UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 5, 2015
Tyme Technologies, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
333-179311 |
45-3864597 |
(State or Other Jurisdiction
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(Commission File Number) |
(I.R.S. Employer
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48 Wall Street - Suite 1100
New York, New York 10005
(Address of principal executive offices, including zip code)
646-205-1603
(Registrant’s telephone number, including area code)
c/o CKR Law LLP
1330 Avenue of the Americas
New York, New York 10019
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
INTRODUCTORY COMMENT – USE OF TERMINOLOGY
Throughout this Current Report on Form 8-K, the terms “Company,” “we,” “us,” and “our” refers to Tyme Technologies, Inc. and, unless the context indicates otherwise, its direct and indirect subsidiaries, Tyme Inc. and Luminant Biosciences, LLC, on a consolidated basis.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Current Report on Form 8-K contains forward-looking statements, including, without limitation, statements in the sections captioned “Description of Business,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Plan of Operations” and elsewhere in this Form 8-K. Any and all statements contained in this Form 8-K that are not statements of historical fact may be deemed forward-looking statements. Terms such as “aim,” “anticipate,” “assume,” “attempt,” “believe,” “can,” “could,” “continue,” “develop,” “envision,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “projection,” “should,” “usually,” “will,” “would” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this Form 8-K may include, without limitation, statements regarding:
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the plans and objectives of our management for future operations, including plans or objectives relating to the development of commercially viable pharmaceuticals; |
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a projection or forecast of revenue, income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items; |
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our future financial performance, including any such statement contained in the discussion and analysis of financial condition and the results of operations by our management included pursuant to the rules and regulations of the United States Securities and Exchange Commission (the “SEC”); |
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our future clinical trials, drug development activities and filings with applicable regulators, including, without limitation, the United States Food and Drug Administration (the “FDA”); |
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obtaining regulatory approval to market any of our product candidates; and |
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the assumptions underlying or relating to any statement described above. |
Forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon our current projections, plans, objectives, beliefs, expectations, estimates and assumptions which are subject to a number of risks and uncertainties and other influences, many of which we have no control over. Actual results and the timing of certain events and circumstances may differ materially from those described in the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of our forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation:
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our ability to obtain and maintain regulatory approval of our initial drug candidate, SM-88, as well as any other drug candidate we may seek regulatory approval for and to commercialize in the future; |
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our ability to successfully commercialize SM-88 or other drug candidates, once approved for marketing; |
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our ability to obtain drug starting materials and substances necessary to manufacture SM-88, as well as any other drug candidate we may seek regulatory approval for and to commercialize in the future; |
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the rate and degree of market acceptance of SM-88, as well as any other drug candidate we may seek regulatory approval for and to commercialize in the future; |
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the accuracy of estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; |
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our ability to obtain and maintain intellectual property (“IP”) protection for SM-88, as well as any other drug candidate we may seek regulatory approval for and to commercialize in the future; |
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our ability to scale up manufacturing of SM-88 or other drug candidates, for commercialization; |
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our ability to successfully establish and maintain appropriate collaborations and derive significant revenue from collaborations, if we enter into collaboration arrangements; |
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challenges to the claims contained in and coverage of our patents and patent applications, whether or not such challenges are successful; |
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our ability to control costs, a significant portion of which may be beyond our control; |
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our reliance on any collaboration partners’ performance, over which we likely will have limited or no control; |
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the actual receipt and timing of any milestone payments or royalties from our collaborators, if any; |
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our reliance on third parties to conduct our clinical trials; |
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our reliance on third-party contract manufacturers to manufacture and supply SM-88 and any other drug candidate we may seek regulatory approval for and to commercialize in the future, to us; |
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our ability to identify, develop, acquire and in-license new products and drug candidates; |
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our ability to enroll patients in our clinical trials at the pace that we project; |
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our ability to retain and recruit key personnel, advisors and consultants; |
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our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act; |
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our financial performance; |
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developments and projections relating to our competitors or our industry; |
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changes to regulations, both domestically and in foreign jurisdictions in which we intend to market our product candidates, that affect our drug candidates; |
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unanticipated results of clinical trials that are necessary for us to obtain regulatory approval to market our product candidates; |
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our inability to obtain adequate financing when needed and on favorable terms; |
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the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity; |
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our inability to expand our business; |
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our lack of product diversification; |
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volatility in the price of raw materials necessary for the manufacture of SM-88 and any other drug products we may seek regulatory approval for and to commercialize in the future; |
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existing, new or increased competition; |
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results of arbitration and litigation, if any; |
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significant government regulation of pharmaceuticals and their manufacture, marketing and distribution; |
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the various economic factors affecting the healthcare industry; |
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stock volatility and illiquidity; and |
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our failure to implement our business plans and/or strategies. |
A description of some of the risks and uncertainties that could cause our actual results to differ materially from those described by the forward-looking statements in this Form 8-K appears in the section captioned “Risk Factors” in Item 2.01 below and elsewhere in this Form 8-K.
