notes of $27,097. Non-cash interest expense related to the debt discount during the three months ended March 31, 2014 and 2013 totaled $3,341 and $3,341, respectively.

 

The Investors, and the principal amount of their respective 2012 Notes and number of shares of common stock issuable upon exercise of their respective warrants, are as set forth below:

 

Investor   Note Principal     Warrants  
Sinaf S.A.   $ 200,000       266,667  
Joseph C. McNay   $ 50,000       66,667  
Allan L. Goldstein   $ 35,000       46,666  
J.J. Finkelstein   $ 15,000       20,000  

 

Sinaf S. A. is a direct wholly-owned subsidiary of Aptafin S.p.A., or Aptafin. Aptafin is owned directly by Paolo Cavazza and members of his family, who directly and indirectly own 38% of Sigma-Tau, our largest stockholder. The other Investors are members of our Board of Directors including Mr. Finkelstein who serves as our CEO and also the Chairman of our Board of Directors and Dr. Goldstein who also serves as our Chief Scientific Advisor.

 

2013 Convertible Notes

 

On March 29, 2013, we completed a private placement of convertible notes (the “March 2013 Notes”) raising an aggregate of $225,000 in gross proceeds. The March 2013 Notes bear interest at a rate of five percent (5%) per annum, mature sixty (60) months after their date of issuance and are convertible into shares of our common stock at a conversion price of six cents ($0.06) per share (subject to adjustment as described in the March 2013 Notes) at any time prior to repayment, at the election of the investor. In the aggregate, the March 2013 Notes are initially convertible into up to 3,750,000 shares of our common stock.

 

At any time prior to maturity of the March 2013 Notes, with the consent of the holders of a majority in interest of the March 2013 Notes, we may prepay the outstanding principal amount of the March 2013 Notes plus unpaid accrued interest without penalty. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the Federal bankruptcy act or the continuation of such petition without dismissal for a period of ninety (90) days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the March 2013 Notes will accelerate and automatically become immediately due and payable.

 

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The investors in the offering included two directors of the Company, Dr. Goldstein and Joseph C. McNay, an outside director. The principal amounts of their respective March 2013 Notes are as set forth below:

 

Investor   Note Principal  
Joseph C. McNay   $ 50,000  
Allan L. Goldstein   $ 25,000  

 

The Company has evaluated the terms of the March 2013 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the March 2013 Notes.  The adjustment would reduce the conversion price of the March 2013 Notes to be equivalent to that of the newly issued stock or stock-related instruments.  As a result, the Company concluded that the conversion feature represented an embedded conversion feature for accounting purposes and should be recognized as a derivative liability, requiring a mark-to-market adjustment at the end of each reporting period until the related March 2013 Notes have been settled. The bifurcated liability of $225,000 was recorded on the date of issuance which resulted in a residual debt value of $0. The Company determined that an adjustment to increase the derivative liability by $562,500 was required at March 31, 2014. Non-cash interest expense recorded during the three months ended March 31, 2014 totaled $11,096. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes.

 

On July 5, 2013, we completed a private placement of convertible notes (the “July 2013 Notes”) raising an aggregate of $100,000 in gross proceeds. The July 2013 Notes bear interest at a rate of five percent (5%) per annum, mature sixty (60) months after their date of issuance and are convertible into shares of our common stock at a conversion price of six cents ($0.06) per share (subject to adjustment as described in the July 2013 Notes) at any time prior to repayment, at the election of the investor. In the aggregate, the July 2013 Notes are initially convertible into up to 1,666,667 shares of our common stock.

 

At any time prior to maturity of the July 2013 Notes, with the consent of the holders of a majority in interest of the July 2013 Notes, we may prepay the outstanding principal amount of the July 2013 Notes plus unpaid accrued interest without penalty. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the Federal bankruptcy act or the continuation of such petition without dismissal for a period of ninety (90) days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the July 2013 Notes will accelerate and automatically become immediately due and payable.

 

The investors in the offering included four directors of the Company, Mr. Finkelstein, Dr. Goldstein, Mr. McNay and L. Thompson Bowles, an outside director. The principal amounts of their respective July 2013 Notes are as set forth below:

 

Investor   Note Principal  
Joseph C. McNay   $ 50,000  
Allan L. Goldstein   $ 10,000  
J.J. Finkelstein   $ 5,000  
L. Thompson Bowles   $ 5,000  

 

The Company has evaluated the terms of the July 2013 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the July 2013 Notes.  The adjustment would reduce the conversion price of the July 2013 Notes to be equivalent to that of the newly issued stock or stock-related instruments.  As a result, the Company concluded that the conversion feature represented an embedded conversion feature for accounting purposes and should be recognized as a derivative liability, requiring a mark-to-market adjustment at the end of each reporting period until the related July 2013 Notes have been settled.  The bifurcated liability of $66,667 was recorded on the date of issuance which resulted in a residual debt value of $33,333. The Company determined that an adjustment to increase the derivative liability by $250,000 was required at March 31, 2014. The accretion of the derivative liability recorded as interest expense during the three months ended March 31, 2014 totaled $3,288. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes.

 

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On September 11, 2013, we completed a private placement of convertible notes raising an aggregate of $321,000 in gross proceeds (the “September 2013 Notes”).  The September 2013 Notes bear interest at a rate of five percent (5%) per annum, mature sixty (60) months after their date of issuance and are convertible into shares of our common stock at a conversion price of six cents ($0.06) per share (subject to adjustment as described in the September 2013 Notes) at any time prior to repayment, at the election of the investor.  In the aggregate, the September 2013 Notes are initially convertible into up to 5,350,000 shares of our common stock. 

 

At any time prior to maturity of the September 2013 Notes, with the consent of the holders of a majority in interest of the September 2013 Notes, we may prepay the outstanding principal amount of the September 2013 Notes plus unpaid accrued interest without penalty.  Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of ninety (90) days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the September 2013 Notes will accelerate and automatically become immediately due and payable.

 

The investors in the offering included an affiliate and four directors of the Company. The principal amounts of the affiliate and directors respective September 2013 Notes are as set forth below:

 

Investor   Note Principal  
SINAF S.A.   $ 150,000  
Joseph C. McNay   $ 100,000  
Allan L. Goldstein   $ 11,000  
L. Thompson Bowles   $ 5,000  
R. Don Elsey   $ 5,000  

 

The Company has evaluated the terms of the September 2013 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the September 2013 Notes.  The adjustment would reduce the conversion price of the September 2013 Notes to be equivalent to that of the newly issued stock or stock-related instruments.  As a result, the Company concluded that the conversion feature represented an embedded conversion feature for accounting purposes and should be recognized as a derivative liability, requiring a mark-to-market adjustment at the end of each reporting period until the related September 2013 Notes have been settled.  The bifurcated liability of $267,500 was recorded on the date of issuance which resulted in a residual debt value of $53,500. The Company determined that an adjustment to increase the derivative liability by $802,500 was required at March 31, 2014. The accretion of the derivative liability recorded as interest expense during the three months ended March 31, 2014 totaled $13,192. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes.

 

2014 Convertible Notes

 

On January 7, 2014, we completed a private placement of convertible notes raising an aggregate of $55,000 in gross proceeds (the “January 2014 Notes”).   The January 2014 Notes will pay interest at a rate of 5% per annum, mature 60 months after their date of issuance and are convertible into shares of our common stock at a conversion price of $0.06 per share (subject to adjustment as described in the January 2014 Notes) at any time prior to repayment, at the election of the Investor.  In the aggregate, the Notes are initially convertible into up to 916,667 shares of our common stock. 

 

At any time prior to maturity of the January 2014 Notes, with the consent of the holders of a majority in interest of the January 2014 Notes, we may prepay the outstanding principal amount of the January 2014 Notes plus unpaid accrued interest without penalty.  Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of 90 days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the January 2014 Notes will accelerate and automatically become immediately due and payable.

 

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The Investors in the offering included three directors of the Company. The principal amounts of their respective Notes are as set forth below:

 

Investor   Note Principal  
Joseph C. McNay   $ 25,000  
Allan L. Goldstein   $ 10,000  
L. Thompson Bowles   $ 5,000  

 

The Company has evaluated the terms of the January 2014 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the January 2014 Notes.  The adjustment would reduce the conversion price of the January 2014 Notes to be equivalent to that of the newly issued stock or stock-related instruments.  As a result, the Company concluded that the conversion feature represented an embedded conversion feature for accounting purposes and should be recognized as a derivative liability, requiring a mark-to-market adjustment at the end of each reporting period until the related January 2014 Notes have been settled.  The bifurcated liability of $55,000 was recorded on the date of issuance which resulted in a residual debt value of $0. The Company determined that an adjustment to increase the derivative liability by $100,833 was required at March 31, 2014. The accretion of the derivative liability recorded as interest expense during the three months ended March 31, 2014 totaled $2,501. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes.

 

7. Stockholders’ Equity

 

On March 7, 2014, the Company signed securities purchase and licensing agreements with G-treeBNT. Under the securities purchase agreement, G-treeBNT invested $1,350,000 for 11,250,000 common shares at $0.12 per share and will invest an additional $1,000,000 for an additional 8,333,333 shares of common stock at $0.12 per share on or before August 31, 2014. Under the terms of the security purchase agreement, G-treeBNT also obtained the option to acquire an additional 5.5 million shares of common stock at $0.15 per share which expires on January 31, 2015. If this option is exercised the Company will receive additional proceeds of $825,000.

 

The licensing agreements for development and commercialization rights in certain territories to two of the Company’s product development candidates, RGN-259 and RGN-137, included upfront payments of $150,000.

 

In addition, G-treeBNT agreed to pay the Company milestone payments upon the achievement of certain commercial sales milestones, as well as with royalties on commercial sales. These license rights are conditioned upon the completion of the $1.35 million and $1.0 million security purchases described above and should both security purchases not occur, G-tree BNT will forfeit all license rights.

 

As the security purchase and licensing agreements were signed in contemplation of each other and the execution of performance under the securities purchase agreement was stipulated as a condition for the retention of the rights granted under the licensing agreements, the three agreements were treated as a multiple-elements arrangement. Following the closing of the agreements, the Company determined that the total consideration received under the three agreements, totaling $1,500,000, should be allocated to identifiable elements within this multiple-elements arrangement (1) the equity investment in the Company’s common shares, including the purchase option and (2) the licensed development and commercialization rights under the two licensing agreements. The fair value of optional investment right is approximately $725,000 which was calculated using the Black Scholes option pricing model at the issuance of this right. As the common shares were issued at a discount to the then market price of the Company’s common stock of $0.20 on the date of closing, all of the proceeds received were allocated to the common shares and the optional investment right leaving no allocation of proceeds to the licensed rights.

 

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

 

This Quarterly Report on Form 10-Q, including this Part I., Item 2., “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements regarding us and our business, financial condition, results of operations and prospects within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” “may” or other similar expressions. In addition, any statements that refer to projections of our future financial performance, our clinical development programs and schedules, our future capital resources and funding requirements, our anticipated growth and trends in our business and other characterizations of future events or circumstances are forward-looking statements. We cannot guarantee that we will achieve the plans, intentions or expectations expressed or implied in our forward-looking statements.  There are a number of important factors that could cause actual results, levels of activity, performance or events to differ materially from those expressed or implied in the forward-looking statements we make, including those described under “Risk Factors” set forth below in Part II., Item 1A. In addition, any forward-looking statements we make in this document speak only as of the date of this report, and we do not intend to update any such forward-looking statements to reflect events or circumstances that occur after that date.

 

Business Overview

 

We are a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tß4, for tissue and organ protection, repair, and regeneration. We have formulated Tß4 into three distinct product candidates in clinical development:

 

•      RGN-259, a preservative-free topical eye drop for regeneration of corneal tissues damaged by injury, disease or other pathology;

 

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•      RGN-352, an injectable formulation to treat cardiovascular diseases, central and peripheral nervous system diseases, and other medical indications that may be treated by systemic administration; and

 

•      RGN-137, a topical gel for dermal wounds and reduction of scar tissue.

 

We are continuing strategic partnership discussions with biotechnology and pharmaceutical companies regarding the further clinical development of all of our product candidates.

 

In addition to our three pharmaceutical product candidates, we are also pursuing limnited development of peptide fragments and derivatives of Tß4 for potential cosmeceutical and other personal care uses. These fragments are select amino acid sequences, and variations thereof, within the Tß4 molecule that have demonstrated activity in several in vitro preclinical research studies that we have sponsored. We believe the biological activities of these fragments may be useful, for example, in developing novel cosmeceutical products for the anti-aging market. Our strategy is to collaborate with another company to develop cosmeceutical formulations based on these peptides.

 

Future Plans

 

On March 7, 2014, we entered into two licensing and one securities purchase agreements with G-treeBNT Co., Ltd. (“G-treeBNT”) formerly known as Digital Aria Co., Ltd. under which G-treeBNT agreed to purchase $2,350,000 of our common stock and receive an option to purchase an additional $825,000 of our common stock over the next eleven months. On March 28, 2014 we received the proceeds from the first equity purchase in the amount of $1,350,000 from G-treeBNT.   With the proceeds from this first sale, coupled with the proceeds from the January 2014 placement of convertible promissory notes of $55,000 from 5 accredited investors, we have resources to continue operations.  The operations include the development of RGN-259 for certain ophthalmic indications, including pursuing clinical development for the treatment of dry-eye syndrome and neurotrophic keratopathy (NK), for which we recently received orphan designation. We believe that we will be able to extend these activities for the next twelve months with the cash on hand plus the proceeds from the second common stock purchase closing with G-treeBNT that is scheduled to occur on or before August 31, 2014.  This estimate may change if we are able to accelerate our development efforts or if we discover that we need to undertake additional efforts to support our objectives in which case we would need additional capital in less than 12 months.  In addition to the RGN-259 development activities we intend to continue to pursue additional partnering activities, particularly for RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications.

 

Development of Product Candidates

 

RGN-259

 

RGN-259 is our proprietary preservative-free eye drop formulation of Thymosin beta 4. In September 2011, we completed a Phase 2a exploratory clinical trial evaluating the safety and efficacy of RGN-259 in 72 patients with moderate dry eye syndrome. Patients were randomly assigned to receive either RGN-259 or placebo in this double-masked, placebo-controlled trial. All patients received either RGN-259 (0.1% concentration) or placebo, twice daily for 30 days. Various signs and symptoms of dry eye, such as the degree of ocular surface damage, ocular itching, burning and grittiness, among others, were graded periodically during and following the treatment period. The trial was conducted by Ora Inc., an ophthalmic contract research organization that specializes in dry eye research and clinical trials, and utilized Ora’s Controlled Adverse Environment (CAE sm ) chamber, which is a model that exacerbates dry eye signs and symptoms in the dry eye patient.

 

In November 2011, we reported preliminary safety and efficacy results from the trial. RGN-259 was deemed safe and well-tolerated, with no observed drug-related adverse events.

 

The co-primary outcome measures evaluated in the trial were inferior corneal fluorescein staining and decreased ocular discomfort on day 29, 24 hours after CAE challenge. Various secondary outcome efficacy measures were also evaluated in the trial. While the study did not meet statistical significance for reducing inferior corneal fluorescein staining, it did show a positive trend in this exploratory trial. RGN-259 did, however, show a statistically significant efficacy result in the other co-primary endpoint of decreased ocular discomfort.

 

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Key outcome measures are as follows:

 

Patients receiving RGN-259 experienced a 325% greater reduction from baseline in central corneal fluorescein staining compared to placebo at the 24 hour recovery period (p = 0.0075). Reduction of fluorescein staining is indicative of a reduction in ocular surface damage of the central cornea;

 

Patients receiving RGN-259 experienced a 257% greater reduction from baseline in exacerbation of superior corneal fluorescein staining in the CAE chamber as compared to the placebo (p = 0.0210); and

 

Patients receiving RGN-259 experienced a 27.3% greater reduction in exacerbation of ocular discomfort at day 28 during a 75-minute challenge in the CAE chamber compared to the placebo group (p = 0.0244). Reduction indicates that RGN-259 can slow progression of ocular symptoms in patients with dry eye syndrome.

 

Other CAE-related findings, such as superior corneal staining reduction and peripheral (combination of the average of superior and inferior) corneal staining reduction, were observed having statistical significance, while others had positive trends after treatment with RGN-259. These observations are in line with the known biological properties and mechanisms of action of RGN-259 reported in various nonclinical studies.

 

With respect to inferior corneal fluorescein staining, we did see a trend toward improvement, meaning that we observed reduced staining, at day 28 during exposure to adverse conditions in the CAE chamber in patients receiving RGN-259 compared to placebo, although this improvement was not deemed to be statistically significant (p = 0.0968).

 

Statistical significance (p value) of ≤ 0.05 is the generally accepted threshold for showing an outcome did not happen merely by chance.

 

The co-primary outcome measures, selected at the outset of this initial exploratory trial, were based on the best available animal data at the time but without the benefit of any actual human clinical experience in dry eye. Therefore, we believe that our not having met one of the two co-primary outcome measures at this stage is not as important as identifying statistically significant outcomes that could potentially serve as approvable endpoints in later stage or in pivotal Phase 3 clinical trials. We believe that the statistically significant observation of reduction in central corneal staining, as well as symptom improvements observed in the trial and described above, reflect actual patient benefits and would represent acceptable outcome measures to the FDA for possible use in follow-up Phase 2 or confirmatory pivotal Phase 3 trials. We are currently preparing a clinical study report for submission to the FDA that will describe the results of the exploratory Phase 2 clinical trial.

 

In June 2012, we reported preliminary results from a double-masked, vehicle-controlled, physician-sponsored Phase 2 clinical trial evaluating RGN-259 for the treatment of severe dry eye. RGN-259 was observed to be safe and well-tolerated and met key efficacy objectives with statistically significant sign and symptom improvements, compared to vehicle control, at various time intervals, including 28 days post-treatment.

 

In the trial, nine patients with severe dry eye (18 eyes) were treated with RGN-259 or vehicle control six times daily over a period of 28 days. They were evaluated upon entering the study after a two week washout period, at weekly intervals during the treatment phase, at the end of the 28-day treatment period, and at a follow-up visit 28 days after treatment. Statistically significant differences in sign and symptom assessments, such as ocular discomfort and corneal fluorescein staining, were seen at various time points throughout the study. Of particular note were the differences between RGN-259 and vehicle control 28 days post-treatment, or the follow-up period. The RGN-259-treated group had a 35.1% reduction of ocular discomfort compared to vehicle control (p = 0.0141), and a 59.1% reduction of total corneal fluorescein staining compared to vehicle control (p = 0.0108).

 

Consistent with the reduction of ocular discomfort and fluorescein staining at the 28-day follow-up visit, other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production. Likewise, these improvements were seen at other time points in the study.

 

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Lee’s Pharmaceuticals . In July 2012, we entered into a License Agreement with Lee’s Pharmaceutical (HK) Limited, headquartered in Hong Kong, for the license of Thymosin Beta 4 in any pharmaceutical form, including our RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan. We understand Lee’s will be filing an investigational new drug application IND in the second quarter with the Chinese FDA to begin clinical development with RGN-259 in China for dry-eye. Lee’s is an affiliate of Sigma-Tau, which collectively with its affiliates is our largest stockholder.

 

G-treeBNT . In March 2014, we entered into a License Agreement with G-treeBNT Co., Ltd., headquartered in Gyeonggi-do, Korea for the license of RGN-259. G-treeBNT licensed certain development and commercialization rights for RGN-259 in Asia (excluding China, Hong Kong, Macau and Taiwan). G-treeBNT simultaneously committed to purchase approximately 19.6 million shares of our common stock in two closings and, after closing the initial purchase on March 28, 2014, is currently our second largest shareholder. G-treeBNT also holds an option to purchase an additional 5.5 million shares of common stock at $0.15 per share until January 31, 2015.

 

Future Clinical Plans . We are in the process of evaluating the best path to reinitiate clinical activity for the treatment of dry eye while also evaluating the use and development of RGN-259 for patients with neurotrophic keratopathy (NK) pursuant to the orphan designation received at year-end.

 

Based on the results of the Phase 2 clinical trials in patients with moderate and severe dry eye syndrome, we are designing a Phase 2b clinical trial that we believe could confirm previous findings and generate important data for future marketing approval. This trial will also likely be a physician-sponsored trial for which we will supply regulatory support and clinical material. We currently expect that the trial will be initiated in the second half of 2014. With the orphan drug designation received from the FDA Office of Orphan Products on December 31, 2013, we are now evaluating the potential for accelerating development of RGN-259 in patients with non-healing NK. Based on the safety profile of RGN-259 and our clinical experience in treating ophthalmic patients, we are considering moving directly into Phase 3 clinical trials. In this event, we will likely need to raise additional capital to complete the trial. Subject to our raising additional capital to fund the trial, we believe a Phase 3 trial in patients with NK could be initiated in the second half of 2014 and completed in the first half of 2015.

 

RGN-352

 

During 2009, we completed a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of the intravenous administration of RGN-352 in 60 healthy subjects. Based on the results of this Phase 1 trial and extensive preclinical efficacy data published in peer-reviewed journals, in the second half of 2010, we began start-up activities for a Phase 2 study to evaluate RGN-352 (Tß4 Injectable Solution) in patients who had suffered an acute myocardial infarction (AMI). We had planned to begin enrolling patients in this clinical trial near the beginning of the second quarter of 2011. However, in March 2011, we were notified by the FDA that the trial was placed on clinical hold as a result of our contract manufacturer’s alleged failure to comply with the current Good Manufacturing Practice (cGMP) regulations. We have since learned that the manufacturer has closed its manufacturing facility and filed for bankruptcy protection. Since the FDA has prohibited us from using any of the active drug or placebo formulated by this manufacturer in human trials, we must have study drug (RGN-352 and RGN-352 placebo) manufactured by a new cGMP-compliant manufacturer in the event we seek to move forward with this trial. Therefore, we have elected to postpone activities on this trial until the requisite funding or a partner is secured.

 

In addition to the potential application of RGN-352 for the treatment of cardiovascular disease, preclinical research published in the scientific journals Neuroscience and the Journal of Neurosurgery indicates that RGN-352 may also prove useful for patients with multiple sclerosis, or MS, as well as patients suffering a stroke or traumatic brain injury. In these preclinical studies, the administration of Tß4 resulted in regeneration of neuronal tissue by promoting remyelination of axons and stimulating oligodendrogenesis, resulting in improvement of neurological functional activity. Based on this preclinical research, depending on our capital resources, we may in the future support a proposed physician-sponsored Phase 1/2 clinical trial to be conducted at a major U.S. medical center to evaluate the therapeutic potential of RGN-352 in patients with MS, stroke or traumatic brain injury.

 

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In 2012, researchers studying Tß4 under a material transfer agreement (MTA) found that Tß4 had beneficial effects in animal models of peripheral neuropathy, one of the major complications of diabetes. This research was published in the journal of Neurobiology of Disease in December 2012 and appears to corroborate previous findings using Tß4 for repair of central nervous system disorders.

 

RGN-137

 

Clinical Development — Epidermolysis Bullosa (EB).   In 2005, we began enrolling patients in a Phase 2 clinical trial designed to assess the safety and effectiveness of RGN-137 for the treatment of patients with EB. EB is a genetic disease of approximately 10 gene mutations that results in fragile skin and other epithelial structures (e.g., cornea and GI tract) that can blister spontaneously or separate at the slightest trauma or friction, creating a wound that at times does not heal or heals poorly. In severe cases, recurrent blistering and tissue loss may be life threatening. EB has been designated as an “orphan” indication by the FDA’s Office of Orphan Drugs. A portion of this trial was funded by a grant of $681,000 received from the FDA. In this randomized, double-blind, placebo-controlled, dose-response trial, nine U.S. clinical sites evaluated the safety, tolerability, and wound healing effectiveness of three different concentrations of RGN-137 compared to placebo. RGN-137 was applied topically to the skin, once daily for up to 56 consecutive days. We completed enrollment of 30 out of the original target of 36 patients and closed the Phase 2 trial in late 2011 as the availability of eligible patients had been exhausted. We have engaged a consultant to draft the final report and we expect it to be submitted to the FDA in the second quarter of 2014.

 

Clinical Development — Pressure Ulcers.   In late 2005, we began enrolling patients in a Phase 2 clinical trial designed to assess the safety and effectiveness of RGN-137 for the treatment of patients with chronic pressure ulcers, commonly known as bedsores. In this randomized, double-blind, placebo-controlled, dose-response trial, 15 clinical sites in the United States enrolled a total of 72 patients to evaluate the safety, tolerability, and wound healing effectiveness of three different concentrations of RGN-137 compared to placebo. RGN-137 was applied topically to patients’ ulcers, once daily for up to 84 consecutive days. Patients in the trial were between 19 and 85 years old and had at least one stable Stage III or IV pressure ulcer with a surface area between 5 and 70 cm 2 . Stage III and IV pressure ulcers are full thickness wounds that penetrate through the skin and muscle, sometimes completely to the bone.

 

In January 2009, we reported final data from this trial. RGN-137 was well-tolerated at all three dose levels studied, with no dose-limiting adverse events, which achieved the primary objective of the study. As for efficacy, all Tß4 doses performed similarly compared to placebo, with no statistically significant efficacy results. However, patients treated with the middle dose showed a 17% rate of wound healing, which was the highest rate among the three active doses evaluated. The improvement in ulcer healing in this middle dose group following nine weeks of treatment was equal to the improvement in patients treated with placebo after 12 weeks of treatment. A follow-on evaluation, reported at the 3rd International Symposium on the Thymosins in Health and Disease in March 2012, showed that for those pressure ulcer patients’ wounds that healed, RGN-137 mid dose (0.02% Tβ4 gel product) accelerated wound closure with a median time to healing of 22 days as compared to 57 days for the placebo. Although those results are clinically significant, they were not statistically significant.

 

Clinical Development — Venous Stasis Ulcers.  In mid-2006 we began enrolling patients in a Phase 2 clinical trial designed to assess the safety and effectiveness of RGN-137 for the treatment of patients with venous stasis ulcers. Venous stasis ulcers are a common type of chronic wound that develops on the ankle or lower leg in patients with chronic vascular disease. In these patients blood flow in the lower extremities is impaired leading to venous hypertension, edema (swelling) and mild redness and scaling of the skin that gradually progresses to ulceration. In this double-blind, placebo-controlled, dose-response study, 8 European sites in Italy (N=5) and Poland (N=3) make up the 72 patients randomized to receive three different concentrations of RGN-137 or placebo. RGN-137 or placebo was applied topically to patients’ ulcers once daily for consecutive days. A patient’s ulcer size and ulcer stability for enrollment were between 3 and 30 cm 2 and at least 6 weeks in duration, respectively.

 

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In 2009, we reported final data from that trial. All doses of RGN-137 were well tolerated. More patients achieved healing in the RGN-137 mid dose (0.03% Tβ4 gel product) than in any other dose group. The mid dose showed both an increased incidence of wound healing and a faster healing time compared to placebo. The mid dose decreased the median time to healing by 45% among those wounds that completely healed. A follow-on evaluation, reported at the 3rd International Symposium on the Thymosins in Health and Disease in March 2012, showed that for those venous stasis ulcer patients’ wounds greater than 3 cm 2 that healed, the RGN-137 mid dose (0.03% Tβ4 gel product) accelerated wound closure with a median time to healing of 49 days as compared to 78 days for the placebo. Those results were both clinically and statistically significant.

 

G-treeBNT . In March 2014, we entered into a License Agreement with G-treeBNT Co., Ltd., to license certain development and commercialization rights for RGN-137 in the U.S. G-treeBNT also committed to purchase an aggregate of approximately 19.6 million shares of our common stock in two closings and, after closing the initial purchase on March 28, 2014, is currently our second largest shareholder. G-treeBNT also holds an option to purchase an additional 5.5 million shares of common stock at $0.15 per share until January 31, 2015.

 

Peptide Fragments for Cosmeceutical Applications

 

We are also seeking to identify and evaluate Tß4 peptide fragments and derivatives that may be useful as novel components in cosmeceutical and consumer products. We have identified several amino acid sequences, and variations thereof, within the Tß4 molecule that have demonstrated in vitro activity in preclinical research studies that we have sponsored, and we have filed a number of patent applications related to this research. We believe the biological activities of these fragments may be useful, for example, in developing novel cosmeceutical products for the anti-aging and, more broadly, the personal care markets. To date, research has suggested that these fragments suppress inflammation, accelerate the deposition of certain types of collagen, promote the production of elastin, and inhibit programmed cell death, among other activities. Our development and commercialization strategy is to identify suitable commercial partners to license these novel fragments for various cosmeceutical applications. We have held discussions with several multinational cosmetics and consumer products companies focused on potential collaborations to further develop and commercialize these fragments.

 

Our Strategy

 

We seek to maximize the value of our product candidates by advancing their clinical development and then identifying suitable partners for further development, regulatory approval, and marketing. We intend to engage in strategic partnerships with companies with clinical development and commercialization strengths in desired pharmaceutical therapeutic fields. We are actively seeking partners with suitable infrastructure, expertise and a long-term initiative in our medical fields of interest.

 

On March 8, 2014, we announced that we had signed a two License Agreements with G-treeBNT Co., Ltd., headquartered in Gyeonggi-do, Korea for certain licenses to our RGN-259 and RGN-137 product candidates. G-treeBNT licensed the development and commercialization rights for RGN-259 in Asia (excluding China, Hong Kong, Macau and Taiwan), while also licensing the development and commercialization rights for RGN-137 in the U.S.

 

We have entered into a strategic partnership with Defiante Farmaceutica S.A., or Defiante, a subsidiary and one of several entities affiliated with Sigma-Tau Group, a leading international pharmaceutical company which collectively comprise our largest shareholder, or Sigma-Tau, for development and marketing of RGN-137 and RGN-352 for specified indications in Europe and other contiguous countries. Defiante merged with Sigma-Tau Industrie Farmaceutiche Riunite S. P. A. in 2013.

 

We have entered into a License Agreement with Lee’s Pharmaceutical (HK) Limited, headquartered in Hong Kong, for the license of Thymosin Beta 4 in any pharmaceutical form, including our RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan. Lee’s is an affiliate of Sigma Tau, which collectively with its affiliates is our largest stockholder.

 

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Financial Operations Overview

 

We have never generated product revenues, and we do not expect to generate product revenues until the FDA approves one of our product candidates, if ever, and we begin marketing and selling it. Subject to the availability of financing, we expect to invest increasingly significant amounts in the furtherance of our current clinical stage programs and may add additional nonclinical studies and new clinical trials as we explore the potential of our current product candidates in target indications and explore the potential use of our Tß4-based product candidates in rare disease and orphan indications. As we expand our clinical development initiatives, we expect to incur substantial and increasing losses. Accordingly, we will need to generate significant product revenues in order to ultimately achieve and then maintain profitability. Also, we expect that we will need to raise substantial additional capital in order to meet product development requirements. We cannot assure investors that such capital will be available when needed, on acceptable terms, or at all.

 

Most of our expenditures to date have been for research and development, or R&D, activities and general and administrative, or G&A, activities. R&D costs include all of the wholly-allocable costs associated with our various clinical programs passed through to us by our outsourced vendors. Those costs include manufacturing Tß4 and peptide fragments, formulation of Tß4 into our product candidates, stability studies for both Tß4, and the various formulations, preclinical toxicology, safety and pharmacokinetic studies, clinical trial management, medical oversight, laboratory evaluations, statistical data analysis, regulatory compliance, quality assurance and other related activities. R&D includes cash and non-cash compensation, payroll taxes, travel and other miscellaneous costs of our internal R&D personnel, three persons in total, who are dedicated on a part-time hourly basis to R&D efforts. R&D also includes a proration of our common infrastructure costs for office space and communications. We expense our R&D costs as they are incurred.

 

R&D expenditures are subject to the risks and uncertainties associated with clinical trials and the FDA review and approval process. As a result, these expenses could exceed our expectations, possibly materially. We are uncertain as to what we will incur in future research and development costs for our clinical studies, as these amounts are subject to, management's continuing assessment of the economics of each individual research and development project and the internal competition for project funding. In May 2010 we were awarded a grant from the NIH to support the development of RGN-352. Subject to our compliance with the terms and conditions of the grant, we were eligible to receive up to $3.0 million over a three-year period in cost reimbursements related to the purposes set forth in the grant. We have used proceeds from the grant for the payment of research and development staff in connection with our grant related research and development activities and heavily relied on this grant for purposes of funding our R&D employees’ reduced salaries. Proceeds from the grant have been used for animal studies supporting our clinical work to develop RGN-352 for myocardial infarction, as well as to manufacture additional quantities of Tβ4. In the first quarter of 2013 we substantially completed all of the work under the grant and have exhausted the grant as a financing source.

 

G&A costs include outside professional fees for legal, business development, audit and accounting services. G&A also includes cash and non-cash compensation, payroll taxes, travel and other miscellaneous costs of our internal G&A personnel, three in total, who are dedicated to G&A efforts. G&A also includes a proration of our common infrastructure costs for office space, and communications. Our G&A expenses also include costs to maintain our intellectual property portfolio. We have expanded our patent prosecution activities and have been reviewing our pending patent applications in the United States, Europe and other countries with the advice of outside legal counsel. In some cases, we have filed patent applications for non-critical strategic purposes intended to prevent others from filing similar patent claims. We continue to closely monitor our patent applications to determine if they will continue to provide strategic benefits. In cases where we believe the benefit has been realized or it becomes unnecessary due to the issuance of other patents, or for other reasons that will not affect the strength of our intellectual property portfolio, we will abandon these patent applications in order to reduce our costs of prosecution.

 

Critical Accounting Policies

 

In Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our Annual Report on Form 10-K for the year ended December 31, 2013, which was filed with the SEC on April 4, 2014, which we refer to as the Annual Report, we included a discussion of the most significant accounting policies and estimates used in the preparation of our financial statements. There has been no material change in the policies and estimates used in the preparation of our financial statements since the filing of our Annual Report.

 

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Results of Operations

 

Comparison of the three months ended March 31, 2014 and 2013

 

Revenues. We did not record any revenue in the three months ended March 31, 2014. For the three months ended March 31, 2013, grant revenue was $29,000. During the three months ended March 31, 2013 we recognized revenue based on costs incurred related to this grant. The revenue recorded in the three months ended March 31, 2013 was the final revenue we will record related to work performed under the grant.

 

R&D Expenses . For the three months ended March 31, 2014, our R&D expenses decreased by approximately $17,000, or 18%, to $75,000 from $91,000 for the same period in 2013. The decrease from 2013 reflects the absence in 2014 of outsourced R&D services associated with the completion of the work under the NIH grant during the three months ended March 31, 2013. The R&D expenses for both periods reflect our limited operating activity and are comprised of compensation, facility and G&A allocation and insurance. In addition to the referenced outsourced services (decrease of $28,000) the decrease 2014 expenses are personnel (decrease of $25,000) and allocations (decrease of $12,000) with offsetting increases in R&D consulting ($24,000) and stock option compensation ($12,000 increase). We expect our R&D expenses to increase as we continue to evaluate and execute on our current development objectives.

 

G&A Expenses. For the three months ended March 31, 2014, our G&A expenses increased by approximately $25,000, or 10%, to $289,000, from $263,000 for the same period in 2013. The increase was primarily the result of diligence costs incurred in association with completing the G-treeBNT transaction (approximately $30,000) including, travel and legal and consulting fees. The 2014 expenses also reflect a small increase in personnel costs of $11,000, allocation increase of $11,000, and stock option expense of $48,000 offset by a decrease in professional services of approximately $80,000. We also expect that our G&A expenses will increase in future periods as we have increased cash compensation paid to our employees.

 

Net Loss. We incurred a net loss of $2,125,000 for the quarter ended March 31, 2014, primarily as a result of our evaluation of the derivative liability associated with the conversion feature of the debt instruments issued over the past year. The value of this conversion feature is indexed to the share price of our common stock and increases as our share price increases. The share price of our common stock increased from $0.05 December 31, 2013 to $0.20 March 31, 2014, which resulted in an increase in valuation of our convertible debt derivative component and the recording of an unrealized loss of $1,715,834.

 

Liquidity and Capital Resources

 

Overview

 

We have not commercialized any of our product candidates to date and have incurred significant losses since inception. We have primarily financed our operations through the issuance of common stock and common stock warrants in private and public financings and most recently through the sale of a series of convertible promissory notes through private placements with accredited investors and the March 2014 private placement of common stock with G-TreeBNT. The report of our independent registered public accounting firm regarding our financial statements for the year ended December 31, 2013 contained an explanatory paragraph regarding our ability to continue as a going concern based upon our history of net losses and dependence on future financing in order to meet our planned operating activities.

 

We had cash and cash equivalents of $1,300,000 at March 31, 2014. Our current operating plan includes the development of RGN-259 for certain ophthalmic indications, including pursuing clinical development for the treatment of dry-eye syndrome and neurotrophic keratopathy (NK), for which we recently received orphan designation. We believe that we will be able to extend these activities for the next twelve months with the cash on hand plus the proceeds from the second common stock purchase closing with G-treeBNT that is scheduled to occur on or before August 31, 2014. This estimate may change if we are able to accelerate our development efforts or if we discover that we need to undertake additional efforts to support our objectives in which case we would need additional capital in less than 12 months. In addition to the RGN-259 development activities we intend to continue to pursue additional partnering activities, particularly for RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications.

 

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Cash Flows for the Three Months Ended March 31, 2014 and 2013

 

Net cash used in operating activities was approximately $261,000 for the three months ended March 31, 2014 as compared to $132,000 used in operating activities for the same three months in 2013. In 2014 our net loss for the period of $2,125,000 was primarily comprised of several significant non-cash items including non-cash compensation and non-cash interest expense of $84,000 and $33,000, respectively and a non-cash loss of $1,716,000 associated with valuation of our convertible debt derivative component. In 2013 the net cash used in operating activities was primarily the result of our net loss during the period mitigated by collection of the year end grant receivable in the amount $177,000. During the first quarter of 2014 we received $1,500,000 pursuant to the sale of common stock to G-treeBNT and the associated licensing agreements and $55,000 in January 2014, representing the net proceeds of the sale of convertible notes as described in Note 6 to our unaudited financial statements included in this report. We did not sell any equity securities during the three months ended March 31, 2013 although we raised net proceeds from the sale of convertible notes of $225,000.

 

Future Funding Requirements

 

The expenditures that will be necessary to execute our business plan are subject to numerous uncertainties that may adversely affect our liquidity and capital resources. We are not currently enrolling patients in any clinical trials. As a result of our financial and strategic discussions over the past two years, coupled with the December 2013 grant of orphan drug status by the FDA and the recent combined licensing and equity sale transaction with G-treeBNT, we have refined our forward-looking strategy to leverage our resources and focus on three potential clinical opportunities with RGN-259 that we feel could provide important results during 2015. The clinical opportunities include a potential Company-sponsored pivotal clinical trial for the treatment for neurotrophic keratopathy (NK), a potential investigator-sponsored clinical trial for patients with severe dry eye, and the anticipated initiation of clinical trials in China by our licensee, Lee’s Pharmaceuticals. With the December 2013 orphan drug status granted to RGN-259, coupled with the capital received in conjunction with the G-treeBNT strategic transaction, we are evaluating a potential accelerated product development opportunity for RGN-259 as a treatment for NK. While the plans associated with the respective clinical trials are not finalized, we believe that there may be an opportunity to go directly into a Phase 3 pivotal clinical trial under the orphan designation. We also believe that the support for an investigator-sponsored clinical trial in severe dry-eye would primarily consist of drug product, as well as time and consultation by RegeneRx staff. We believe that supporting these trials, while maintaining existing operations such as our intellectual property portfolio, negotiations with prospective strategic partners, evaluation of any financial or grant opportunities that become available, and maintaining compliance with our SEC reporting obligations can be accomplished for the next twelve months with the $2.5 million in capital to be received in 2014 from the G-treeBNT transaction. Based on the outcome of our evaluation of the potential development path for RGN-259 as a treatment for neurotrophic keratopathy under the orphan status, we may determine that we need additional financial resources before the end of the 12 months to pursue certain components of this development path. We have been informed that Lee’s will file its IND shortly. It is also our expectation that G-treeBNT will move quickly to initiate clinical activities in both the U.S. and Korea, although the initiation of clinical trials will depend on a number of factors including the timing of commencing joint development committee activities in addition to the preparation and filing of an IND with the Korean FDA, in addition to other regulatory requirements in their licensed territories. In addition, the length of time required for clinical trials varies substantially according to the type, complexity, novelty and intended use of a product candidate. Some of the factors that could impact our liquidity and capital needs include, but are not limited to:

 

· the progress of our clinical trials;

 

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· the progress of our research activities;

 

· the number and scope of our research programs;

 

· the progress of our preclinical development activities;

 

· the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent and other intellectual property claims;

 

· the costs related to development and manufacture of preclinical, clinical and validation lots for regulatory purposes and commercialization of drug supply associated with our product candidates;

 

· our ability to enter into corporate collaborations and the terms and success of these collaborations;

 

· the costs and timing of regulatory approvals; and

 

· the costs of establishing manufacturing, sales and distribution capabilities.

 

In addition, the duration and the cost of clinical trials may vary significantly over the life of a project as a result of differences arising during the clinical trial protocol, including, among others, the following:

 

· the number of patients that ultimately participate in the trial;

 

· the duration of patient follow-up that seems appropriate in view of the results;

 

· the number of clinical sites included in the trials; and

 

· the length of time required to enroll suitable patient subjects.

 

Also, we test our product candidates in numerous preclinical studies to identify indications for which they may be efficacious. We may conduct multiple clinical trials to cover a variety of indications for each product candidate. As we obtain results from trials, we may elect to discontinue clinical trials for certain product candidates or for certain indications in order to focus our resources on more promising product candidates or indications.

 

Our proprietary product candidates also have not yet achieved FDA regulatory approval, which is required before we can market them as therapeutic products. In order to proceed to subsequent clinical trial stages and to ultimately achieve regulatory approval, the FDA must conclude that our clinical data establish safety and efficacy. Historically, the results from preclinical studies and early clinical trials have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologics have shown promising results in clinical trials, but subsequently failed to establish sufficient safety and efficacy data to obtain necessary regulatory approvals.

 

We are not currently conducting clinical trials and therefore do not have any significant financial commitments for research and development activities. We were previously committed under an office space lease through January 2013. We are currently utilizing this space on a month to month basis that requires base rental payments of approximately $8,300 per month.

 

Sources of Liquidity

 

We have not commercialized any of our product candidates to date and have primarily financed our operations through the issuance of common stock and common stock warrants in private and public financings in addition to a series of five convertible debt placements from October 2012 to January 2014. In March 2014 we entered into a strategic transaction with G-treeBNT which includes the purchase of approximately 19.6 million shares of common stock by G-treeBNT in two tranches. The first closed on March 28, 2014 in the amount of $1,350,000 and the second, in the amount of $1,000,000 is scheduled to close on or before August 31, 2014. G-treeBNT also holds an option to purchase an additional 5.5 million shares of common stock on or before January 31, 2015, if elected the option would result in proceeds of $825,000. We also received $150,000 from G-treeBNT pursuant to two associated licensing agreements and as a result of the initial common stock purchase, G-treeBNT is now our second largest stockholder. Our largest stockholder group, which we refer to as Sigma-Tau, has historically provided significant equity capital to us, including $200,000 pursuant to the convertible debt placement in October 2012 and $150,000 pursuant to the convertible debt placement in September 2013.

 

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Licensing Agreements

 

As noted above, we have entered into two license agreements with G-treeBNT. G-treeBNT licensed the development and commercialization rights for RGN-259, in Asia (excluding China, Hong Kong, Macau and Taiwan) while also licensing the development and commercialization rights for RGN-137 in the U.S. Both licenses provide for the opportunity for us to receive milestone payments upon specified commercial events and royalty payments in connection with any commercial sales of the licensed products in the respective territories. However, there are no assurances that we will be able to attain any such milestones or generate any such royalty payments under the agreements.

 

We have a license agreement with Sigma-Tau that provides the opportunity for us to receive milestone payments upon specified events and royalty payments in connection with commercial sales of Tß4 in Europe. However, we have not received any milestone payments to date, and there can be no assurance that we will be able to attain such milestones and generate any such payments under the agreement.

 

We also have entered into a license agreement with Lee’s Pharmaceuticals that provides for the opportunity for us to receive milestone payments upon specified events and royalty payments in connection with any commercial sales of Tß4-based products in China, Hong Kong, Macau and Taiwan. However, there are no assurances that we will be able to attain any such milestones or generate any such royalty payments under the agreement.

 

Government Grants

 

In May 2010, we were awarded a grant from the NIH’s National Heart, Lung and Blood Institute to support the requisite nonclinical development of RGN-352 for patients who have suffered a heart attack. These nonclinical activities were completed while our pending Phase 2 clinical trial of RGN-352 was on clinical hold. Subject to our compliance with the terms and conditions of the grant, we are eligible to receive up to $3.0 million over a three-year period in cost reimbursements related to the purposes set forth in the grant. We have used proceeds from the grant for the payment of research and development staff in connection with our grant related research and development activities and we have relied on this grant for purposes of funding our R&D employees’ reduced salaries. In the first quarter of 2013 we substantially completed all of the work under the grant and have exhausted the grant as a financing source. Revenue from the grant was recorded during the same periods when we incurred eligible expenses.

 

Other Financing Sources

 

Other potential sources of outside capital include entering into strategic business relationships, additional issuances of equity securities or debt financing or other similar financial instruments. If we raise additional capital through a strategic business relationship, we may have to give up valuable rights to our intellectual property. If we raise funds by selling additional shares of our common stock or securities convertible into our common stock, the ownership interest of our existing stockholders may be significantly diluted. In addition, if additional funds are raised through the issuance of preferred stock or debt securities, these securities are likely to have rights, preferences and privileges senior to our common stock and may involve significant fees, interest expense, restrictive covenants and the granting of security interests in our assets.

 

Our failure to successfully address ongoing liquidity requirements would have a materially negative impact on our business, including the possibility of surrendering our rights to some technologies or product opportunities, delaying our clinical trials, or ceasing operations. There can be no assurance that we will be able to obtain additional capital in sufficient amounts, on acceptable terms, or at all.

 

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Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements, as such term is defined in Item 303(a)(4) of Regulation S-K.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

Our cash equivalents, which are generally comprised of Federally-insured bank deposits, are subject to default, changes in credit rating and changes in market value. These investments are also subject to interest rate risk and will decrease in value if market interest rates increase. As of March 31, 2014, these cash equivalents were $1,300,000. Due to the short-term nature of these investments, if market interest rates differed by 10% from their levels as of March 31, 2014, the change in fair value of our financial instruments would not have been material.

 

Item 4. Controls and Procedures

 

a) Evaluation of Disclosure Controls and Procedures

 

Our management, under the supervision and with the participation of our President and Chief Executive Officer, in his capacity as our principal executive officer and our principal financial officer, performed an evaluation of the effectiveness of the design and operation of our “disclosure controls and procedures” (as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended) as of March 31, 2014. Based upon this evaluation, management has concluded that, as of March 31, 2014, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed is recorded, processed, summarized and reported within the time periods specified under applicable rules of the SEC, and that such information is accumulated and communicated to management, including our President and Chief Executive Officer, as appropriate, to allow timely decisions regarding required disclosures.

 

b) Changes in Internal Controls

 

There were no changes in our internal control over financial reporting during the three months ended March 31, 2014 that have materially affected, or which are reasonably likely to materially affect, our internal control over financial reporting. The Company appointed a new Chief Financial Officer on April 16, 2014. The CFO has assumed the responsibilities of Principal Accounting Officer previously held by the Company’s CEO and the Company does not expect this change to materially affect our internal control over financial reporting.

 

Part II – Other Information

 

Item 1. Legal Proceedings

 

None.

 

Item 1A. Risk Factors

 

Set forth below and elsewhere in this report and in other documents we file with the SEC are risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements contained in this report. The descriptions below include any material changes to and supersede the description of the risk factors affecting our business previously disclosed in “Part II, Item 1A. Risk Factors” of the Annual Report.

 

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Risks Related to Our Liquidity and Need for Financing

 

Before giving effect to any potential additional sales of our securities, we estimate that our existing capital resources and G-treeBNT’s committed equity purchase will only be sufficient to fund our operations for, at most, the next 12 months.

 

As of March 31, 2014 we had cash on hand of approximately $1,300,000, primarily representing the March 28, 2014 sale proceeds from the first equity purchase in the amount of $1,350,000 from G-treeBNT, pursuant to the March 2014 securities purchase agreement with G-treeBNT. With the proceeds from this first sale, coupled with the proceeds from the January 2014 placement of convertible promissory notes for $55,000 from five accredited investors, we have resources to continue operations. The operations include continuing the development of RGN-259 for certain ophthalmic indications, including limited support of a physician-sponsored Phase 2 trial for the treatment of dry eye syndrome and initiating clinical development of RGN-259 for the treatment of neurotrophic keratopathy (NK), for which we recently received orphan designation. We believe that we will be able to extend these activities for the next twelve months with the cash on hand plus the proceeds from the second common stock purchase closing with G-treeBNT that is scheduled to occur on or before August 31, 2014. This estimate will change and we will need additional capital in less than 12 months if we are able to accelerate or we need to undertake additional efforts to support our objectives. In addition to the RGN-259 development activities we intend to continue to pursue additional partnering activities, most notably for RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications. Therefore, we could need to complete an additional financing or strategic transaction within the next twelve months to continue as a going concern, or we may be forced to cease or wind down operations, seek protection under the provisions of the U.S. Bankruptcy Code, or liquidate and dissolve our company.

 

Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this report. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

 

In addition to our current development objectives, we will need substantial additional capital for the continued development of product candidates through marketing approval and for our longer-term future operations.

 

Beyond our current liquidity needs, we anticipate that substantial new capital resources will be required to continue our longer-term independent product development efforts, including any and all follow-on trials that will result from our current clinical programs beyond those currently contemplated, and to scale up manufacturing processes for our product candidates. However, the actual amount of funds that we will need will be determined by many factors, some of which are beyond our control. These factors include, without limitation:

 

· the scope of our clinical trials, which is significantly influenced by the quality of clinical data achieved as trials are completed and the requirements established by regulatory authorities;
· the speed with which we complete our clinical trials, which depends on our ability to attract and enroll qualifying patients and the quality of the work performed by our clinical investigators and contract research organizations chosen to conduct the studies;
· the time required to prosecute, enforce and defend our intellectual property rights, which depends on evolving legal regimes and infringement claims that may arise between us and third parties;
· the ability to manufacture at scales sufficient to supply commercial quantities of any of our product candidates that receive regulatory approval, which may require levels of effort not currently anticipated; and
· the successful commercialization of our product candidates, which will depend on our ability to either create or partner with an effective commercialization organization and which could be delayed or prevented by the emergence of equal or more effective therapies.

 

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Emerging biotechnology companies like us may raise capital through corporate collaborations and by licensing intellectual property rights to other biotechnology or pharmaceutical enterprises. We intend to pursue this strategy, but there can be no assurance that we will be able to license our intellectual property or product development programs on commercially reasonable terms, if at all. There are substantial challenges and risks that will make it difficult to successfully implement any of these alternatives. If we are successful in raising additional capital through such a license or collaboration, we may have to give up valuable rights to our intellectual property. In addition, the business priorities of a strategic partner may change over time, which creates the possibility that the interests of the strategic partner in developing our technology may diminish and could have a potentially material negative impact on the value of our interest in the licensed intellectual property or product candidates.

 

Further, if we raise additional funds by selling shares of our common stock or securities convertible into our common stock the ownership interest of our existing stockholders may be significantly diluted. If additional funds are raised through the issuance of preferred stock or debt securities, these securities are likely to have rights, preferences and privileges senior to our common stock and may involve significant fees, interest expense, restrictive covenants or the granting of security interests in our assets.

 

Our failure to successfully address our long-term liquidity requirements would have a material negative impact on our business, including the possibility of surrendering our rights to some technologies or product opportunities, delaying our clinical trials or ceasing our operations.

 

We have incurred losses since inception and expect to incur significant losses in the foreseeable future and may never become profitable.

 

We have not commercialized any product candidates to date and incurred net operating losses every year since our inception in 1982. We believe these losses will continue for the foreseeable future, and may increase, as we pursue our product development efforts related to Tß4. As of March 31, 2014, our accumulated deficit totaled approximately $99 million.

 

As we expand our research and development efforts and seek to obtain regulatory approval of our product candidates to make them commercially viable, we anticipate substantial and increasing operating losses. Our ability to generate revenues and to become profitable will depend largely on our ability, alone or through the efforts of third-party licensees and collaborators, to efficiently and successfully complete the development of our product candidates, obtain necessary regulatory approvals for commercialization, scale-up commercial quantity manufacturing capabilities either internally or through third-party suppliers, and market our product candidates. There can be no assurance that we will achieve any of these objectives or that we will ever become profitable or be able to maintain profitability. Even if we do achieve profitability, we cannot predict the level of such profitability. If we sustain losses over an extended period of time and are not otherwise able to raise necessary funds to continue our development efforts and maintain our operations, we may be forced to cease operations.

 

Our common stock is quoted on the over-the-counter market, which subjects us to the SEC’s penny stock rules and decreases the liquidity of our common stock.

 

Our common stock is traded over-the-counter on the OTC Bulletin Board. Over-the-counter markets are generally considered to be less efficient than, and not as broad as, a stock exchange. There may be a limited market for our stock now that it is quoted on the OTC Bulletin Board, trading in our stock may become more difficult and our share price could decrease. Specifically, you may not be able to resell your shares of common stock at or above the price you paid for such shares or at all.

 

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In addition, our ability to raise additional capital may be impaired because of the less liquid nature of the over-the-counter markets. While we cannot guarantee that we would be able to complete an equity financing on acceptable terms, or at all, we believe that dilution from any equity financing while our shares are quoted on an over-the-counter market would likely be substantially greater than if we were to complete a financing while our common stock is traded on a national securities exchange. Further, we are unable to use short-form registration statements on Form S-3 for the registration of our securities, which could impair our ability to raise additional capital as needed.

 

Our common stock is also subject to penny stock rules, which impose additional sales practice requirements on broker-dealers who sell our common stock. The SEC generally defines “penny stock” as an equity security that has a market price of less than $5.00 per share, subject to certain exceptions. The ability of broker-dealers to sell our common stock and the ability of our stockholders to sell their shares in the secondary market will be limited and, as a result, the market liquidity for our common stock will likely be adversely affected. We cannot assure you that trading in our securities will not be subject to these or other regulations in the future.

 

The report of our independent registered public accounting firm contains explanatory language that substantial doubt exists about our ability to continue as a going concern.

 

The report of our independent registered public accounting firm on our financial statements for the year ended December 31, 2013 contains explanatory language that substantial doubt exists about our ability to continue as a going concern, without raising additional capital. As described in this report, we estimate that our existing capital resources, including the money received from G-treeBNT in March 2014 coupled with the contractual equity purchase on or before August 31, 2014 will be adequate to fund our operations for the next twelve months. This estimate will change and we will need additional capital in less than 12 months if we are able to accelerate or we need to undertake additional efforts to support our objectives.  Therefore, we continue to seek other sources of capital, but if we are unable to obtain sufficient financing to support and complete these activities, then we would, in all likelihood, experience severe liquidity problems and may have to curtail our operations. If we curtail our operations, we may be placed into bankruptcy or undergo liquidation, the result of which will adversely affect the value of our common shares.

 

Risks Related to Our Business and Operations

 

Our planned Phase 2 clinical trial of RGN-352 was placed on clinical hold by the FDA in March 2011 and we are unsure when, if ever, we will be able to resume this trial.

 

In the second half of 2010, we implemented the development plans for our phase 2 clinical trial to evaluate RGN-352 in patients who have suffered an acute myocardial infarction, or AMI. We had planned to begin enrolling patients near the end of the first quarter of 2011. However, in March 2011, we were notified by the FDA that the trial was placed on clinical hold as a result of our contract manufacturer’s alleged failure to comply with current Good Manufacturing Practice regulations. The FDA has prohibited us from using any of the active drug or placebo manufactured by this manufacturer in human trials, which will require us to identify a cGMP-compliant manufacturer and to have new material produced in the event that we seek to resume this trial. We have also learned that the contract manufacturer has closed its manufacturing facility and has filed for bankruptcy protection. Significant preparatory time and procedures will be required before any new suitable manufacturer would be able to manufacture RGN-352 for the AMI trial. Since we are unable to estimate the length of time that the trial will be on clinical hold, we have elected to cease activities on this trial until the FDA clinical hold is resolved and the requisite funding might be secured. Consequently, there can be no assurance that we will be able to timely initiate trial activities or complete this trial, if at all.

 

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All of our drug candidates are based on a single compound.

 

Our current primary business focus is the development of Tß4, and its analogues, derivatives and fragments, for the regeneration and accelerated repair of damaged tissue from non-healing dermal and corneal wounds, cardiac injury, central/peripheral nervous system diseases and other conditions, as well as an improvement in various functions, such as, but not limited to, cardiac and neurological. Unlike many pharmaceutical companies that have a number of unique chemical entities in development, we are dependent on a single molecule, formulated for different routes of administration and different clinical indications, for our potential commercial success. As a result, any common safety or efficacy concerns for Tß4-based products that cross formulations would have a much greater impact on our business prospects than if our product pipeline were more diversified.

 

We may never be able to commercialize our product candidates.

 

Although Tß4 has shown biological activity in in vitro studies and in vivo animal models and while we observed clinical activity and efficacious outcomes in our recent RGN-259 Phase 2a trial and earlier Phase 2 dermal trials, we cannot assure you that our product candidates will exhibit activity or importance in humans in large-scale trials. Our drug candidates are still in research and development, and we do not expect them to be commercially available for the foreseeable future, if at all. Only a small number of research and development programs ultimately result in commercially successful drugs. Potential products that appear to be promising at early stages of development may not reach the market for a number of reasons. These include the possibility that the potential products may:

 

· be found ineffective or cause harmful side effects during preclinical studies or clinical trials;
· fail to receive necessary regulatory approvals;
· be precluded from commercialization by proprietary rights of third parties;
· be difficult to manufacture on a large scale; or
· be uneconomical or otherwise fail to achieve market acceptance.

 

If any of these potential problems occurs, we may never successfully market Tß4-based products.

 

We are subject to intense government regulation, and we may not receive regulatory approvals for our drug candidates.

 

Our product candidates will require regulatory approvals prior to sale. In particular, therapeutic agents are subject to stringent approval processes, prior to commercial marketing, by the FDA and by comparable agencies in most foreign countries. The process of obtaining FDA and corresponding foreign approvals is costly and time-consuming, and we cannot assure you that such approvals will be granted. Also, the regulations we are subject to change frequently and such changes could cause delays in the development of our product candidates.

 

Three of our drug candidates are currently in the clinical development stage, and we cannot be certain that we or our collaborators will successfully complete the clinical trials necessary to receive regulatory product approvals. The regulatory approval process is lengthy, unpredictable and expensive. To obtain regulatory approvals in the United States, we or a collaborator must ultimately demonstrate to the satisfaction of the FDA that our product candidates are sufficiently safe and effective for their proposed administration to humans. Many factors, known and unknown, can adversely impact clinical trials and the ability to evaluate a product candidate’s safety and efficacy, including:

 

· the FDA or other health regulatory authorities, or institutional review boards, or IRBs, do not approve a clinical trial protocol or place a clinical trial on hold;
· suitable patients do not enroll in a clinical trial in sufficient numbers or at the expected rate, for reasons such as the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the perceptions of investigators and patients regarding safety, and the availability of other treatment options;

 

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· clinical trial data is adversely affected by trial conduct or patient withdrawal prior to completion of the trial;
· there may be competition with ongoing clinical trials and scheduling conflicts with participating clinicians;
· patients experience serious adverse events, including adverse side effects of our drug candidates, for a variety of reasons that may or may not be related to our product candidates, including the advanced stage of their disease and other medical problems;
· patients in the placebo or untreated control group exhibit greater than expected improvements or fewer than expected adverse events;
· third-party clinical investigators do not perform the clinical trials on the anticipated schedule or consistent with the clinical trial protocol and good clinical practices, or other third-party organizations do not perform data collection and analysis in a timely or accurate manner;
· service providers, collaborators or co-sponsors do not adequately perform their obligations in relation to the clinical trial or cause the trial to be delayed or terminated;
· we are unable to obtain a sufficient supply of manufactured clinical trial materials;
· regulatory inspections of manufacturing facilities, which may, among other things, require us or a co-sponsor to undertake corrective action or suspend the clinical trials, such as the clinical hold with respect to our Phase 2 clinical trial of RGN-352;
· the interim results of the clinical trial are inconclusive or negative;
· the clinical trial, although approved and completed, generates data that is not considered by the FDA or others to be clinically relevant or sufficient to demonstrate safety and efficacy; and
· changes in governmental regulations or administrative actions affect the conduct of the clinical trial or the interpretation of its results.

 

There can be no assurance that our clinical trials will in fact demonstrate, to the satisfaction of the FDA and others, that our product candidates are sufficiently safe or effective. The FDA or we may also restrict or suspend our clinical trials at any time if it is believed that subjects participating in the trials are being exposed to unacceptable health risks.

 

Clinical trials for product candidates such as ours are often conducted with patients who have more advanced forms of a particular condition or other unrelated conditions. For example, in clinical trials for our product candidate RGN-137, we have studied patients who are not only suffering from chronic epidermal wounds but who are also older and much more likely to have other serious adverse conditions. During the course of treatment with our product candidates, patients could die or suffer other adverse events for reasons that may or may not be related to the drug candidate being tested. Further, and as a consequence that all of our drug candidates are based on Tß4, crossover risk exists such that a patient in one trial may be adversely impacted by one drug candidate, and that adverse event may have implications for our other trials and other drug candidates. However, even if unrelated to our product candidates, such adverse events can nevertheless negatively impact our clinical trials, and our business prospects would suffer.

 

These factors, many of which may be outside of our control, may have a negative impact on our business by making it difficult to advance product candidates or by reducing or eliminating their potential or perceived value. As a consequence, we may need to perform more or larger clinical trials than planned. Further, if we are forced to contribute greater financial and clinical resources to a study, valuable resources will be diverted from other areas of our business. If we fail to complete or if we experience material delays in completing our clinical trials as currently planned, or we otherwise fail to commence or complete, or experience delays in, any of our other present or planned clinical trials, including as a result of the actions of third parties upon which we rely for these functions, our ability to conduct our business as currently planned could materially suffer.

 

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We may not successfully establish and maintain development and testing relationships with third-party service providers and collaborators, which could adversely affect our ability to develop our product candidates.

 

We have only limited resources, experience with and capacity to conduct requisite testing and clinical trials of our drug candidates. As a result, we rely and expect to continue to rely on third-party service providers and collaborators, including corporate partners, licensors and contract research organizations, or CROs, to perform a number of activities relating to the development of our drug candidates, including the design and conduct of clinical trials, and potentially the obtaining of regulatory approvals. For example, we currently rely on several third-party contractors to manufacture and formulate Tß4 into the product candidates used in our clinical trials, develop assays to assess Tß4’s effectiveness in complex biological systems, recruit clinical investigators and sites to participate in our trials, manage the clinical trial process and collect, evaluate and report clinical results.

 

We may not be able to maintain or expand our current arrangements with these third parties or maintain such relationships on favorable terms. Our agreements with these third parties may also contain provisions that restrict our ability to develop and test our product candidates or that give third parties rights to control aspects of our product development and clinical programs. In addition, conflicts may arise with our collaborators, such as conflicts concerning the interpretation of clinical data, the achievement of milestones, the interpretation of financial provisions or the ownership of intellectual property developed during the collaboration. If any conflicts arise with our existing or future collaborators, they may act in their self-interest, which may be adverse to our best interests. Any failure to maintain our collaborative agreements and any conflicts with our collaborators could delay or prevent us from developing our product candidates. We and our collaborators may fail to develop products covered by our present and future collaborations if, among other things:

 

· we do not achieve our objectives under our collaboration agreements;
· we or our collaborators are unable to obtain patent protection for the products or proprietary technologies we develop in our collaborations;
· we are unable to manage multiple simultaneous product development collaborations;
· our collaborators become competitors of ours or enter into agreements with our competitors;
· we or our collaborators encounter regulatory hurdles that prevent commercialization of our product candidates; or
· we develop products and processes or enter into additional collaborations that conflict with the business objectives of our other collaborators.

 

We also have less control over the timing and other aspects of our clinical trials than if we conducted the monitoring and supervision entirely on our own. Third parties may not perform their responsibilities for our clinical trials on our anticipated schedule or consistent with a clinical trial protocol or applicable regulations. We also rely on clinical research organizations to perform much of our data management and analysis. They may not provide these services as required or in a timely manner. If any of these parties do not meet deadlines or follow proper procedures, including procedures required by law, the preclinical studies and clinical trials may take longer than expected, may be delayed or may be terminated, which would have a materially negative impact on our product development efforts. If we were forced to find a replacement entity to perform any of our preclinical studies or clinical trials, we may not be able to find a suitable entity on favorable terms or at all. Even if we were able to find a replacement, resulting delays in the tests or trials may result in significant additional expenditures and delays in obtaining regulatory approval for drug candidates, which could have a material adverse impact on our results of operations and business prospects.

 

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G-treeBNT Co., Ltd. has limited drug development experience.

 

We recently completed two licensing agreements, for the development and commercialization of RGN-259 and RGN-137 in certain territories, with G-treeBNT Co., Ltd., headquartered outside of Seoul, Korea. G-treeBNT’s current business focus is the IT software industry in Korea with strong IP positions addressing specific software tools and apps such as optimized multimedia software for smart phones. G-treeBNT made a strategic decision last November to expand into the biopharmaceutical business through selected strategic alliances with biopharmaceutical companies in the US and EU. The collaboration with RegeneRx is the first strategic investment in this initiative. While G-treeBNT has recently hired executives and staff with significant pharmaceutical experience, the company has no internal drug development experience. As a result, G-treeBNT may face more and different challenges in the development of these product candidates than would more established pharmaceutical companies.

 

We are subject to intense competition from companies with greater resources and more mature products, which may result in our competitors developing or commercializing products before or more successfully than we do.

 

We are engaged in a business that is highly competitive. Research and development activities for the development of drugs to treat indications within our focus are being sponsored or conducted by private and public research institutions and by major pharmaceutical companies located in the United States and a number of foreign countries. Most of these companies and institutions have financial and human resources that are substantially greater than our own and they have extensive experience in conducting research and development activities and clinical trials and in obtaining the regulatory approvals necessary to market pharmaceutical products that we do not have. As a result, they may develop competing products more rapidly that are safer, more effective, or have fewer side effects, or are less expensive, or they may develop and commercialize products that render our product candidates non-competitive or obsolete.

 

With respect to our product candidate RGN-259, there are also numerous ophthalmic companies developing drugs for corneal wound healing and other outside-of-the-eye diseases and injuries. Amniotic membranes have been successfully used to treat corneal wounds in certain cases, as have topical steroids and antibacterial agents.

 

We have initially targeted our product candidate RGN-352 for cardiovascular indications. Most large pharmaceutical companies and many smaller biomedical companies are vigorously pursuing the development of therapeutics to treat patients after heart attacks and for other cardiovascular indications.

 

With respect to our product candidate RGN-137 for wound healing, Johnson & Johnson has previously marketed Regranex™ for this purpose in patients with diabetic foot ulcers. Other companies, such as Novartis, are developing and marketing artificial skins, which we believe could also compete with RGN-137. Moreover, wound healing is a large and highly fragmented marketplace attracting many companies, large and small, to develop products for treating acute and chronic wounds, including, for example, honey-based ointments, hyperbaric oxygen therapy, and low frequency cavitational ultrasound.

 

We are also developing potential cosmeceutical products, which are loosely defined as products that bridge the gap between cosmetics and pharmaceuticals, for example, by improving skin texture and reducing the appearance of aging. This industry is intensely competitive, with potential competitors ranging from large multinational companies to very small specialty companies. New cosmeceutical products often have a short product life and are frequently replaced with newer products developed to address the latest trends in appearance and fashion. We may not be able to adapt to changes in the industry as quickly as larger and more experienced cosmeceutical companies. Further, larger cosmetics companies have the financial and marketing resources to effectively compete with smaller companies like us in order to sell products aimed at larger markets.

 

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Even if approved for marketing, our technologies and product candidates are unproven and they may fail to gain market acceptance.

 

Our product candidates, all of which are based on the molecule Tß4, are new and unproven and there is no guarantee that health care providers or patients will be interested in our product candidates, even if they are approved for use. If any of our product candidates are approved by the FDA, our success will depend in part on our ability to demonstrate sufficient clinical benefits, reliability, safety, and cost effectiveness of our product candidates relative to other approaches, as well as on our ability to continue to develop our product candidates to respond to competitive and technological changes. If the market does not accept our product candidates, when and if we are able to commercialize them, then we may never become profitable. Factors that could delay, inhibit or prevent market acceptance of our product candidates may include:

 

· the timing and receipt of marketing approvals;
· the safety and efficacy of the products;
· the emergence of equivalent or superior products;
· the cost-effectiveness of the products; and
· ineffective marketing.

 

It is difficult to predict the future growth of our business, if any, and the size of the market for our product candidates because the markets are continually evolving. There can be no assurance that our product candidates will prove superior to products that may currently be available or may become available in the future or that our research and development activities will result in any commercially profitable products.

 

We have no marketing experience, sales force or distribution capabilities. If our product candidates are approved, and we are unable to recruit key personnel to perform these functions, we may not be able to commercialize them successfully.

 

Although we do not currently have any marketable products, our ability to produce revenues ultimately depends on our ability to sell our product candidates if and when they are approved by the FDA and other regulatory authorities. We currently have no experience in marketing or selling pharmaceutical products, and we do not have a marketing and sales staff or distribution capabilities. Developing a marketing and sales force is also time-consuming and could delay the launch of new products or expansion of existing product sales. In addition, we will compete with many companies that currently have extensive and well-funded marketing and sales operations. If we fail to establish successful marketing and sales capabilities or fail to enter into successful marketing arrangements with third parties, our ability to generate revenues will suffer.

 

If we enter markets outside the United States our business will be subject to political, economic, legal and social risks in those markets, which could adversely affect our business.

 

There are significant regulatory and legal barriers to entering markets outside the United States that we must overcome if we seek regulatory approval to market our product candidates in countries other than the United States. We would be subject to the burden of complying with a wide variety of national and local laws, including multiple and possibly overlapping and conflicting laws. We also may experience difficulties adapting to new cultures, business customs and legal systems. Any sales and operations outside the United States would be subject to political, economic and social uncertainties including, among others:

 

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· changes and limits in import and export controls;
· increases in custom duties and tariffs;
· changes in currency exchange rates;
· economic and political instability;
· changes in government regulations and laws;
· absence in some jurisdictions of effective laws to protect our intellectual property rights; and
· currency transfer and other restrictions and regulations that may limit our ability to sell certain product candidates or repatriate profits to the United States.

 

Any changes related to these and other factors could adversely affect our business if and to the extent we enter markets outside the United States. Additionally, we have entered into license agreements with Sigma-Tau Spa, Lee’s Pharmaceutical Limited and G-treeBNT Co, Ltd. for the development of certain of our product candidates in international markets. As a result, these development activities will be subject to compliance in all respects with local laws and regulations and may be subject to many of the risks described above.

 

Governmental and third-party payors may subject any product candidates we develop to sales and pharmaceutical pricing controls that could limit our product revenues and delay profitability.

 

The successful commercialization of our product candidates, if they are approved by the FDA, will likely depend on our ability to obtain reimbursement for the cost of the product and treatment. Government authorities, private health insurers and other organizations, such as health maintenance organizations, are increasingly seeking to lower the prices charged for medical products and services. Also, the trend toward managed health care in the United States, the growth of healthcare maintenance organizations, and recently enacted legislation reforming healthcare and proposals to reform government insurance programs could have a significant influence on the purchase of healthcare services and products, resulting in lower prices and reducing demand for our product candidates. The cost containment measures that healthcare providers are instituting and any healthcare reform could reduce our ability to sell our product candidates and may have a material adverse effect on our operations. We cannot assure you that reimbursement in the United States or foreign countries will be available for any of our product candidates, and that any reimbursement granted will be maintained, or that limits on reimbursement available from third-party payors will not reduce the demand for, or the price of, our product candidates. The lack or inadequacy of third-party reimbursements for our product candidates would decrease the potential profitability of our operations. We cannot forecast what additional legislation or regulation relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future, or what effect the legislation or regulation would have on our business.

 

We have no manufacturing or formulation capabilities and are dependent upon third-party suppliers to provide us with our product candidates. If these suppliers do not manufacture our product candidates in sufficient quantities, at acceptable quality levels and at acceptable cost, or if we are unable to identify suitable replacement suppliers if needed, our clinical development efforts could be delayed, prevented or impaired.

 

We do not own or operate manufacturing facilities and have little experience in manufacturing pharmaceutical products. We currently rely, and expect to continue to rely, primarily on peptide manufacturers to supply us with Tß4 for further formulation into our product candidates. We have historically engaged three separate smaller drug formulation contractors for the formulation of clinical grade product candidates, one for each of our three product candidates in clinical development, although, as described in this report, the contractor we engaged for RGN-352 has filed for bankruptcy and closed its manufacturing facility, and our clinical trial involving RGN-352 has been placed on clinical hold. We currently do not have an alternative source of supply for either Tß4 or the individual drug candidates. If these suppliers, together or individually, are not able to supply us with either Tß4 or individual product candidates on a timely basis, in sufficient quantities, at acceptable levels of quality and at a competitive price, or if we are unable to identify a replacement manufacturer to perform these functions on acceptable terms as needed, our development programs could be seriously jeopardized.

 

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The clinical hold on our RGN-352 trial will require us to have new material manufactured by a cGMP-compliant manufacturer in the event that we seek to resume this trial. Significant preparatory time and procedures will be required before any new manufacturer would be able to manufacture RGN-352 for the AMI trial, due to the time required for revalidation of processes and assays related to such production that were already in place with the original manufacturer. Since we are unable to estimate the length of time that the trial will be on clinical hold, we have elected to cease activities on this trial until the FDA clinical hold is resolved and the requisite funding might be secured.

 

Other risks of relying solely on single suppliers for each of our product candidates include:

 

· the possibility that our other manufacturers, and any new manufacturer that we may identify for RGN-352, may not be able to ensure quality and compliance with regulations relating to the manufacture of pharmaceuticals;
· their manufacturing capacity may not be sufficient or available to produce the required quantities of our product candidates based on our planned clinical development schedule, if at all;
· they may not have access to the capital necessary to expand their manufacturing facilities in response to our needs;
· commissioning replacement suppliers would be difficult and time-consuming;
· individual suppliers may have used substantial proprietary know-how relating to the manufacture of our product candidates and, in the event we must find a replacement or supplemental supplier, our ability to transfer this know-how to the new supplier could be an expensive and/or time-consuming process;
· an individual supplier may experience events, such as a fire or natural disaster, that force it to stop or curtail production for an extended period;
· an individual supplier could encounter significant increases in labor, capital or other costs that would make it difficult for them to produce our products cost-effectively; or
· an individual supplier may not be able to obtain the raw materials or validated drug containers in sufficient quantities, at acceptable costs or in sufficient time to complete the manufacture, formulation and delivery of our product candidates.

 

Our suppliers may use hazardous and biological materials in their businesses. Any claims relating to improper handling, storage or disposal of these materials could be time-consuming and costly to us, and we are not insured against such claims.

 

Our product candidates and processes involve the controlled storage, use and disposal by our suppliers of certain hazardous and biological materials and waste products. We and our suppliers and other collaborators are subject to federal, state and local regulations governing the use, manufacture, storage, handling and disposal of materials and waste products. Even if we and these suppliers and collaborators comply with the standards prescribed by law and regulation, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated. In the event of an accident, we could be held liable for any damages that result, and we do not carry insurance for this type of claim. We may also incur significant costs to comply with current or future environmental laws and regulations.

 

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We face the risk of product liability claims, which could adversely affect our business and financial condition.

 

We may be subject to product liability claims as a result of our testing, manufacturing, and marketing of drugs. In addition, the use of our product candidates, when and if developed and sold, will expose us to the risk of product liability claims. Product liability may result from harm to patients using our product candidates, such as a complication that was either not communicated as a potential side effect or was more extreme than anticipated. We require all patients enrolled in our clinical trials to sign consents, which explain various risks involved with participating in the trial. However, patient consents provide only a limited level of protection, and it may be alleged that the consent did not address or did not adequately address a risk that the patient suffered. Additionally, we will generally be required to indemnify our clinical product manufacturers, clinical trial centers, medical professionals and other parties conducting related activities in connection with losses they may incur through their involvement in the clinical trials.

 

Our ability to reduce our liability exposure for human clinical trials and commercial sales, if any, of Tß4 is dependent in part on our ability to obtain sufficient product liability insurance or to collaborate with third parties that have adequate insurance. Although we intend to obtain and maintain product liability insurance coverage if we gain approval to market any of our product candidates, we cannot guarantee that product liability insurance will continue to be available to us on acceptable terms, or at all, or that its coverage will be sufficient to cover all claims against us. A product liability claim, even one without merit or for which we have substantial coverage, could result in significant legal defense costs, thereby potentially exposing us to expenses significantly in excess of our revenues, as well as harm to our reputation and distraction of our management.

 

If any of our key employees discontinue their services with us, our efforts to develop our business may be delayed.

 

We are highly dependent on the principal members of our management team. The loss of our chairman and chief scientific advisor, Allan Goldstein, or chief executive officer, J.J. Finkelstein could prevent or significantly delay the achievement of our goals. In December 2011, we terminated our employment agreements with Dr. Goldstein and Mr. Finkelstein, who are currently engaged only as part-time employees. And substantially all of our employees are now working only part-time schedules. We cannot assure you that Dr. Goldstein or Mr. Finkelstein, or any other key employees, will not elect to terminate their employment. We do not currently have a full-time chief financial officer. In addition, we do not maintain a key man life insurance policy with respect to any of our management personnel. In the future, we anticipate that we will also need to add additional management and other personnel. Competition for qualified personnel in our industry is intense, and our success will depend in part on our ability to attract and retain highly skilled personnel. We cannot assure you that our efforts to attract or retain such personnel will be successful.

 

Mauro Bove, a member of our Board, is also a director and officer of entities affiliated with Sigma-Tau and a director of Lee’s Pharmaceuticals, relationships which could give rise to a conflict of interest involving Mr. Bove.

 

Mauro Bove, a member of our Board of Directors, and until March 31, 2014 was also a director and officer of entities affiliated with Sigma-Tau, which collectively make up our largest stockholder group. At this time Mr. Bove remains engaged with Sigma-Tau as a consultant. Sigma-Tau has provided us with significant funding, may continue doing so in the future, and is also our strategic partner in Europe with respect to the development of certain of our drug candidates. We have issued shares of common stock, convertible promissory notes and common stock warrants to Sigma-Tau and its affiliates in several private placement financing transactions, including as recently as September 2013. We have licensed certain rights to our product candidates generally for the treatment of dermal and internal wounds to Sigma-Tau. Under the license agreement, upon the completion of a Phase 2 clinical trial of either of these product candidates that yields positive results in terms of clinical efficacy and safety, Sigma-Tau is obligated to either make a $5 million milestone payment to us or to initiate and fund a pivotal Phase 3 clinical trial of the product candidate. In 2009, we completed two Phase 2 clinical trials of RGN-137, but these trials were not sufficient to trigger the milestone obligation. There can be no assurance that we will ever receive this payment or be able to initiate a pivotal Phase 3 clinical trial of RGN-137 that would be funded by Sigma-Tau. As a result of Mr. Bove’s relationship with Sigma-Tau, there could be a conflict of interest between Sigma-Tau and our other stockholders with respect to these and other agreements and circumstances that may require the exercise of the Board’s discretion with respect to Sigma-Tau. Any decision in the best interests of Sigma-Tau may not be in the best interest of our other stockholders.