Readers are cautioned not to place undue reliance on forward-looking statements because of the risks and uncertainties related to them. We disclaim any obligation to update the forward-looking statements contained in this Form 8-K to reflect any new information or future events or circumstances or otherwise.
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EXPLANATORY NOTE
We were incorporated as Global Group Enterprises Corp. in Florida on November 22, 2011. Our initial intention was to distill, bottle, market and distribute alcoholic beverages (primarily an ultra-premium vodka), but we never acted on such intention, other than initial planning.
As previously reported in our Current Report on Form 8-K (Date of Report: September 18, 2014), filed with the SEC on September 19, 2014, effective as of September 18, 2014, we reincorporated in the State of Delaware by merging with and into Tyme Technologies, Inc., our newly-formed, wholly-owned Delaware subsidiary, which was the surviving corporation in such merger and our successor-in-interest (the “Reincorporation”). As a result of the Reincorporation, among other things,
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we changed our jurisdiction of incorporation from Florida to Delaware (the “Re-Domicile”); |
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we changed our name from Global Group Enterprises Corp. to Tyme Technologies, Inc. (the “Name Change”); |
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each share of Global Group Enterprises Corp.’s common stock outstanding at the time of the Reincorporation was automatically converted into 4.3334 issued and outstanding and fully paid and non-assessable shares of the surviving corporation’s common stock, with the result that the aggregate 12,000,000 shares of Global Group Enterprises Corp.’s common stock outstanding immediately prior to the Reincorporation were converted into an aggregate of 52,000,800 shares of our common stock (the “Share Conversion”); and |
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we increased our authorized capital stock from 250 million shares of common stock, par value $0.0001 per share, to 300 million shares of common stock, par value $0.0001 per share (our “Common Stock”) and 10 million shares of “blank check” preferred stock, par value $0.0001 per share (our “Preferred Stock”). |
All share and per share numbers in this Form 8-K relating to our Common Stock have been adjusted to give effect to the Share Conversion, unless otherwise stated.
On March 5, 2015, our wholly owned subsidiary, Tyme Acquisition Corp., a corporation formed in the State of Delaware on February 18, 2015 (“Acquisition Sub”), merged (the “Merger”) with and into Tyme, Inc., a corporation incorporated in the State of Delaware on July 26, 2013 (“Tyme”). Tyme was the surviving corporation in the Merger and became our wholly-owned subsidiary. All of the outstanding Tyme stock was converted into shares of our Common Stock, as described in more detail below.
In connection with the Merger and pursuant to the Split-Off Agreement (defined below), we transferred all of our pre-Merger assets and liabilities to one of our pre-Merger principal stockholders who was a founder and former executive officer of our Company, in exchange for the surrender by him and cancellation of 13,000,200 shares of our Common Stock (the “Split-Off Transaction”). (See Item 2.01, “Split-Off,” below.)
As a result of the Split-Off and Merger, we discontinued our pre-Merger business and acquired the business of Tyme, a research and development company focused on developing drug candidates for the treatment of cancer in humans. We intend to continue the existing business operations of Tyme as our wholly-owned subsidiary. At the present time, we do not intend to operate any other business other than Tyme, although such operations may be conducted through one or more direct and/or indirect subsidiaries as we believe appropriate.