 

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Additionally, Mr. Bove is a non-executive director of Lee’s Pharmaceuticals, in which affiliates of Sigma-Tau have a significant equity interest. In July 2012, we entered into a license agreement for TB4 in any pharmaceutical form, including our RGN-259, RGN-352 and RGN-137 product candidates for development in China, Hong Kong, Macau and Taiwan. There can be no assurance that we will ever receive any further payments from Lee’s under the agreement. As a result of Mr. Bove’s relationship with Lee’s and Sigma-Tau, Mr. Bove may be subject to a conflict of interest in fulfilling his duties to Lee’s, Sigma-Tau and us, in connection with these and other agreements and circumstances that may require the exercise of the Board’s discretion with respect to Lee’s. These conflicts could potentially result in decisions that may not be in the best interest of our other stockholders.

 

Risks Related To Our Intellectual Property

 

We are partially reliant on our license from the National Institutes of Health for the rights to Tß4, and any loss of these rights could adversely affect our business.

 

We have received an exclusive worldwide license to intellectual property discovered at the National Institutes of Health, or NIH, pertaining to the use of Tß4 in wound healing and tissue repair. The intellectual property rights from this license, along with independent patent applications we have filed, as well as patents and patent applications under licenses we acquired, form the basis for our current commercial development focus with Tß4. The NIH license terminates upon the last to expire of the patent applications that are filed, or any patents that may issue from such applications, in connection with the license. This license requires us to pay a minimum annual royalty to the NIH, regardless of the success of our product development efforts, plus certain other royalties upon the sale of products created by the intellectual property granted under the license. In 2013 we amended certain provisions of the exclusive license; we were permitted to credit amounts paid to prosecute or maintain the licensed patent rights during the 2013 calendar year against the 2013 minimum annual royalty of $25,000. Beginning in 2014 the minimum annual royalty is $2,000. While to date we believe that we have complied with all requirements to maintain the license, including the required payments for 2013 and the minimum annual royalty for 2014 , the loss of this license could have an adverse effect on our business and business prospects.

 

We may not be able to maintain broad patent protection for our product candidates, which could limit the commercial potential of our product candidates.

 

Our success will depend in part on our ability to obtain, defend and enforce patents, both in the United States and abroad. We have attempted to create a substantial intellectual property portfolio, submitting patent applications for various compositions of matter, methods of use and fragments and derivatives of Tß4. As described elsewhere in this report, we currently do not have adequate financial resources to fund our ongoing business activities substantially beyond 12 months without additional funding. As a result of our current financial condition, we continuously evaluate our issued patents and patent applications and may decide to limit their therapeutic and/or geographic coverage in an effort to enhance our ability to focus on certain medical conditions and countries within our financial constraints. As a result, we may not be able to protect our intellectual property rights in indications and/or territories that we otherwise would, and, therefore, our ability to commercialize Tß4, if at all, could be substantially limited, which could have a material adverse impact on our future results of operations.

 

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If we are not able to maintain adequate patent protection for our product candidates, we may be unable to prevent our competitors from using our technology or technology that we license.

 

Our success will depend in substantial part on our ability to obtain, defend and enforce patents, maintain trade secrets and operate without infringing upon the proprietary rights of others, both in the United States and abroad. Pursuant to an exclusive worldwide license from the NIH, we have exclusive rights to use Tß4 in the treatment of non-healing wounds. While patents covering our use of Tß4 have issued in some countries, we cannot guarantee whether or when corresponding patents will be issued, or the scope of any patents that may be issued, in other countries. We have attempted to create a substantial intellectual property portfolio, submitting patent applications for various compositions of matter, methods of use and fragments and derivatives of Tß4. We have also in-licensed other intellectual property rights from third parties that could be subject to the same risks as our own patents. If any of these patent applications do not issue, or do not issue in certain countries, or are not enforceable, the ability to commercialize Tß4 in various medical indications could be substantially limited or eliminated.

 

In addition, the patent positions of the products being developed by us and our collaborators involve complex legal and factual uncertainties. As a result, we cannot assure you that any patent applications filed by us, or by others under which we have rights, will result in patents being issued in the United States or foreign countries. In addition, there can be no assurance that any patents will be issued from any pending or future patent applications of ours or our collaborators, that the scope of any patent protection will be sufficient to provide us with competitive advantages, that any patents obtained by us or our collaborators will be held valid if subsequently challenged or that others will not claim rights in or ownership of the patents and other proprietary rights we or our collaborators may hold. Unauthorized parties may try to copy aspects of our product candidates and technologies or obtain and use information we consider proprietary. Policing the unauthorized use of our proprietary rights is difficult. We cannot guarantee that no harm or threat will be made to our or our collaborators’ intellectual property. In addition, changes in, or different interpretations of, patent laws in the United States and other countries may also adversely affect the scope of our patent protection and our competitive situation.

 

Due to the significant time lag between the filing of patent applications and the publication of such patents, we cannot be certain that our licensors were the first to file the patent applications we license or, even if they were the first to file, also were the first to invent, particularly with regards to patent rights in the United States. In addition, a number of pharmaceutical and biotechnology companies and research and academic institutions have developed technologies, filed patent applications or received patents on various technologies that may be related to our product candidates. Some of these technologies, applications or patents may conflict with our or our licensors’ technologies or patent applications. A conflict could limit the scope of the patents, if any, that we or our licensors may be able to obtain or result in denial of our or our licensors’ patent applications. If patents that cover our activities are issued to other companies, we may not be able to develop or obtain alternative technology.

 

Additionally, there is certain subject matter that is patentable in the United States but not generally patentable outside of the United States. Differences in what constitutes patentable subject matter in various countries may limit the protection we can obtain outside of the United States. For example, methods of treating humans are not patentable in many countries outside of the United States. These and other issues may prevent us from obtaining patent protection outside of the United States, which would have a material adverse effect on our business, financial condition and results of operations.

 

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Changes to U.S. patent laws could materially reduce any value our patent portfolio may have.

 

The value of our patents depends in part on their duration. A shorter period of patent protection could lessen the value of our rights under any patents that may be obtained and may decrease revenues derived from its patents. For example, the U.S. patent laws were previously amended to change the term of patent protection from 17 years following patent issuance to 20 years from the earliest effective filing date of the application. Because the time from filing to issuance of biotechnology applications may be more than three years depending on the subject matter, a 20-year patent term from the filing date may result in substantially shorter patent protection. Future changes to patent laws could shorten our period of patent exclusivity and may decrease the revenues that we might derive from the patents and the value of our patent portfolio.

 

We may not have adequate protection for our unpatented proprietary information, which could adversely affect our competitive position.

 

In addition to our patents, we also rely on trade secrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain our competitive position. However, others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. To protect our trade secrets, we may enter into confidentiality agreements with employees, consultants and potential collaborators. However, we may not have such agreements in place with all such parties and, where we do, these agreements may not provide meaningful protection of our trade secrets or adequate remedies in the event of unauthorized use or disclosure of such information. Also, our trade secrets or know-how may become known through other means or be independently discovered by our competitors. Any of these events could prevent us from developing or commercializing our product candidates.

 

We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of former employers.

 

As is commonplace in the biotechnology industry, we employ now, and may hire in the future, individuals who were previously employed at other biotechnology or pharmaceutical companies, including competitors or potential competitors. Although there are no claims currently pending against us, we may be subject to claims that we or certain employees have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and would be a significant distraction to management.

 

Risks Related To Our Securities

 

Our common stock price is volatile, our stock is highly illiquid, and any investment in our securities could decline substantially in value.

 

For the period from January 1, 2013 through May 12, 2014 the closing price of our common stock has ranged from $0.05 to $0.28, with an average daily trading volume of approximately 75,000 shares. In light of our small size and limited resources, as well as the uncertainties and risks that can affect our business and industry, our stock price is expected to continue to be highly volatile and can be subject to substantial drops, with or even in the absence of news affecting our business. The following factors, in addition to the other risk factors described in this report, and the potentially low volume of trades in our common stock since it is not listed on a national securities exchange, may have a significant impact on the market price of our common stock, some of which are beyond our control:

 

· results of pre-clinical studies and clinical trials;
· commercial success of approved products;
· corporate partnerships;
· technological innovations by us or competitors;

 

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· changes in laws and government regulations both in the U.S. and overseas;
· changes in key personnel at our company;
· developments concerning proprietary rights, including patents and litigation matters;
· public perception relating to the commercial value or safety of any of our product candidates;
· other issuances of our common stock, or securities convertible into or exercisable for our common stock, causing dilution;
· anticipated or unanticipated changes in our financial performance;
· general trends related to the biopharmaceutical and biotechnological industries; and
· general conditions in the stock market.

 

The stock market in general has recently experienced relatively large price and volume fluctuations. In particular, the market prices of securities of smaller biotechnology companies have experienced dramatic fluctuations that often have been unrelated or disproportionate to the operating results of these companies. Continued market fluctuations could result in extreme volatility in the price of our common stock, which could cause a decline in its value. You should also be aware that price volatility may be worse if the trading volume of the common stock remains limited or declines.

 

Our principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders.

 

Our officers, directors and principal stockholders together control approximately 49% of our outstanding common stock. Included in this group is Sigma-Tau and its affiliates, which together hold outstanding shares representing approximately 32% of our outstanding common stock and G-treeBNT which owns approximately 12% of our outstanding common stock. These stockholders also hold options, warrants, convertible promissory notes and stock purchase rights that provide them with the right to acquire significantly more shares of common stock. Accordingly, if these stockholders acted together they could control the outcome of all stockholder votes. This concentration of ownership may have the effect of delaying or preventing a change in control and might adversely affect the market price of our common stock, and therefore may not be in the best interest of our other stockholders.

 

If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, the price of our common stock and other securities and their trading volume could decline.

 

The trading market for our common stock and other securities will depend in part on the research and reports that securities or industry analysts publish about us or our business. We do not currently have and may never obtain research coverage by securities and industry analysts. If securities or industry analysts do not commence or maintain coverage of us, the trading price for our common stock and other securities would be negatively affected. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who covers us downgrades our securities, the price of our securities would likely decline. If one or more of these analysts ceases to cover us or fails to publish regular reports on us, interest in the purchase of our securities could decrease, which could cause the price of our common stock and other securities and their trading volume to decline.

 

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The exercise of options and warrants, conversion of convertible promissory notes, and other issuances of shares of common stock or securities convertible into common stock will dilute your interest.

 

As of March 31, 2014, there were outstanding options to purchase an aggregate of 6,655,608 shares of our common stock under our 2000 and 2010 incentive equity plans at exercise prices ranging from $0.14 per share to $3.82 per share and outstanding warrants to purchase 11,468,901 shares of our common stock at a weighted average exercise price of $0.64 per share. In addition to the outstanding options and warrants we have also issued five series of convertible promissory notes, including one in January 2014, which are presently convertible into an aggregate of 13,683,334 shares of our common stock. In October 2012, we sold convertible promissory notes totaling $300,000 that are convertible into 2,000,000 shares of common stock at a conversion price of $0.15 per share. In 2013, we sold a three additional series of convertible promissory notes, which notes totaled $646,000 and are initially convertible into 10,766,667 shares of common stock at a conversion price of $0.06 per share. In January 2014, we sold a fifth series of convertible promissory notes, which notes totaled $55,000 and are initially convertible into 916,667 shares of common stock at a conversion price of $0.06 per share. The notes issued in 2013 and January 2014 contain down round provisions under which the conversion prices of these notes could be decreased as a result of future equity offerings below the conversion price of the notes. We are also committed to issue 8,333,333 shares of common stock to G-treeBNT at a purchase price of $0.12 per share on or before August 31, 2014 and G-treeBNT has an option to purchase an additional 5.5 million shares of common stock at $0.15 per share on or before January 31, 2015. The exercise of options and warrants or note conversions at prices below the market price of our common stock could adversely affect the price of shares of our common stock. Additional dilution may result from the issuance of shares of our capital stock in connection with collaborations or manufacturing arrangements or in connection with other financing efforts.

 

Any issuance of our common stock that is not made solely to then-existing stockholders proportionate to their interests, such as in the case of a stock dividend or stock split, will result in dilution to each stockholder by reducing his, her or its percentage ownership of the total outstanding shares. Moreover, if we issue options or warrants to purchase our common stock in the future and those options or warrants are exercised or we issue restricted stock, stockholders may experience further dilution. Holders of shares of our common stock have no preemptive rights that entitle them to purchase their pro rata share of any offering of shares of any class or series.

 

In addition, most of the outstanding warrants to purchase shares of our common stock have an exercise price above the current market price for our common stock. As a result, these warrants may not be exercised prior to their expiration, in which case we would not realize any proceeds from their exercise.

 

Our certificate of incorporation and Delaware law contain provisions that could discourage or prevent a takeover or other change in control, even if such a transaction would be beneficial to our stockholders, which could affect our stock price adversely and prevent attempts by our stockholders to replace or remove our current management.

 

Our certificate of incorporation provides our Board with the power to issue shares of preferred stock without stockholder approval. In addition, we are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law. Subject to specified exceptions, this section provides that a corporation may not engage in any business combination with any interested stockholder, as defined in that statute, during the three-year period following the time that such stockholder becomes an interested stockholder. This provision could also have the effect of delaying or preventing a change of control of our company. The foregoing factors could reduce the price that investors or an acquirer might be willing to pay in the future for shares of our common stock.

 

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We may become involved in securities class action litigation that could divert management’s attention and harm our business and our insurance coverage may not be sufficient to cover all costs and damages.

 

The stock market has from time to time experienced significant price and volume fluctuations that have affected the market prices for the common stock of pharmaceutical and biotechnology companies. These broad market fluctuations may cause the market price of our common stock to decline. In the past, following periods of volatility in the market price of a particular company’s securities, securities class action litigation has often been brought against that company. We may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which could hurt our business, operating results and financial condition.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

During the three months ended March 31, 2014, the Company issued 11,250,000 shares of common stock to G-treeBNT, Co. Ltd. for aggregate cash proceeds of $1,350,000. The offer, sale, and issuance of the shares to G-treeBNT were exempt from registration under the Securities Act under Section 4(2) of the Securities Act and Regulation D promulgated thereunder as transactions by an issuer not involving a public offering. G-treeBNT represented to the Company that it is an accredited investor as defined in Rule 501 promulgated under the Securities Act.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 

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Item 6. Exhibits

 

Exhibit No.   Description of Exhibit   Reference*
         
3.1   Restated Certificate of Incorporation   Exhibit 3.1 to Registration Statement on Form S-1 (File No. 333-166146) (filed April 16, 2010)
         
3.2   Certificate of Amendment to Restated Certificate of Incorporation   Exhibit 3.2 to Registration Statement on Form S-1 (File No. 333-166146) (filed April 16, 2010)
         
3.3   Certificate of Amendment to Restated Certificate of Incorporation   Exhibit 3.3 to Registration Statement on Form S-1 (File No. 333-166146) (filed April 16, 2010)
         
3.4   Certificate of Amendment to Restated Certificate of Incorporation   Exhibit 3.4 to Registration Statement on Form S-8 (File No. 333-168252) (filed July 21, 2010)
         
3.5   Certificate of Designation of Series A Participating Cumulative Preferred Stock   Exhibit 3.4 to Registration Statement on Form S-1 (File No. 333-166146) (filed April 16, 2010)
         
3.6   Amended and Restated Bylaws   Exhibit 3.4 to the Company’s Quarterly Report on Form 10-Q (filed August 14, 2006)
         
3.7   Amendment to Amended and Restated Bylaws   Exhibit 3.6 to the Company’s Registration Statement on Form S-8 (File No. 333-152250) (filed July 10, 2008)
         
4.1   Specimen Common Stock Certificate   Exhibit 4.1 to Registration Statement on Form S-1 (File No. 333-166146) (filed April 16, 2010)
         
4.2   Specimen Rights Certificate   Exhibit 4.2 to Registration Statement on Form S-1 (File No. 333-166146) (filed April 16, 2010)

 

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4.3   Rights Agreement, dated April 29, 1994, between the Company and American Stock Transfer & Trust Company, as Rights Agent   Exhibit 4.3 to Registration Statement on Form S-1 (File No. 333-166146) (filed April 16, 2010)
         
4.4   Amendment No. 1 to Rights Agreement, dated March 4, 2004, between the Company and American Stock Transfer & Trust Company, as Rights Agent   Exhibit 4.4 to Registration Statement on Form S-1 (File No. 333-166146) (filed April 16, 2010)
         
4.5   Warrant Agreement, dated May 21, 2010, between the Company and American Stock Transfer & Trust Company, as Warrant Agent   Exhibit 4.6 to Current Report on Form 8-K (File No. 001-15070) (filed May 21, 2010)
         
4.6   Form of Warrant Certificate   Exhibit 4.6 to Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-166146) (filed May 17, 2010)

 

10.1   Form of Convertible Promissory Note   Exhibit 4.1 to Current Report on Form 8-K (File No. 001-15070) (filed January 9, 2014)
         
10.2   Convertible Note Purchase Agreement   Exhibit 10.1 to Current Report on Form 8-K (File No. 001-15070) (filed January 9, 2014)
         
10.3   Letter Agreement between the Company and J.J. Finkelstein, dated January 7, 2014   Exhibit 10.2 to Current Report on Form 8-K (File No. 001-15070) (filed January 9, 2014)
         
10.4   Letter Agreement between the Company and Allan L. Goldstein, dated January 7, 2014   Exhibit 10.3 to Current Report on Form 8-K (File No. 001-15070) (filed January 9, 2014)
         
10.5   Securities Purchase Agreement   Filed herewith
         
10.6+   License Agreement RGN-259 dated March 7, 2014 with G-treeBNT (formerly Digital Aria)   Filed herewith

 

 

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10.7+   License Agreement RGN-137 dated March 7, 2014 with G-treeBNT (formerly Digital Aria)   Filed herewith
         

31.1   Certification of Principal Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934   Filed herewith
         
31.2   Certification of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934   Filed herewith
         
32.1   Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002   Filed herewith**
         
32.2   Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002   Filed herewith**
         
101   The following materials from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) Balance Sheets at March 31, 2013 and December 31, 2012; (ii) Statements of Operations for the three months ended March 31, 2013 and 2012; (iii) Statements of Cash Flows for the three months ended March 31, 2013 and 2012; and (iv) Notes to Financial Statements.   Filed herewith***

 

 

 

* Except where noted, the exhibits referred to in this column have heretofore been filed with the Securities and Exchange Commission as exhibits to the documents indicated and are hereby incorporated by reference thereto. The Registration Statements referred to are Registration Statements of the Company.

 

** This certification is being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

*** Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files included in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those Sections.
   
+ Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Exchange Act. The entire exhibit has been separately filed with the Securities and Exchange Commission.

 

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Signatures

 

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

 

  RegeneRx Biopharmaceuticals, Inc.
  (Registrant)
   
Date:     May 15, 2014 /s/J.J. Finkelstein
  J.J. Finkelstein
  President and Chief Executive Officer
  (On Behalf of the Registrant)
   
   
Date:      May 15, 2014 /s/Dane Sagio
  Dane Saglio
  Chief Financial Officer
  (Principal Financial Officer and Principal Accounting Officer)

 

47

 

Exhibit 10.5

 

SECURITIES PURCHASE AGREEMENT

 

Dated as of March 7, 2014

 

Between

 

REGENERX BIOPHARMACEUTICALS, INC.

 

and

 

DIGITAL ARIA CO., LTD.

 

 
 

 

Table of Contents

 

    Page
     
SECTION 1. DEFINITIONS 1
SECTION 2. ISSUANCE AND SALE OF THE SHARES 3
SECTION 3. THE CLOSING 3
3.1 Closing 3
3.2 Deliveries by the Company 4
3.3 Deliveries by the Investor 5
SECTION 4. REPRESENTATIONS, WARRANTIES AND COVENANTS 5
4.1 Representations and Warranties of the Company 5
4.2 Representations and Warranties of the Investor 7
SECTION 5. CONDITIONS TO CLOSING 9
5.1 Conditions to Closing by the Investor 9
5.2 Conditions to Closing by the Company 9
SECTION 6. Termination 10
SECTION 7. MISCELLANEOUS 10
7.1 Waivers and Amendments 10
7.2 Costs and Expenses 10
7.3 Remedies Cumulative 10
7.4 Remedies Not Waived 10
7.5 Entire Agreement 11
7.6 Specific Performance 11
7.7 Governing Law 11
7.8 Notices 11
7.9 Counterparts 12
7.10 Successors and Assigns 12
7.11 Third Parties 12
7.12 Schedules and Exhibits 12
7.13 Headings 12

 

- i -
 

 

SECURITIES PURCHASE AGREEMENT

 

THIS SECURITIES PURCHASE AGREEMENT (this “ Agreement ”), dated as of March 7 , 2014, is entered into by and between RegeneRx Biopharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and Digital Aria Co., Ltd. with offices at 22 nd FL, Parkview Tower, 248 Jungjail-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-863, Republic of Korea ( the “ Investor ”). (The Company and the Investor, individually, a “ Party ”, collectively, the “ Parties ”)

 

RECITALS

 

Whereas , the Company and Investor have entered into a strategic relationship including the licensing of developmental and commercialization rights to certain of the Company’s clinical development product candidates in certain territories pursuant to that certain RGN-137 License Agreement and that certain RGN-259 License Agreement (collectively, the “ Licensing Agreement ”) entered into by and between the Company and the Investor as of even date herewith, which agreement contemplates the common stock purchases, including the optional common stock purchase, pursuant to the terms of this Agreement;

 

Whereas , the Company has authorized the sale and issuance of an aggregate of 25,083,333 shares of its Common Stock (the “ Shares ”) for an aggregate purchase amount of no less than $3,175,000, pursuant to the terms of this Agreement;

 

Whereas , the Investor desires to purchase the Shares in the amounts and over the timeframes designated in Section 2 hereof on the terms and conditions set forth herein; and

 

Whereas , the Company desires to issue and sell the Shares to the Investor on the terms and conditions set forth herein.

 

Agreement

 

Now, Therefore , in consideration of the foregoing recitals and the mutual promises, representations, warranties, and covenants hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

SECTION 1. DEFINITIONS

 

The following terms when used in this Agreement shall have the following respective meanings:

 

Affiliate ” has the meaning set forth in Rule 501(b) of Regulation D.

 

Applicable Laws ” has the meaning set forth in Section 4.1(f) hereof.

 

Board of Directors ” means the Board of Directors of the Company.

 

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Capital Stock ” means (i) with respect to any Person that is a corporation, any and all shares, interests or equivalents in capital stock (whether voting or nonvoting and whether common or preferred) of such corporation and (ii) with respect to any Person that is not a corporation, any and all partnership, membership, limited liability company or other equity interests of such Person; and in each case, any and all warrants, rights or options to purchase any of the foregoing.

 

Certificate of Incorporation ” means the Certificate of Incorporation of the Company, as in effect and on file with the Secretary of State of the State of Delaware on the date of this Agreement.

 

Closing ” has the meaning set forth in Section 3.1 hereof.

 

Closing Date ” has the meaning set forth in Section 3.1 hereof.

 

Common Stock ” means the Common Stock of the Company, par value $0.001 per share.

 

Exchange Act ” means the Securities Exchange Act of 1934, as amended.

 

Governmental Authority ” means the United States, any state, county or municipality, the government of any foreign country, any subdivision of any of the foregoing or any authority, department, commission, board, bureau, agency, court or instrumentality of any of the foregoing.

 

Knowledge of the Company ,” including the terms “ Know ,” “ Known ” and other derivatives thereof, means, with respect to the Company, the actual knowledge, after reasonable investigation, of any Responsible Officer.

 

Lien ” means any mortgage, lien, pledge, security interest, easement, conditional sale or other title retention agreement or other encumbrance of any kind except for liens relating to taxes that have accrued but are not yet payable which do not have a Material Adverse Effect.

 

Material Adverse Effect ” means a material adverse effect upon (i) the condition (financial or otherwise), operations, business, properties or assets of the Company, (ii) the ability of the Company to perform its obligations under this Agreement or any of the other agreements or documents contemplated hereby to which it is a party or (iii) the legality, validity or enforceability of this Agreement or any of the other agreements or documents contemplated hereby or the rights and remedies of the Investor and the other parties hereunder and thereunder.

 

Material Agreements ” has the meaning set forth in Section 4.1(e) hereof.

 

Party ” and “ Parties ” have the meanings set forth in the first paragraph hereof.

 

Person ” means an individual, corporation, partnership, joint venture, trust, unincorporated organization, or Governmental Authority.

 

Purchase Price ” has the meaning set forth in Section 2 hereof.

 

Regulation D ” has the meaning set forth in Section 4.2(c) hereof.

 

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Responsible Officer ” means, with respect to the Company, the President and Chief Executive Officer, the Chief Financial Officer or the Chairman of the Board of Directors.

 

Returns ” has the meaning set forth in Section 4.1(i) hereof.

 

SEC ” means the U.S. Securities and Exchange Commission.

 

SEC Reports ” has the meaning set forth in Section 4.1(h)(i) hereof.

 

Securities Act ” means the Securities Act of 1933, as amended.

 

Shares ” has the meaning set forth in the Preamble.

 

Stockholders ” has the meaning set forth in Section 4.1(b) hereof.

 

Tax ” or “ Taxes ” refers to any and all federal, state, national, local, foreign and other taxes, assessments and other governmental charges, duties, levies, impositions and liabilities relating to taxes, including taxes based upon or measured by gross receipts, income, profits, sales, use and occupation, and value added, ad valorem, transfer, franchise, withholding, payroll, recapture, employment, excise and property taxes, together with all interest, penalties and additions imposed with respect to such amounts and any obligations under any agreements or arrangements with any other person with respect to such amounts and including any liability for taxes of a predecessor entity.

 

SECTION 2. ISSUANCE AND SALE OF THE SHARES

 

At the respective Closings, the Company shall issue and sell to the Investor and the Investor shall purchase from the Company the number of Shares set forth in the table below (provided, however, that in the case of the Optional Closing, the Investor shall not be obligated to purchase such Shares);

 

Description     Timeframe     # Shares     Share Price     Purchase Price  
Initial Closing     On or before March 28, 2014       11,250,000     $ 0.12     $ 1,350,000  
2 nd Closing     On or before August 31, 2014       8,333,333     $ 0.12     $ 1,000,000  
Optional Closing     On or before January 31, 2015       5,500,000     $ 0.15     $ 825,000  

 

SECTION 3. THE CLOSING

 

3.1 Closing

 

The closing of each issuance and sale of the Shares pursuant to Section 2 hereof and certain of the other transactions contemplated hereby (the “ Closing ”) shall take place at the offices of Cooley LLP, One Freedom Square, Reston Town Center, 11951 Freedom Drive, Reston, Virginia 20190, with the Initial Closing to occur March 28, 2014 and the subsequent Closings within two business days following the receipt of notice by the Company of Investor’s request to complete the Second Closing and, if applicable, the Optional Closing, or at such other time or place as the Parties shall mutually agree (each of such actual date(s) being referred to herein as a “ Closing Date ”). The Parties agree that each Closing may occur by facsimile signature and delivery and that the Parties need not appear in person at any Closing.

 

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3.2 Deliveries by the Company

 

At or prior to each Closing, the Company shall deliver or cause to be delivered to the Investor the following items:

 

(a)          One or more stock certificates evidencing a number of Shares purchased by the Investor in such Closing, registered in the name of such Investor and subject to the legends and other restrictions set forth herein (which may be delivered by pdf at closing with physical delivery of the original certificates as promptly as practicable); provided that, upon written request of the Investor to the Company (which request shall be made no later than three business days prior to the Closing Date), the Company shall deliver such stock certificate(s) to a designated securities account of the Investor established in the U.S. within two business days following the Closing Date; notwithstanding anything in this Section 3.2(a), if the parties mutually agree to book entry settlement, the Company may, instead of delivering physical stock certificates evidencing the Shares, deliver the Shares via book entry on the records of the Company’s transfer agent;

 

(b)          a certificate of the Secretary of State of the State of Delaware as to the good standing of the Company dated within thirty days prior to such Closing Date; and

 

(c)          a certificate of the Secretary or Assistant Secretary of the Company, in form and substance satisfactory to counsel for the Investor, certifying that attached thereto are true and correct copies of resolutions duly and validly adopted by the Board of Directors authorizing the allotment and issuance of the relevant Shares to the Investor

 

As promptly as practicable following such Closing, the Company will deliver to the Purchaser the updated register of shareholders of the Company reflecting the purchase of the relevant Shares.

 

At or prior to the Initial Closing, the Company shall deliver or cause to be delivered to the Investor the following items:

(d)          a copy of the Certificate of Incorporation certified by the Secretary of State of the State of Delaware as of a date within thirty days prior to the Initial Closing Date;

 

(e)          a certificate of the Secretary or Assistant Secretary of the Company, in form and substance satisfactory to counsel for the Investor, certifying that attached thereto are true and correct copies of (i) the bylaws of the Company, and (ii) resolutions duly and validly adopted by the Board of Directors authorizing the allotment and issuance of the relevant Shares to the Investor, execution and delivery of this Agreement and the consummation of the transactions contemplated hereby; and

 

4
 

 

(f)          a counterpart of this Agreement duly executed by the Company. 

 

In addition to the above deliveries, the Company shall take all steps and actions as the Investor may reasonably request or as may otherwise be necessary to effectuate the sale and purchase of the Shares as contemplated herein.

 

3.3 Deliveries by the Investor

 

At or prior to each Closing, the Investor shall deliver or cause to be delivered to the Company the following items:

 

(a)          payment of the Purchase Price in immediately available funds by wire transfer to an account designated in writing by the Company prior to the Closing Date.

 

SECTION 4. REPRESENTATIONS, WARRANTIES AND COVENANTS

 

4.1 Representations and Warranties of the Company

 

In order to induce the Investor to purchase the Shares it is purchasing hereunder, the Company represents and warrants to the Investor as of the date hereof that:

 

(a)           Organization and Standing . The Company is duly incorporated and validly existing under the laws of the State of Delaware and has all requisite corporate power and authority to own or lease its properties and assets and to conduct its business as it is presently being conducted.

 

(b)           Capitalization . Immediately subsequent to the consummation of the transactions contemplated by this Agreement, (i) the authorized Capital Stock, (ii) the number of issued and outstanding shares of Capital Stock, and (iii) the number of issued shares of Capital Stock held as treasury shares of the Company shall be as set forth on Schedule 4.1(b) hereto. The outstanding shares of Capital Stock are all duly and validly authorized and issued, fully paid and nonassessable, and based in part on the representations of the stockholders of the Company (the “ Stockholders ”) made in connection with the issuance thereof, were issued in compliance with all applicable federal and state securities laws. Except as set forth in Schedule 4.1(b) and except for this Agreement, there are no agreements, arrangements, options, warrants, calls, rights (including preemptive rights) or commitments of any character relating to the issuance, sale, purchase or redemption of any shares of Capital Stock of the Company.

 

5
 

 

(c)           Capacity of the Company; Consents; Execution of Agreements . The Company has all requisite power, authority and capacity to enter into this Agreement and to perform the transactions and obligations to be performed by it hereunder. The execution and delivery of this Agreement and any agreements contemplated hereby by the Company, and the performance by the Company of the transactions and obligations contemplated hereby and thereby, including, without limitation, the issuance and delivery of the Shares to the Investor, has been duly authorized by all requisite action of the Company and Stockholders. This Agreement has been duly executed and delivered by a duly authorized officer of the Company and constitutes a valid and legally binding agreement of the Company, enforceable in accordance with its respective terms, except as enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws of the United States (both state and federal), affecting the enforcement of creditors’ rights or remedies in general and general equity principles.

 

(d)           Reservation of Common Stock . The Shares to be issued and purchased hereunder, when issued by the Company to the Investor and paid for by the Investor pursuant to the terms of this Agreement, will (i) be duly authorized, validly issued, fully paid and nonassessable, (ii) based on the Investor’s representations in Section 4.2, have been issued in compliance with all applicable United States federal and state securities laws and (iii) be free and clear of all Liens. The Company has available sufficient shares of Common Stock for issuance pursuant to the terms of this Agreement.

 

(e)           Conflicts; Defaults . The execution and delivery of this Agreement by the Company and the performance by the Company of the transactions and obligations contemplated hereby to be performed by it will not (i) materially violate, conflict with, or constitute a default under any of the terms or provisions of, the Certificate of Incorporation, the bylaws, or any provisions of, or result in the acceleration of any obligation under, any material contract, note, debt instrument, security agreement, or other instrument to which the Company is a party or by which the Company, or any of their assets is bound (collectively, the “ Material Agreements ”); (ii) result in the creation or imposition of any Liens or claims upon the Company’s assets or upon the Company’s Common Stock; (iii) assuming the accuracy of the Investor’s representations in Section 4.2, constitute a material violation of any law, statute, judgment, decree, order, rule, or regulation of a Governmental Authority applicable to the Company; or (iv) constitute an event which, after notice or lapse of time or both, would result in any of the foregoing. The Company is not presently in violation of its Certificate of Incorporation or bylaws.

 

(f)           Compliance with Laws . The Company is not in violation of, nor do any of its respective operations violate in any respect, any statute, law, or regulation of any Governmental Authority applicable to the Company (“ Applicable Laws ”), which violation would have a Material Adverse Effect.

 

(g)           Litigation . As of the date hereof: (i) the Company is not subject to any order of, or written agreement or memorandum of understanding with, any Governmental Authority which would have a Material Adverse Effect; (ii) there are no material actions, suits, claims, investigations, or proceedings pending at law or in equity or before or by any Governmental Authority, or, to the Knowledge of the Company, threatened, against the Company or any of its assets or properties or the transactions contemplated by this Agreement, and to the Knowledge of the Company, there exist no facts or circumstances which reasonably could be anticipated to result in any such action, suit, claim, investigation, or proceeding; and (iii) no Person has asserted, and, to the Knowledge of the Company, no Person has a valid basis upon which to assert, any claims against the Company that would materially adversely affect the transactions contemplated by this Agreement or result in or form the basis of any such action, suit, claim, investigation or proceeding. There is no material action, suit, proceeding or investigation by the Company currently pending or which the Company intends to initiate.

 

6
 

 

(h)           Securities Laws .

 

(i)          The Company has filed all forms, reports and documents with the SEC required to be filed by it pursuant to the federal securities laws and the SEC rules and regulations thereunder, all of which complied in all material respects with all applicable requirements of the Securities Act and the Exchange Act (collectively, the “ SEC Reports ”). None of the SEC Reports, including, without limitation, any financial statements or schedules included therein, at the time filed (or if amended or superseded by a filing prior to the date of this Agreement, then on the date of such filing) contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of circumstances under which they were made, not misleading.

 

(ii)         Based on the Investor’s representations in Section 4.2, no consent, authorization, approval, permit, or order of or filing with any Governmental Authority is required in order for the Company to execute and deliver this Agreement or in order for the Company to offer, issue, sell, or deliver the Shares. Based in part on the representations of the Investor and under the circumstances contemplated hereby and under current laws and regulations, the offer, issuance, sale and delivery of the Shares to the Investor is exempt from the registration requirements of the Securities Act.

 

4.2 Representations and Warranties of the Investor

 

The Investor hereby represents and warrants to the Company that as of the date hereof:

 

(a)           Investment Intent . The Shares to be purchased by the Investor hereunder are being purchased for its own account and not with the view to, or for resale in connection with, any distribution or public offering thereof within the meaning of the Securities Act. The Investor understands that the Shares have not been registered under the Securities Act by reason of their issuance in transactions exempt from the registration and prospectus delivery requirements of the Securities Act pursuant to Section 4(a)(2) thereof. The Investor further understands that the certificates representing the Shares will bear the following legend and the Investor agrees that it will hold such shares subject thereto:

 

“THESE SECURITIES HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT” ), OR ANY APPLICABLE STATE SECURITIES LAWS AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE STATE SECURITIES LAWS OR BLUE SKY LAWS.”

 

7
 

 

The Investor shall be entitled to have the above legend removed from the certificates representing the Shares upon the Investor’s tender of an opinion of legal counsel satisfactory to the Company stating that the proposed share transfer is exempt from public registration under the Securities Act in which case the Company shall provide necessary cooperation to the Investor and/or the transfer agent.

 

(b)           Capacity of the Investor; Execution of Agreement . The Investor has all requisite power, authority and capacity to enter into this Agreement, deliver the Purchase Price, and to perform the transactions and obligations to be performed by it hereunder. This Agreement has been duly authorized, executed and delivered by them and constitutes its valid and legally binding obligation, enforceable in accordance with its terms, except as enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws, both state and federal, affecting the enforcement of creditors’ rights or remedies in general from time to time in effect and the exercise by courts of equity powers or their application of principles of public policy.

 

(c)           Accredited Investor . The Investor is an “accredited investor” as defined in Rule 501(a) of Regulation D promulgated under the Securities Act (“ Regulation D ”).

 

(d)           Suitability and Sophistication . (i) The Investor has such knowledge and experience in financial and business matters that it is capable of independently evaluating the risks and merits of purchasing the Shares; (ii) the Investor has independently evaluated the risks and merits of purchasing the Shares and has independently determined that the Shares are a suitable investment for it; and (iii) the Investor has sufficient financial resources to bear the loss of their entire investment in the Shares.

 

(e)           Receipt of Information . The Investor believes, after due inquiry and investigation, that it has received all of the information that it considers necessary or appropriate for deciding whether to purchase the Shares. The Investor further represents that it has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the offering of the Shares and the business, properties, prospects and financial condition of the Company and to obtain additional information (to the extent the Company possessed such information or could acquire it without unreasonable effort or expense) necessary to verify the accuracy of any information furnished to the Investor. No provision contained in the foregoing Section 4.2(d) and this Section 4.2(e), however, limits or modifies the representations and warranties of the Company provided in Section 4 of this Agreement or in the License Agreement or the right of the Investor to rely thereon.

 

(f)           Independent Existence . The Investor was not formed for the specific purpose of purchasing the Shares.

 

8
 

 

SECTION 5. CONDITIONS TO CLOSING

 

5.1 Conditions to Closing by the Investor

 

The obligations of the Investor to consummate the purchase of the Shares pursuant to Section 2 hereof and certain of the transactions contemplated by this Agreement are subject to the satisfaction on or prior to the Initial Closing Date of the following conditions, any of which may be waived in whole or in part in writing by the Investor: 

 

(a)          The Investor and the Company shall have entered into the Licensing Agreement;

 

(b)          all representations and warranties of the Company contained in this Agreement shall be true and correct as of the date of this Agreement;

 

(c)          the Company shall have delivered to the Investor the items required by Section 3.2 of this Agreement;

 

(d)          the Company shall have performed and complied with all agreements and conditions required by this Agreement to be performed and complied with by it prior to or as of the Initial Closing Date; and

 

(e)          all pre-issuance registrations, qualifications, permits and approvals required, if any, under applicable state securities laws or stock exchange listing rules for the lawful execution and delivery of this Agreement and the offer, sale, issuance and delivery of the Shares shall have been obtained.

 

5.2 Conditions to Closing by the Company

 

The obligations of the Company to consummate the issuance and sale of the Shares pursuant to Section 2 hereof and certain of the transactions contemplated by this Agreement are subject to the satisfaction on or prior to such Closing Date of the following conditions, any of which may be waived in whole or in part in writing by the Company:

 

(a)          all representations and warranties of the Investor contained in this Agreement shall be true and correct as of the date of this Agreement and as of the date of such Closing as though made as of such date;

 

(b)          the Investor shall have delivered to the Company the items required by Section 3.3 of this Agreement; and

 

(c)          the Investor shall have performed and complied with all agreements and conditions required by this Agreement to be performed and complied with by it prior to or as of such Closing Date.

 

9
 

 

SECTION 6. TERMINATION

 

In the event either Party is in breach of any material obligation hereunder, the non-breaching Party may give written notice to the breaching Party specifying the claimed particulars of such breach, and in the event such material breach is not cured within sixty (60) days following the date of such written notification, without prejudice to any other rights and remedies available at any time to the non-breaching Party, the non-breaching Party shall have the right thereafter to terminate this Agreement by giving thirty (30) days prior written notice to the breaching Party to such effect.

 

Either Party may terminate this Agreement by written notice to the other Party effective immediately if both of the License Agreement are terminated under Sections 13.2(a) (only if the termination is due to the other Party’s breach), 13.2(b), 13(c), or 13(d) thereunder.

 

Termination of this Agreement by either Party shall not affect any claim, demand, liability or right of a Party arising pursuant to this Agreement prior to such termination hereof.

 

SECTION 7. MISCELLANEOUS

 

7.1 Waivers and Amendments

 

This Agreement may be amended or modified in whole or in part only by a writing which makes reference to this Agreement that is executed by the Investor and the Company. The obligations of any Party hereunder may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the party claimed to have given the waiver; provided, however, that any waiver by any party of any violation of, breach of, or default under any provision of this Agreement or any other agreement provided for herein shall not be construed as, or constitute, a continuing waiver of such provision, or waiver of any other violation of, breach of or default under any other provision of this Agreement or any other agreement provided for herein.

 

7.2 Costs and Expenses

 

Each Party agrees to pay its own costs and expenses in connection with the preparation, execution and delivery of this Agreement and other instruments and documents to be delivered hereunder and thereunder.

 

7.3 Remedies Cumulative

 

No specific right, power, or remedy conferred by this Agreement shall be exclusive, and each such right, power, or remedy shall be cumulative and in addition to every other right, power, or remedy, whether conferred hereby or by any security of the Company or now or hereafter available, at law or in equity, by statute or otherwise.

 

7.4 Remedies Not Waived

 

No course of dealing between the Company and the Investor, and no delay in exercising any right, power, or remedy conferred hereby or by any security issued by the Company, or now or hereafter available at law or in equity, by statute or otherwise, shall operate as a waiver of or otherwise prejudice any such right, power, or remedy.

 

10
 

 

7.5 Entire Agreement

 

This Agreement and the other agreements and instruments expressly provided for herein, together set forth the entire understanding of the Parties and supersede in their entirety all prior contracts, agreements, arrangements, communications, discussions, representations and warranties, whether oral or written, among the parties with respect to the subject matter hereof.

 

7.6 Specific Performance

 

The Company and the Investor acknowledge and agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with the specific terms hereof or were otherwise breached. It is accordingly agreed that, to the fullest extent permitted by law or equity, each of the Parties shall be entitled to an injunction or injunctions to prevent or cure breaches of the provisions of this Agreement and to enforce specifically the terms and provisions hereof, this being in addition to any other remedy to which the Parties may be entitled by law or equity.

 

7.7 Governing Law

 

This Agreement shall in all respects be governed by and construed in accordance with the internal substantive laws of the State of New York without giving effect to the principles of conflicts of law thereof.

 

7.8 Notices

 

Any notice, request or other communication required or permitted hereunder shall be in writing and be deemed to have been duly given (a) when personally delivered or sent by facsimile transmission (the receipt of which is confirmed in writing), (b) one business day after being sent by a nationally recognized overnight courier service or (c) five business days after being sent by registered or certified mail, return receipt requested, postage prepaid, to the parties at their respective addresses set forth below.

 

If to the Company:

 

RegeneRx Biopharmaceuticals, Inc.

15245 Shady Grove Road

Suite 470

Rockville, MD 20850

Attention: J.J. Finkelstein

Facsimile: 301-280-1991

With a copy, which shall not constitute notice, to:

 

Cooley LLP

One Freedom Square, Reston Town Center

11951 Freedom Drive

Reston, VA 20190

 

11
 

 

Attention: Kenneth J. Krisko, Esq.

Facsimile: 703-456-8100

 

If to the Investor:

 

Digital Aria Co., Ltd.

22nd FL, Parkview Tower

248 Jungjail-ro, Bundang-gu

Seongnam-si, Gyeonggi-do 463-863

Republic of Korea

Attn: CEO

Phone: +82 31 786 7700

Fax.:    +82 31 786 7801

 

Either Party by written notice to the other Party may change the address or the persons to whom notices or copies thereof shall be directed.

 

7.9 Counterparts

 

This Agreement may be executed in counterparts, each of which shall be deemed to be an original, and all of which together shall constitute one and the same instrument.

 

7.10 Successors and Assigns

 

This Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and assigns, subject to the restrictions on transfer contained herein.

 

7.11 Third Parties

 

Nothing expressed or implied in this Agreement is intended, or shall be construed, to confer upon or give any Person other than the Parties any rights or remedies under or by reason of this Agreement.

 

7.12 Schedules and Exhibits

 

The schedules and exhibits attached to this Agreement are incorporated herein and shall be part of this Agreement for all purposes.

 

7.13 Headings

 

The headings in this Agreement are solely for convenience of reference and shall not be given any effect in the construction or interpretation of this Agreement.

 

12
 

 

IN WITNESS WHEREOF , the parties have duly executed, or have caused their duly authorized officer or representative to execute, this Securities Purchase Agreement as of the date first above written.

 

REGENERX BIOPHARMACEUTICALS, INC.
 
By: /s/J.J. Finkelstein  
Name: J.J. Finkelstein  
Title: President and Chief Executive Officer  

 

DIGITAL ARIA CO., LTD.
 
By: /s/ Ill Park  
Name: Ill Park  
Title: CEO  

 

13
 

 

Schedule 4.1(b)

 

Capitalization

 

[ DA Note: Please provide. ]

 

RegeneRx 3/5/2014

Capitalization table                              
    Authorized     Outstanding     DA Sale     DA Option     Post Transaction  
                               
Preferred Stock     1,000,000       -                       -  
                                         
Common Stock*     200,000,000       81,733,247       19,583,333       5,500,000       106,816,580  
                                         
Common Shares Reserved                                        
Convertible Debt             13,683,333                       13,683,333  
Accrued Interest on Convertible Debt @2/28           499,864                       499,864  
Outstanding Warrants             11,468,901                       11,468,901  
Stock Options Plans (issued & reserved)             9,068,635                       9,068,635  
                                         
Total Common Shares Issued & Reserved             116,453,980       19,583,333       5,500,000       141,537,313  
                                         
Unencumbered Common Shares             83,546,020                       58,462,687  

 

* Each Share of Common Stock includes an associated Series A Participating Cumulative Preferred Stock Purchase Rights pursuant to the Company's anti-takeover plan that expires in April 2014.

 

14

 

 

Exhibit 10.6

*** text ommitted and filed seperately

confidential treatment requested

under 17 c.f.r.§§200.80(b)(4) and 240.24b-2

 

RGN-259 LICENSE Agreement

  

This License Agreement (this “ Agreement ” or this “ License Agreement ”) is effective as of March 7, 2014 (the “ Effective Date ”) by and between RegeneRx Biopharmaceuticals, Inc., a company organized and existing under the laws of the state of Delaware, with offices at 15245 Shady Grove Road, Suite 470, Rockville, Maryland, U.S.A. (hereinafter “ Licensor ”), and Digital Aria Co., Ltd. with offices at 22 nd FL, Parkview Tower, 248 Jungjail-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-863, Republic of Korea (hereinafter “ Licensee ”), each a “ Party ” and, collectively, the “ Parties .”

 

Recitals

 

WHEREAS, Licensor is engaged in the business of developing biopharmaceutical products, including the clinical development of a drug candidate referred to as RGN-259, which utilizes Tβ4 (as defined herein) as the biologically active ingredient;

 

WHEREAS, Licensee is engaged in the business of developing, marketing, manufacturing, and distributing biopharmaceutical products;

 

WHEREAS, Licensee wishes to obtain the rights to develop, manufacture finished product and commercialize the Licensed Product in the Field, in the Territory (as each such term is defined herein); and

 

WHEREAS, Licensor and Licensee wish to specify certain terms relating to the manufacture and supply of the Licensed Product and/or the API (as defined herein).

 

NOW, THEREFORE, in consideration of the premises and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

Section 1. Definitions

 

As used in this Agreement, the following capitalized terms shall have the following meanings:

 

Affiliate ” shall mean, with respect to a Person, any Person that Controls, is Controlled by or is under common Control with such first Person. For purposes of this definition only, “ Control ” means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities, or by contract relating to voting rights or corporate governance, or (b) to own, directly or indirectly, at least fifty percent (50%) of the outstanding voting securities or other ownership interest of such Person.

 

Agreement ” shall have the meaning given such term in the preamble.

 

API ” shall mean Tβ4 in the form of an active ingredient to be utilized as a component in the Licensed Product.

 

Challenge ” shall have the meaning given such term in Section 8.8(b).

 

Change of Control ” shall mean, with respect to a Party, the occurrence of any of the following:

 

1 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 
 

 

(a) any consolidation, merger, recapitalization or reorganization of a Party with or into any Third Party, or any other corporate reorganization involving a Third Party (“ Merger ”), as long as the stockholders of such Party immediately prior to the Merger own less than fifty percent (50%) of the surviving entity’s voting power immediately after the Merger;

 

(b) a change in the beneficial ownership of more than fifty percent (50%) of the voting securities of any Party (whether in a single transaction or series of related transactions) where, immediately after giving effect to such change, the legal or beneficial owner of more than fifty percent (50%) of the voting securities of such Party is a Third Party.

 

(c) the sale, transfer, lease, license or other disposition to a Third Party of all or substantially all of a Party’s assets, to which this Agreement relates, in one or a series of related transactions.

 

Commercialization Plan ” shall have the meaning given such term in Section 4.1.

 

Commercially Diligent Efforts ” shall mean, with respect to the development and commercialization by Licensee of at least one Licensed Product, the level of efforts and resources generally used by similarly situated pharmaceutical companies marketing compounds or products throughout the Territory (including internally developed, acquired and in-licensed compounds or products) with similar commercial potential at a similar stage in their lifecycle (assuming continuing development of such product).

 

Confidential Information ” shall mean any and all information, data, results, Inventions, trade secrets, techniques, material, or compositions of matter of any type or kind, including without limitation all Know-How and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, personnel, financial, legal and commercial information or data, whether communicated in writing, orally or by any other method, that a Party treats or identifies as confidential and, in each case, is disclosed by one Party to the other Party under this Agreement.

 

Control ”, “ Controls ” and “ Controlled ” shall mean, with respect to a particular item of information or intellectual property right, that the applicable Party or any Affiliate of such Party owns or has a license to such item or right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or rights as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing as of the Effective Date or thereafter.

 

Development Plan ” shall have the meaning given such term in Section 3.1.

 

Disclosing Party ” shall have the meaning given such term in Section 9.1.

 

Distributor ” shall mean any Third Party appointed by Licensee to distribute, market and sell Licensed Product purchased from Licensee or any of its Affiliates (regardless of whether such Third Party has the right or obligation to provide packaging or labeling services with respect to such Licensed Product).

 

Effective Date ” shall have the meaning given such term in the preamble.

 

FDA ” shall mean the United States Food and Drug Administration or any successor U.S. governmental agency performing similar functions.

 

2 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 
 

 

Field ” shall mean the treatment of all human ophthalmic diseases and conditions in the Territory using Tβ4 in any formulation delivered topically to the eye, provided, however, that “Field” shall not include any use of the Licensed Product incorporated into the form of any type of cosmetic or food product.

 

First Commercial Sale ” shall mean the initial sale of Licensed Product by or on behalf of Licensee, its Affiliates, Sublicensees or Distributors in exchange for cash or some equivalent to which value can be assigned for the purpose of determining Net Sales in the Territory following Regulatory Approval of the Licensed Product in the Territory. For clarity, First Commercial Sale shall not include transfers of Licensed Product at below cost by or on behalf of Licensee, its Affiliates, Sublicensees or Distributors in connection with compassionate use, emergency use, treatment INDs, or the like authorized by the FDA or any corresponding Governmental Authorities in the Territory.

 

GAAP ” shall mean, in the case of the Licensor, Generally Accepted Accounting Principles recognized in the United States, and in the case of the Licensee, Generally Accepted Accounting Principles recognized in the Republic of Korea.

 

Generic or Branded Generic ” shall mean a drug product containing the same active ingredients as Licensed Products and is subject to the regulations of the governments of countries where they are dispensed and is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.

 

GCP ” shall mean the then current good clinical practices as defined in U.S. Regulations 21 C.F.R. §§ 50, 54, 56, 312 and 314, the International Conference of Harmonization (ICH) E6 “Good Clinical Practice: Consolidated Guidance,” and in any successor regulation or any official guidance documents issued by a Governmental Authority.

 

GLP ” shall mean the then current good laboratory practice standards as defined by the FDA pursuant to 21 C.F.R. Part 58, and in any successor regulation or any official guidance documents issued by a Governmental Authority.

 

GMP ” shall mean the then current good manufacturing practices as defined by the FDA pursuant to 21 C.F.R. §§ 210 and 211 and in any successor regulation or any official guidance documents issued by a Governmental Authority.

 

Governmental Action ” shall have the meaning given such term in Section 13.2(b).

 

Governmental Authority ” shall mean: (i) any national, federal, provincial, state, municipal or other governmental body in any jurisdiction in the Territory, the United States or elsewhere, (ii) any international or multi-lateral body, (iii) any subdivision, ministry, department, secretariat, bureau, agency, commission, board, instrumentality or authority of any of the foregoing governments or bodies, (iv) any quasi-governmental or private body exercising any regulatory, expropriation or taxing authority under or for any of the foregoing governments or bodies, or (v) any international, multi-lateral, or multi-national judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal, commission, board or panel, in each case having jurisdiction over the United States or any jurisdiction in the Territory.

 

ICC Rules ” shall have the meaning given such term in Section 14.814.8(c).

 

IND ” shall mean an investigational new drug application filed with the FDA, or the equivalent in any jurisdiction in the Territory.

 

3 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 
 

 

Indemnified Party ” shall have the meaning given such term in Section 11.3.

 

Indemnifying Party ” shall have the meaning given such term in Section 11.3.

 

Intellectual Property ” shall mean any Inventions, Patents, patent rights, utility models, copyrights, trade secrets, Trademarks, service marks, Know-How, technical information and all other intellectual property rights.

 

Invention ” shall mean any process, method, use, composition of matter, article of manufacture, discovery, finding or invention, whether or not patentable.

 

Joint Development Committee ” shall have the meaning given such term in Section 3.4.

 

Joint Inventions ” shall have the meaning given such term in Section 8.2(c).

 

Know-How ” shall mean all tangible and intangible (i) techniques, technology, practices, trade secrets, methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms, and (ii) compounds, compositions of matter, and physical, biological or chemical material.

 

Laws ” shall mean (i) all constitutions, treaties, laws, statutes, codes, ordinances, guidance, orders, decrees, rules, regulations, and municipal by-laws, whether domestic or international, anywhere in the Territory or as may otherwise be agreed in writing between the Parties, (ii) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards of any Governmental Authority, and (iii) all policies, practices and guidelines of any Governmental Authority.

 

Licensed Know-How ” shall mean Know-How owned or Controlled by Licensor that exists as of the Effective Date or at any time thereafter during the Term, in each case that is necessary or useful for the development, registration, manufacture, promotion, marketing, distribution, or sale of the Licensed Product in the Field in the Territory.

 

Licensed Patents ” shall mean the Patents owned or Controlled by Licensor as of the Effective Date (as listed in Exhibit A hereto), to the extent that such Patents disclose or claim the Licensed Product as well as any future Patents owned or Controlled by Licensor or its Affiliates during the Term, to the extent that such future Patents disclose or claim the Licensed Product.

 

Licensed Product ” shall mean the Licensor’s drug candidate referred to as RGN-259 that utilizes Tβ4 as at least one of the biologically active ingredients and/or improvements thereto developed or acquired by or on behalf of Licensor for the Field in the Territory, in each case to the extent such improvements are owned or Controlled by Licensor. The term “Licensed Product” shall include both clinical and commercial applications of any such product.

 

Licensee ” shall have the meaning given such term in the preamble.

 

Licensee Inventions ” shall have the meaning given such term in Section 8.2(a).

 

Licensee Product Data ” shall have the meaning given such term in Section 13.313.3(b)(i).

 

Licensor ” shall have the meaning given such term in the preamble.

 

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Licensor Inventions ” shall have the meaning given such term in Section 8.2(b).

 

Losses ” shall have the meaning given such term in Section 11.1.

 

Marketing Approval ” shall mean all approvals, licenses, registrations, or authorizations of a Regulatory Authority in any jurisdiction of the Territory necessary for the manufacture, use, storage, marketing, importation or sale of the Licensed Product in such jurisdiction.

 

Marketing Year ” shall mean the period commencing on the date of the first Marketing Approval in any country in the Territory and ending on December 31 of the same year. Thereafter, and for the duration of this Agreement, each subsequent Marketing Year will correspond to a calendar year period (i.e., from January 1 to December 31).

 

Net Sales ” shall mean the gross receipts for sales made by Licensee, its Affiliates, Sublicensees and Distributors of the Licensed Product to other independent buyer(s) in bona fide arm’s length transactions, less the following deductions with respect to such sale, to the extent applicable to the Licensed Product and to the extent actually allowed and taken: (i) quantity and/or cash discounts actually allowed or taken to the extent customary; (ii) customs, duties, excise taxes, if any, directly related to the sale of the Licensed Product and actually paid; (iii) amounts allowed by reason of rejections and return of goods; (iv) Third-Party rebates related to the sale of the Licensed Product; and (v) import tax, value-added tax and other similar sales taxes related to the sale of the Licensed Product, all to the extent in accordance with GAAP as consistently applied across all products of Licensee. No deductions shall be made for commissions paid to individuals, whether with independent sales agencies or regularly employed by Licensee, its Affiliates, Sublicensees or Distributors, and on its payroll, or for the cost of collections. On sales made in other than in arm’s length transaction, the value of Net Sales attributed to such a transaction shall be that which would have been received in an arm’s length transaction, based on sales of like quantity and quality products on or about the time of such transaction.

 

Panel ” shall have the meaning given such term in Section 14.814.8(c)(i).

 

Parties and “ Party ” shall have the meanings given such terms in the preamble.

 

Patents ” shall mean any and all patents and/or patent applications, and any patents issuing on such patent applications, as well as any continuations, divisions, reissues and re-examinations of any of the foregoing.

 

Person ” shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

 

PHS ” shall mean the National Institutes of Health, the Centers for Disease Control, and/or the FDA, agencies of the United States Public Health Service within the Department of Health and Human Services.

 

PHS License ” shall mean the Patent License Agreement, dated as of February 6, 2001, between PHS and Licensor, attached hereto as Exhibit B.

 

Product Liability Claim ” shall mean any Third Party proceedings involving any actual or alleged death or bodily injury arising out of or resulting from the use of the Licensed Product sold by Licensee or its Sublicensees.

 

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Prohibited List ” shall mean (a) the HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://www.oig.hhs.gov ); (b) the General Services Administration’s List of Parties Excluded from Federal Programs (available through the Internet at http://www.epls.gov ); and (c) the FDA Debarment List (available through the Internet at http://www.fda.gov/ora/compliance_ref/debar/ ).

 

Prosecute ” shall have the meaning given such term in Section 8.5(a).

 

Receiving Party ” shall have the meaning given such term in Section 9.1.

 

Regulatory Approval ” shall mean any and all approvals (including, to the extent necessary, pricing approvals), licenses, registrations or authorizations of any Governmental Authority, necessary for the promotion, development (including without limitation the conduct of clinical trials), marketing, distribution, manufacture, sale or importation of a Licensed Product.

 

Regulatory Authority ” shall mean any applicable Governmental Authority in any jurisdiction in the Territory from which Regulatory Approval is required to be obtained.

 

Regulatory Laws ” shall mean all applicable Laws governing (i) marketing approval or clearance, import, export, testing, investigation, development, manufacture, packaging, labeling, handling, storage, distribution, installation, servicing, marketing, or sale, (ii) recordkeeping and reporting obligations, (iii) recalls, or (iv) similar regulatory matters, with respect to the Licensed Product.

 

Relevant Period ” shall mean, on a Licensed Product-by-Licensed Product basis and on a country-by-country basis, the period starting from the Effective Date and ending on (i) the expiration of the last-to-expire valid and applicable Licensed Patent within the given country of the Territory or (ii) the fifteenth (15 th ) anniversary of the First Commercial Sale of each Licensed Product in such country, whichever is later.

 

RGN-137 Agreement ” shall mean that certain RGN-137 License Agreement dated as of even date herewith and executed concurrently herewith between the Parties.

 

Royalty Term ” shall mean the period commencing on the First Commercial Sale and ending at the expiration of or the effective date of termination of this Agreement.

 

Semi-exclusive ” shall mean the license granted by Licensor to Licensee in a given country to manufacture, offer to sell, sell and import the Licensed Product in the Field in the Territory, pursuant to which Licensor may simultaneously, directly or through its Affiliate, manufacture, offer to sell, sell and import Licensed Product in that same country.

 

Sublicensee ” shall mean any Affiliate or Third Party to whom Licensee sublicenses any rights as permitted by Section 2.1(e).

 

Tβ4 ” shall mean the 43 amino acid peptide commonly referred to as Thymosin Beta 4.

 

Territory ” or “ Territories ” shall mean the following countries: Japan, Australia, New Zealand, Brunei, Cambodia, East Timor, Indonesia, Korea, Laos, Malaysia, Mongolia, Myanmar (Burma), Philippines, Singapore, Thailand and Vietnam, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, and Uzbekistan.

 

Third Party shall mean any Person other than Licensor, Licensee, and Affiliates of either Party.

 

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Trademark ” shall mean any trademark, trade dress, brand mark, trade name, brand name, logo, business symbol or other similar indicia of origin.

 

Valid Claim ” shall mean a claim of an issued and unexpired Licensed Patent, that has not been revoked or held unenforceable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction, and that is not appealable or has not been appealed within the time allowed for appeal, and that has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise.

 

Section 2. License Grant and Other Rights

 

2.1            License Grants to Licensee

 

(a)           Non-Exclusive License to Use to Develop . Subject to the terms of this Agreement, Licensor hereby grants to Licensee a non-exclusive, irrevocable (except as otherwise provided for in this Agreement and in the PHS License), royalty-free license to use the Licensed Patents and the Licensed Know-How to develop the Licensed Product in the Field in the Territory.

 

(b)           Exclusive License to Make and Sell . Subject to the terms of this Agreement, Licensor hereby grants to Licensee an exclusive irrevocable (except as otherwise provided for in this Agreement and in the PHS License) royalty-bearing license to use the Licensed Patents and the Licensed Know-How to manufacture, offer to sell, sell and import the Licensed Product in the Field in the following countries of the Territory: Japan, Australia, New Zealand, Brunei, Cambodia, East Timor, Indonesia, Korea, Laos, Malaysia, Mongolia, Myanmar (Burma), Philippines, Singapore, Thailand, Vietnam and Kazakhstan.

 

(c)           Semi-exclusive License to Make and Sell . Subject to the terms of this Agreement, Licensor hereby grants to Licensee a Semi-exclusive irrevocable (except as otherwise provided for in this Agreement and in the PHS License) royalty-bearing license to use the Licensed Patents and the Licensed Know-How to manufacture, offer to sell, sell and import the Licensed Product in the Field in the following countries of the Territory: Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka, Kyrgyzstan, Tajikistan, Turkmenistan, Uzbekistan.

 

(d)           Early Termination of License . Subject to the terms of this Agreement, the License granted to Licensee regarding the countries of Australia, New Zealand, and Kazakhstan, shall terminate if Licensee does not initiate and begin enrollment of patients in at least one Phase 2 ophthalmic clinical trial in Australia within three (3) years from the execution date of this Agreement. In such a case, such rights regarding Australia, New Zealand, and Kazakhstan shall be automatically terminated.

 

(e)           Sublicensing .

 

(i)          Licensee shall be entitled to sublicense any or all of the rights granted to Licensee pursuant to Section 2.1(a), 2.1(b) or 2.1(c) to any of its Affiliates or Third Party upon thirty (30) days’ prior written notice to Licensor (subject to Licensor’s approval, which approval shall not be unreasonably withheld), which notice shall include the identity of such Affiliate or Third Party.

 

(ii)         All sublicenses granted to Affiliates or Third Parties pursuant to Section 2.1(e)(i) above shall be subject to all terms, conditions, obligations and covenants of this Agreement and all applicable provisions of the PHS License. No sublicense shall relieve Licensee of any of its obligations hereunder.

 

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(f)           No Further Licenses . Except for the licenses granted to Licensee pursuant to Sections 2.1(a), 2.1(b) and 2.1(c), no further rights or licenses are granted to Licensee in or under this Agreement, whether expressly or by implication.

 

(g)           Licensor’s Retained Rights . Notwithstanding the rights granted to Licensee in Sections 2.1(a), 2.1(b) and 2.1(c) and without limiting the generality of Section 2.1(h), Licensor retains the rights to:

 

(i)          conduct or have conducted clinical trials and other studies involving the Licensed Product in the Territory for the generation of data in support of regulatory submissions to the Regulatory Authorities outside the countries of the Territory where the exclusive license is granted to Licensee as per Section 2.1(b) above; or

 

(ii)         conduct activities in the Territory with respect to the manufacture, formulation and processing of the Licensed Product for use and commercialization outside the countries of the Territory where the exclusive license is granted to the Licensee as per Section 2.1(b) above.

 

(h)           Negative Covenant . Licensee covenants that it will not, and it will not permit any of its Affiliates to, use or practice any Licensed Patents and Licensed Know-How outside the scope of the license granted to it under Sections 2.1(a), 2.1(b) and 2.1(c) above.

 

2.2            Transfer of Licensed Know-How . Upon the reasonable request of Licensee and at no cost to Licensee, Licensor shall promptly provide Licensee with such tangible embodiments of the Licensed Know-How as are in Licensor’s possession or control so as to permit Licensee to enjoy the licenses granted to it pursuant to Sections 2.1(a), 2.1(b) and 2.1(c) above.

 

2.3            Use of Affiliates . At Licensor’s option, any of Licensor’s rights under this Agreement may be exercised by any Affiliate of Licensor. Further, at Licensor’s option, any of Licensor’s obligations under this Agreement may be performed by any Affiliate of Licensor, and such obligations will be deemed satisfied upon performance by such Affiliate. For the avoidance of doubt, nothing contained in this Article 2.3 shall relieve Licensee of any of its obligations hereunder unless fully performed by its Affiliate.

 

2.4            PHS Reserved Rights . Notwithstanding anything contained in Section 2.1 to the contrary, Licensee:

 

(a)          acknowledges that PHS has retained certain rights and interests in the Licensed Patents pursuant to the PHS License;

 

(b)          agrees that the provisions of the PHS License contained in Exhibit C shall be binding on Licensee and its successors as if Licensee or its successors were the licensee under the PHS License; and

 

(c)          shall assist Licensor in complying with Licensor’s obligations under the PHS License.

 

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Section 3. Development

 

3.1            Development Plan .

 

(a)           Initial Development Plan . Licensee shall carry out all development activities with respect to the Licensed Product in the Territory in accordance with a development plan as agreed upon in writing by the Parties (the “ Development Plan”) .

 

(b)           Development Activities . For purposes of this Agreement, development activities shall mean all activities that are reasonably required to obtain Regulatory Approval of the Licensed Product in the Territory, including without limitation toxicology, in vitro testing, in vivo testing, in silico testing, stability testing, statistical analysis and report writing, packaging and regulatory affairs, preclinical studies and clinical trials.

 

3.2            Content of Development Plans . The Development Plan (as amended after the Effective Date) shall include, to the extent applicable, (i) the identity of the Licensed Product to be developed, (ii) a description of the overall program of development for such Licensed Product through Regulatory Approval in the Territory, (iii) a description of the development activities including preclinical studies, pharmacology, toxicology, formulation, clinical pharmacology studies, clinical studies and regulatory plans and other key elements necessary to obtain Regulatory Approval for the Licensed Product, (iv) specific plans and protocols for clinical studies, including Licensee’s good faith forecast of the quantity of clinical supplies of API that Licensee will require, (v) a schedule for all such activities, and (vi) specific tentative deadlines for meeting specified regulatory milestones.

 

3.3            Updates and Amendments to the Development Plan . The Parties shall amend the Development Plan at least once every twelve (12) months to expand and refine the description of the activities specified in the initial Development Plan or other then current Development Plan and to add other development activities, and the anticipated schedule and budgets for all such activities. Such amended Development Plan shall become effective only upon the approval of the Joint Development Committee. If the Parties fail to update the Development Plan as required by this Section 3.3 the most recently approved Development Plan shall continue in effect until such time as an amended Development Plan becomes effective.

 

3.4            Joint Development Committee . Within ninety (90) days from the Effective Date, the Parties shall establish a joint development committee (the “ Joint Development Committee ”) to coordinate and oversee the development of the Licensed Product in the Territory.

 

(a)           Composition of the Joint Development Committee . The Joint Development Committee shall be comprised of an equal number of representatives from each Party, initially consisting of four persons (two persons from each Party), each of whom has relevant experience and skill appropriate for service on the Joint Development Committee, such as heads of clinical, manufacturing, and commercial development. The Parties may establish and later change the number of representatives that each Party has on the Joint Development Committee, as long as an equal number of representatives from each Party is maintained (unless such Party desires to have fewer representatives). Each Party may change any of its representatives on the Joint Development Committee at any time upon notice to the other Party.

 

(b)           Decisions of the Joint Development Committee . Except as otherwise provided in this Agreement, in the event that the Joint Development Committee cannot reach a decision in any matter properly before it, Licensee shall have final decision-making authority with respect to such matter, including approval and amendments of the Development Plan; provided, however, that any such matter under dispute shall first be referred to the Parties’ respective Presidents or chief executive officers, for attempted resolution by good faith negotiations within fourteen (14) days; further provided, that any final decision made by Licensee shall (i) be consistent with the terms of this Agreement (including Licensee’s diligence obligations hereunder); (ii) not materially affect the rights and obligations of Licensor under this Agreement without Licensor’s consent; (iii) not materially affect the development, manufacture or commercialization of the Licensed Products outside the Field and/or outside the Territory, as reasonably determined by Licensor.

 

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(c)           Activities of the Joint Development Committee . The Joint Development Committee shall be responsible for establishing and approving the Development Plan.

 

(d)           Meetings of the Joint Development Committee . The Joint Development Committee shall hold its first meeting within ninety (90) days after the Effective Date and shall meet thereafter on a schedule and at locations mutually determined by the Parties. The Joint Development Committee will convene at least monthly by teleconference and periodically in person either in Korea or in the U.S. to discuss and agree on the development of the Licensed Products in the Territory and share information relating thereto. This committee may also discuss development plans of RGN-259 as to the U.S. Ad hoc meetings of the Joint Development Committee may be called by either Party upon reasonable advance notice to the other. Subject to the Parties’ mutual agreement, regular and ad hoc meetings may be face-to-face or by teleconference or videoconference.

 

(e)           Joint Development Committee Expenses . Each Party shall bear the expense of the participation of its representatives on the Joint Development Committee and in Joint Development Committee meetings.

 

3.5            Clinical Trials . Licensee shall be responsible for conducting or having conducted all clinical trials of the Licensed Product in the Territory and for paying all fees, costs and other expenses associated therewith.

 

3.6            Regulatory Approvals . Licensee shall be responsible for obtaining and maintaining all Regulatory Approvals necessary to conduct such clinical trials and for paying all fees, costs and other expenses associated therewith.

 

3.7            Licensor’s Cooperation . As reasonably requested by Licensee, Licensor shall cooperate with and assist Licensee in obtaining any Regulatory Approvals necessary to conduct clinical trials and commercialization of the Licensed Product in the Territory. In connection therewith, Licensor shall provide Licensee upon request with copies of any regulatory materials and/or data as are reasonably necessary for these purposes.

 

3.8            Clinical Supply of Licensed Product .

 

(a)           Clinical Supply . Licensor shall supply Licensee with up to a combined total of fifty (50) grams free of charge of the API as required by Licensee in order to conduct development activities in accordance with the Development Plan hereunder and the Development Plan as defined in the RGN-137 Agreement, including clinical trials of the Licensed Product hereunder and as defined therein.

 

(b)           Clinical Supply Costs . Subject to the other provisions hereof, Licensor shall supply API for clinical trials required by Licensee over and above the fifty (50) grams as provided in Section 3.8(a), at Licensor’s cost plus fifteen percent (15%). In all cases, Licensee shall be responsible for the cost of formulating, filling and finishing Licensed Product in accordance with applicable Laws in the relevant jurisdiction.

 

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3.9            Diligence . Notwithstanding anything specified in any Development Plan, Licensee shall at all times exert no less than Commercially Diligent Efforts to develop the Licensed Product in the Territory, including seeking Regulatory Approval and Marketing Approval of the Licensed Product in the Territory. Licensee shall require any Affiliates, Sublicensees, and/or Third Parties it uses to develop the Licensed Product to use such efforts on Licensee's behalf.

 

3.10          Cooperation in Development . The Parties mutually acknowledge that, subject to other provisions of this Agreement, Licensor and Licensee shall closely collaborate (as the Parties may reasonably agree) in the development and commercialization of Licensed Product on global basis.

 

Section 4. Commercialization of Licensed Product

 

4.1            Commercialization Plan .

 

(a)           Initial Commercialization Plan . Licensee shall provide Licensor with the plan for commercialization of the Licensed Product in the Territory (the “ Commercialization Plan ”) and carry out all commercialization activities with respect to the Licensed Product in the Territory. The initial Commercialization Plan shall be provided to Licensor within ninety (90) days from the expected First Commercial Sale date within the Territory.

 

(b)           Commercialization Activities . For purposes of this Agreement, commercialization activities shall mean all appropriate activities undertaken before and after Regulatory Approval relating specifically to the marketing, sale and distribution of the Licensed Product in the Territory, including, without limitation, (i) sales force detailing, advertising, education, planning, marketing, sales force training and distribution, (ii) scientific and medical affairs, and (iii) pricing and related terms for the Licensed Product.

 

4.2            Content of Commercialization Plan .

 

(a)           Description of Activities . The Commercialization Plan (as amended, if needed) shall include a reasonable description of the activities that Licensee shall undertake in order to market the Licensed Product in the Territory, including, but not limited to, (i) media marketing plans, promotional activities and similar matters, including detailed budgets, and (ii) the identity of intended major Distributors and Sublicensees, if any.

 

(b)           Net Sales Targets . The Parties acknowledge that, as of the Effective Date, specific Net Sales targets in any Marketing Year are difficult to determine. The Commercialization Plan shall specific a broad range of Net Sales targets that will be refined and updated in amendments to the Commercialization Plan as the Licensed Product in the Territory approaches Regulatory Approval.

 

4.3            Amendments to the Commercialization Plan . The Parties shall amend the Commercialization Plan at least once every twelve (12) months after the First Commercial Sale to refine the description of the activities specified in the initial Commercialization Plan and any subsequently amended Commercialization Plan, and to add other commercialization activities, to update the anticipated schedule and budgets for all such activities, and to update the Net Sales targets. Such amended Commercialization Plan shall comply with the provisions of Section 4.2. If the Parties fail to update the Commercialization Plan as required by this Section 4.3, the most recently approved Commercialization Plan shall continue in effect until such time as an amended Commercialization Plan becomes effective pursuant to this Section 4.3.

 

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4.4            Diligence . Licensee shall at all times exert no less than Commercially Diligent Efforts to promote, market and distribute at least one Licensed Product in the Territory. Licensee shall require any Affiliates, Sublicensees, Distributors, and/or other Third Parties it uses to promote, market and distribute the Licensed Product to use such efforts on Licensee's behalf.

 

4.5            Notification of Benchmarks and Milestones . Licensee shall report in writing to Licensor the date of the First Commercial Sale in each country of the Territory and the achievement of any milestone specified in this Agreement within ten (10) days of such occurrences.

 

Section 5. Manufacture and Supply of Licensed Product

 

5.1            Supply Terms . Licensee shall purchase all of its commercial requirements of API from Licensor at a cost plus price to be discussed and agreed upon by the Parties, subject to Licensor’s ability to deliver required amounts of API pursuant to the terms of a commercial supply agreement to be negotiated by the Parties. Upon reasonable request by Licensee, Licensor shall provide Licensee with data supporting its calculation of cost in reasonable details. Licensee shall be entitled to manufacture or source API from suppliers of its choice, only if Licensor is unable or unwilling to provide API according to the terms herein. In such a case, Licensor shall promptly identify and introduce to Licensee one or more alternative sources of API which together shall possess adequate capacity to supply such required amount of API to Licensee.

 

5.2            Manufacturing License . Licensor hereby grants to Licensee the rights under the Licensed Patents and Licensed Know-How as may be necessary in order for Licensee to manufacture or have manufactured by an Affiliate or by a Third Party the API, pursuant to Section 5.1 and the Licensed Product in the Territory for the sole purpose of exercising the licenses granted to Licensee pursuant to Sections 2.1(a), 2.1(b) and 2.1(c).

 

Section 6. Royalties, License Fees and Equity Investments

 

6.1            Royalties .

 

(a)          During the Royalty Term, on a semi-annual basis, Licensee shall pay Licensor royalties equal to [***] and [***] percent [***]% of aggregate annual Net Sales. Each such payment shall be due and payable no later than sixty (60) days after the end of the semi-annual period ending on December 31st and June 30th, in which the applicable Net Sales were made. In case any Generic/Branded Generic of any Licensed Product by any Third Party becomes commercially available in a country within the Territory without a direct or indirect agreement with the Licensee, its Affiliates or their Sublicensees or Distributors and such Generic/Branded Generic taken in the aggregate have according to IMS or similar data source a market share (in terms of unit quantity) in such country of at least 30% (thirty percent), then the royalties’ rate applicable and payable by Licensee on the Net Sales in such country will be reduced by fifty percent (50%).

 

(b)          If it is necessary for Licensee to obtain a license from a Third Party under any Patent in a particular country in the Territory in order to use, make, or sell a Licensed Product and Licensee obtains such a license, Licensee may deduct, from the royalty payment that would otherwise have been due pursuant to Section 6.1(a) with respect to Net Sales of the applicable Licensed Product in such country in a particular applicable semi-annual period an amount equal to fifty percent (50%) of the royalties paid by Licensee to such Third Party pursuant to such license on account of the sale of such Licensed Product in such country during such applicable semi-annual period.

 

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6.2            License Fee and Equity Investment .

 

(a)          On February 10, 2014, Licensee paid Licensor US$150,000 as a license fee ($100,000 of which is to be allocated to this RGN-259 license) pursuant to the terms set forth in the Binding Term Sheet that was executed between the Parties on February 7, 2014, the receipt of which is hereby acknowledged by Licensor.

 

(b)          Licensee shall purchase US$1.35 million of Licensor common stock by March 28, 2014 at a price of US$0.12 per share.

 

(c)          Licensee shall purchase US$1.0 million of Licensor common stock by August 31, 2014 at a price of US$0.12 per share.

 

(d)          A failure of Licensee to make payments pursuant to Sections 6.2(b) and 6.2(c) by the deadlines set forth herein shall constitute a breach of material obligation under Section 13.1(a) and give Licensor the right to terminate this Agreement as provided in Section 13. For the avoidance of doubt, the equity investments provided in the foregoing subsections (b) and (c) of this Section 6.2 refer to the same equity investments provided in the Section 6.2 of the RGN-137 Agreement.

 

6.3            Equity Investment Option . Licensor hereby grants Licensee an option to purchase 5.5 million shares of Licensor common stock in a single tranche at a price of US$0.15 per share, at any time during the period commencing on the date hereof and expiring on January 31, 2015. Upon exercise of the option, Licensee shall immediately pay the entire sum due. For the avoidance of doubt, the equity investment option provided in this Section 6.3 refers to the same equity investment option provided in the Section 6.3 of the RGN-137 Agreement.