Also on March 5, 2015, we closed a private placement offering (the “PPO”) of 2,716,000 shares of our Common Stock, at a purchase price of $2.50 per share. Additional information concerning the PPO is presented below under Item 2.01, “Merger and Related Transactions - the PPO” and “Description of Securities,” and Item 3.02, “Unregistered Sales of Equity Securities.”
The Merger resulted in a change of control of our Company, as the pre-Merger stockholders of Tyme own approximately 79% of our Common Stock as a result of the shares issued to them in the Merger and giving effect to the PPO, Split-Off Transaction and other related transactions discussed elsewhere in this Form 8-K. In accordance with “reverse merger” accounting treatment, our historical financial statements as of and for periods ended prior to the Merger will be replaced with the historical financial statements of Tyme prior to the Merger in all future filings with the SEC.
Also on March 5, 2015, we changed our fiscal year from a fiscal year ending on November 30 th of each year, which was used in our most recent filing with the SEC, to one ending on December 31 st of each year, which is the fiscal year end of Tyme.
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This Form 8-K contains summaries of the material terms of various agreements executed in connection with the transactions described herein. The summaries of these agreements are subject to and are qualified in their entirety by, reference to these agreements, which are filed as exhibits hereto and incorporated herein by reference.
This Form 8-K responds to the following Items of Form 8-K:
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Item 1.01. |
Entry into a Material Definitive Agreement |
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Item 2.01. |
Completion of Acquisition or Disposition of Assets |
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Item 3.02. |
Unregistered Sales of Equity Securities |
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Item 4.01. |
Changes in Registrant’s Certifying Accountant |
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Item 5.01. |
Changes in Control of Registrant |
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Item 5.02. |
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers |
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Item 5.03. |
Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year |
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Item 5.06. |
Change in Shell Company Status |
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Item 9.01. |
Financial Statements and Exhibits |
Prior to the Merger, we were a “shell company,” as such term is defined in Rule 12b-2 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As a result of the Merger, we have ceased to be a shell company. The information contained in this Form 8-K, together with the information contained in our Annual Report on Form 10-K for the fiscal year ended November 30, 2014 constitute the current “Form 10 information” necessary to satisfy the conditions contained in Rule 144(i)(2) promulgated under the Securities Act of 1933, as amended (the “Securities Act”).
Item 1.01 |
Entry into a Material Definitive Agreement |
The information contained in Item 2.01 below relating to the various agreements described therein is incorporated into this Item 1.01 by reference.
Item 2.01 |
Completion of Acquisition or Disposition of Assets |
THE MERGER AND RELATED TRANSACTIONS
Merger Agreement
On March 5, 2015, our Company, Acquisition Sub, Tyme and certain other parties entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”). Simultaneous with the execution of the Merger Agreement, we and the other parties to the Merger Agreement consummated the transactions contemplated by the Merger Agreement. We refer to the date that the transactions contemplated by the Merger Agreement, including the Merger, were consummated as the “Closing Date.” Pursuant to the terms of the Merger Agreement, Acquisition Sub merged with and into Tyme. Tyme was the surviving corporation in the Merger and thus became our wholly-owned subsidiary. In accordance with the Merger Agreement, we also completed the Split-Off Transaction whereby we transferred all of our pre-Merger assets and liabilities to a newly formed subsidiary, Global Group Enterprises Corp., a Florida corporation (“Split-Off Subsidiary”) and transferred our entire equity interest in Split-Off Sub to a pre-Merger principal stockholder, who was a founder and former executive officer of our Company, in consideration for his surrender to us for cancellation of all of his 13,000,200 shares of our Common Stock. As a result of the consummation of the Merger and Split-Off Transaction, our sole business at this time is the business of Tyme, a research and development company focused on developing drug candidates for the treatment of cancer in humans.