 

6.4            Commercial Milestone Payments .

 

(a)          Licensee shall promptly pay to Licensor a non-refundable sum of US$[***] upon the First Commercial Sale of Licensed Product in Korea.

 

(b)          Licensee shall promptly pay to Licensor a non-refundable sum of US$[***] upon obtaining US$[***] of aggregate, cumulative commercial Net Sales of Licensed Product in Japan.

 

(c)          Licensee shall promptly pay to Licensor a non-refundable sum of US$[***] million upon obtaining US$[***] million of aggregate, cumulative commercial Net Sales of Licensed Product in the Territory (one time only), and Licensee shall pay to Licensor such US$[***] million in three equal installments of US$[***] million per year for three (3) consecutive years with the first payment due by the thirtieth (30th) day from obtaining the Net Sales defined hereunder and the two (2) subsequent payments due on the first and second anniversary of such first due date.

 

6.5            Royalty Reports . Licensee shall furnish to Licensor on each of March 1 and September 1 of each calendar year during the Royalty Term, a complete, detailed and accurate written report for the preceding six month period from the prior report showing (i) the gross amount of sales, on an item-by-item basis, of Licensed Products by Licensee, Sublicensees and Distributors to independent buyers (whether an end-user, wholesaler or otherwise) in bona fide arm’s length transactions; (ii) the adjustments resulting from the deductions in the definition of “Net Sales; (iii) total Net Sales and (iv) the conversion into United States Dollars, pursuant to Section 6.7, of any such Net Sales made in another currency; and (v) the calculation of royalties due.

 

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6.6            Manner of Payments . All payments due Licensor under this Agreement shall be payable in United States Dollars by wire transfer of immediately available funds to such bank account(s) as Licensor shall designate, or by such other method as Licensor may reasonably designate.

 

6.7            Exchange Rate . When converting any amount in another currency into United States Dollars, Licensee shall use an exchange rate equal to New York foreign exchange rate quoted in the Wall Street Journal on the business day that is five (5) days prior to the date a payment under this Agreement is due.

 

6.8            Interest on Late Payments . Any payment not paid within thirty (30) calendar days from the date such payment is due under this Agreement shall be subject to interest from and including the date such payment is due through and including the date such payment is actually made at an annual rate equal to the sum of two percent (2%) plus the annual prime rate of interest quoted in the Money Rates Section of the Wall Street Journal calculated daily on the basis of a 365-day year, or, if such rate is not available for any reason, similar reputable data source, or, if lower, the highest rate permitted under applicable law. The payment of such interest shall not limit Licensor from exercising any other rights it may have as a consequence of the lateness of any payment.

 

6.9            Records; Audit Rights .

 

(a)           Records . Licensee shall maintain, and shall require its Affiliates, Sublicensees and Distributors to maintain, during the Term and for a period of five (5) years thereafter, complete, detailed and accurate books and records in connection with the sale of Licensed Product as necessary to allow the accurate determination of any and all financial and accounting information relevant to either Party’s payment obligations hereunder, including without limitation as necessary for the calculation of the royalties due to Licensor hereunder.

 

(b)           Audit Rights .

 

(i)          Licensor or its representative shall have the right to annually audit Licensee’s, its Affiliates’, its Sublicensees’ and its Distributors’ records as set forth in this Section 6.8. Licensee shall permit Licensor or its representative to have access during normal business hours to such records of Licensee, its Affiliates and its Sublicensees as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any Marketing Year ending not more than five (5) years prior to the date of such request. Annual audits can take place no more often than once per each calendar year. Notice of Licensor’s intent to conduct an audit must be provided within thirty (30) days of the later of: (i) Licensor’s receipt of the periodic royalty report reflecting full yearly sales of Licensed Product or (ii) Licensee’s filing of its official report in accordance with the Korean Stock Exchange regulations. Except as otherwise provided in Section 6.9(b)(ii), Licensor shall be responsible for its own costs and expenses relating to any audit conducted under this Section 6.9(b)(i). Licensee shall cause its Affiliates and Sublicensees to agree to make their records available for audit by Licensor or its representative as set forth in this Section 6.9.

 

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(ii)         If any audit conducted by Licensor or its representative shows an underpayment of royalties to Licensor, Licensee shall remit to Licensor the amount of such underpayment within thirty (30) days after its receipt of Licensor’s request therefor. If an underpayment in royalties exceeds five percent (5%) of the total amount owed for the period then being audited, Licensee shall be responsible, and promptly shall reimburse Licensor, for Licensor’s reasonable out-of-pocket costs for conducting the audit. If any audit conducted by Licensor or its representative shows an overpayment of royalties to Licensor, such overpayment shall be refunded to Licensee promptly.

 

(c)           Confidentiality . Licensor shall treat all financial information of Licensee, its Affiliates, Sublicensees and Distributors that Licensor reviews in connection with any audit conducted under this Section 6.9 as Confidential Information of Licensee subject to the provisions of Section 9 of this Agreement.

 

Section 7. Regulatory Matters

 

7.1            Regulatory Approvals . Licensee shall have the sole authority and responsibility to obtain in its own name and maintain any Regulatory Approvals and Marketing Approvals with respect to the Licensed Product in the Territory. Licensor shall, promptly after the Effective Date, provide Licensee with a copy of any relevant data related to the Licensed Product owned by Licensor that have been filed with the FDA. Subject to the prevailing applicable Regulatory Law in the Territory, Licensor shall retain the sole right, but not the obligation, to be designated as the sponsor of any and all clinical trials of Licensed Product conducted by Licensee, and Licensor shall have the sole right to decide, to the extent permitted by the applicable Regulatory Law in the Territory, whether any clinical trials shall be conducted under an IND issued by the FDA or under an IND issued by the relevant local Regulatory Authority. Irrespective of the exercise of such rights, Licensee shall at all times be responsible for ensuring that any and all clinical trials are conducted in compliance with all applicable Regulatory Laws and other requirements of any Regulatory Authority in the Territory, and all Regulatory Laws and other requirements of any Governmental Authority (including any promulgated by the FDA) that would be applicable if such clinical trials were sponsored under Licensor’s IND or otherwise subject to the jurisdiction of the FDA.

 

7.2            Contact with Governmental Authorities . Subject to the other provisions of this Section 7.2, Licensee shall be solely responsible for responding to all inquiries, notices of violation, warning letters, inspectional observations, and other actions from or by Governmental Authorities in the Territory, in each case to the extent related to the Licensed Product in the Territory. Licensor and Licensee shall immediately forward to each other copies of any material correspondence from any Governmental Authority that it receives in respect of the Licensed Product. Notwithstanding the other provisions of this Section 7.2, Licensee shall not respond to any inquiries or other correspondence from a Governmental Authority with respect to the Licensed Product in the Territory without first providing Licensor with a copy of its proposed response, and incorporating any reasonable comments of Licensor in such response. Licensor shall cooperate with Licensee in responding to any inquiry or other correspondence from a Governmental Authority in a timely manner, including by promptly responding to all inquiries of Licensee relating thereto.

 

7.3            Regulatory Information . Each Party agrees to provide the other Party with all reasonable assistance and take all actions reasonably requested by the other Party that are necessary or desirable to enable the other Party to comply with any Law or other requirement of any Governmental Authority applicable to the Licensed Product. Such assistance and actions shall include, among other things, (a) informing the other Party, within five (5) business days, of receiving notice of any action by, or notification or other information which it receives (directly or indirectly) from any Governmental Authority that: (i) raises any material concerns regarding the safety or efficacy of the Licensed Product; (ii) indicates or suggests a potential material liability for either Party to Third Parties arising in connection with the Licensed Product; or (iii) is reasonably likely to lead to a field alert report, recall or market withdrawal of the Licensed Product; provided, that neither Party shall be obliged to disclose information in breach of any contractual restriction; and (b) Licensee immediately reporting to Licensor the occurrence of any adverse reaction (including without limitation death) or other incident during any clinical trial or medicinal exam and any other information so as to enable Licensor to fulfill its reporting obligations to any Governmental Authority, as further specified by the Safety Agreement.

 

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7.4            Official Documentation . Licensee shall provide to Licensor one exact copy of any official registration and/or importation documents supplied by the relevant Regulatory Authorities immediately upon issuance. In case of early termination of this Agreement, Licensee shall provide to Licensor any original versions of such registrations and/or documents that are not otherwise in Licensor’s possession as per Section 13.3(a).

 

7.5            Clinical Trial Reports . Without limiting any of Licensee’s obligations under this Agreement, Licensee shall be responsible for preparing the clinical trial yearly progress reports, clinical trial final report and any other reports as may be required by a Regulatory Authority in connection with clinical trials of the Licensed Product; provided, however that Licensee shall provide drafts of such reports for Licensor’s knowledge prior to submission to the applicable Regulatory Authority and provide all final reports submitted to applicable Regulatory Authorities. With respect to all clinical trials for products containing Tβ4 that are directly related to the development of Licensed Products in the Field and the Territory that have been completed prior to, or are in progress as of the date hereof, Licensor shall provide Licensee with copies of the related clinical trial reports, that Licensor has the right to disclose, promptly upon the execution hereof or upon the finalization of the report, as applicable.

 

7.6            Unknown Side Effects; Adverse Reactions .

 

(a)           Reporting Unknown Side Effects and Adverse Reactions . Each Party shall provide promptly to the other Party any information and data relating to any serious or previously unknown side effects or adverse reactions relating to the Licensed Product that the providing Party receives from any source, as further specified in the Safety Agreement.

     

(b)           Safety Agreement . Promptly after the Effective Date and before the date that Licensee commences any clinical trials of the Licensed Product in the Territory, the Parties shall enter into a separate written safety agreement containing (i) appropriate provisions addressing safety issues relating to the Licensed Products, (ii) a description of the types of side effects and reactions that must be reported pursuant to Section 7.6(a) and any other complaints or information requests that must be reported, and (iii) such cooperative working procedures as are reasonably necessary to ensure that satisfactory systems and processes are in place to ensure the effective exchange of safety and other medical information relating to the Licensed Product (the “ Safety Agreement ”).

 

Section 8. Intellectual Property

 

8.1            Trademarks . Licensee shall be free to use Licensee’s Trademarks or any other Trademark(s) owned by the Licensee in the Territory for the Licensed Product.

 

8.2            Ownership of Inventions .

 

(a)           Licensee Inventions . Subject to any licenses granted to Licensor herein, Licensee shall own all Inventions having as inventors only employees, consultants or contractors of Licensee (“ Licensee Inventions ”). Licensee shall have written agreements in place with its employees, consultants, and contractors giving Licensee all rights and authority necessary to grant the license in Section 8.3(a).

 

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A- 1
 

 

(b)           Licensor Inventions . Subject to any licenses granted to Licensee herein, Licensor shall own all Inventions having as inventors only employees, consultants or contractors of Licensor (“ Licensor Inventions ”). Licensor shall have written agreements in place with its employees, consultants, and contractors giving Licensor all rights and authority necessary to grant the license in Section 8.3(b).

 

(c)           Joint Inventions . Licensee and Licensor shall own jointly all Inventions having as inventors employees, consultants or contractors of both Licensee and Licensor (“ Joint Inventions ”). The Parties will agree on a case-by-case basis the appropriate allocation of cost and control concerning matters regarding the prosecution, maintenance, defense and infringement of Patents for such Joint Inventions.

 

8.3            Licenses to Certain Inventions .

 

(a)           License Grant to Licensor . To the extent that any Licensee Invention or any Joint Invention relates to the development, promotion, marketing, distribution, manufacturing or sale of the Licensed Product, Licensee hereby grants to Licensor, and Licensor hereby accepts, an exclusive, perpetual, transferable, sublicensable (through multiple tiers) license under Licensee’s rights in such Licensee Invention or Joint Invention, as applicable, to research, develop, promote, market, distribute, manufacture, have manufactured, sell, offer for sale or import the Licensed Product outside the Territory and/or outside the Field. The foregoing license shall include a right of reference (transferable by Licensor to its Affiliates and sublicensees) to all regulatory filings made by Licensee in the Territory and all data from any clinical trials conducted by Licensee pursuant to this Agreement for the development, manufacture and commercialization of any Licensed Product outside the Territory and/or outside the Field. Licensee shall promptly disclose all Licensee Inventions and Joint Inventions in writing to Licensor. If Licensor desires to use any such Licensee Invention and/or Joint Invention for the development, manufacture and commercialization of the Licensed Products outside the Territory and/or outside the Field, Licensor shall notify Licensee in writing.

 

(b)           License Grant to Licensee . To the extent that any Licensor Invention or any Joint Invention relates to the development, promotion, marketing, distribution, or sale of the Licensed Product, then such Licensor Invention or Licensor’s interest in such Joint Invention, as applicable, shall be deemed a Licensed Patent and shall be subject to the licenses granted to Licensee pursuant to Sections 2.1(a), 2.1(b) and 2.1(c). The Parties shall promptly disclose to the other Party all Inventions that are relevant to Licensed Products and subject to the Licenses granted hereunder.

 

8.4            Patent Marking . Licensee shall, and shall cause its Affiliates, Sublicensees and Distributors to mark all Licensed Products sold or otherwise distributed pursuant to this Agreement in accordance with the applicable patent statutes and other relevant regulations in the jurisdiction of the Territory in which such Licensed Product is manufactured, sold or otherwise distributed.

 

8.5            Prosecution and Maintenance of Licensed Patents in the Territory .

 

(a)           Prosecution . As between Licensor and Licensee, Licensor shall have the right, but not the obligation, to prepare, file, prosecute, and maintain the Licensed Patents in the Territory, and to pursue any proceeding (including interferences, re-examinations, examinations, protests, reissues, opposition proceedings and the like) relating to any of the Licensed Patents (collectively “ Prosecute ”) in the Territory, such costs and expenses shall be shared equally by the Parties. The Parties agree to utilize Licensee’s local intellectual property counsel and counsel shall promptly provide Licensor with all information related to such prosecution. In the event that Licensor decides not to Prosecute any Licensed Patent, Licensor shall notify Licensee of its decision and the reason therefor, and subject to Licensor’s consent (which will not be unreasonably withheld or delayed), Licensee shall have the right to Prosecute such Licensed Patent in the Territory at its expense.

 

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(b)           Cooperation . In connection with any of Licensor’s activities to Prosecute any of the Licensed Patents, Licensee shall cooperate fully and provide Licensor with any information or assistance that Licensor reasonably requests, including executing such documents as may be necessary with respect to such prosecution activity. If Licensee becomes aware of any patent, information, proceeding or other matter that may affect the preparation, filing, prosecution, or maintenance of any of the Licensed Patents or that may adversely impact the validity, scope, title or enforceability of any of the Licensed Patents, Licensee shall promptly notify Licensor of such patent, information, proceeding, or matter.

 

8.6            Infringement by Third Parties .

 

(a)           Notice . If Licensee learns of any actual or possible infringement of any Licensed Patent in the Territory, or any actual or possible misappropriation or misuse of Licensed Know-How, Licensee shall promptly notify Licensor of such infringement, misappropriation or misuse.

 

(b)           Right to Bring Suit in the Territory .

 

(i)          As between Licensor and Licensee, Licensor shall have the right, but not the obligation, to bring and control any legal action or proceeding with respect to any infringement of Licensed Patents or any misappropriation or misuse of Licensed Know-How by Third Parties in the Territory, at its own expense and using counsel of its own choice.

 

(ii)         In the event that Licensor declines to take legal action with respect to any infringement of the Licensed Patents, Licensee shall have the right, after giving Licensor ten (10) working days’ prior notice of its intent to do so, to take such legal action at its own expense, with the concomitant right to choose legal counsel reasonably acceptable to Licensor and to determine legal strategy. Licensor shall have the right to participate in any such legal action using its own counsel, at its own expense. Licensee may not settle or compromise any such controversy with any Third Party without the prior written approval of Licensor, which shall not be unreasonably withheld or delayed.

 

(iii)        For any action or proceeding brought by Licensor pursuant to this Section 8.6, if Licensor is unable to initiate or prosecute such action solely in its own name, then Licensee shall join such action voluntarily and shall execute all documents necessary to initiate litigation to prosecute and maintain such action.

 

(iv)        In connection with any action or proceeding brought by Licensor pursuant to this Section 8.6, Licensee shall cooperate fully and will provide Licensor with any information or assistance that Licensor reasonably requests.

 

8.7            Certifications . Each Party shall inform the other Party of any certification related to the Licensed Product regarding any Licensed Patents it receives pursuant to either 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions, or any equivalent regulations in any jurisdiction of the Territory, and shall provide the other Party with a copy of such certification within five (5) days of receipt by such Party. Licensor’s and Licensee’s rights with respect to the initiation and prosecution of any legal action as a result of such certification or any recovery obtained as a result of such legal action shall be as set forth in this Section 8.

 

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8.8            Defense of Third Party Claims .

 

(a)           Notice . If either Party learns that a Third Party has commenced or plans to commence, either as a claim, a counterclaim, or an action for declaratory judgment, an action or proceeding challenging any of the Licensed Patents in any jurisdiction of the Territory, such Party shall promptly provide the other Party with notice thereof.

 

(b)           Licensor’s Right to Defend . As between Licensor and Licensee, Licensor shall have the right, but not the obligation, to defend and control any claim, counterclaim or other action initiated by a Third Party challenging any of the Licensed Patents in any jurisdiction of the Territory (each a “Challenge”), at its own expense and using counsel of its own choice.

 

(i)          For the defense of any Challenge pursuant to this Section 8.8, if Licensor is unable to initiate or prosecute such defense solely in its own name, then Licensee (subject to any necessary approval of the relevant court) shall join such action voluntarily and shall execute all documents necessary to initiate litigation to prosecute and maintain such action.

 

(ii)         In connection with the defense of any Challenge brought by Licensor pursuant to this Section 8.8, Licensee shall cooperate fully and will provide Licensor with any information or assistance that Licensor reasonably requests.

 

8.9            Awards and Recovery . Any recovery obtained by Licensor in connection with or as a result of any action contemplated by Section 8.6 or 8.8, whether by settlement of otherwise, shall be shared by the Parties as follows:

 

(a)          such recovery shall first be allocated to Licensor for reimbursement in respect of its respective out-of-pocket costs and expenses incurred in connection with such action; and

 

(b)          any remaining amounts after such reimbursement shall be split equally by the Parties.

 

Section 9. Confidentiality and Press Releases

 

9.1            Confidential Information . Except to the extent expressly authorized by this Agreement, or otherwise agreed in writing by the Parties, the Parties agree that the receiving Party (the “ Receiving Party ”) shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any Confidential Information which is disclosed to it by the other Party (or an Affiliate thereof) (each, a “ Disclosing Party ”), except to the extent that the Receiving Party can demonstrate by competent written evidence that such Confidential Information:

 

(a)          was already legally in the possession of the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party;

 

(b)          was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;

 

(c)          became generally available to the public or was otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement;

 

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(d)          was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or

 

(e)          is independently discovered or developed by the Receiving Party without the use of Confidential Information provided by the Disclosing Party.

 

9.2            Exceptions . The obligations of this Section 9 shall not apply to Confidential Information that:

 

(a)          is submitted to Governmental Authorities by the Receiving Party to facilitate the issuance of any Regulatory Approval for the Licensed Product, or to obtain, maintain, enforce or defend Patents (in each case only to the extent permitted by this Agreement; provided that (A) such disclosure may be only to the extent reasonably necessary to obtain Regulatory Approvals or Patents, as applicable, and (B) the Receiving Party shall take reasonable measures to assure confidential treatment of such information to the extent applicable;

 

(b)          is provided by the Receiving Party to Third Parties (including, in the case of Licensee, to its Affiliates, Sublicensees or Distributors) under written confidentiality agreements having provisions at least as stringent as those in this Agreement, for consulting, development, external testing, marketing trials and other similar activities to the extent that such Receiving Party is permitted to conduct such activities pursuant to this Agreement; or

 

(c)          is otherwise required to be disclosed by the Receiving Party in compliance with Laws (including, without limitation and for the avoidance of doubt, the requirements of the U.S. Securities and Exchange Commission, the American Stock Exchange, the Korean Stock Exchange, and any other stock exchange on which securities issued by a Party are traded) or order by a court or other Governmental Authority having competent jurisdiction; provided, however, that the Receiving Party shall first give written notice to the Disclosing Party in order to allow the Disclosing Party the opportunity to seek confidential treatment of the Confidential Information. Confidential Information that is disclosed pursuant to Law or an order by a court or other Governmental Authority shall remain otherwise subject to the confidentiality and non-use provisions of this Section 9, and the Party disclosing Confidential Information pursuant to a Law or order by a court or other Governmental Authority shall take all reasonable steps necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.

 

9.3            Disclosure to PHS . Licensor may disclose certain Confidential Information of Licensee to PHS in order to comply with the PHS License. In such event, such Confidential Information shall be subject to the applicable confidentiality provisions of the PHS License.

 

9.4            Return of Confidential Information Upon Expiration or Termination of Agreement . Within thirty (30) days after any expiration or termination of this Agreement, each Party shall destroy (and certify to the other Party such destruction) or return (as requested by the other Party) all Confidential Information provided by the other Party except as otherwise set forth in this Agreement, and except that each Party may retain a single copy of the Confidential Information in its confidential legal files for the sole purpose of ascertaining its ongoing rights and responsibilities regarding the Confidential Information and for defending or enforcing its legal rights.

 

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9.5            Written Agreements . The Receiving Party shall have in effect or obtain written agreements from each of its employees, consultants and contractors who have access to Confidential Information of the Disclosing Party, which agreements shall obligate such persons to similar obligations of confidentiality, and to assign to the Receiving Party all Know-How, information and Inventions conceived, made or reduced to practice by such persons during the course of performing the Receiving Party’s obligations under this Agreement. Each Party will notify the other Party promptly upon discovery of any unauthorized use or disclosure of the Confidential Information of the other Party.

 

9.6            Remedies . Each Party shall be entitled, in addition to any other right or remedy it may have, at law or in equity, to seek an injunction, without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Section 9.

 

9.7            Prior Confidentiality Agreement . The Confidential Disclosure Agreement, dated as of November 6, 2013, between Licensor and Licensee shall remain in effect with respect to disclosures made thereunder prior to the Effective Date.

 

9.8            Press Releases . Except as required by Law (including, without limitation and for the avoidance of doubt, the requirements of the U.S. Securities and Exchange Commission, the American Stock Exchange, the Korean Stock Exchange, and any other stock exchange on which securities issued by a Party are traded) or any Governmental Authority, neither Party shall make any press release or other public announcement relating to this Agreement or the transactions described herein without the prior written consent of the other Party.

 

Section 10. Representations, Warranties and Covenants

 

10.1          Licensor Representations, Warranties and Covenants . Licensor hereby represents, warrants and covenants to Licensee as follows:

 

(a)          the execution, delivery and performance by Licensor of this Agreement and the consummation of the transactions contemplated hereby are within Licensor’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensor. This Agreement constitutes the legal, valid and binding obligation of Licensor, enforceable against Licensor in accordance with its terms;

 

(b)          the execution, delivery and performance of this Agreement by Licensor will not violate any Law or any order of any Governmental Authority;

 

(c)          except as may be required to permit the sale or exportation of Licensed Product into the Territory from time to time during the Term, the execution, delivery or performance of this Agreement by Licensor will not require Licensor to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensor is a Party;

 

(d)          Licensor has the right and authority to grant the licenses granted in Section 2 of this Agreement;

 

(e)          to the best of our knowledge, without any investigation or due inquiry, all issued Licensed Patents are valid;

 

(f)          Licensor has not received any written communication from a third party alleging that Licensor’s practice of the Licensed Patents infringes the right of such third party; and

 

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(g)          Licensor, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensor, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensor shall promptly notify Licensee upon learning of any such debarment, conviction, threat or indictment.

 

10.2          Licensee Representations, Warranties and Covenants . Licensee hereby represents, warrants and covenants to Licensor as follows:

 

(a)          the execution, delivery and performance by Licensee of this Agreement and the consummation of the transactions contemplated hereby are within Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms;

 

(b)          Licensee will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to carry out its activities hereunder;

 

(c)          the execution, delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority;

 

(d)          except for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;

 

(e)          Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment;

 

(f)          Licensee and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement;

 

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(g)          Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.1, GMP;

 

(h)          As of the Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried out, all of its obligations and activities contemplated under this Agreement;

 

(i)          Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Term any product in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval. and

 

(j)          Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Field.

 

10.3          Disclaimer of Warranties . EXCEPT AS SET FORTH IN THIS AGREEMENT, NEITHER PARTY GIVES ANY OTHER WARRANTY, EXPRESS OR IMPLIED REGARDING THE LICENSED PRODUCTS, THE LICENSED KNOW-HOW, THE LICENSED PATENTS, OR THE SCOPE OR VALIDITY THEREOF. ALL OTHER WARRANTIES, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT ARE EXPRESSLY DISCLAIMED.

 

Section 11. Indemnification

 

11.1          Indemnification by Licensor . Licensor shall defend, indemnify and hold harmless Licensee, its Affiliates, and its and their respective officers, directors, employees and agents from and against any and all losses, liabilities, claims, damages, penalties, fines, costs and expenses (including reasonable legal fees and other litigation costs, regardless of outcome) (collectively “ Losses ”) arising as a result of (a) any breach of representations or warranties of Licensor provided in Section 10.1; (b) any Product Liability Claims or mandatory or voluntary recall of the Licensed Product in any jurisdiction of the Territory, if and to the extent that such Losses are caused by (i) failure of any Licensed Product provided by Licensor to conform to the relevant specifications therefor as specified with any clinical supplies provided to Licensee; or (ii) any willful act or negligence of Licensor and/or its manufacturer of clinical supplies in relation to the Licensed Product; provided, however, that Licensor shall have no obligation under this Section 11.1 if Licensee or any of its Affiliates, Sublicensees or Distributors has been negligent, whether in testing, storing, handling or otherwise dealing with the Licensed Product, or in case such Losses arise out of or are attributable to any breach of this Agreement by Licensee.

 

11.2          Indemnification by Licensee . Licensee shall defend, indemnify and hold harmless Licensor, its Affiliates, and its and their respective officers, directors, employees and agents from and against any and all Losses arising as a result of (a) any breach of representations or warranties of Licensee provided in Section 10.2; and (b) any and all Third Party claims if and to the extent that such Losses are caused by Licensee’s and/or any Affiliate’s, Sublicensee’s or Distributor’s manufacture, storage, development, use, promotion, marketing, distribution, and sale of the Licensed Product, provided, however, that Licensee shall have no obligation under this Section 11.2 if Licensor and/or its manufacturer have been negligent, whether in manufacturing, testing, storing, handling or otherwise dealing with the Licensed Product, or in the case said claims arise out of or are attributable to any breach of this Agreement by Licensor.

 

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11.3          Procedures . The Party seeking indemnification under this Section 11 (the “ Indemnified Party ”) shall give prompt notice to the Party against whom indemnity is sought (the “ Indemnifying Party ”) of the assertion or commencement of any claim for indemnification pursuant to this Section 11, and shall provide the Indemnifying Party such information with respect thereto that the Indemnifying Party may reasonably request. The failure to give such notice will relieve the Indemnifying Party of its indemnification obligations hereunder only to the extent that the Indemnifying Party has suffered actual prejudice thereby. The Indemnifying Party shall assume and control the defense and settlement of any such action, suit or proceeding at its own expense. The Indemnified Party shall, if requested by the Indemnifying Party, cooperate in all reasonable respects in such defense, at the Indemnifying Party’s expense, subject to the following. The Indemnified Party will be entitled at its own expense to participate in such defense and to employ separate counsel for such purpose. For so long as the Indemnifying Party is diligently defending any action, suit or proceeding pursuant to this Section 11, the Indemnifying Party will not be liable under this Section 11 for any settlement effected without its consent. No Party shall enter into any compromise or settlement which commits the other Party to take, or to forbear to take, any action without the other Party’s prior written consent.

 

11.4          Consequential Damages . NEITHER PARTY SHALL BE LIABLE TO OR OTHERWISE RESPONSIBLE TO THE OTHER PARTY HERETO FOR ANY LOSS OF PROFITS, DIMINUTION IN VALUE, OR INCIDENTAL, INDIRECT, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES THAT ARISE OUT OF OR RELATE TO THIS AGREEMENT OR THE PERFORMANCE OR BREACH HEREOF OR OTHERWISE AND WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE; PROVIDED, THAT, THE FOREGOING LIMITATION SHALL NOT APPLY: (I) TO A PARTY’S INDEMNIFICATION OBLIGATIONS PURSUANT TO SECTIONS 11.1 AND 11.2 ABOVE; (II) TO ANY GROSSLY NEGLIGENT ACT OR WILLFUL MISCONDUCT OF A PARTY; OR (III) TO A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS PURSUANT TO SECTION 9 HEREOF.

 

11.5          Insurance .

 

(a)           General Liability . Each Party shall maintain as and when available comprehensive general liability insurance, including blanket contractual liability insurance through the Term and for five (5) years thereafter, which insurance shall afford limits of not less than US$3,000,000 for each occurrence for bodily injury liability, personal injury liability, products liability, property damage liability, contractual liability and completed operations liability. Each Party shall ensure that such insurance will include coverage for defense costs.

 

(b)           Product Liability . Each Party shall maintain as and when available and thereafter throughout the Term product liability insurance on commercially standard terms for the pharmaceutical manufacturing industry, with a reputable insurer, in an amount not less than US$5,000,000 per occurrence and US$5,000,000 in the annual aggregate.

 

(c)           Certificate of Insurance . Each Party will provide, upon request and as and when available, the other with certificate(s) of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and the limits of liability. Each Party shall cause its insurance policy to name the other Party hereto as an additional insured. Each Party’s general liability insurance policy shall contain a waiver of subrogation rights which that Party’s insurer(s) may have against the other Party.

 

24 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 
 

  

Section 12. Information and Reporting

 

12.1         After the completion of equity investment as provided in Section 6.2, Licensee may examine, upon reasonable prior written request having been made to Licensor, but not more than twice per year, the books, records and accounts of Licensor. Licensee shall be entitled to receive reasonable information, including management accounts and operating statistics and other business and financial information, which exist at the time of request, to keep it properly informed about the business and affairs of Licensor and relevant to its interest as a shareholder.

 

12.2         Licensor shall provide reasonable access to Licensee’s personnel, upon reasonable notice and during normal business hours, but not more than twice per year, to access such books, records, accounts and other information relating to Licensor, which exist at the time of request, as may be necessary for them to review the information provided to Licensee pursuant to Sections 12.1.

 

12.3         Any information or documents provided to or made available for review by Licensee shall constitute Confidential Information and shall be protected accordingly as provided under Section 9 above.

 

Section 13. Term and Termination

 

13.1          Term and Rules Post Expiration: This Agreement shall enter into full force and effect at the Effective Date and as provided under this Section 13, the term of this Agreement (the “ Term ”) shall be on a Licensed Product by Licensed Product basis and on a country-by-country basis and shall continue until the expiration of the last-to-expire valid and applicable patent within the patent rights in the given country of the Territory, or following fifteen (15) years from the first commercial sale of each Licensed Product in such country, whichever is later.

 

13.2          Term and Rules Post Termination :

 

(a)          In the event either Party is in breach of any material obligation hereunder or under the RGN-137 License Agreement (the “ Breaching Party ”), the non-breaching Party may give written notice to the Breaching Party specifying the claimed particulars of such breach, and in the event such material breach is not cured, within sixty (60) days following the date of such written notification, without prejudice to any other rights and remedies available at any time to the non-breaching Party, the non-breaching Party shall have the right thereafter to terminate this Agreement by giving thirty (30) days prior written notice to the Breaching Party to such effect.

 

(b)           Termination for Governmental Action . Either Party may terminate this Agreement upon ten (10) days’ prior written notice in the event that any Governmental Authority takes any action or raises any objection (“ Governmental Action ”) that prevents Licensee, for a period of not less than one hundred eighty (180) days, from importing, exporting, purchasing or selling the Licensed Product in the Territory, or that has the effect of making Licensor’s manufacture of the Licensed Product unlawful.

 

(c)           Termination by Licensor for Patent Challenge . Licensor may terminate this Agreement in its entirety immediately upon written notice to Licensee if Licensee or its Affiliates, Sublicensees or Distributors (directly or indirectly, individually or in association with any person or entity) challenges the validity, enforceability or scope of any Licensed Patents anywhere in the world.

 

(d)           Termination or Conversion Pursuant to the PHS License . In the event that PHS terminates the PHS License under Article 13 therein or rescinds a Licensed Field of Use (as that term is defined in the PHS License) that includes any portion of the Field in which Licensee is licensed hereunder, Licensee may, at its option:

 

25 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 
 

  

(i)          terminate this Agreement; or

 

(ii)         convert this Agreement to a license between Licensee, on the one hand, and Licensor and PHS, on the other hand, with such conversion subject to the approval of PHS, which shall not be unreasonably withheld, and contingent upon Licensee’s acceptance of all of the provisions of the PHS License.

 

(e)           Termination for Bankruptcy . To the extent permitted under applicable Law, if at any time during the Term, an Event of Bankruptcy (as defined below) relating to either Party (the “Bankrupt Party”) occurs, the other Party (the “Other Party”) shall have, in addition to all other legal and equitable rights and remedies available hereunder, the option to terminate this Agreement upon sixty (60) days written notice to the Bankrupt Party. It is agreed and understood that if the Other Party does not elect to terminate this Agreement upon the occurrence of an Event of Bankruptcy, except as may otherwise be agreed with the trustee or receiver appointed to manage the affairs of the Bankrupt Party, the Other Party shall continue to make all payments required of it under this Agreement as if the Event of Bankruptcy had not occurred, the Bankrupt Party shall not have the right to terminate any license granted herein. The term “Event of Bankruptcy” means: (i) filing in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Bankrupt Party or of its assets; (ii) proposing a written agreement of composition or extension of a Bankrupt Party’s debts; (iii) being served with an involuntary petition against the Bankrupt Party, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof; (iv) proposing or being a party to any dissolution or liquidation when insolvent; or (v) making an assignment for the benefit of creditors. Without limitation, the Bankrupt Party’s rights under this Agreement shall include those rights afforded by 11 U.S.C. § 365(n) of the United States Bankruptcy Code (the “Bankruptcy Code”) and any successor thereto. If the bankruptcy trustee of a Bankrupt Party as a debtor or debtor-in-possession rejects this Agreement under 11 U.S.C. § 365(o) of the Bankruptcy Code, the Other Party may elect to retain its rights licensed from the Bankrupt Party hereunder (and any other supplementary agreements hereto) for the duration of this Agreement and avail itself of all rights and remedies to the full extent contemplated by this Agreement and 11 U.S.C. § 365(n) of the Bankruptcy Code, and any other relevant laws.

 

13.3          Effects of Termination .

 

(a)           Return of Material . In the event of early termination of this Agreement for any reason: (i) all rights and licenses granted to Licensee under this Agreement shall terminate (including all rights and licenses with respect to Licensed Patents and Licensed Know-How), and (ii) Licensee shall transfer to Licensor all data, files, records, information and other materials (including clinical supplies of Licensed Product and including the originals of any registrations and/or importation documents as specified in Section 7.4) in its possession or control relating to, containing or comprising the Licensed Product, including Licensor’s Confidential Information .

     

(b)           Transfer of Materials . In the event of early termination of this Agreement for any reason:

 

(i)          to the extent not transferred pursuant to Section 13.3(a), Licensee shall provide to Licensor a copy of any and all documentation and data owned by Licensee and in tangible form at the time of termination of the Agreement that has been generated with respect to the Licensed Product and is necessary to enable Licensor to continue development of a Licensed Product and the commercialization thereof in the Territory (collectively, the “ Licensee Product Data ”), and Licensor may use such Licensee Product Data at its discretion on an exclusive basis, to the extent necessary to enable Licensor, its Affiliates and Third Parties on behalf of Licensor or its Affiliates to continue to develop and commercialize a Licensed Product in the Territory; and

 

26 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

A- 2
 

 

(ii)         if such termination occurs after a Licensed Product has received Regulatory Approval, Licensee shall, if permitted under applicable Law, promptly transfer and deliver to Licensor original copies of any and all Regulatory Approvals obtained in connection with the Licensed Product in the Territory (including any and all official registrations, licenses, permits, certificates, and/or importation documents issued by Regulatory Authorities in the Territory), as well as any and all regulatory documentation and applications for Regulatory Approval submitted to Regulatory Authorities in the Territory in connection with the Licensed Product; Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 13.3(b)(ii);

 

(iii)        to the extent that any Regulatory Approval is issued in the name of Licensee, its Affiliates, Sublicensees or other designee, Licensee shall, to the extent permitted by applicable Law, promptly assign or procure the assignment to Licensor (or its designee) such Regulatory Approvals, and in the event assignment is not permitted under applicable Law or cannot be carried out for any other reason, the Licensee shall take all steps that are necessary and/or desirable to assist Licensor to obtain such Regulatory Approvals in the name of Licensor (or its designee) in the Territory, with such actions including without limitation coordinating with the applicable Regulatory Authority, furnishing all necessary information and documents in respect thereof, and promptly cancelling and terminating (as necessary) all Regulatory Approvals held by the Licensee, its Affiliate(s), Sublicensee(s) and/or other designee(s) which are not otherwise assignable or transferable to the Licensor (or its designee); Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 13.3(b)(iii); and

 

(iv)         Licensee shall assign (or cause its Affiliates to assign) to Licensor all agreements with any Third Party with respect to the conduct of clinical trials for the Licensed Product, including agreements with contract research organizations, clinical sites and investigators, unless expressly prohibited by any such agreement or unless such agreement covers clinical trials for products in addition to the Licensed Products (in which case Licensee shall cooperate with Licensor in all reasonable respects to secure the consent of such Third Party to such assignment or to the conclusion of a new agreement between the Licensor and the Third Party on terms substantially similar to the agreement between Licensee and the Third Party), and Licensor shall assume all obligations under all such agreements.

 

(c)           Survival of Sublicenses . All sublicenses granted by Licensee to Sublicensees shall survive termination of this Agreement, and Licensor shall assume all such sublicenses as the Licensor thereunder in accordance with the terms of such sublicenses; provided, however, that Licensor may elect to terminate any such sublicenses, and Licensor shall not be required under this Section 13 to assume obligations under any such sublicense that are greater in scope than those set forth in this Agreement.

 

(d)           Remedies for Termination . Expiration or termination of this Agreement by either Party shall not affect any claim, demand, liability or right of a Party arising pursuant to this Agreement prior to such termination or expiration hereof.

 

13.4          Survival . The following provisions shall survive the termination or expiration of this Agreement: Section 6 (with respect to Net Sales made prior to expiration or termination of this Agreement), Sections 7.3, 7.6(a), 9, 11, 13.3, 13.4, and 14, and all provisions of the PHS License that are binding on Licensee and are specified in the PHS License as surviving the expiration or termination thereof.

 

27 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 
 

  

Section 14. Miscellaneous

 

14.1          Waiver . The waiver by any Party of a breach of any provision of this Agreement shall not operate, or be construed, as a waiver of any subsequent breach.

 

14.2          Modification . No change, modification, or waiver of any term of this Agreement shall be valid unless it is in writing and signed by both Parties.

 

14.3          Entire Agreement . This Agreement (including all exhibits and attachments hereto, all of which are incorporated herein by reference) constitutes the entire agreement between the Parties (and their Affiliates) with respect to the subject matter hereof and thereof, and supersedes all prior agreements and understandings, whether oral or written, between the Parties, except for the Confidential Disclosure Agreement described in Section 9.7.

 

14.4          English Language . This Agreement is written and executed in the English language. Any translation into any other language shall not be an official version of this Agreement and in the event of any conflict in interpretation between the English version and such translation, the English version shall prevail.