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At the closing of the Merger, the shares of Tyme’s common stock issued and outstanding immediately prior to the Merger were converted into shares of outstanding Common Stock resulting in an aggregate of 68 million shares of our Common Stock being issued in connection with the Merger to the holders of Tyme’s common stock immediately preceding the effective time of the Merger (the “pre-Merger Tyme stockholders”). Tyme’s common stock was Tyme’s sole authorized class of equity securities. Tyme had no outstanding warrants, options or convertible securities outstanding as of the closing of the Merger.
The Merger Agreement contained customary representations and warranties and pre- and post-closing covenants of each party and customary closing conditions. Breaches of the representations and warranties will be subject to indemnification provisions. Each of the pre-Merger Tyme stockholders initially received in the Merger 95% of the shares to which each such stockholder is entitled under the terms of the Merger Agreement, with the remaining 5% of such shares being held in escrow for two years to satisfy post-closing claims for indemnification by the Company (“Indemnity Shares”), pursuant to an Indemnification Shares Escrow Agreement. Any of the Indemnity Shares remaining in escrow at the end of such two-year period shall be distributed to the pre-Merger Tyme stockholders on a pro rata basis. The Merger Agreement also contains a provision providing for a post-Merger share issuance as a means for which claims for indemnity may be made by the pre-Merger Tyme stockholders. Pursuant to this provision, up to 1 million additional shares (“R&W Shares”) of our Common Stock may be issued to the pre-Merger Tyme stockholders during the one-year period following the Merger for breaches of representations and warranties of the pre-Merger Company contained in the Merger Agreement. The value of the Indemnity Shares and the R&W Shares issued pursuant to these indemnification provisions is fixed at $0.50 per share. The foregoing mechanisms are the exclusive remedies of the Company on the one hand and the pre-Merger Tyme stockholders on the other hand for satisfying indemnification claims under the Merger Agreement, other than claims based on fraud or willful misconduct.
The Merger Agreement also called for the surrender for cancellation, effective as of the Merger Closing, of a number of shares of our Common Stock by the owners of such shares. In addition to the surrender and cancellation of 13,000,200 shares in connection with the Split-Off Transaction, a further 26,276,600 shares (the “Merger Related Surrendered Shares”) were surrendered by their owners and canceled.
The Merger will be treated as a recapitalization of the Company for financial accounting purposes. Tyme will be considered the acquirer for accounting purposes and our historical financial statements before the Merger will be replaced with the historical financial statements of Tyme before the Merger in all future filings with the SEC.
The Merger is intended to be treated as a tax-free reorganization under Section 368(a) of the Internal Revenue Code of 1986, as amended.
The issuance of shares of our Common Stock to holders of Tyme’s common stock in connection with the Merger was not registered under the Securities Act, in reliance upon the exemption from registration provided by Section 4(2) of the Securities Act, which exempts transactions by an issuer not involving any public offering. These securities may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirement and are subject to further contractual restrictions on transfer as described below.
We also agreed, subject to one exception discussed below, not to register under the Securities Act for resale any of the shares of our Common Stock issued to the pre-Merger Tyme stockholders for the two years following the closing of the Merger. Notwithstanding the restriction on registering shares of our Common Stock received in the Merger by the pre-Merger Tyme stockholders, we did agree to register 9% of the shares of our Common Stock issued in connection with the Merger to the pre-Merger Tyme stockholders.
In addition, two of the pre-Merger Tyme stockholders who each are executive officers and directors of our Company and are holders of 10% or more of our Common Stock (the “Restricted Stockholders”) have each entered into a Lock-Up and No Shorting Agreement (each, a “Lock-Up Agreement”), whereby they agreed to certain restrictions on the sale or disposition (including pledges) of shares of our Common Stock held by them for one year following the closing of the Merger. The Lock-Up Agreements exclude the shares which we agreed to register for all of the pre-Merger Tyme stockholders discussed in the immediately preceding paragraph, as well as an additional 1 million shares each which they are permitted to sell only in private transactions.
The form of the Merger Agreement, Indemnification Shares Escrow Agreement and Lock-Up Agreements have been filed as exhibits to this Current Report on Form 8-K.
All descriptions of the Merger Agreement, Indemnification Shares Escrow Agreement and Lock-Up Agreements herein are qualified in their entireties by reference to the texts thereof filed as exhibits hereto, which is incorporated herein by reference.
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Split-Off Transaction
Immediately prior to the closing of the Merger, under the terms of a Split-Off Agreement and a General Release Agreement, we (x) transferred all of our pre-Merger operating assets and liabilities to Split-Off Subsidiary, our wholly-owned special-purpose subsidiary and (y) transferred all of the outstanding shares of capital stock of Split-Off Subsidiary to Andrew Keck, our founder and a principal stockholder of our Company prior to the consummation of the Merger, in consideration of and in exchange for (i) the surrender for cancellation of an aggregate of 13,000,200 shares of our Common Stock owned by him and (ii) certain representations, covenants and indemnities (the “Split-Off”). Mr. Keck served as our sole executive officer and director from our initial formation through April 26, 2013.
All descriptions of the Split-Off Agreement and the General Release Agreement herein are qualified in their entireties by reference to the texts thereof filed as exhibits hereto, which are incorporated herein by reference.
Bridge Financing
In July 2014, Tyme offered and sold to an accredited investor a Tyme senior subordinated secured convertible note in the principal amount of $1.1 million. The note bore interest at 10% per annum and was payable on October 11, 2015, subject to earlier conversion as described below. In November of 2014, the holder of such note loaned Tyme an additional $250,000 and the note was amended and restated to reflect a principal amount of $1.35 million. In January of 2015, the holder of such note loaned Tyme an additional $960,000 and the note was further amended and restated to reflect a principal amount of $2.31 million. In February of 2015, the note was further amended to reflect a change in its mandatory conversion feature to a fixed amount, as further discussed below. The note as amended and restated is referred to in this Current Report on Form 8-K as the “Bridge Note.”
Interest on the Bridge Note would have been payable at maturity; however, upon conversion of the Bridge Note as described below, accrued interest was, in accordance with the terms of the Bridge Note, forgiven. The Bridge Note was secured by a security interest on all of the assets of Tyme and its Luminant Biosciences, LLC wholly-owned subsidiary (“Luminant”), subject to certain limited exceptions, as well as a pledge of certain shares of stock of Tyme held by two principal stockholders of Tyme and Tyme’s membership interest in Luminant.
Upon the closing of the Merger and the PPO, the outstanding principal amount of the Bridge Note was automatically converted into 2.31 million shares (the “Conversion Shares”) of our Common Stock, at a rate of one share for every $1.00 of Bridge Note principal then outstanding. The security interest and pledges terminated upon conversion of the Bridge Note.
No broker or finder was engaged in connection with the sale of the Bridge Note and no fee or commission was paid. Tyme utilized and plans to utilize the proceeds from the sale of the Bridge Note to pay a portion of its outstanding accounts payable, to pay the accounting and auditing costs with respect to the preparation of the financial statements of Tyme contained elsewhere in this Form 8-K, to continue to proceed with its development of its drug candidates, to proceed with additional required clinical trials necessary to obtain regulatory approval of such drug candidates (which approval is not assured), to pay other costs relating to obtaining such regulatory approval and for general working capital purposes.
All descriptions of the Bridge Note original and as amended and restated, herein are qualified in their entireties by reference to the texts thereof which have been filed as exhibits hereto, which are incorporated herein by reference.
The PPO
Concurrently with the closing of the Merger and in contemplation of the Merger, we held a closing of the PPO in which we sold 2,716,000 shares of our Common Stock at a purchase price of $2.50 per share for gross proceeds of $6.79 million. Only $4.29 million of such gross proceeds was paid in cash. The remaining $2.5 million was paid by the delivery to us of a 90-day, limited recourse promissory note in the principal amount of $2.5 million (the “PPO Note”). The PPO Note is secured by an escrow of 5 million shares of our Common Stock, pursuant to a Subscription Note Shares Escrow Agreement among the purchaser in the PPO, our Company and an escrow agent (the “PPO Note Escrow Agreement”). To the extent that the PPO Note is not paid at or prior to its maturity date of June 5, 2015 (the “PPO Note Maturity Date”), the escrowed shares will be forfeited to us for cancellation at the rate of one share for every $0.50 of PPO Note principal not paid to us.