 

14.5          Assignment . Except as expressly permitted otherwise in this Agreement, Licensor and Licensee may not assign its rights or delegate its obligations hereunder to any Person without the consent of the other Party; provided that either Party may (i) assign its rights or delegate its obligations hereunder to any of its Affiliates without the consent of the other Party upon (30) thirty days’ prior written notice to the other Party and (ii) either Party may assign or transfer this Agreement and any rights and obligations hereunder to any Third Party in connection with a change in control. All sublicenses granted to Affiliates or Third Parties in accordance with this Agreement shall be subject to all terms, conditions, obligations and covenants of this Agreement and all applicable provisions of the PHS License. No such assignment shall remove or mitigate the obligations or liability of the assigning Party unless otherwise agreed in writing by the non-assigning Party. If Licensor is involved in a Change of Control, the Intellectual Property of the Third Party that has become an Affiliate of Licensor through the transaction that constituted such Change of Control and the Intellectual Property of such Third Party’s Affiliates existing as of the closing of such Change of Control or developed outside of any activities under this Agreement, shall be automatically excluded from the definitions of Licensed Patents and Licensed Know-How licensed to Licensee under this Agreement.

 

14.6          Independent Contractor . This Agreement shall not be construed as constituting a partnership, joint venture or any other form of legal association that would impose liability upon one Party for the act or failure to act of the other Party, or as providing either Party with the right, power or authority (express or implied) to create any duty or obligation of the other Party.

 

14.7          Third Party Beneficiaries . Any sublicense granted by Licensee to an Affiliate or Third Party pursuant to Section 2.1(e) is intended by the Parties to be a third party beneficiary of this Agreement; provided that such Sublicense is in compliance with all of its obligations under any such sublicense to the extent that such obligations are required under this Agreement. Except as expressly provided in this Section 14.7, the Parties do not intend, nor will any Section of this Agreement be interpreted, to create for any person any third party beneficiary rights.

 

28 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 
 

  

14.8          Disputes . Disputes regarding the scope, validity or enforceability of Patents are excluded from this Section 14.8.

 

(a)           Good Faith Negotiations by Officers . In the event of disputes between the Parties arising out of or relating to this Agreement, or the breach, termination (other than termination for convenience in accordance with Section 13.2 (d)) or invalidity thereof, a Party seeking to resolve such dispute will, by written notice to the other, have such dispute referred to their respective chief executive officers, for attempted resolution by good faith negotiations within fourteen (14) days after such notice is received.

 

(b)           Mediation . In the event that the Parties are unable to resolve a dispute through good faith negotiations pursuant to Section 14.8(a), the Parties agree to submit such dispute to non-binding mediation using an industry expert mutually acceptable to the Parties. The costs of any such mediation shall be shared by the Parties equally.

 

(c)           Arbitration . If all good faith attempts to resolve a dispute through negotiations and mediation pursuant to Sections 14.814.8(a) and (b) have failed after sixty (60) days from notice provided pursuant to Section 14.8(a), then upon the request of either Party, the dispute shall be finally resolved by binding arbitration administered by I.C.C. Arbitration (the “ICC Rules”).

 

(i)          The arbitration shall be conducted by a panel of three neutral arbitrators (the “ Panel ”) appointed in accordance with the ICC Rules.

 

(ii)         The arbitration proceedings shall take place in New York, NY, USA. The arbitral proceedings and all pleadings shall be in the English language.

 

(iii)        The Panel shall have the power to decide all questions of arbitrability.

 

(iv)        At the request of either Party, the Panel will enter an appropriate protective order to maintain the confidentiality of information produced or exchanged in the course of the arbitration proceedings.

 

(v)         The Panel is empowered to award any remedy allowed by law, including monetary damages, prejudgment interest and punitive damages, and to grant final, complete, interim or interlocutory relief, including injunctive relief.

 

(vi)        The Parties may apply to a court of competent jurisdiction within the United States for a temporary restraining order, preliminary injunction, or other interim or conservatory relief, as necessary, without breach of this arbitration agreement and without any abridgment of the powers of the arbitrators. Judgment on the award rendered by the Panel may be entered in any court having jurisdiction thereof. Each Party hereby waives any defenses it may have to the personal jurisdiction and venue of such courts to resolve such disputes, including without limitation the defense of forum non conveniens , and each Party agrees not to file any motion to seek any relief under any forum non conveniens defense.

 

(vii)       Each Party shall bear its own legal fees arising in connection with the dispute. The Panel may assess costs, fees and expenses of the ICC and the Panel to the Parties in the manner the Panel deems appropriate under the circumstances.

 

29 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 
 

  

14.9          Notices . Except as otherwise provided herein, all notices or other communications hereunder shall be deemed sufficient if given in writing, via registered mail (return receipt requested), postage paid, or by reputable high speed delivery service ( e.g. , FedEx) or by courier addressed to the appropriate Party at the address set forth below, or at such other place as such Party may designate in writing to the other Party.

  

If to Licensor: RegeneRx Biopharmaceuticals, Inc.
  15245 Shady Grove Road
  Suite 470
  Rockville, Maryland 20850
  U.S.A.
  Attn:   President and CEO
  Phone: 301.208.9191
  Fax:   301.208.9194
   
With a copy to: Ken Krisko, Esq.
  Cooley LLP
  One Freedom Square
  Reston Town Center
  11951 Freedom Drive
  Reston, VA  20190-5656
  Direct: (703) 456-8187
  Fax: (703) 456-8100
   
If to Licensee: Digital Aria Co., Ltd.
  22 nd FL, Parkview Tower
  248 Jungjail-ro, Bundang-gu
  Seongnam-si, Gyeonggi-do 463-863
  Republic of Korea
  Attn:  CEO
  Phone: +82 31 786 7700
  Fax.:  +82 31 786 7801

 

All such notices shall be effective upon receipt.

 

14.10          Governing Law . This Agreement shall be governed and construed in accordance with the laws of New York, USA without regard to its principles of conflict of laws. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.

 

14.11          Severability . The provisions of this Agreement are severable. If any item or provision of this Agreement shall to any extent be invalid or unenforceable, the remainder of this Agreement shall not be affected thereby, and each term and provision of this Agreement shall be valid and shall be enforced to the fullest extent permitted by law. The Parties will use diligent good faith efforts to revise this Agreement as and to the extent reasonably necessary to effectuate their original intent and purpose under this Agreement.

 

30 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 
 

 

end of page
[ signatures appear on following page]

 

31 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 
 

 

IN WITNESS WHEREOF, this Agreement has been executed by a duly authorized officer of each Party as of the Effective Date.

 

  RegeneRx Biopharmaceuticals, Inc.
   
  By: /s/J.J. Finkelstein
  Name: J.J. Finkelstein
  Title: President & CEO
   
  Digital Aria Co., Ltd.
   
  By: /s/Ill Park
  Name: Ill Park
  Title: CEO

 

32 | Page*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 
 

  

Exhibits

 

Exhibit A - Licensed Patents: to be filled by RegeneRx

Exhibit B - PHS License Terms Applicable to Licensee

 

33 | Page

 

 
 

 

Exhibit A

 

LICENSED PATENTS

 

Summary of OPHTHALMIC Patents and Patent Applications with Relevant Claims in Pan Asia

 

[Rest of Page Intentionally Left Blank]

 

A- 1
 

 

2600-   Country   Serial No.
or
Patent No.
 

Filing Date 

  Status   Representative Claims
109   Australia   766826   7-29-1999   Issued  

1. A method for promoting wound healing in a subject in need of such treatment comprising administering to the subject a wound-healing effective amount of a composition containing a wound healing polypeptide said polypeptide comprising properties of having actin sequestering or actin binding activity said polypeptide comprising the amino acid sequence LKKTET.

13. A method for promoting wound healing in a subject in need of such treatment comprising administration to the subject of a wound-healing effective amount of a composition containing a polypeptide, said polypeptide comprising properties of having actin sequestering or actin binding capability, said polypeptide comprising amino acid sequence LKKTET; wherein said administration is selected from the group consisting of topical delivery, inhalation, systemic administration, oral administration, intranasal administration, aerosol administration, intravenous administration, intraperitoneal administration, intramuscular administration, intracavity administration, and transdermal administration.

24. A method for reducing inflammation in tissue of a subject comprising administering to a subject a therapeutically effective amount of a composition containing an inflammation-reducing polypeptide said polypeptide comprising properties of having actin sequestering or actin binding capability, said polypeptide comprising amino acid sequence LKKTET.

42. A method of inhibiting wound healing in a subject, comprising administering to the subject an effective amount of a composition containing an agent which decreases thymosin β4 activity.

46. A method of diagnosing a pathological state in a subject suspected of having pathology characterized by a wound healing disorder associated with thymosin β4, comprising: obtaining a sample suspected of containing thymosin β4 from the subject; detecting a level of thymosin β4 in the sample; and comparing the level of thymosin β4 in the sample to the level of thymosin β4 in a normal standard sample.

48. A method for ameliorating a wound healing disorder associated with thymosin β4, comprising treating a subject having the disorder, at the site of the disorder, with an effective amount of an agent which regulates thymosin β4 or the activity of a thymosin β4 isoform.

51. A method for identifying a compound which modulates wound healing, angiogenesis or cell migration activity, comprising contacting thymosin β4 or an isoform of thymosin β4 with a compound suspected of having thymosin β4 modulating activity and detecting an effect on thymosin β4 or thymosin β4 isoform activity.

54. A method of promoting epithelial cell migration in a subject, comprising contacting an epithelial cell with an effective amount of a composition including a polypeptide comprising properties of having actin sequestering or actin binding capability, said polypeptide comprising thymosin β4 or an isoform of thymosin β4.

63. A pharmaceutical composition comprising a fragment of a polypeptide, said fragment including amino acid sequence LKKTET, said fragment comprising properties of having actin sequestering or actin binding capability, said fragment having wound-healing or inflammation-reducing activity, said composition further including a pharmaceutically acceptable carrier when used to modulate wound healing or reduce inflammation.

69. A method for promoting wound healing in a subject in need of such treatment comprising administering to the subject a wound-healing effective amount of a composition containing a wound healing polypeptide other than thymosin β4, said polypeptide comprising properties of having actin sequestering or actin binding capability, said polypeptide having wound healing activity, and said polypeptide comprising the amino acid sequence LKKTET.

 

A- 2
 

 

190   Australia   2006261156   6-19-2006   Issued  

1.          Use of a peptide agent comprising amino acid sequence LKKTET or a conservative variant thereof, LKKTNT or a conservative variant thereof, KLKKTET, LKKTETQ, Thymosin β4 (Tβ4), a Tβ4 isoform, analogue or derivative, Tβ4 sulfoxide, an N-terminal variant of Tβ4, a C-terminal variant of Tβ4, Tβ4 ala , Tβ9, Tβ10, Tβ11, Tβ12, Tβ13, Tβ14, Tβ15, gelsolin, vitamin D binding protein (DBP), profilin, cofilin, depactin, DNasel, vilin, fragmin, severin, capping protein, β-actinin or acumentin, or a stimulating agent that stimulates production of said peptide agent, in the manufacture of a medicament for treating elevated intraocular pressure in a subject, wherein said medicament is formulated as an ophthalmically acceptable composition.

2.          A method of treating elevated intraocular pressure in a subject, comprising administering to the subject an ophthalmically acceptable composition comprising a peptide agent comprising amino acid sequence LKKTET or a conservative variant thereof, LKKTNT or a conservative variant thereof, KLKKTET, LKKTETQ, Thymosin β4 (Tβ4), a Tβ4 isoform, analogue or derivative, Tβ4 sulfoxide, an N-terminal variant of Tβ4, a C-terminal variant of Tβ4, Tβ4 ala , Tβ9, Tβ10, Tβ11, Tβ12, Tβ13, Tβ14, Tβ15, gelsolin, vitamin D binding protein (DBP), profilin, cofilin, depactin, DNasel, vilin, fragmin, severin, capping protein, β-actinin or acumentin, or a stimulating agent that stimulates production of said peptide agent.

9.          A method of treating dry eye syndrome in a subject, comprising administering to the subject an ophthalmically acceptable composition having a pH of about 6.8 to 8.1 and comprising a peptide agent comprising amino acid sequence LKKTET, or a conservative variant thereof, LKKTNT or a conservative variant thereof. KLKKTET, LKKTETQ, Thymosin β4 (Tβ4), a Tβ4 isoform, analogue or derivative, Tβ4 sulfoxide, an N-terminal variant of Tβ4, a C-terminal variant of 1134, Tβ4 ala , Tβ9, Tβ10, Tβ11, Tβ12, Tβ13, Tβ14, Tβ15, gelsolin, vitamin D binding protein (DBP), profiling, cofilin, depactin, Dnasel, vilin, fragmin, severin, capping protein, p-actinin, or acumentin, or a stimulating agent that stimulates production of said pept i de agent.

 

A- 3
 

 

230   Australia   2009258034   3-13-2009   Pending  

1. A peptide fragment having an amino acid sequence corresponding to a portion of at least one of a thymosin beta 4, a thymosin beta 10 or a thymosin beta 15 amino acid sequence, said fragment comprising amino acid sequence H-Leu-I_ys-I_ys-Thr-Glu-Thr-OH, Ac-Leu-Lys-Lys-Thr-Glu- Thr-OH, H-Ser-Asp-Lys-Pro-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle- Glu-Lys-Phe-Asp-Lys-Ser-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle- Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, Ac- Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, H-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys- Glu-Thr-OH, Ac-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-OH, H-IIe-GIu- Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser-OH, Ac-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly- Glu-Ser-OH, H-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, Ac-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Leu-Lys-Lys-Thr-Glu-Thr, Ac-Leu- Lys-Lys-Thr-Glu-Thr, H-Ser-Asp-Lys-Pro, H-Ser-Asp-Lys-Pro-Asp-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu- Ile-Glu-Lys-Phe-Asp-Lys-Ser, H-Leu-Lys-Lys-Thr-Glu-Thr-Gln, Ac-Leu-Lys- Lys-Thr-Glu-Thr-Gln, H-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr, Ac-GIu- Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr, H-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly- Glu-Ser, Ac-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser, H-Met-Ala-Glu-lle- Glu-Lys-Phe-Asp-Lys-Ser, Ac-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Leu-Lys-Lys-Thr-Glu-Thr-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu- Lys-Phe-Asp-Lys-Ser-OH, Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, Glu-Lys-Asn- Pro-Leu-Pro-Ser-Lys-Glu-Thr-OH, Ile-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu- Ser-OH, Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr- Glu-Thr-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp- Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-OH, H-Ser-Asp-Lys-Pro-Asp-Met- Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln- OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser- Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu- Lys-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys- Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu-Lys-OH, H-Leu-Lys-Lys-Thr-Glu- Thr-Gln-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys- Gln-Ala-Gly-Glu-Ser-OH, Ac-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn- Pro-Leu-Pro-Ser-Lys-GIu-Thr-lle-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys- Leu-Lys-Lys-Thr-Glu-Thr, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu- Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr, H-Ser-Asp-Lys-Pro- Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu- Thr-Gln, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys- Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln, H-Ser-Asp-Lys-Pro-Asp-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu- Lys, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser- Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys, H-Leu-Lys-Lys-Thr-Glu-Thr-GIn- Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys-Gln-Ala- Gly-Glu-Ser, Ac-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn-Pro-Leu-Pro- Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser, Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr- Glu-Thr-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys- Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu- Lys-OH, Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys- Glu-Thr-lle-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, a methionine- containing variant of said fragment in which said methionine is oxidized or superoxidized, a variant of said fragment which normally is methionine- containing but which has an amino acid substituent substituted for at least one methionine of the normally methionine-containing fragment, an isolated R-enantiomer of said fragment, an isolated S-enantiomer of said fragment, or a combination thereof.

22. A method of at least one of suppressing inflammation in tissue of a subject, stimulating cell migration in tissue of a subject, protecting tissue from cytotoxicity in tissue of a subject, inhibiting apoptosis in tissue of a subject, stimulating collagen in tissue of a subject, inhibiting collagen in tissue of a subject, stimulating collagen IV in tissue of a subject, stimulating elastin in tissue of a subject, inhibiting NFkB translocation in tissue of a subject, inhibiting tissue damage caused by ultraviolet (UV) radiation, protecting tissue from ultraviolet (UV) radiation damage, promoting neurite outgrowth, promoting neuron survival, stimulating production of L1 , inhibiting IKBa phosphorylation, or restoring impaired T-lymphocyte blastogenic response comprising administering to said subject a peptide fragment having an amino acid sequence corresponding to a portion of a thymosin beta 4, a thymosin beta 10 or a thymosin beta 15 amino acid sequence, said fragment comprising amino acid sequence H-Leu-Lys-Lys-Thr-Glu-Thr-OH, Ac-Leu-Lys-Lys-Thr-Glu-Thr-OH, H-Ser-Asp-Lys-Pro-OH, H-Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, Ac-Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Leu-Lys-Lys-Thr- Glu-Thr-Gln-OH, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, H-Glu-Lys-Asn-Pro- Leu-Pro-Ser-Lys-Glu-Thr-OH, Ac-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-OH, H-lle-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, Ac-IIe-GIu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, H-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, Ac-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Leu-Lys-Lys-Thr-Glu-Thr, Ac-Leu-Lys-Lys-Thr-Glu-Thr, H-Ser-Asp-Lys-Pro, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, H-Leu-Lys-Lys-Thr-Glu-Thr-Gln, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln, H-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr, Ac-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr, H-IIe-GIu-Gln-Glu-Lys-GIn-Ala-Gly-Glu-Ser, Ac-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser, H-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Ac-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Leu-Lys-Lys-Thr-Glu-Thr-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-OH, He-GIu-GIn-GIu-Lys-GIn-Ala-Gly-Glu-Ser-OH, Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-OH, H-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-Ile-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu- Thr-GIn-Glu-Lys, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe- Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-GIu-Thr-GIn-Glu-Lys, H-Leu-Lys-Lys- Thr-Glu-Thr-Gln-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln- Glu-Lys-GIn-Ala-Gly-Glu-Ser, Ac-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys- Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu- Ser, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys- Leu-Lys-Lys-Thr-Glu-Thr-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu- Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr- Glu-Thr-GIn-Glu-Lys-OH, Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn-Pro- Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, a methionine-containing variant of said fragment in which said methionine is oxidized or superoxidized, a variant of said fragment which normally is methionine-containing but which has an amino acid substituent substituted for at least one methionine of the normally methionine-containing fragment, an isolated R-enantiomer of said fragment, an isolated S-enantiomer of said fragment, or a combination thereof.

 

A- 4
 

 

230   Japan  

500875/2011

 

  3-13-2009   Pending  

1. A peptide fragment having an amino acid sequence corresponding to a portion of at least one of a thymosin beta 4, a thymosin beta 10 or a thymosin beta 15 amino acid sequence, said fragment comprising amino acid sequence H-Leu-I_ys-I_ys-Thr-Glu-Thr-OH, Ac-Leu-Lys-Lys-Thr-Glu- Thr-OH, H-Ser-Asp-Lys-Pro-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle- Glu-Lys-Phe-Asp-Lys-Ser-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle- Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, Ac- Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, H-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys- Glu-Thr-OH, Ac-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-OH, H-IIe-GIu- Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser-OH, Ac-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly- Glu-Ser-OH, H-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, Ac-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Leu-Lys-Lys-Thr-Glu-Thr, Ac-Leu- Lys-Lys-Thr-Glu-Thr, H-Ser-Asp-Lys-Pro, H-Ser-Asp-Lys-Pro-Asp-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu- Ile-Glu-Lys-Phe-Asp-Lys-Ser, H-Leu-Lys-Lys-Thr-Glu-Thr-Gln, Ac-Leu-Lys- Lys-Thr-Glu-Thr-Gln, H-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr, Ac-GIu- Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr, H-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly- Glu-Ser, Ac-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser, H-Met-Ala-Glu-lle- Glu-Lys-Phe-Asp-Lys-Ser, Ac-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Leu-Lys-Lys-Thr-Glu-Thr-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu- Lys-Phe-Asp-Lys-Ser-OH, Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, Glu-Lys-Asn- Pro-Leu-Pro-Ser-Lys-Glu-Thr-OH, Ile-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu- Ser-OH, Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr- Glu-Thr-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp- Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-OH, H-Ser-Asp-Lys-Pro-Asp-Met- Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln- OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser- Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu- Lys-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys- Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu-Lys-OH, H-Leu-Lys-Lys-Thr-Glu- Thr-Gln-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys- Gln-Ala-Gly-Glu-Ser-OH, Ac-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn- Pro-Leu-Pro-Ser-Lys-GIu-Thr-lle-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys- Leu-Lys-Lys-Thr-Glu-Thr, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu- Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr, H-Ser-Asp-Lys-Pro- Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu- Thr-Gln, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys- Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln, H-Ser-Asp-Lys-Pro-Asp-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu- Lys, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser- Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys, H-Leu-Lys-Lys-Thr-Glu-Thr-GIn- Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys-Gln-Ala- Gly-Glu-Ser, Ac-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn-Pro-Leu-Pro- Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser, Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr- Glu-Thr-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys- Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala- Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu- Lys-OH, Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys- Glu-Thr-lle-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, a methionine- containing variant of said fragment in which said methionine is oxidized or superoxidized, a variant of said fragment which normally is methionine- containing but which has an amino acid substituent substituted for at least one methionine of the normally methionine-containing fragment, an isolated R-enantiomer of said fragment, an isolated S-enantiomer of said fragment, or a combination thereof.

 

22. Use of a peptide fragment having an amino acid sequence corresponding to a portion of a thymosin beta 4, a thymosin beta 10 or a thymosin beta 15 amino acid sequence in the preparation of a medicament for at least one of suppressing inflammation in tissue of a subject, stimulating cell migration in tissue of a subject, protecting tissue from cytotoxicity in tissue of a subject, inhibiting apoptosis in tissue of a subject, stimulating collagen in tissue of a subject, inhibiting collagen in tissue of a subject, stimulating collagen IV in tissue of a subject, stimulating elastin in tissue of a subject, inhibiting NFkB translocation in tissue of a subject, inhibiting tissue damage caused by ultraviolet (UV) radiation, protecting tissue from ultraviolet (UV) radiation damage, promoting neurite outgrowth, promoting neuron survival, stimulating production of L1 , inhibiting IKBa phosphorylation, or restoring impaired T-lymphocyte blastogenic response, said fragment comprising amino acid sequence H-Leu-Lys-Lys-Thr-Glu-Thr-OH, Ac-Leu-Lys-Lys-Thr-Glu-Thr-OH, H-Ser-Asp-Lys-Pro-OH, H-Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, Ac-Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Leu-Lys-Lys-Thr- Glu-Thr-Gln-OH, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, H-Glu-Lys-Asn-Pro- Leu-Pro-Ser-Lys-Glu-Thr-OH, Ac-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-OH, H-lle-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, Ac-IIe-GIu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, H-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, Ac-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Leu-Lys-Lys-Thr-Glu-Thr, Ac-Leu-Lys-Lys-Thr-Glu-Thr, H-Ser-Asp-Lys-Pro, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, H-Leu-Lys-Lys-Thr-Glu-Thr-Gln, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln, H-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr, Ac-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr, H-IIe-GIu-Gln-Glu-Lys-GIn-Ala-Gly-Glu-Ser, Ac-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser, H-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Ac-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser, Leu-Lys-Lys-Thr-Glu-Thr-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-OH, He-GIu-GIn-GIu-Lys-GIn-Ala-Gly-Glu-Ser-OH, Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-OH, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-OH, H-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-Ile-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu-Ser-OH, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-Gln, H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu- Thr-GIn-Glu-Lys, Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe- Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-GIu-Thr-GIn-Glu-Lys, H-Leu-Lys-Lys- Thr-Glu-Thr-Gln-Glu-Lys-Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln- Glu-Lys-GIn-Ala-Gly-Glu-Ser, Ac-Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys- Asn-Pro-Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-Gln-Glu-Lys-Gln-Ala-Gly-Glu- Ser, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys- Leu-Lys-Lys-Thr-Glu-Thr-OH, Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-lle-Glu- Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr-Glu-Thr-GIn-OH, Ser-Asp-Lys- Pro-Asp-Met-Ala-Glu-lle-Glu-Lys-Phe-Asp-Lys-Ser-Lys-Leu-Lys-Lys-Thr- Glu-Thr-GIn-Glu-Lys-OH, Leu-Lys-Lys-Thr-Glu-Thr-GIn-Glu-Lys-Asn-Pro- Leu-Pro-Ser-Lys-Glu-Thr-lle-Glu-GIn-Glu-Lys-GIn-Ala-Gly-Glu-Ser-OH, a methionine-containing variant of said fragment in which said methionine is oxidized or superoxidized, a variant of said fragment which normally is methionine-containing but which has an amino acid substituent substituted for at least one methionine of the normally methionine-containing fragment, an isolated R-enantiomer of said fragment, an isolated S-enantiomer of said fragment, or a combination thereof.

 

A- 5
 

 

Exhibit B

 

PHS LICENSE TERMS

APPLICABLE TO LICENSEE

 

For the purposes of this Exhibit C only, terms in bold have the meanings given such terms in the PHS License.

 

5.01 PHS reserves on behalf of the Government an irrevocable, nonexclusive, non-transferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory. Prior to the First Commercial Sale , Licensee agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes solely for PHS research use and not for purposes of commercial development, manufacture or distribution, at a price equal to Licensee’s cost of such.

 

5.02 Licensee agrees that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS .

 

5.03 Licensee acknowledges that PHS may enter into future Cooperative Research and Development Agreements (CRADAs) under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement . PHS agrees to notify Licensee , as soon as is practical of any proposed CRADA that relates to the subject matter of this Agreement . Licensee agrees not to unreasonably deny requests for a Research License from such future collaborators with PHS when acquiring such rights is necessary in order to make a Cooperative Research and Development Agreement (CRADA) project feasible. As of the effective date of this Agreement , Licensee requests that Licensee have an opportunity to join as a party to any proposed Cooperative Research and Development Agreement (CRADA).

 

5.04 In addition to the reserved license of Paragraph 5.01 above, PHS reserves the right to grant such nonexclusive Research Licenses directly or to require Licensee to grant nonexclusive Research Licenses on commercially reasonable terms. The purpose of this Research License is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights , however, PHS shall consult with Licensee before granting to commercial entities a Research License or providing to them research samples of Licensed Products or materials made through the Licensed Processes , provided however that PHS will not provide materials obtained from Licensee under Paragraph 5.01 above to third parties, except with Licensee’s prior written consent, which shall not be unreasonably withheld.

 

8.01 Licensee agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed Processes practiced under this Agreement appropriate to determine the amount of royalties due PHS . Such records shall be retained for at least five (5) years following a given reporting period and shall be available during normal business hours upon five (5) business days prior written notice from PHS to Licensee for inspection at the expense of PHS by an accountant or other designated auditor selected by PHS for the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose to PHS information relating to the accuracy of reports and payments made under this Agreement. If an inspection shows an under reporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then Licensee shall reimburse PHS for the cost of the inspection at the time Licensee pays the unreported royalties, including any late charges as required by Paragraph 9.08 of this Agreement . All payments required under this Paragraph shall be due within thirty (30) days of the date PHS provides Licensee notice of the payment due.

 

B- 1
 

 

10.01 Licensee shall use its reasonable best efforts to bring the Licensed Products and Licensed Processes to Practical Application . “Reasonable best efforts” for the purposes of this provision shall include substantial adherence to the Commercial Development Plan at Appendix F and substantial performance of the Benchmarks at Appendix E as may be amended from time to time by mutual written consent. The efforts of sublicensees and Affiliates shall be considered the efforts of Licensee . To the extent that the Benchmarks or development obligations set forth in Appendix E differ from or conflict with those set forth in the Commercial Development Plan in Appendix F, Appendix E shall be considered to supersede Appendix F and the Commercial Development Plan in Appendix F shall be amended to be consistent with Appendix E.

 

10.02 Upon the First Commercial Sale , until the expiration of this Agreement , Licensee shall use its reasonable best efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public.

 

12.05 Licensee shall indemnify and hold PHS , its employees, students, fellows, agents, and consultants (the “Indemnified Parties” ) harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage (the “Indemnified Losses” ) suffered by an Indemnified Party in connection with or arising out of a) the use by or on behalf of Licensee , its sublicensees, directors, employees, or third parties of any Licensed Patent Rights , or b) the design, manufacture, distribution, or use of any Licensed Products , Licensed Processes or materials by Licensee , or other products or processes developed in connection with or arising out of the Licensed Patent Rights . Licensee agrees to maintain a liability insurance program consistent with sound business practice. Notwithstanding any other provision to the contrary, Licensee shall have no obligation to indemnify an Indemnified Party from an Indemnified Loss in connection with or arising out of the design, manufacture, distribution or use of any Licensed Product or Licensed Process by or on behalf of the Indemnified Party .

 

13.05 PHS shall specifically have the right to terminate or, with Licensee’s consent, modify, at its option, this Agreement , if PHS determines that the Licensee : 1) is not using its reasonable best efforts to effectuate the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes ; 2) has not used its reasonable best efforts to achieve the Benchmarks as my be modified under Paragraph 9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement ; 4) has committed a material breach of a covenant or agreement contained in the license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; 6) cannot reasonably satisfy unmet health and safety needs; or 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.02 unless waived. In making this determination, PHS will take into account the normal course of commercial development programs conduct with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.02. Prior to invoking this right, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’s concerns as to the previous items 1) to 7). If Licensee fails to alleviate PHS’s concerns as to the previous items 1) to 7) or fails to initiate corrective action to PHS’s reasonable satisfaction, PHS may terminate this Agreement .

 

B- 2
 

 

13.07 PHS reserves the right according to 35 U.S.C. § 209(1)(4) to terminate or modify this Agreement if it is determined that such action is necessary to meet requirements for public use specified by federal regulations issued after the date of the license and such requirements are not reasonably satisfied by Licensee .

 

13.08 Within thirty (30) days of receipt of written notice of PHS’s unilateral decision to modify or terminate this Agreement , Licensee may, consistent with the provisions of 37 C.F.R. 404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.

 

13.09 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by Licensee . Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to PHS shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with PHS and Licensee pursuant to Paragraph 4.03.

 

B- 3

 

 

Exhibit 10.7

*** text ommitted and filed seperately

confidential treatment requested

under 17 c.f.r.§§200.80(b)(4) and 240.24b-2

rgn-137 LICENSE Agreement

 

This License Agreement (this “ Agreement ” or this “ License Agreement ”) is effective as of March 7, 2014 (the “ Effective Date ”) by and between RegeneRx Biopharmaceuticals, Inc., a company organized and existing under the laws of the state of Delaware, with offices at 15245 Shady Grove Road, Suite 470, Rockville, Maryland, U.S.A. (hereinafter “ Licensor ”), and Digital Aria Co., Ltd. with offices at 22 nd FL, Parkview Tower, 248 Jungjail-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-863, Republic of Korea (hereinafter “ Licensee ”), each a “ Party ” and, collectively, the “ Parties .”

 

Recitals

 

WHEREAS, Licensor is engaged in the business of developing biopharmaceutical products, including the clinical development of a drug candidate referred to as RGN-137 which utilizes Tβ4 (as defined herein) as the biologically active ingredient;

 

WHEREAS, Licensee is engaged in the business of developing, marketing, manufacturing, and distributing biopharmaceutical products;

 

WHEREAS, Licensee wishes to obtain the rights to develop, manufacture finished product and commercialize the Licensed Product in the Field, in the Territory (as each such term is defined herein); and

 

WHEREAS, Licensor and Licensee wish to specify certain terms relating to the manufacture and supply of the Licensed Product and/or the API (as defined herein).

 

NOW, THEREFORE, in consideration of the premises and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

Section 1. Definitions

 

As used in this Agreement, the following capitalized terms shall have the following meanings:

 

Affiliate ” shall mean, with respect to a Person, any Person that Controls, is Controlled by or is under common Control with such first Person. For purposes of this definition only, “ Control ” means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities, or by contract relating to voting rights or corporate governance, or (b) to own, directly or indirectly, at least fifty percent (50%) of the outstanding voting securities or other ownership interest of such Person.

 

Agreement ” shall have the meaning given such term in the preamble.

 

API ” shall mean Tβ4 in the form of an active ingredient to be utilized as a component in the Licensed Product.

 

Challenge ” shall have the meaning given such term in Section 8.8(b).

 

Change of Control ” shall mean, with respect to a Party, the occurrence of any of the following:

 

(a) any consolidation, merger, recapitalization or reorganization of a Party with or into any Third Party, or any other corporate reorganization involving a Third Party (“ Merger ”), as long as the stockholders of such Party immediately prior to the Merger own less than fifty percent (50%) of the surviving entity’s voting power immediately after the Merger;

 

1 | Page
 

 

(b) a change in the beneficial ownership of more than fifty percent (50%) of the voting securities of any Party (whether in a single transaction or series of related transactions) where, immediately after giving effect to such change, the legal or beneficial owner of more than fifty percent (50%) of the voting securities of such Party is a Third Party.

 

(c) the sale, transfer, lease, license or other disposition to a Third Party of all or substantially all of a Party’s assets, to which this Agreement relates, in one or a series of related transactions.

 

Commercialization Plan ” shall have the meaning given such term in Section 4.1.

 

Commercially Diligent Efforts ” shall mean, with respect to the development and commercialization by Licensee of at least one Licensed Product, the level of efforts and resources generally used by similarly situated pharmaceutical companies marketing compounds or products throughout the Territory (including internally developed, acquired and in-licensed compounds or products) with similar commercial potential at a similar stage in their lifecycle (assuming continuing development of such product).

 

Confidential Information ” shall mean any and all information, data, results, Inventions, trade secrets, techniques, material, or compositions of matter of any type or kind, including without limitation all Know-How and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, personnel, financial, legal and commercial information or data, whether communicated in writing, orally or by any other method, that a Party treats or identifies as confidential and, in each case, is disclosed by one Party to the other Party under this Agreement.

 

Control ”, “ Controls ” and “ Controlled ” shall mean, with respect to a particular item of information or intellectual property right, that the applicable Party or any Affiliate of such Party owns or has a license to such item or right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or rights as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing as of the Effective Date or thereafter.

 

Development Plan ” shall have the meaning given such term in Section 3.1.

 

Disclosing Party ” shall have the meaning given such term in Section 9.1.

 

Distributor ” shall mean any Third Party appointed by Licensee to distribute, market and sell Licensed Product purchased from Licensee or any of its Affiliates (regardless of whether such Third Party has the right or obligation to provide packaging or labeling services with respect to such Licensed Product).

 

Effective Date ” shall have the meaning given such term in the preamble.

 

FDA ” shall mean the United States Food and Drug Administration or any successor U.S. governmental agency performing similar functions.

 

Field ” shall mean the treatment of all human dermal diseases and conditions in the Territory using Tβ4 in any formulation delivered topically to the dermis, provided, however, that “Field” shall not include any use of the Licensed Product incorporated into the form of any type of cosmetic or food product.

 

2 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

First Commercial Sale ” shall mean the initial sale of Licensed Product by or on behalf of Licensee, its Affiliates, Sublicensees or Distributors in exchange for cash or some equivalent to which value can be assigned for the purpose of determining Net Sales in the Territory following Regulatory Approval of the Licensed Product in the Territory. For clarity, First Commercial Sale shall not include transfers of Licensed Product at below cost by or on behalf of Licensee, its Affiliates, Sublicensees or Distributors in connection with compassionate use, emergency use, treatment INDs, or the like authorized by the FDA or any corresponding Governmental Authorities in the Territory.

 

GAAP ” shall mean, in the case of the Licensor, Generally Accepted Accounting Principles recognized in the United States, and in the case of the Licensee, Generally Accepted Accounting Principles recognized in the Republic of Korea.

 

Generic or Branded Generic ” shall mean a drug product containing the same active ingredients as Licensed Products and is subject to the regulations of the governments of countries where they are dispensed and is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.

 

GCP ” shall mean the then current good clinical practices as defined in U.S. Regulations 21 C.F.R. §§ 50, 54, 56, 312 and 314, the International Conference of Harmonization (ICH) E6 “Good Clinical Practice: Consolidated Guidance,” and in any successor regulation or any official guidance documents issued by a Governmental Authority.

 

GLP ” shall mean the then current good laboratory practice standards as defined by the FDA pursuant to 21 C.F.R. Part 58, and in any successor regulation or any official guidance documents issued by a Governmental Authority.

 

GMP ” shall mean the then current good manufacturing practices as defined by the FDA pursuant to 21 C.F.R. §§ 210 and 211 and in any successor regulation or any official guidance documents issued by a Governmental Authority.

 

Governmental Action ” shall have the meaning given such term in Section 13.2(b).

 

Governmental Authority ” shall mean: (i) any national, federal, provincial, state, municipal or other governmental body in any jurisdiction in the Territory or elsewhere, (ii) any international or multi-lateral body, (iii) any subdivision, ministry, department, secretariat, bureau, agency, commission, board, instrumentality or authority of any of the foregoing governments or bodies, (iv) any quasi-governmental or private body exercising any regulatory, expropriation or taxing authority under or for any of the foregoing governments or bodies, or (v) any international, multi-lateral, or multi-national judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal, commission, board or panel, in each case having jurisdiction over the jurisdiction in the Territory.

 

ICC Rules ” shall have the meaning given such term in Section 14.8(c).

 

IND ” shall mean an investigational new drug application filed with the FDA.

 

Indemnified Party ” shall have the meaning given such term in Section 11.3.

 

Indemnifying Party ” shall have the meaning given such term in Section 11.3.

 

3 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Intellectual Property ” shall mean any Inventions, Patents, patent rights, utility models, copyrights, trade secrets, Trademarks, service marks, Know-How, technical information and all other intellectual property rights.

 

Invention ” shall mean any process, method, use, composition of matter, article of manufacture, discovery, finding or invention, whether or not patentable.

 

Joint Development Committee ” shall have the meaning given such term in Section 3.4.

 

Joint Inventions ” shall have the meaning given such term in Section 8.2(c).

 

Know-How ” shall mean all tangible and intangible (i) techniques, technology, practices, trade secrets, methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms, and (ii) compounds, compositions of matter, and physical, biological or chemical material.

 

Laws ” shall mean (i) all constitutions, treaties, laws, statutes, codes, ordinances, guidance, orders, decrees, rules, regulations, and municipal by-laws, whether domestic or international, anywhere in the Territory or as may otherwise be agreed in writing between the Parties, (ii) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards of any Governmental Authority, and (iii) all policies, practices and guidelines of any Governmental Authority.

 

Licensed Know-How ” shall mean Know-How owned or Controlled by Licensor that exists as of the Effective Date or at any time thereafter during the Term, in each case that is necessary or useful for the development, registration, manufacture, promotion, marketing, distribution, or sale of the Licensed Product in the Field in the Territory.

 

Licensed Patents ” shall mean the Patents owned or Controlled by Licensor as of the Effective Date (as listed in Exhibit A hereto), to the extent that such Patents disclose or claim the Licensed Product as well as any future Patents owned or Controlled by Licensor or its Affiliates during the Term, to the extent that such future Patents disclose or claim the Licensed Product.

 

Licensed Product ” shall mean the Licensor’s drug candidate referred to as RGN-137 that utilizes Tβ4 as at least one of the biologically active ingredients and/or improvements thereto developed or acquired by or on behalf of Licensor for the Field in the Territory, in each case to the extent such improvements are owned or Controlled by Licensor. The term “Licensed Product” shall include both clinical and commercial applications of any such product.

 

Licensee ” shall have the meaning given such term in the preamble.

 

Licensee Inventions ” shall have the meaning given such term in Section 8.2(a).

 

Licensee Product Data shall have the meaning given such term in Section 13.3(b)(i).

 

Licensor ” shall have the meaning given such term in the preamble.

 

Licensor Inventions ” shall have the meaning given such term in Section 8.2(b).

 

Losses ” shall have the meaning given such term in Section 11.1.

 

4 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Marketing Approval ” shall mean all approvals, licenses, registrations, or authorizations of a Regulatory Authority in any jurisdiction of the Territory necessary for the manufacture, use, storage, marketing, importation or sale of the Licensed Product in such jurisdiction.

 

Marketing Year ” shall mean the period commencing on the date of the first Marketing Approval in any country in the Territory and ending on December 31 of the same year. Thereafter, and for the duration of this Agreement, each subsequent Marketing Year will correspond to a calendar year period (i.e., from January 1 to December 31).

 

Net Sales ” shall mean the gross receipts for sales made by Licensee, its Affiliates, Sublicensees and Distributors of the Licensed Product to other independent buyer(s) in bona fide arm’s length transactions, less the following deductions with respect to such sale, to the extent applicable to the Licensed Product and to the extent actually allowed and taken: (i) quantity and/or cash discounts actually allowed or taken to the extent customary; (ii) customs, duties, excise taxes, if any, directly related to the sale of the Licensed Product and actually paid; (iii) amounts allowed by reason of rejections and return of goods; (iv) Third-Party rebates related to the sale of the Licensed Product; and (v) import tax, value-added tax and other similar sales taxes related to the sale of the Licensed Product, all to the extent in accordance with GAAP as consistently applied across all products of Licensee. No deductions shall be made for commissions paid to individuals, whether with independent sales agencies or regularly employed by Licensee, its Affiliates, Sublicensees or Distributors, and on its payroll, or for the cost of collections. On sales made in other than in arm’s length transaction, the value of Net Sales attributed to such a transaction shall be that which would have been received in an arm’s length transaction, based on sales of like quantity and quality products on or about the time of such transaction.

 

Panel ” shall have the meaning given such term in Section 14.8(c)(i).

 

Parties and “ Party ” shall have the meanings given such terms in the preamble.

 

Patents ” shall mean any and all patents and/or patent applications, and any patents issuing on such patent applications, as well as any continuations, divisions, reissues and re-examinations of any of the foregoing.

 

Person ” shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

 

PHS ” shall mean the National Institutes of Health, the Centers for Disease Control, and/or the FDA, agencies of the United States Public Health Service within the Department of Health and Human Services.

 

PHS License ” shall mean the Patent License Agreement, dated as of February 6, 2001, between PHS and Licensor, attached hereto as Exhibit B.

 

Product Liability Claim ” shall mean any Third Party proceedings involving any actual or alleged death or bodily injury arising out of or resulting from the use of the Licensed Product sold by Licensee or its Sublicensees.

 

Prohibited List ” shall mean (a) the HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://www.oig.hhs.gov ); (b) the General Services Administration’s List of Parties Excluded from Federal Programs (available through the Internet at http://www.epls.gov ); and (c) the FDA Debarment List (available through the Internet at http://www.fda.gov/ora/compliance_ref/debar/ ).

 

5 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Prosecute ” shall have the meaning given such term in Section 8.5(a).

 

Receiving Party ” shall have the meaning given such term in Section 9.1.

 

Regulatory Approval ” shall mean any and all approvals (including, to the extent necessary, pricing approvals), licenses, registrations or authorizations of any Governmental Authority, necessary for the promotion, development (including without limitation the conduct of clinical trials), marketing, distribution, manufacture, sale or importation of a Licensed Product.

 

Regulatory Authority ” shall mean any applicable Governmental Authority in any jurisdiction in the Territory from which Regulatory Approval is required to be obtained.

 

Regulatory Laws ” shall mean all applicable Laws governing (i) marketing approval or clearance, import, export, testing, investigation, development, manufacture, packaging, labeling, handling, storage, distribution, installation, servicing, marketing, or sale, (ii) recordkeeping and reporting obligations, (iii) recalls, or (iv) similar regulatory matters, with respect to the Licensed Product.

 

Relevant Period ” shall mean the period starting from the Effective Date and ending on (i) the expiration of the last-to-expire valid and applicable Licensed Patent within the Territory or (ii) the fifteenth (15 th ) anniversary of the First Commercial Sale of the Licensed Product in the Territory, whichever is later.

 

RGN-259 Agreement ” shall mean that certain RGN-259 License Agreement dated as of even date herewith and executed concurrently herewith between the Parties.

 

Royalty Term ” shall mean the period commencing on the First Commercial Sale and ending at the expiration of or the effective date of termination of this Agreement.

 

Sublicensee ” shall mean any Affiliate or Third Party to whom Licensee sublicenses any rights as permitted by Section 2.1(d).

 

Tβ4 ” shall mean the 43 amino acid peptide commonly referred to as Thymosin Beta 4.

 

Territory ” shall mean the United States of America.

 

Third Party shall mean any Person other than Licensor, Licensee, and Affiliates of either Party.

 

Trademark ” shall mean any trademark, trade dress, brand mark, trade name, brand name, logo, business symbol or other similar indicia of origin.

 

Valid Claim ” shall mean a claim of an issued and unexpired Licensed Patent, that has not been revoked or held unenforceable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction, and that is not appealable or has not been appealed within the time allowed for appeal, and that has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise.

 

6 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Section 2. License Grant and Other Rights

 

2.1            License Grants to Licensee

 

(a)           Non-Exclusive License to Use to Develop . Subject to the terms of this Agreement, Licensor hereby grants to Licensee a non-exclusive, irrevocable (except as otherwise provided for in this Agreement and in the PHS License), royalty-free license to use the Licensed Patents and the Licensed Know-How to develop the Licensed Product in the Field in the Territory.

 

(b)           Exclusive License to Make and Sell . Subject to the terms of this Agreement, Licensor hereby grants to Licensee an exclusive irrevocable (except as otherwise provided for in this Agreement and in the PHS License) royalty-bearing license to use the Licensed Patents and the Licensed Know-How to manufacture, offer to sell, sell and import the Licensed Product in the Field in the Territory.

 

(c)           Early Termination of License . Subject to the terms of this Agreement, the License granted to Licensee in the Territory shall terminate if Licensee does not initiate and begin enrollment of patients in at least one Phase 2 dermal clinical trial within the Territory within three (3) years from the execution date of this Agreement. In such a case, this Agreement shall be automatically terminated.

 

(d)         Sublicensing .

 

(i)          Licensee shall be entitled to sublicense any or all of the rights granted to Licensee pursuant to Sections 2.1(a) and 2.1(b) to any of its Affiliates or Third Party upon thirty (30) days’ prior written notice to Licensor (subject to Licensor’s approval, which approval shall not be unreasonably withheld), which notice shall include the identity of such Affiliate or Third Party.

 

(ii)         All sublicenses granted to Affiliates or Third Parties pursuant to Section above 2.1(d)(i) shall be subject to all terms, conditions, obligations and covenants of this Agreement and all applicable provisions of the PHS License. No sublicense shall relieve Licensee of any of its obligations hereunder.

 

(e)         No Further Licenses . Except for the licenses granted to Licensee pursuant to Sections 2.1(a) and 2.1(b) no further rights or licenses are granted to Licensee in or under this Agreement, whether expressly or by implication.

 

(f)         Licensor’s Retained Rights . Notwithstanding the rights granted to Licensee in Sections 2.1(a) and 2.1(b) and without limiting the generality of Section 2.1(g), Licensor retains the rights to:

 

(i)          conduct or have conducted clinical trials and other studies involving the Licensed Product in the Territory for the generation of data in support of regulatory submissions to the Regulatory Authorities outside the Territory; or

 

(ii)         conduct activities in the Territory with respect to the manufacture, formulation and processing of the Licensed Product for use and commercialization outside the Territory.

 

(g)         Negative Covenant . Licensee covenants that it will not, and it will not permit any of its Affiliates to, use or practice any Licensed Patents and Licensed Know-How outside the scope of the license granted to it under Sections 2.1(a) and 2.1(b) above.

 

7 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

2.2            Transfer of Licensed Know-How . Upon the reasonable request of Licensee and at no cost to Licensee, Licensor shall promptly provide Licensee with such tangible embodiments of the Licensed Know-How as are in Licensor’s possession or control so as to permit Licensee to enjoy the licenses granted to it pursuant to Sections 2.1(a) and 2.1(b).

 

2.3            Use of Affiliates . At Licensor’s option, any of Licensor’s rights under this Agreement may be exercised by any Affiliate of Licensor. Further, at Licensor’s option, any of Licensor’s obligations under this Agreement may be performed by any Affiliate of Licensor, and such obligations will be deemed satisfied upon performance by such Affiliate. For the avoidance of doubt, nothing contained in this Article 2.3 shall relieve Licensee of any of its obligations hereunder unless fully performed by its Affiliate.

 

2.4            PHS Reserved Rights . Notwithstanding anything contained in Section 2.1 to the contrary, Licensee:

 

(a)          acknowledges that PHS has retained certain rights and interests in the Licensed Patents pursuant to the PHS License;

 

(b)          agrees that the provisions of the PHS License contained in Exhibit C shall be binding on Licensee and its successors as if Licensee or its successors were the licensee under the PHS License; and

 

(c)          shall assist Licensor in complying with Licensor’s obligations under the PHS License.

 

Section 3. Development

 

3.1            Development Plan .

 

(a)           Initial Development Plan . Licensee shall carry out all development activities with respect to the Licensed Product in the Territory in accordance with a development plan as agreed upon in writing by the Parties (the “ Development Plan”) .

 

(b)           Development Activities . For purposes of this Agreement, development activities shall mean all activities that are reasonably required to obtain Regulatory Approval of the Licensed Product in the Territory, including without limitation toxicology, in vitro testing, in vivo testing, in silico testing, stability testing, statistical analysis and report writing, packaging and regulatory affairs, preclinical studies and clinical trials.

 

3.2            Content of Development Plans . The Development Plan (as amended after the Effective Date) shall include, to the extent applicable, (i) the identity of the Licensed Product to be developed, (ii) a description of the overall program of development for such Licensed Product through Regulatory Approval in the Territory, (iii) a description of the development activities including preclinical studies, pharmacology, toxicology, formulation, clinical pharmacology studies, clinical studies and regulatory plans and other key elements necessary to obtain Regulatory Approval for the Licensed Product, (iv) specific plans and protocols for clinical studies, including Licensee’s good faith forecast of the quantity of clinical supplies of API that Licensee will require, (v) a schedule for all such activities, and (vi) specific tentative deadlines for meeting specified regulatory milestones.

 

8 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

3.3            Updates and Amendments to the Development Plan . The Parties shall amend the Development Plan at least once every twelve (12) months to expand and refine the description of the activities specified in the initial Development Plan or other then current Development Plan and to add other development activities, and the anticipated schedule and budgets for all such activities. Such amended Development Plan shall become effective only upon the approval of the Joint Development Committee. If the Parties fail to update the Development Plan as required by this Section 3.3 the most recently approved Development Plan shall continue in effect until such time as an amended Development Plan becomes effective.

 

3.4            Joint Development Committee . Within ninety (90) days from the Effective Date, the Parties shall establish a joint development committee (the “ Joint Development Committee ”) to coordinate and oversee the development of the Licensed Product in the Territory.

 

(a)           Composition of the Joint Development Committee . The Joint Development Committee shall be comprised of an equal number of representatives from each Party, initially consisting of four persons (two persons from each Party), each of whom has relevant experience and skill appropriate for service on the Joint Development Committee, such as heads of clinical, manufacturing, and commercial development. The Parties may establish and later change the number of representatives that each Party has on the Joint Development Committee, as long as an equal number of representatives from each Party is maintained (unless such Party desires to have fewer representatives). Each Party may change any of its representatives on the Joint Development Committee at any time upon notice to the other Party.

 

(b)           Decisions of the Joint Development Committee . Except as otherwise provided in this Agreement, in the event that the Joint Development Committee cannot reach a decision in any matter properly before it, Licensee shall have final decision-making authority with respect to such matter, including approval and amendments of the Development Plan; provided, however, that any such matter under dispute shall first be referred to the Parties’ respective Presidents or chief executive officers, for attempted resolution by good faith negotiations within fourteen (14) days; further provided, that any final decision made by Licensee shall (i) be consistent with the terms of this Agreement (including Licensee’s diligence obligations hereunder); (ii) not materially affect the rights and obligations of Licensor under this Agreement without Licensor’s consent; (iii) not materially affect the development, manufacture or commercialization of the Licensed Products outside the Field and/or outside the Territory, as reasonably determined by Licensor.

 

(c)           Activities of the Joint Development Committee . The Joint Development Committee shall be responsible for establishing and approving the Development Plan.

 

(d)           Meetings of the Joint Development Committee . The Joint Development Committee shall hold its first meeting within ninety (90) days after the Effective Date and shall meet thereafter on a schedule and at locations mutually determined by the Parties. The Joint Development Committee will convene at least monthly by teleconference and periodically in person either in Korea or in the U.S. to discuss and agree on the development of the Licensed Products in the Territory and share information relating thereto. Ad hoc meetings of the Joint Development Committee may be called by either Party upon reasonable advance notice to the other. Subject to the Parties’ mutual agreement, regular and ad hoc meetings may be face-to-face or by teleconference or videoconference.

 

(e)           Joint Development Committee Expenses . Each Party shall bear the expense of the participation of its representatives on the Joint Development Committee and in Joint Development Committee meetings.

 

9 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

3.5            Clinical Trials . Licensee shall be responsible for conducting or having conducted all clinical trials of the Licensed Product in the Territory and for paying all fees, costs and other expenses associated therewith.

 

3.6            Regulatory Approvals . Licensee shall be responsible for obtaining and maintaining all Regulatory Approvals necessary to conduct such clinical trials and for paying all fees, costs and other expenses associated therewith.

 

3.7            Licensor’s Cooperation . As reasonably requested by Licensee, Licensor shall cooperate with and assist Licensee in obtaining any Regulatory Approvals necessary to conduct clinical trials and commercialization of the Licensed Product in the Territory. In connection therewith, Licensor shall provide Licensee upon request with copies of any regulatory materials and/or data as are reasonably necessary for these purposes.

 

3.8            Clinical Supply of Licensed Product .

 

(a)           Clinical Supply . Licensor shall supply Licensee with up to a combined total of fifty (50) grams free of charge of the API as required by Licensee in order to conduct development activities in accordance with the Development Plan hereunder and the Development Plan as defined in the RGN-259 Agreement, including clinical trials of the Licensed Product hereunder and as defined therein.

 

(b)           Clinical Supply Costs . Subject to the other provisions hereof, Licensor shall supply API for clinical trials required by Licensee over and above the fifty (50) grams as provided in Section 3.8(a), at Licensor’s cost plus fifteen percent (15%). In all cases, Licensee shall be responsible for the cost of formulating, filling and finishing Licensed Product in accordance with applicable Laws in the relevant jurisdiction.

 

3.9            Diligence . Notwithstanding anything specified in any Development Plan, Licensee shall at all times exert no less than Commercially Diligent Efforts to develop the Licensed Product in the Territory, including seeking Regulatory Approval and Marketing Approval of the Licensed Product in the Territory. Licensee shall require any Affiliates, Sublicensees, and/or Third Parties it uses to develop the Licensed Product to use such efforts on Licensee's behalf.

 

Section 4. Commercialization of Licensed Product

 

4.1            Commercialization Plan .

 

(a)           Initial Commercialization Plan . Licensee shall provide Licensor with the plan for commercialization of the Licensed Product in the Territory (the “ Commercialization Plan ”) and carry out all commercialization activities with respect to the Licensed Product in the Territory. The initial Commercialization Plan shall be provided to Licensor within ninety (90) days from the expected First Commercial Sale date within the Territory.

 

(b)           Commercialization Activities . For purposes of this Agreement, commercialization activities shall mean all appropriate activities undertaken before and after Regulatory Approval relating specifically to the marketing, sale and distribution of the Licensed Product in the Territory, including, without limitation, (i) sales force detailing, advertising, education, planning, marketing, sales force training and distribution, (ii) scientific and medical affairs, and (iii) pricing and related terms for the Licensed Product.

 

10 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

4.2            Content of Commercialization Plan .

 

(a)           Description of Activities . The Commercialization Plan (as amended, if needed) shall include a reasonable description of the activities that Licensee shall undertake in order to market the Licensed Product in the Territory, including, but not limited to, (i) media marketing plans, promotional activities and similar matters, including detailed budgets, and (ii) the identity of intended major Distributors and Sublicensees, if any.

 

(b)           Net Sales Targets . The Parties acknowledge that, as of the Effective Date, specific Net Sales targets in any Marketing Year are difficult to determine. The Commercialization Plan shall specific a broad range of Net Sales targets that will be refined and updated in amendments to the Commercialization Plan as the Licensed Product in the Territory approaches Regulatory Approval.

 

4.3            Amendments to the Commercialization Plan . The Parties shall amend the Commercialization Plan at least once every twelve (12) months after the First Commercial Sale to refine the description of the activities specified in the initial Commercialization Plan and any subsequently amended Commercialization Plan, and to add other commercialization activities, to update the anticipated schedule and budgets for all such activities, and to update the Net Sales targets. Such amended Commercialization Plan shall comply with the provisions of Section 4.2. If the Parties fail to update the Commercialization Plan as required by this Section 4.3, the most recently approved Commercialization Plan shall continue in effect until such time as an amended Commercialization Plan becomes effective pursuant to this Section 4.3.

 

4.4            Diligence . Licensee shall at all times exert no less than Commercially Diligent Efforts to promote, market and distribute at least one Licensed Product in the Territory. Licensee shall require any Affiliates, Sublicensees, Distributors, and/or other Third Parties it uses to promote, market and distribute the Licensed Product to use such efforts on Licensee's behalf.

 

4.5            Notification of Benchmarks and Milestones . Licensee shall report in writing to Licensor the date of the First Commercial Sale in the Territory and the achievement of any milestone specified in this Agreement within ten (10) days of such occurrences.

 

Section 5. Manufacture and Supply of Licensed Product

 

5.1            Supply Terms . Licensee shall purchase all of its commercial requirements of API from Licensor at a cost plus price to be discussed and agreed upon by the Parties, subject to Licensor’s ability to deliver required amounts of API pursuant to the terms of a commercial supply agreement to be negotiated by the Parties. Upon reasonable request by Licensee, Licensor shall provide Licensee with data supporting its calculation of cost in reasonable details. Licensee shall be entitled to manufacture or source API from suppliers of its choice, only if Licensor is unable or unwilling to provide API according to the terms herein. In such a case, Licensor shall promptly identify and introduce to Licensee one or more alternative sources of API which together shall possess adequate capacity to supply such required amount of API to Licensee.

 

5.2            Manufacturing License . Licensor hereby grants to Licensee the rights under the Licensed Patents and Licensed Know-How as may be necessary in order for Licensee to manufacture or have manufactured by an Affiliate or by a Third Party the API, pursuant to Section 5.1 and the Licensed Product in the Territory for the sole purpose of exercising the licenses granted to Licensee pursuant to Sections 2.1(a) and 2.1(b).

 

11 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Section 6. Royalties, License Fees and Equity Investments

 

6.1            Royalties.

 

(a)          During the Royalty Term, on a semi-annual basis, Licensee shall pay Licensor royalties equal to [***] and [***] percent [***] % of aggregate annual Net Sales. Each such payment shall be due and payable no later than sixty (60) days after the end of the semi-annual period ending on December 31 st and June 30 th , in which the applicable Net Sales were made. In case any Generic/Branded Generic of any Licensed Product by any Third Party becomes commercially available in the Territory without a direct or indirect agreement with the Licensee, its Affiliates or their Sublicensees or Distributors and such Generic/Branded Generic taken in the aggregate have according to IMS or similar data source a market share (in terms of unit quantity) in the Territory of at least 30% (thirty percent), then the royalties’ rate applicable and payable by Licensee on the Net Sales in the Territory will be reduced by fifty percent (50%).

 

(b)          If it is necessary for Licensee to obtain a license from a Third Party under any Patent in the Territory in order to use, make, or sell a Licensed Product and Licensee obtains such a license, Licensee may deduct, from the royalty payment that would otherwise have been due pursuant to Section 6.1(a) with respect to Net Sales of the applicable Licensed Product in the Territory in a particular applicable semi-annual period an amount equal to fifty percent (50%) of the royalties paid by Licensee to such Third Party pursuant to such license on account of the sale of such Licensed Product in the Territory during such applicable semi-annual period.

 

6.2            License Fee and Equity Investment .

 

(a)          On February 10, 2014, Licensee paid Licensor US$150,000 as a license fee ($50,000 of which is to be allocated to this RGN-137 License) pursuant to the terms set forth in the Binding Term Sheet that was executed between the Parties on February 7, 2014, the receipt of which is hereby acknowledged by Licensor.

 

(b)          Licensee shall purchase US$1.35 million of Licensor common stock by March 28, 2014 at a price of US$0.12 per share.

 

(c)          Licensee shall purchase US$1.0 million of Licensor common stock by August 31, 2014 at a price of US$0.12 per share.

 

(d)          A failure of Licensee to make payments pursuant to Sections 6.2(a) and 6.2(c) by the deadlines set forth herein shall constitute a breach of material obligation under Section 13.1(a) and give Licensor the right to terminate this Agreement as provided in Section 13. For the avoidance of doubt, the equity investments provided in this Section 6.2 refer to the same equity investments provided in the Section 6.2 of the RGN-259 Agreement.

 

6.3            Equity Investment Option . Licensor hereby grants Licensee an option to purchase 5.5 million shares of Licensor common stock in a single tranche at a price of US$0.15 per share, at any time during the period commencing on the date hereof and expiring on January 31, 2015. Upon exercise of the option, Licensee shall immediately pay the entire sum due. For the avoidance of doubt, the equity investment option provided in this Section 6.3 refers to the same equity investment option provided in the Section 6.3 of the RGN-259 Agreement.

 

12 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

6.4            Commercial Milestone Payments .

  

(a)          Licensee shall promptly pay to Licensor a non-refundable sum of US$[***] upon the First Commercial Sale of Licensed Product in the Territory.

 

(b)          Licensee shall promptly pay to Licensor a non-refundable sum of US $[***] million upon obtaining US $[***] million of aggregate, cumulative commercial Net Sales of Licensed Product in the Territory (one time only), and Licensee shall pay to Licensor such US $[***] million in three equal installments of US $[***] million per year for three (3) consecutive years with the first payment due by the thirtieth (30 th ) day from obtaining the Net Sales defined hereunder and the two (2) subsequent payments due on the first and second anniversary of such first due date.

 

6.5            Royalty Reports . Licensee shall furnish to Licensor on each of March 1 and September 1 of each calendar year during the Royalty Term, a complete, detailed and accurate written report for the preceding six month period from the prior report showing (i) the gross amount of sales, on an item-by-item basis, of Licensed Products by Licensee, Sublicensees and Distributors to independent buyers (whether an end-user, wholesaler or otherwise) in bona fide arm’s length transactions; (ii) the adjustments resulting from the deductions in the definition of “Net Sales; (iii) total Net Sales and (iv) the conversion into United States Dollars, pursuant to Section 6.7, of any such Net Sales made in another currency; and (v) the calculation of royalties due.

 

6.6            Manner of Payments . All payments due Licensor under this Agreement shall be payable in United States Dollars by wire transfer of immediately available funds to such bank account(s) as Licensor shall designate, or by such other method as Licensor may reasonably designate.

 

6.7            Exchange Rate . When converting any amount in another currency into United States Dollars, Licensee shall use an exchange rate equal to New York foreign exchange rate quoted in the Wall Street Journal on the business day that is five (5) days prior to the date a payment under this Agreement is due.

 

6.8            Interest on Late Payments . Any payment not paid within thirty (30) calendar days from the date such payment is due under this Agreement shall be subject to interest from and including the date such payment is due through and including the date such payment is actually made at an annual rate equal to the sum of two percent (2%) plus the annual prime rate of interest quoted in the Money Rates Section of the Wall Street Journal calculated daily on the basis of a 365-day year, or, if such rate is not available for any reason, similar reputable data source, or, if lower, the highest rate permitted under applicable law. The payment of such interest shall not limit Licensor from exercising any other rights it may have as a consequence of the lateness of any payment.

 

6.9            Records; Audit Rights .

 

(a)           Records . Licensee shall maintain, and shall require its Affiliates, Sublicensees and Distributors to maintain, during the Term and for a period of five (5) years thereafter, complete, detailed and accurate books and records in connection with the sale of Licensed Product as necessary to allow the accurate determination of any and all financial and accounting information relevant to either Party’s payment obligations hereunder, including without limitation as necessary for the calculation of the royalties due to Licensor hereunder.

 

13 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

(b)         Audit Rights .

 

(i)          Licensor or its representative shall have the right to annually audit Licensee’s, its Affiliates’, its Sublicensees’ and its Distributors’ records as set forth in this Section 6.99. Licensee shall permit Licensor or its representative to have access during normal business hours to such records of Licensee, its Affiliates and its Sublicensees as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any Marketing Year ending not more than five (5) years prior to the date of such request. Annual audits can take place no more often than once per each calendar year. Notice of Licensor’s intent to conduct an audit must be provided within thirty (30) days of the later of: (i) Licensor’s receipt of the periodic royalty report reflecting full yearly sales of Licensed Product or (ii) Licensee’s filing of its official report in accordance with the Korean Stock Exchange regulations. Except as otherwise provided in Section 6.9(b)(ii), Licensor shall be responsible for its own costs and expenses relating to any audit conducted under this Section 6.9(b)(i). Licensee shall cause its Affiliates and Sublicensees to agree to make their records available for audit by Licensor or its representative as set forth in this Section 6.9.

 

(ii)         If any audit conducted by Licensor or its representative shows an underpayment of royalties to Licensor, Licensee shall remit to Licensor the amount of such underpayment within thirty (30) days after its receipt of Licensor’s request therefor. If an underpayment in royalties exceeds five percent (5%) of the total amount owed for the period then being audited, Licensee shall be responsible, and promptly shall reimburse Licensor, for Licensor’s reasonable out-of-pocket costs for conducting the audit. If any audit conducted by Licensor or its representative shows an overpayment of royalties to Licensor, such overpayment shall be refunded to Licensee promptly.

 

(c)           Confidentiality . Licensor shall treat all financial information of Licensee, its Affiliates, Sublicensees and Distributors that Licensor reviews in connection with any audit conducted under this Section 6.9 as Confidential Information of Licensee subject to the provisions of Section 9 of this Agreement.

 

Section 7. Regulatory Matters

 

7.1            Regulatory Approvals . Licensee shall have the sole authority and responsibility to obtain in its own name and maintain any Regulatory Approvals and Marketing Approvals with respect to the Licensed Product in the Territory. Licensor shall, promptly after the Effective Date, provide Licensee with a copy of any relevant data related to the Licensed Product owned by Licensor that have been filed with the FDA. Subject to the prevailing applicable Regulatory Law in the Territory, Licensor shall retain the sole right, but not the obligation, to be designated as the sponsor of any and all clinical trials of Licensed Product conducted by Licensee. Irrespective of the exercise of such rights, Licensee shall at all times be responsible for ensuring that any and all clinical trials are conducted in compliance with all applicable Regulatory Laws and other requirements of any Regulatory Authority in the Territory, and all Regulatory Laws and other requirements of any Governmental Authority (including any promulgated by the FDA) that would be applicable if such clinical trials were sponsored under Licensor’s IND or otherwise subject to the jurisdiction of the FDA.

 

7.2            Contact with Governmental Authorities . Subject to the other provisions of this Section 7.2, Licensee shall be solely responsible for responding to all inquiries, notices of violation, warning letters, inspectional observations, and other actions from or by Governmental Authorities in the Territory, in each case to the extent related to the Licensed Product in the Territory. Licensor and Licensee shall immediately forward to each other copies of any material correspondence from any Governmental Authority that it receives in respect of the Licensed Product. Notwithstanding the other provisions of this Section 7.2, Licensee shall not respond to any inquiries or other correspondence from a Governmental Authority with respect to the Licensed Product in the Territory without first providing Licensor with a copy of its proposed response, and incorporating any reasonable comments of Licensor in such response. Licensor shall cooperate with Licensee in responding to any inquiry or other correspondence from a Governmental Authority in a timely manner, including by promptly responding to all inquiries of Licensee relating thereto.

 

14 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

7.3            Regulatory Information . Each Party agrees to provide the other Party with all reasonable assistance and take all actions reasonably requested by the other Party that are necessary or desirable to enable the other Party to comply with any Law or other requirement of any Governmental Authority applicable to the Licensed Product. Such assistance and actions shall include, among other things, (a) informing the other Party, within five (5) business days, of receiving notice of any action by, or notification or other information which it receives (directly or indirectly) from any Governmental Authority that: (i) raises any material concerns regarding the safety or efficacy of the Licensed Product; (ii) indicates or suggests a potential material liability for either Party to Third Parties arising in connection with the Licensed Product; or (iii) is reasonably likely to lead to a field alert report, recall or market withdrawal of the Licensed Product; provided, that neither Party shall be obliged to disclose information in breach of any contractual restriction; and (b) Licensee immediately reporting to Licensor the occurrence of any adverse reaction (including without limitation death) or other incident during any clinical trial or medicinal exam and any other information so as to enable Licensor to fulfill its reporting obligations to any Governmental Authority, as further specified by the Safety Agreement.

 

7.4            Official Documentation . Licensee shall provide to Licensor one exact copy of any official registration and/or importation documents supplied by the relevant Regulatory Authorities immediately upon issuance. In case of early termination of this Agreement, Licensee shall provide to Licensor any original versions of such registrations and/or documents that are not otherwise in Licensor’s possession as per Section 13.3(a).

 

7.5            Clinical Trial Reports . Without limiting any of Licensee’s obligations under this Agreement, Licensee shall be responsible for preparing the clinical trial yearly progress reports, clinical trial final report and any other reports as may be required by a Regulatory Authority in connection with clinical trials of the Licensed Product; provided, however that Licensee shall provide drafts of such reports for Licensor’s knowledge prior to submission to the applicable Regulatory Authority and provide all final reports submitted to applicable Regulatory Authorities. With respect to all clinical trials for products containing Tβ4 that are directly related to the development of Licensed Products in the Field and the Territory that have been completed prior to, or are in progress as of the date hereof, Licensor shall provide Licensee with copies of the related clinical trial reports, that Licensor has the right to disclose, promptly upon the execution hereof or upon the finalization of the report, as applicable.

 

7.6            Unknown Side Effects; Adverse Reactions

 

(a)           Reporting Unknown Side Effects and Adverse Reactions . Each Party shall provide promptly to the other Party any information and data relating to any serious or previously unknown side effects or adverse reactions relating to the Licensed Product that the providing Party receives from any source, as further specified in the Safety Agreement.

 

(b)           Safety Agreement . Promptly after the Effective Date and before the date that Licensee commences any clinical trials of the Licensed Product in the Territory, the Parties shall enter into a separate written safety agreement containing (i) appropriate provisions addressing safety issues relating to the Licensed Products, (ii) a description of the types of side effects and reactions that must be reported pursuant to Section 7.6(a) and any other complaints or information requests that must be reported, and (iii) such cooperative working procedures as are reasonably necessary to ensure that satisfactory systems and processes are in place to ensure the effective exchange of safety and other medical information relating to the Licensed Product (the “ Safety Agreement ”).

 

15 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Section 8. Intellectual Property

 

8.1            Trademarks . Licensee shall be free to use Licensee’s Trademarks or any other Trademark(s) owned by the Licensee in the Territory for the Licensed Product.

 

8.2            Ownership of Inventions .

 

(a)           Licensee Inventions . Subject to any licenses granted to Licensor herein, Licensee shall own all Inventions having as inventors only employees, consultants or contractors of Licensee (“ Licensee Inventions ”). Licensee shall have written agreements in place with its employees, consultants, and contractors giving Licensee all rights and authority necessary to grant the license in Section 8.3(a).

 

(b)           Licensor Inventions . Subject to any licenses granted to Licensee herein, Licensor shall own all Inventions having as inventors only employees, consultants or contractors of Licensor (“ Licensor Inventions ”). Licensor shall have written agreements in place with its employees, consultants, and contractors giving Licensor all rights and authority necessary to grant the license in Section 8.3(b).

 

(c)           Joint Inventions . Licensee and Licensor shall own jointly all Inventions having as inventors employees, consultants or contractors of both Licensee and Licensor (“ Joint Inventions ”). The Parties will agree on a case-by-case basis the appropriate allocation of cost and control concerning matters regarding the prosecution, maintenance, defense and infringement of Patents for such Joint Inventions.

 

8.3            Licenses to Certain Inventions .

 

(a)           License Grant to Licensor . To the extent that any Licensee Invention or any Joint Invention relates to the development, promotion, marketing, distribution, manufacturing or sale of the Licensed Product, Licensee hereby grants to Licensor, and Licensor hereby accepts, an exclusive, perpetual, transferable, sublicensable (through multiple tiers) license under Licensee’s rights in such Licensee Invention or Joint Invention, as applicable, to research, develop, promote, market, distribute, manufacture, have manufactured, sell, offer for sale or import the Licensed Product outside the Territory and/or outside the Field. The foregoing license shall include a right of reference (transferable by Licensor to its Affiliates and sublicensees) to all regulatory filings made by Licensee in the Territory and all data from any clinical trials conducted by Licensee pursuant to this Agreement for the development, manufacture and commercialization of any Licensed Product outside the Territory and/or outside the Field. Licensee shall promptly disclose all Licensee Inventions and Joint Inventions in writing to Licensor. If Licensor desires to use any such Licensee Invention and/or Joint Invention for the development, manufacture and commercialization of the Licensed Products outside the Territory and/or outside the Field, Licensor shall notify Licensee in writing.

 

(b)           License Grant to Licensee . To the extent that any Licensor Invention or any Joint Invention relates to the development, promotion, marketing, distribution, or sale of the Licensed Product, then such Licensor Invention or Licensor’s interest in such Joint Invention, as applicable, shall be deemed a Licensed Patent and shall be subject to the licenses granted to Licensee pursuant to Sections 2.1(a) and 2.1(b). The Parties shall promptly disclose to the other Party all Inventions that are relevant to Licensed Products and subject to the Licenses granted hereunder.

 

16 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

8.4            Patent Marking . Licensee shall, and shall cause its Affiliates, Sublicensees and Distributors to mark all Licensed Products sold or otherwise distributed pursuant to this Agreement in accordance with the applicable patent statutes and other relevant regulations in the jurisdiction of the Territory in which such Licensed Product is manufactured, sold or otherwise distributed.

 

8.5            Prosecution and Maintenance of Licensed Patents in the Territory .

 

(a)           Prosecution . As between Licensor and Licensee, Licensor shall have the right, but not the obligation, to prepare, file, prosecute, and maintain the Licensed Patents in the Territory, and to pursue any proceeding (including interferences, re-examinations, examinations, protests, reissues, opposition proceedings and the like) relating to any of the Licensed Patents (collectively “ Prosecute ”) in the Territory, such costs and expenses shall be shared equally by the Parties. The Parties agree to utilize Licensee’s local intellectual property counsel and counsel shall promptly provide Licensor with all information related to such prosecution. In the event that Licensor decides not to Prosecute any Licensed Patent, Licensor shall notify Licensee of its decision and the reason therefor, and subject to Licensor’s consent (which will not be unreasonably withheld or delayed), Licensee shall have the right to Prosecute such Licensed Patent in the Territory at its expense.

 

(b)           Cooperation . In connection with any of Licensor’s activities to Prosecute any of the Licensed Patents, Licensee shall cooperate fully and provide Licensor with any information or assistance that Licensor reasonably requests, including executing such documents as may be necessary with respect to such prosecution activity. If Licensee becomes aware of any patent, information, proceeding or other matter that may affect the preparation, filing, prosecution, or maintenance of any of the Licensed Patents or that may adversely impact the validity, scope, title or enforceability of any of the Licensed Patents, Licensee shall promptly notify Licensor of such patent, information, proceeding, or matter.

 

8.6            Infringement by Third Parties .

 

(a)           Notice . If Licensee learns of any actual or possible infringement of any Licensed Patent in the Territory, or any actual or possible misappropriation or misuse of Licensed Know-How, Licensee shall promptly notify Licensor of such infringement, misappropriation or misuse.

 

(b)           Right to Bring Suit in the Territory.

 

(i)          As between Licensor and Licensee, Licensor shall have the right, but not the obligation, to bring and control any legal action or proceeding with respect to any infringement of Licensed Patents or any misappropriation or misuse of Licensed Know-How by Third Parties in the Territory, at its own expense and using counsel of its own choice.

 

(ii)         In the event that Licensor declines to take legal action with respect to any infringement of the Licensed Patents, Licensee shall have the right, after giving Licensor ten (10) working days’ prior notice of its intent to do so, to take such legal action at its own expense, with the concomitant right to choose legal counsel reasonably acceptable to Licensor and to determine legal strategy. Licensor shall have the right to participate in any such legal action using its own counsel, at its own expense. Licensee may not settle or compromise any such controversy with any Third Party without the prior written approval of Licensor, which shall not be unreasonably withheld or delayed.

 

(iii)        For any action or proceeding brought by Licensor pursuant to this Section 8.6, if Licensor is unable to initiate or prosecute such action solely in its own name, then Licensee shall join such action voluntarily and shall execute all documents necessary to initiate litigation to prosecute and maintain such action.

 

17 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

(iv)        In connection with any action or proceeding brought by Licensor pursuant to this Section 8.6, Licensee shall cooperate fully and will provide Licensor with any information or assistance that Licensor reasonably requests.

 

8.7            Certifications . Each Party shall inform the other Party of any certification related to the Licensed Product regarding any Licensed Patents it receives pursuant to either 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions, or any equivalent regulations in any jurisdiction of the Territory, and shall provide the other Party with a copy of such certification within five (5) days of receipt by such Party. Licensor’s and Licensee’s rights with respect to the initiation and prosecution of any legal action as a result of such certification or any recovery obtained as a result of such legal action shall be as set forth in this Section 8.

 

8.8            Defense of Third Party Claims .

 

(a)           Notice . If either Party learns that a Third Party has commenced or plans to commence, either as a claim, a counterclaim, or an action for declaratory judgment, an action or proceeding challenging any of the Licensed Patents in any jurisdiction of the Territory, such Party shall promptly provide the other Party with notice thereof.

 

(b)           Licensor’s Right to Defend . As between Licensor and Licensee, Licensor shall have the right, but not the obligation, to defend and control any claim, counterclaim or other action initiated by a Third Party challenging any of the Licensed Patents in any jurisdiction of the Territory (each a “ Challenge ”), at its own expense and using counsel of its own choice.

 

(i)          For the defense of any Challenge pursuant to this Section 8.8, if Licensor is unable to initiate or prosecute such defense solely in its own name, then Licensee (subject to any necessary approval of the relevant court) shall join such action voluntarily and shall execute all documents necessary to initiate litigation to prosecute and maintain such action.

 

(ii)         In connection with the defense of any Challenge brought by Licensor pursuant to this Section 8.8, Licensee shall cooperate fully and will provide Licensor with any information or assistance that Licensor reasonably requests.

 

8.9            Awards and Recovery . Any recovery obtained by Licensor in connection with or as a result of any action contemplated by Section 8.6 or 8.8, whether by settlement of otherwise, shall be shared by the Parties as follows:

 

(a)          such recovery shall first be allocated to Licensor for reimbursement in respect of its respective out-of-pocket costs and expenses incurred in connection with such action; and

 

(b)          any remaining amounts after such reimbursement shall be split equally by the Parties.

 

18 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Section 9. Confidentiality and Press Releases

 

9.1            Confidential Information . Except to the extent expressly authorized by this Agreement, or otherwise agreed in writing by the Parties, the Parties agree that the receiving Party (the “ Receiving Party ”) shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any Confidential Information which is disclosed to it by the other Party (or an Affiliate thereof) (each, a “ Disclosing Party ”), except to the extent that the Receiving Party can demonstrate by competent written evidence that such Confidential Information:

 

(a)          was already legally in the possession of the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party;

 

(b)          was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;

 

(c)          became generally available to the public or was otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement;

 

(d)          was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or

 

(e)          is independently discovered or developed by the Receiving Party without the use of Confidential Information provided by the Disclosing Party.