The PPO investor and the Bridge Note purchaser who received the Conversion Shares upon the automatic conversion of the Bridge Note which occurred simultaneous with the closing of the PPO, were granted, pursuant to the subscription agreement for the PPO and pursuant to the Bridge Note, anti-dilution protection on the shares purchased in the PPO and the Conversion Shares (as the case may
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be) such that, if within two years after the closing of the Merger, our Company issues additional shares of our Common Stock or Common Stock equivalents (subject to customary exceptions, including but not limited to Exempt Securities (defined below)) for a consideration per share less than $0.50 (the “Lower Price”), the PPO investor and former Bridge Note holder will be entitled to receive from the Company additional shares of our Common Stock (the “Lower Price Shares”) in an amount such that, when added to the number of shares initially purchased by such investor or received upon conversion of the Bridge Note, will equal the number of shares that such investor’s PPO subscription amount would have purchased or the Bridge Note holder would have received upon conversion of the Bridge Note at the Lower Price.
“Exempt Securities” include: (a) options and other equity awards issued under our 2015 Equity Incentive Plan (as discussed below); (b) shares of our Common Stock, options or convertible securities issued pursuant to or in conjunction with a joint venture, development, technology license or similar type of collaboration or strategic partnership agreement; (c) shares issued in the Merger and (d) securities issued to financial institutions, institutional investors or lessors in connection with credit arrangements, equipment financings, lease arrangements or similarly transaction (in each case, subject to a maximum number equal to 10% of the number of shares of our Common Stock outstanding at the time of issuance); provided, however, no such issuance shall include any type of “death spiral” provision.
The PPO was exempt from registration under Section 4(2) of the Securities Act. The sole investor in the PPO was GEM Global Yield Fund LLC SCS, a “société en commaudite simple” formed under the laws of Luxembourg (“GEM”). The Bridge Note investor designated GEM as the party to receive the Conversion Shares. GEM was a principal stockholder of our pre-Merger company, and the purchaser of the Bridge Note is the manager of GEM.
The closing of the PPO and the closing of the Merger were conditioned upon each other.
All descriptions herein of the subscription agreement for the PPO, PPO Note and PPO Note Escrow Agreement are qualified in their entireties by reference to the texts thereof filed as exhibits hereto, which are incorporated herein by reference.
Share Adjustment
The Merger Agreement provides that, in the event we raise additional capital in a public or private offering (in one or more closings) for gross proceeds of at least $20 million (a “Qualified Offering”), based on a pre-money valuation of our Company of at least $200 million, within five months of the earlier of the (i) date on which the PPO Note has been fully satisfied and (ii) PPO Note Maturity Date, subject to certain conditions, we will issue to the holders of record of our Common Stock as of the Closing Date (the “Pre-Merger Company Stockholders”), pro rata , 1,333,333 additional restricted shares of our Common Stock (the “Qualified Offering Shares”).
The Merger Agreement further provides that:
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if the pre-money valuation of our Company upon a Qualified Offering is $150 million or more but less than $200 million, the Pre-Merger Company Stockholders will surrender to us for cancellation without consideration 1 million shares of our Common Stock; |
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if the pre-money valuation of our Company upon a Qualified Offering is $100 million or more but less than $150 million, the Pre-Merger Company Stockholders will surrender to us for cancellation without consideration 2 million shares of our Common Stock; and |
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if the pre-money valuation of the Company upon a Qualified Offering is less than $100 million (which Qualified Offering may be rejected in the Company’s sole and absolute discretion) or if no Qualified Offering occurs within five months of the PPO Note Satisfaction Date, the Pre-Merger Company Stockholders will surrender to us for cancellation without consideration 3.5 million shares of our Common Stock. |
The Pre-Merger Company Stockholders have placed into escrow, pursuant to an Adjustment Shares Escrow Agreement, 3.5 million shares of our Common Stock (the “Adjustment Shares”) to secure such surrender obligations.