 

9.2            Exceptions . The obligations of this Section 9 shall not apply to Confidential Information that:

 

(a)          is submitted to Governmental Authorities by the Receiving Party to facilitate the issuance of any Regulatory Approval for the Licensed Product, or to obtain, maintain, enforce or defend Patents (in each case only to the extent permitted by this Agreement; provided that (A) such disclosure may be only to the extent reasonably necessary to obtain Regulatory Approvals or Patents, as applicable, and (B) the Receiving Party shall take reasonable measures to assure confidential treatment of such information to the extent applicable;

 

(b)          is provided by the Receiving Party to Third Parties (including, in the case of Licensee, to its Affiliates, Sublicensees or Distributors) under written confidentiality agreements having provisions at least as stringent as those in this Agreement, for consulting, development, external testing, marketing trials and other similar activities to the extent that such Receiving Party is permitted to conduct such activities pursuant to this Agreement; or

 

(c)          is otherwise required to be disclosed by the Receiving Party in compliance with Laws (including, without limitation and for the avoidance of doubt, the requirements of the U.S. Securities and Exchange Commission, the American Stock Exchange, the Korean Stock Exchange, and any other stock exchange on which securities issued by a Party are traded) or order by a court or other Governmental Authority having competent jurisdiction; provided, however, that the Receiving Party shall first give written notice to the Disclosing Party in order to allow the Disclosing Party the opportunity to seek confidential treatment of the Confidential Information. Confidential Information that is disclosed pursuant to Law or an order by a court or other Governmental Authority shall remain otherwise subject to the confidentiality and non-use provisions of this Section 9, and the Party disclosing Confidential Information pursuant to a Law or order by a court or other Governmental Authority shall take all reasonable steps necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.

 

19 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

9.3            Disclosure to PHS . Licensor may disclose certain Confidential Information of Licensee to PHS in order to comply with the PHS License. In such event, such Confidential Information shall be subject to the applicable confidentiality provisions of the PHS License.

 

9.4            Return of Confidential Information Upon Expiration or Termination of Agreement . Within thirty (30) days after any expiration or termination of this Agreement, each Party shall destroy (and certify to the other Party such destruction) or return (as requested by the other Party) all Confidential Information provided by the other Party except as otherwise set forth in this Agreement, and except that each Party may retain a single copy of the Confidential Information in its confidential legal files for the sole purpose of ascertaining its ongoing rights and responsibilities regarding the Confidential Information and for defending or enforcing its legal rights.

 

9.5            Written Agreements . The Receiving Party shall have in effect or obtain written agreements from each of its employees, consultants and contractors who have access to Confidential Information of the Disclosing Party, which agreements shall obligate such persons to similar obligations of confidentiality, and to assign to the Receiving Party all Know-How, information and Inventions conceived, made or reduced to practice by such persons during the course of performing the Receiving Party’s obligations under this Agreement. Each Party will notify the other Party promptly upon discovery of any unauthorized use or disclosure of the Confidential Information of the other Party.

 

9.6            Remedies . Each Party shall be entitled, in addition to any other right or remedy it may have, at law or in equity, to seek an injunction, without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Section 9.

 

9.7            Prior Confidentiality Agreement . The Confidential Disclosure Agreement, dated as of November 6, 2013, between Licensor and Licensee shall remain in effect with respect to disclosures made thereunder prior to the Effective Date.

 

9.8            Press Releases . Except as required by Law (including, without limitation and for the avoidance of doubt, the requirements of the U.S. Securities and Exchange Commission, the American Stock Exchange, the Korean Stock Exchange, and any other stock exchange on which securities issued by a Party are traded) or any Governmental Authority, neither Party shall make any press release or other public announcement relating to this Agreement or the transactions described herein without the prior written consent of the other Party.

 

Section 10. Representations, Warranties and Covenants

 

10.1          Licensor Representations, Warranties and Covenants . Licensor hereby represents, warrants and covenants to Licensee as follows:

 

(a)          the execution, delivery and performance by Licensor of this Agreement and the consummation of the transactions contemplated hereby are within Licensor’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensor. This Agreement constitutes the legal, valid and binding obligation of Licensor, enforceable against Licensor in accordance with its terms;

 

20 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

 

(b)          the execution, delivery and performance of this Agreement by Licensor will not violate any Law or any order of any Governmental Authority;

 

(c)          except as may be required to permit the sale or exportation of Licensed Product into the Territory from time to time during the Term, the execution, delivery or performance of this Agreement by Licensor will not require Licensor to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensor is a Party;

 

(d)          Licensor has the right and authority to grant the licenses granted in Section 2 of this Agreement;

 

(e)          to the best of our knowledge, without any investigation or due inquiry, all issued Licensed Patents are valid;

 

(f)          Licensor has not received any written communication from a third party alleging that Licensor’s practice of the Licensed Patents infringes the right of such third party; and

 

(g)          Licensor, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensor, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensor shall promptly notify Licensee upon learning of any such debarment, conviction, threat or indictment.

 

10.2          Licensee Representations, Warranties and Covenants . Licensee hereby represents, warrants and covenants to Licensor as follows:

 

(a)          the execution, delivery and performance by Licensee of this Agreement and the consummation of the transactions contemplated hereby are within Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms;

 

(b)          Licensee will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to carry out its activities hereunder;

 

(c)          the execution, delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority;

 

21 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

(d)          except for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;

 

(e)          Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment;

 

(f)          Licensee and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement;

 

(g)          Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.1, GMP;

 

(h)          As of the Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried out, all of its obligations and activities contemplated under this Agreement;

 

(i)          Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Term any product in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval. and

 

(j)          Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Field.

 

10.3          Disclaimer of Warranties . EXCEPT AS SET FORTH IN THIS AGREEMENT, NEITHER PARTY GIVES ANY OTHER WARRANTY, EXPRESS OR IMPLIED REGARDING THE LICENSED PRODUCTS, THE LICENSED KNOW-HOW, THE LICENSED PATENTS, OR THE SCOPE OR VALIDITY THEREOF. ALL OTHER WARRANTIES, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT ARE EXPRESSLY DISCLAIMED.

 

22 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Section 11. Indemnification

 

11.1          Indemnification by Licensor . Licensor shall defend, indemnify and hold harmless Licensee, its Affiliates, and its and their respective officers, directors, employees and agents from and against any and all losses, liabilities, claims, damages, penalties, fines, costs and expenses (including reasonable legal fees and other litigation costs, regardless of outcome) (collectively “ Losses ”) arising as a result of (a) any breach of representations or warranties of Licensor provided in Section 10.1; (b) any Product Liability Claims or mandatory or voluntary recall of the Licensed Product in any jurisdiction of the Territory, if and to the extent that such Losses are caused by (i) failure of any Licensed Product provided by Licensor to conform to the relevant specifications therefor as specified with any clinical supplies provided to Licensee; or (ii) any willful act or negligence of Licensor and/or its manufacturer of clinical supplies in relation to the Licensed Product; provided, however, that Licensor shall have no obligation under this Section 11.1 if Licensee or any of its Affiliates, Sublicensees or Distributors has been negligent, whether in testing, storing, handling or otherwise dealing with the Licensed Product, or in case such Losses arise out of or are attributable to any breach of this Agreement by Licensee.

 

11.2          Indemnification by Licensee . Licensee shall defend, indemnify and hold harmless Licensor, its Affiliates, and its and their respective officers, directors, employees and agents from and against any and all Losses arising as a result of (a) any breach of representations or warranties of Licensee provided in Section 10.2; and (b) any and all Third Party claims if and to the extent that such Losses are caused by Licensee’s and/or any Affiliate’s, Sublicensee’s or Distributor’s manufacture, storage, development, use, promotion, marketing, distribution, and sale of the Licensed Product, provided, however, that Licensee shall have no obligation under this Section 11.2 if Licensor and/or its manufacturer have been negligent, whether in manufacturing, testing, storing, handling or otherwise dealing with the Licensed Product, or in the case said claims arise out of or are attributable to any breach of this Agreement by Licensor.

 

11.3          Procedures . The Party seeking indemnification under this Section 11 (the “ Indemnified Party ”) shall give prompt notice to the Party against whom indemnity is sought (the “ Indemnifying Party ”) of the assertion or commencement of any claim for indemnification pursuant to this Section 11, and shall provide the Indemnifying Party such information with respect thereto that the Indemnifying Party may reasonably request. The failure to give such notice will relieve the Indemnifying Party of its indemnification obligations hereunder only to the extent that the Indemnifying Party has suffered actual prejudice thereby. The Indemnifying Party shall assume and control the defense and settlement of any such action, suit or proceeding at its own expense. The Indemnified Party shall, if requested by the Indemnifying Party, cooperate in all reasonable respects in such defense, at the Indemnifying Party’s expense, subject to the following. The Indemnified Party will be entitled at its own expense to participate in such defense and to employ separate counsel for such purpose. For so long as the Indemnifying Party is diligently defending any action, suit or proceeding pursuant to this Section 11, the Indemnifying Party will not be liable under this Section 11 for any settlement effected without its consent. No Party shall enter into any compromise or settlement which commits the other Party to take, or to forbear to take, any action without the other Party’s prior written consent.

 

11.4          Consequential Damages . NEITHER PARTY SHALL BE LIABLE TO OR OTHERWISE RESPONSIBLE TO THE OTHER PARTY HERETO FOR ANY LOSS OF PROFITS, DIMINUTION IN VALUE, OR INCIDENTAL, INDIRECT, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES THAT ARISE OUT OF OR RELATE TO THIS AGREEMENT OR THE PERFORMANCE OR BREACH HEREOF OR OTHERWISE AND WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE; PROVIDED, THAT, THE FOREGOING LIMITATION SHALL NOT APPLY: (I) TO A PARTY’S INDEMNIFICATION OBLIGATIONS PURSUANT TO SECTIONS 11.1 AND 11.2 ABOVE; (II) TO ANY GROSSLY NEGLIGENT ACT OR WILLFUL MISCONDUCT OF A PARTY; OR (III) TO A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS PURSUANT TO SECTION 9 HEREOF.

 

23 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

11.5          Insurance .

 

(a)           General Liability . Each Party shall maintain as and when available comprehensive general liability insurance, including blanket contractual liability insurance through the Term and for five (5) years thereafter, which insurance shall afford limits of not less than US$3,000,000 for each occurrence for bodily injury liability, personal injury liability, products liability, property damage liability, contractual liability and completed operations liability. Each Party shall ensure that such insurance will include coverage for defense costs.

 

(b)           Product Liability . Each Party shall maintain as and when available and thereafter throughout the Term product liability insurance on commercially standard terms for the pharmaceutical manufacturing industry, with a reputable insurer, in an amount not less than US$5,000,000 per occurrence and US$5,000,000 in the annual aggregate.

 

(c)           Certificate of Insurance . Each Party will provide, upon request and as and when available, the other with certificate(s) of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and the limits of liability. Each Party shall cause its insurance policy to name the other Party hereto as an additional insured. Each Party’s general liability insurance policy shall contain a waiver of subrogation rights which that Party’s insurer(s) may have against the other Party.

 

Section 12. Information and Reporting

 

12.1         After the completion of equity investment as provided in Section 6.2, Licensee may examine, upon reasonable prior written request having been made to Licensor, but not more than twice per year, the books, records and accounts of Licensor. Licensee shall be entitled to receive reasonable information, including management accounts and operating statistics and other business and financial information, which exist at the time of request, to keep it properly informed about the business and affairs of Licensor and relevant to its interest as a shareholder.

 

12.2         Licensor shall provide reasonable access to Licensee’s personnel, upon reasonable notice and during normal business hours, but not more than twice per year, to access such books, records, accounts and other information relating to Licensor, which exist at the time of request, as may be necessary for them to review the information provided to Licensee pursuant to Sections 12.1.

 

12.3         Any information or documents provided to or made available for review by Licensee shall constitute Confidential Information and shall be protected accordingly as provided under Section 9 above.

 

Section 13. Term and Termination

 

13.1          Term and Rules Post Expiration: This Agreement shall enter into full force and effect at the Effective Date and as provided under this Section 13, the term of this Agreement (the “ Term ”) shall continue until the expiration of the last-to-expire valid and applicable patent within the patent rights in the Territory, or following fifteen (15) years from the first commercial sale of the Licensed Product in the Territory, whichever is later.

 

24 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

13.2          Term and Rules Post Termination :

 

(a)          In the event either Party is in breach of any material obligation hereunder or under the RGN-259 License Agreement (the “ Breaching Party ”), the non-breaching Party may give written notice to the Breaching Party specifying the claimed particulars of such breach, and in the event such material breach is not cured, within sixty (60) days following the date of such written notification, without prejudice to any other rights and remedies available at any time to the non-breaching Party, the non-breaching Party shall have the right thereafter to terminate this Agreement by giving thirty (30) days prior written notice to the Breaching Party to such effect.

 

(b)           Termination for Governmental Action . Either Party may terminate this Agreement upon ten (10) days’ prior written notice in the event that any Governmental Authority takes any action or raises any objection (“ Governmental Action ”) that prevents Licensee, for a period of not less than one hundred eighty (180) days, from importing, exporting, purchasing or selling the Licensed Product in the Territory, or that has the effect of making Licensor’s manufacture of the Licensed Product unlawful.

 

(c)           Termination by Licensor for Patent Challenge . Licensor may terminate this Agreement in its entirety immediately upon written notice to Licensee if Licensee or its Affiliates, Sublicensees or Distributors (directly or indirectly, individually or in association with any person or entity) challenges the validity, enforceability or scope of any Licensed Patents anywhere in the world.

 

(d)           Termination or Conversion Pursuant to the PHS License . In the event that PHS terminates the PHS License under Article 13 therein or rescinds a Licensed Field of Use (as that term is defined in the PHS License) that includes any portion of the Field in which Licensee is licensed hereunder, Licensee may, at its option:

 

(i)          terminate this Agreement; or

 

(ii)        convert this Agreement to a license between Licensee, on the one hand, and Licensor and PHS, on the other hand, with such conversion subject to the approval of PHS, which shall not be unreasonably withheld, and contingent upon Licensee’s acceptance of all of the provisions of the PHS License.

 

(e)           Termination for Bankruptcy . To the extent permitted under applicable Law, if at any time during the Term, an Event of Bankruptcy (as defined below) relating to either Party (the “Bankrupt Party”) occurs, the other Party (the “Other Party”) shall have, in addition to all other legal and equitable rights and remedies available hereunder, the option to terminate this Agreement upon sixty (60) days written notice to the Bankrupt Party. It is agreed and understood that if the Other Party does not elect to terminate this Agreement upon the occurrence of an Event of Bankruptcy, except as may otherwise be agreed with the trustee or receiver appointed to manage the affairs of the Bankrupt Party, the Other Party shall continue to make all payments required of it under this Agreement as if the Event of Bankruptcy had not occurred, the Bankrupt Party shall not have the right to terminate any license granted herein. The term “Event of Bankruptcy” means: (i) filing in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Bankrupt Party or of its assets; (ii) proposing a written agreement of composition or extension of a Bankrupt Party’s debts; (iii) being served with an involuntary petition against the Bankrupt Party, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof; (iv) proposing or being a party to any dissolution or liquidation when insolvent; or (v) making an assignment for the benefit of creditors. Without limitation, the Bankrupt Party’s rights under this Agreement shall include those rights afforded by 11 U.S.C. § 365(n) of the United States Bankruptcy Code (the “Bankruptcy Code”) and any successor thereto. If the bankruptcy trustee of a Bankrupt Party as a debtor or debtor-in-possession rejects this Agreement under 11 U.S.C. § 365(o) of the Bankruptcy Code, the Other Party may elect to retain its rights licensed from the Bankrupt Party hereunder (and any other supplementary agreements hereto) for the duration of this Agreement and avail itself of all rights and remedies to the full extent contemplated by this Agreement and 11 U.S.C. § 365(n) of the Bankruptcy Code, and any other relevant laws.

 

25 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

13.3          Effects of Termination .

 

(a)           Return of Material . In the event of early termination of this Agreement for any reason: (i) all rights and licenses granted to Licensee under this Agreement shall terminate (including all rights and licenses with respect to Licensed Patents and Licensed Know-How), and (ii) Licensee shall transfer to Licensor all data, files, records, information and other materials (including clinical supplies of Licensed Product and including the originals of any registrations and/or importation documents as specified in Section 7.4) in its possession or control relating to, containing or comprising the Licensed Product, including Licensor’s Confidential Information.

 

(b)           Transfer of Materials . In the event of early termination of this Agreement for any reason:

 

(i)          to the extent not transferred pursuant to Section 13.3(a), Licensee shall provide to Licensor a copy of any and all documentation and data owned by Licensee and in tangible form at the time of termination of the Agreement that has been generated with respect to the Licensed Product and is necessary to enable Licensor to continue development of a Licensed Product and the commercialization thereof in the Territory (collectively, the “ Licensee Product Data ”), and Licensor may use such Licensee Product Data at its discretion on an exclusive basis, to the extent necessary to enable Licensor, its Affiliates and Third Parties on behalf of Licensor or its Affiliates to continue to develop and commercialize a Licensed Product in the Territory; and

 

(ii)         if such termination occurs after a Licensed Product has received Regulatory Approval, Licensee shall, if permitted under applicable Law, promptly transfer and deliver to Licensor original copies of any and all Regulatory Approvals obtained in connection with the Licensed Product in the Territory (including any and all official registrations, licenses, permits, certificates, and/or importation documents issued by Regulatory Authorities in the Territory), as well as any and all regulatory documentation and applications for Regulatory Approval submitted to Regulatory Authorities in the Territory in connection with the Licensed Product; Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 13.3(b)(ii);

 

(iii)        to the extent that any Regulatory Approval is issued in the name of Licensee, its Affiliates, Sublicensees or other designee, Licensee shall, to the extent permitted by applicable Law, promptly assign or procure the assignment to Licensor (or its designee) such Regulatory Approvals, and in the event assignment is not permitted under applicable Law or cannot be carried out for any other reason, the Licensee shall take all steps that are necessary and/or desirable to assist Licensor to obtain such Regulatory Approvals in the name of Licensor (or its designee) in the Territory, with such actions including without limitation coordinating with the applicable Regulatory Authority, furnishing all necessary information and documents in respect thereof, and promptly cancelling and terminating (as necessary) all Regulatory Approvals held by the Licensee, its Affiliate(s), Sublicensee(s) and/or other designee(s) which are not otherwise assignable or transferable to the Licensor (or its designee); Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 13.3(b)(iii); and

 

26 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

(iv)         Licensee shall assign (or cause its Affiliates to assign) to Licensor all agreements with any Third Party with respect to the conduct of clinical trials for the Licensed Product, including agreements with contract research organizations, clinical sites and investigators, unless expressly prohibited by any such agreement or unless such agreement covers clinical trials for products in addition to the Licensed Products (in which case Licensee shall cooperate with Licensor in all reasonable respects to secure the consent of such Third Party to such assignment or to the conclusion of a new agreement between the Licensor and the Third Party on terms substantially similar to the agreement between Licensee and the Third Party), and Licensor shall assume all obligations under all such agreements.

 

(c)           Survival of Sublicenses . All sublicenses granted by Licensee to Sublicensees shall survive termination of this Agreement, and Licensor shall assume all such sublicenses as the Licensor thereunder in accordance with the terms of such sublicenses; provided, however, that Licensor may elect to terminate any such sublicenses, and Licensor shall not be required under this Section 13 to assume obligations under any such sublicense that are greater in scope than those set forth in this Agreement.

 

(d)           Remedies for Termination . Expiration or termination of this Agreement by either Party shall not affect any claim, demand, liability or right of a Party arising pursuant to this Agreement prior to such termination or expiration hereof.

 

13.4          Survival . The following provisions shall survive the termination or expiration of this Agreement: Section 6 (with respect to Net Sales made prior to expiration or termination of this Agreement), Sections 7.3, 7.6(a), Section 9, Section 11, 13.3, 13.4, and 14, and all provisions of the PHS License that are binding on Licensee and are specified in the PHS License as surviving the expiration or termination thereof.

 

Section 14. Miscellaneous

 

14.1          Waiver . The waiver by any Party of a breach of any provision of this Agreement shall not operate, or be construed, as a waiver of any subsequent breach.

 

14.2          Modification . No change, modification, or waiver of any term of this Agreement shall be valid unless it is in writing and signed by both Parties.

 

14.3          Entire Agreement . This Agreement (including all exhibits and attachments hereto, all of which are incorporated herein by reference) constitutes the entire agreement between the Parties (and their Affiliates) with respect to the subject matter hereof and thereof, and supersedes all prior agreements and understandings, whether oral or written, between the Parties, except for the Confidential Disclosure Agreement described in Section 9.7.

 

14.4          English Language . This Agreement is written and executed in the English language. Any translation into any other language shall not be an official version of this Agreement and in the event of any conflict in interpretation between the English version and such translation, the English version shall prevail.

 

14.5          Assignment . Except as expressly permitted otherwise in this Agreement, Licensor and Licensee may not assign its rights or delegate its obligations hereunder to any Person without the consent of the other Party; provided that either Party may (i) assign its rights or delegate its obligations hereunder to any of its Affiliates without the consent of the other Party upon (30) thirty days’ prior written notice to the other Party and (ii) either Party may assign or transfer this Agreement and any rights and obligations hereunder to any Third Party in connection with a change in control. All sublicenses granted to Affiliates or Third Parties in accordance with this Agreement shall be subject to all terms, conditions, obligations and covenants of this Agreement and all applicable provisions of the PHS License. No such assignment shall remove or mitigate the obligations or liability of the assigning Party unless otherwise agreed in writing by the non-assigning Party. If Licensor is involved in a Change of Control, the Intellectual Property of the Third Party that has become an Affiliate of Licensor through the transaction that constituted such Change of Control and the Intellectual Property of such Third Party’s Affiliates existing as of the closing of such Change of Control or developed outside of any activities under this Agreement, shall be automatically excluded from the definitions of Licensed Patents and Licensed Know-How licensed to Licensee under this Agreement.

 

27 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

14.6          Independent Contractor . This Agreement shall not be construed as constituting a partnership, joint venture or any other form of legal association that would impose liability upon one Party for the act or failure to act of the other Party, or as providing either Party with the right, power or authority (express or implied) to create any duty or obligation of the other Party.

 

14.7          Third Party Beneficiaries . Any sublicense granted by Licensee to an Affiliate or Third Party pursuant to Section 2.1(d) is intended by the Parties to be a third party beneficiary of this Agreement; provided that such Sublicense is in compliance with all of its obligations under any such sublicense to the extent that such obligations are required under this Agreement. Except as expressly provided in this Section 14.7, the Parties do not intend, nor will any Section of this Agreement be interpreted, to create for any person any third party beneficiary rights.

 

14.8          Disputes . Disputes regarding the scope, validity or enforceability of Patents are excluded from this Section 14.8.

 

(a)           Good Faith Negotiations by Officers . In the event of disputes between the Parties arising out of or relating to this Agreement, or the breach, termination (other than termination for convenience in accordance with Section 13.2(d)) or invalidity thereof, a Party seeking to resolve such dispute will, by written notice to the other, have such dispute referred to their respective chief executive officers, for attempted resolution by good faith negotiations within fourteen (14) days after such notice is received.

 

(b)           Mediation . In the event that the Parties are unable to resolve a dispute through good faith negotiations pursuant to Section 14.8(a), the Parties agree to submit such dispute to non-binding mediation using an industry expert mutually acceptable to the Parties. The costs of any such mediation shall be shared by the Parties equally.

 

(c)           Arbitration . If all good faith attempts to resolve a dispute through negotiations and mediation pursuant to Sections 14.8(a) and (b) have failed after sixty (60) days from notice provided pursuant to Section 14.8(a), then upon the request of either Party, the dispute shall be finally resolved by binding arbitration administered by I.C.C. Arbitration (the “ICC Rules”).

 

(i)          The arbitration shall be conducted by a panel of three neutral arbitrators (the “ Panel ”) appointed in accordance with the ICC Rules.

 

(ii)         The arbitration proceedings shall take place in New York, NY, USA. The arbitral proceedings and all pleadings shall be in the English language.

 

(iii)        The Panel shall have the power to decide all questions of arbitrability.

 

28 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

(iv)        At the request of either Party, the Panel will enter an appropriate protective order to maintain the confidentiality of information produced or exchanged in the course of the arbitration proceedings.

 

(v)         The Panel is empowered to award any remedy allowed by law, including monetary damages, prejudgment interest and punitive damages, and to grant final, complete, interim or interlocutory relief, including injunctive relief.

 

(vi)        The Parties may apply to a court of competent jurisdiction within the United States for a temporary restraining order, preliminary injunction, or other interim or conservatory relief, as necessary, without breach of this arbitration agreement and without any abridgment of the powers of the arbitrators. Judgment on the award rendered by the Panel may be entered in any court having jurisdiction thereof. Each Party hereby waives any defenses it may have to the personal jurisdiction and venue of such courts to resolve such disputes, including without limitation the defense of forum non conveniens , and each Party agrees not to file any motion to seek any relief under any forum non conveniens defense.

 

(vii)       Each Party shall bear its own legal fees arising in connection with the dispute. The Panel may assess costs, fees and expenses of the ICC and the Panel to the Parties in the manner the Panel deems appropriate under the circumstances.

 

14.9          Notices . Except as otherwise provided herein, all notices or other communications hereunder shall be deemed sufficient if given in writing, via registered mail (return receipt requested), postage paid, or by reputable high speed delivery service ( e.g. , FedEx) or by courier addressed to the appropriate Party at the address set forth below, or at such other place as such Party may designate in writing to the other Party.

 

If to Licensor:   RegeneRx Biopharmaceuticals, Inc.
    15245 Shady Grove Road
    Suite 470
    Rockville, Maryland 20850
    U.S.A.
    Attn:   President and CEO
    Phone: 301.208.9191
    Fax:   (301) 208.9194
     
With a copy to:   Ken Krisko, Esq.
    Cooley LLP
    One Freedom Square
    Reston Town Center
    11951 Freedom Drive
    Reston, VA  20190-5656
    Direct: (703) 456-8187
    Fax: (703) 456-8100

 

29 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

If to Licensee:   Digital Aria Co., Ltd.
    22 nd FL, Parkview Tower
    248 Jungjail-ro, Bundang-gu
    Seongnam-si, Gyeonggi-do 463-863
    Republic of Korea
    Attn:  CEO
    Phone: +82 31 786 7700
    Fax.:  +82 31 786 7801

 

All such notices shall be effective upon receipt.

 

14.10          Governing Law . This Agreement shall be governed and construed in accordance with the laws of New York, USA without regard to its principles of conflict of laws. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.

 

14.11          Severability . The provisions of this Agreement are severable. If any item or provision of this Agreement shall to any extent be invalid or unenforceable, the remainder of this Agreement shall not be affected thereby, and each term and provision of this Agreement shall be valid and shall be enforced to the fullest extent permitted by law. The Parties will use diligent good faith efforts to revise this Agreement as and to the extent reasonably necessary to effectuate their original intent and purpose under this Agreement.

 

end of page
[ signatures appear on following page]

 

30 | Page *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

 

IN WITNESS WHEREOF, this Agreement has been executed by a duly authorized officer of each Party as of the Effective Date.

 

  RegeneRx Biopharmaceuticals, Inc.
     
  By: /s/J.J. Finkelstein
  Name: J.J. Finkelstein
  Title: President & CEO
   
  Digital Aria Co., Ltd.
     
  By: /s/ Ill Park
  Name: Ill Park
  Title: CEO

   

31 | Page
 

 

Exhibits

 

Exhibit A - Licensed Patents: to be filled by RegeneRx

Exhibit B - PHS License Terms Applicable to Licensee

 

32 | Page
 

 

Exhibit A

 

LICENSED PATENTS

 

Summary of DERMAL Patents and Patent Applications with Relevant Claims in U.S.

   

2600-   Country   Serial No.
or
Patent
No.
  Filing Date   Status   Representative Claims
                     
109   United States   09/772445   1-29-2001   Pending  

United States

 

295. In a method for treating tissue in a human with thymosin beta 4 (Tβ4), the method comprising targeting cells of said tissue to be treated prior to administration of said Tβ4, then administering said Tβ4 to said targeted tissue so as to promote repair and revitalization of said tissue, wherein said Tβ4 is administered in an amount effective to promote repair and revitalize said tissue, wherein said human is suffering from a wound.

                     
124   United States   7,268,118   5-26-2004   Issued  

United States

 

1. A composition comprising a polypeptide comprising amino acid sequence LKKTET [SEQ ID NO:1] or a conservative variant thereof, the composition further comprising a carrier for application to a surface of human body, wherein said carrier is for application to an external surface of said body or to an internal surface of said body, the composition comprising a gel, cream, paste, lotion, spray, suspension, dispersion, salve, hydrogel or ointment, wherein said polypeptide is gelsolin, vitamin D binding protein (DBP), profilin, cofilin, depactin, DNaseI, vilin, fragmin, severin, capping protein, beta-actinin, acumentin, TB4, TB4 ala , TB9, TB10, TB11, TB12, TB13, TB14, or TB15, wherein said polypeptide is at a concentration in said carrier of at least about 0.01 ng/ml, and up to about 60 micrograms per 300 microliter.

 

7. A composition comprising a polypeptide agent consisting essentially of TB4, TB4 ala , TB9, TB10, TB11, TB12, TB13, TB14, or TB15, the composition further comprising a carrier for application to a surface of human body, wherein said carrier is for application to an external surface of said body or to an internal surface of said body, the composition comprising a gel, cream, paste, lotion, spray, suspension, dispersion, salve, hydrogel or ointment, wherein said polypeptide is at a concentration in said carrier of at least about 0.01 ng/ml, and up to about 60 micrograms per 300 microliter.

 

A- 1
 

 

182   United States   8,143,218   11-22-2005   Issued  

United States

 

4. A method for improving damage to the skin, the method comprising: applying topically to said damaged skin a composition comprising a tissue regeneration promoting amount of human thymosin β4 of SEQ ID NO:3; and a pharmaceutically acceptable topical vehicle.

                     
208   United States   11/715997   3-9-2007   Pending  

United States

 

21. A method of treatment for treating damage or injury to skin, dermal or epidermal tissue or portion of said tissue, for promoting regeneration of skin, or for inducing an epidermal cellular mechanism or process for formation or maintenance of an epidermal tissue or portion thereof, in a subject in need thereof, the method comprising contacting said skin, tissue or portion of said tissue with a composition comprising an agent comprising at least one of gelsolin, vitamin D binding protein (DBP), profilin, cofilin, depactin, DNaseI, vilin, fragmin, severin, capping protein, beta-actinin, acumentin TB4, a TB4 isoform, a functional fragment of TB4 or a TB4 isoform having biological activity of TB4 or a TB4 isoform, TB4ala, TB9, TB10, TB11, TB12, TB13, TB14, or TB15.

 

A- 2
 

 

258   United States   13/758,751   2-04-2013   Pending  

United States

 

1. A peptide having an amino acid sequence selected from Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3), Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (SEQ ID NO: 4), a variant of said Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH which has an amino acid substituent substituted for said methionine residue, an isolated R-enantiomer of Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3) or Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (SEQ ID NO: 4), an isolated S-enantiomer of Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3) or Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (SEQ ID NO: 4), or a methionine-containing variant thereof in which any methionine is oxidized or superoxidized.

 

5. A method of at least one of suppressing inflammation in tissue of a subject in need thereof, stimulating cell migration in tissue of a subject in need thereof, protecting tissue from cytotoxicity in tissue of a subject in need thereof, inhibiting apoptosis in tissue of a subject in need thereof, stimulating collagen in tissue of a subject in need thereof, inhibiting collagen in tissue of a subject in need thereof, stimulating collagen IV in tissue of a subject in need thereof, stimulating elastin in tissue of a subject in need thereof, inhibiting NFkB translocation in tissue of a subject in need thereof, inhibiting tissue damage caused by ultraviolet (UV) radiation in need thereof, protecting tissue from ultraviolet (UV) radiation damage in need thereof, promoting neurite outgrowth in a subject in need thereof, promoting neuron survival in a subject in need thereof, stimulating production of L1 in a subject in need thereof, inhibiting IKBa phosphorylation in a subject in need thereof, or restoring impaired T-lymphocyte blastogenic response in a subject in need thereof comprising administering to said subject a peptide having an amino acid sequence selected from Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3), Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (SEQ ID NO: 4), H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3), H-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (SEQ ID NO: 4), a variant of Ac- or H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3) that has an amino acid substituent substituted for said methionine residue, an isolated R-enantiomer of Ac- or H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3) or Ac- or H-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (SEQ ID NO: 4), an isolated S-enantiomer of Ac- or H-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3) or Ac- or H-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (SEQ ID NO: 4), a methionine-containing variant thereof in which any methionine is oxidized or superoxidized, or a combination thereof.

 

19. A composition comprising a peptide having amino acid sequence Ac-Ser-Asp-Lys-Pro-Asp-Met-Ala-Glu-Ile-Glu-Lys-Phe-Asp-Lys-Ser-OH (SEQ ID NO: 3) and a peptide having amino acid sequence Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (SEQ ID NO: 4).

  

A- 3
 

 

Exhibit B

 

PHS LICENSE TERMS

APPLICABLE TO LICENSEE

 

For the purposes of this Exhibit C only, terms in bold have the meanings given such terms in the PHS License.

 

5.01 PHS reserves on behalf of the Government an irrevocable, nonexclusive, non-transferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory. Prior to the First Commercial Sale , Licensee agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes solely for PHS research use and not for purposes of commercial development, manufacture or distribution, at a price equal to Licensee’s cost of such.

 

5.02 Licensee agrees that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS .

 

5.03 Licensee acknowledges that PHS may enter into future Cooperative Research and Development Agreements (CRADAs) under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement . PHS agrees to notify Licensee , as soon as is practical of any proposed CRADA that relates to the subject matter of this Agreement . Licensee agrees not to unreasonably deny requests for a Research License from such future collaborators with PHS when acquiring such rights is necessary in order to make a Cooperative Research and Development Agreement (CRADA) project feasible. As of the effective date of this Agreement , Licensee requests that Licensee have an opportunity to join as a party to any proposed Cooperative Research and Development Agreement (CRADA).

 

5.04 In addition to the reserved license of Paragraph 5.01 above, PHS reserves the right to grant such nonexclusive Research Licenses directly or to require Licensee to grant nonexclusive Research Licenses on commercially reasonable terms. The purpose of this Research License is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights , however, PHS shall consult with Licensee before granting to commercial entities a Research License or providing to them research samples of Licensed Products or materials made through the Licensed Processes , provided however that PHS will not provide materials obtained from Licensee under Paragraph 5.01 above to third parties, except with Licensee’s prior written consent, which shall not be unreasonably withheld.

 

8.01 Licensee agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed Processes practiced under this Agreement appropriate to determine the amount of royalties due PHS . Such records shall be retained for at least five (5) years following a given reporting period and shall be available during normal business hours upon five (5) business days prior written notice from PHS to Licensee for inspection at the expense of PHS by an accountant or other designated auditor selected by PHS for the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose to PHS information relating to the accuracy of reports and payments made under this Agreement. If an inspection shows an under reporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then Licensee shall reimburse PHS for the cost of the inspection at the time Licensee pays the unreported royalties, including any late charges as required by Paragraph 9.08 of this Agreement . All payments required under this Paragraph shall be due within thirty (30) days of the date PHS provides Licensee notice of the payment due.

 

B- 1
 

 

10.01 Licensee shall use its reasonable best efforts to bring the Licensed Products and Licensed Processes to Practical Application . “Reasonable best efforts” for the purposes of this provision shall include substantial adherence to the Commercial Development Plan at Appendix F and substantial performance of the Benchmarks at Appendix E as may be amended from time to time by mutual written consent. The efforts of sublicensees and Affiliates shall be considered the efforts of Licensee . To the extent that the Benchmarks or development obligations set forth in Appendix E differ from or conflict with those set forth in the Commercial Development Plan in Appendix F, Appendix E shall be considered to supersede Appendix F and the Commercial Development Plan in Appendix F shall be amended to be consistent with Appendix E.

 

10.02 Upon the First Commercial Sale , until the expiration of this Agreement , Licensee shall use its reasonable best efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public.

 

12.05 Licensee shall indemnify and hold PHS , its employees, students, fellows, agents, and consultants (the “Indemnified Parties” ) harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage (the “Indemnified Losses” ) suffered by an Indemnified Party in connection with or arising out of a) the use by or on behalf of Licensee , its sublicensees, directors, employees, or third parties of any Licensed Patent Rights , or b) the design, manufacture, distribution, or use of any Licensed Products , Licensed Processes or materials by Licensee , or other products or processes developed in connection with or arising out of the Licensed Patent Rights . Licensee agrees to maintain a liability insurance program consistent with sound business practice. Notwithstanding any other provision to the contrary, Licensee shall have no obligation to indemnify an Indemnified Party from an Indemnified Loss in connection with or arising out of the design, manufacture, distribution or use of any Licensed Product or Licensed Process by or on behalf of the Indemnified Party .

 

13.05 PHS shall specifically have the right to terminate or, with Licensee’s consent, modify, at its option, this Agreement , if PHS determines that the Licensee : 1) is not using its reasonable best efforts to effectuate the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes ; 2) has not used its reasonable best efforts to achieve the Benchmarks as my be modified under Paragraph 9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement ; 4) has committed a material breach of a covenant or agreement contained in the license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; 6) cannot reasonably satisfy unmet health and safety needs; or 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.02 unless waived. In making this determination, PHS will take into account the normal course of commercial development programs conduct with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.02. Prior to invoking this right, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’s concerns as to the previous items 1) to 7). If Licensee fails to alleviate PHS’s concerns as to the previous items 1) to 7) or fails to initiate corrective action to PHS’s reasonable satisfaction, PHS may terminate this Agreement .

 

B- 2
 

 

13.07 PHS reserves the right according to 35 U.S.C. § 209(1)(4) to terminate or modify this Agreement if it is determined that such action is necessary to meet requirements for public use specified by federal regulations issued after the date of the license and such requirements are not reasonably satisfied by Licensee .

 

13.08 Within thirty (30) days of receipt of written notice of PHS’s unilateral decision to modify or terminate this Agreement , Licensee may, consistent with the provisions of 37 C.F.R. 404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.

 

13.09 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by Licensee . Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to PHS shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with PHS and Licensee pursuant to Paragraph 4.03.

 

B- 3

 

EXHIBIT 31.1

 

CERTIFICATION

 

I, J.J. Finkelstein certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of RegeneRx Biopharmaceuticals, Inc.;

 

2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the issuer, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 15, 2014

 

  /s/J.J. Finkelstein
  J.J. Finkelstein
  President and Chief Executive Officer
 

(Principal Executive Officer) 

 

 

 

EXHIBIT 31.2

 

CERTIFICATION

 

I, Dane Saglio certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of RegeneRx Biopharmaceuticals, Inc.;

 

2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the issuer, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(c) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(d) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 15, 2014

 

  /s/Dane Saglio
  Dane Saglio
  Chief Financial Officer
  (Principal Financial Officer and Principal Accounting Officer)

 

 

 

 

EXHIBIT 32.1

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of RegeneRx Biopharmaceuticals, Inc. (the “Company”) for the period ended March 31, 2014 (the “Report”), I, J.J. Finkelstein, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)); and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company as of and for the periods presented in the Report.

 

This certification accompanies this Report to which it relates, shall not be deemed “filed” with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.

 

Date: May 15, 2014

 

  /s/J.J. Finkelstein
  J.J. Finkelstein
  President and Chief Executive Officer
  (Principal Executive Officer)

 

 

 

EXHIBIT 32.2

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on form 10-Q of RegeneRx Biopharmaceuticals, Inc. (the “Company”) for the period ended March 31, 2014 (the “Report”), I, Dane Saglio, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)); and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company as of and for the periods presented in the Report.

 

This certification accompanies this Report to which it relates, shall not be deemed “filed” with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.

 

Date: May 15, 2014

 

  /s/Dane Saglio
  Dane Saglio
  Chief Financial Officer
  (Principal Financial Officer and Principal Accounting Officer)