We have the sole authority to determine all matters relating to the Qualified Offering, including the subscription price, pre-money valuation and whether or not to accept any subscriber’s subscription offer. While GEM has agreed to assist us in the Qualified Offering, GEM is prohibited under the Merger Agreement from performing certain acts which would require GEM to be registered as a broker/dealer and/or a member of FINRA in order to receive compensation in connection with the Qualified Offering.
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Registration Rights
In connection with the PPO and Merger, we entered into a Registration Rights Agreement (the “Registration Rights Agreement”), pursuant to which we have agreed that promptly, but no later than 90 days following the earlier of the (i) date on which the PPO Note has been fully satisfied and (ii) the PPO Note Maturity Date (such earlier date, the “PPO Note Satisfaction Date”), we will file a registration statement with the SEC (the “Registration Statement”) covering (a) the shares of our Common Stock issued in the PPO (the “PPO Shares”) (a total of 2.716 million shares), (b) the Conversion Shares issued upon conversion of the Bridge Note (a total of 2.31 million shares), (c) the Lower Price Shares, if any, (d) 9% of the shares issued to the pre-Merger Tyme stockholders in the Merger (a total of 6.12 million shares) (the “Tyme Merger Registrable Shares”) and (e) any shares of our Common Stock issued or issuable with respect to the PPO Shares, Conversion Shares, Tyme Merger Registrable Shares and Lower Price Shares upon any stock split, dividend or other distribution, recapitalization or similar event (collectively, the “Registrable Shares”). Pursuant to a separate consulting agreement, we also agreed to include in the Registration Statement the 250,000 shares of our Common Stock issued to the consultant as part of its compensation under such consulting agreement. We are required to use commercially reasonable efforts to ensure that the Registration Statement is declared effective within 180 calendar days of its filing with the SEC. If we are late in filing the Registration Statement or if the Registration Statement is not declared effective within 180 days of its filing with the SEC, liquidated damages payable by the Company to the holders of the PPO Shares and Conversion Shares that have not been so registered will commence to accrue at a rate equal to $0.01 per share with respect to Conversion Shares and $0.025 per share with respect to the PPO Shares for each full month that (i) the Company is late in filing the Registration Statement or (ii) the Registration Statement is late in being declared effective by the SEC; provided, however, that in no event shall the aggregate of any such liquidated damages exceed $0.08 per Conversion Share and $0.20 per PPO Share. No liquidated damages will accrue with respect to any Registrable Shares removed from the Registration Statement in response to a comment from the staff of the SEC limiting the number of shares of Common Stock which may be included in the Registration Statement (a “Cutback Comment”), after the shares may be resold under Rule 144 under the Securities Act or another exemption from registration under the Securities Act or in other specified situations.
The Company must keep the Registration Statement “evergreen” for two years from the date it is declared effective by the SEC or until Rule 144 is available to the holders of Registrable Shares who are not and have not been affiliates of our Company with respect to all of their Registrable Shares, whichever is earlier.
The holders of Registrable Shares (including any Registrable Shares removed from the Registration Statement as a result of a Cutback Comment) will have “piggyback” registration rights for such shares with respect to any registration statement filed by our Company following the effectiveness of the Registration Statement that would permit the inclusion of such Registrable Shares.
We will pay all expenses in connection with any registration obligation provided in the Registration Rights Agreement, including, without limitation, all registration, filing, stock exchange fees, printing expenses, all fees and expenses of complying with applicable securities laws and the fees and disbursements of our counsel and of our independent accountants. Each holder of any Registrable Shares included in the Registration Statement will be responsible for its own sales commissions, if any, transfer taxes and the expenses of any attorney or other advisor such holder decides to employ in connection with the Registration Statement and/or the sale of such holder’s Registrable Shares.
All descriptions of the Registration Rights Agreement herein are qualified in their entirety by reference to the text thereof filed as an exhibit hereto, which is incorporated herein by reference.
2015 Equity Incentive Plan
Prior the closing of the Merger, our Board of Directors adopted and our stockholders approved, our 2015 Equity Incentive Plan (the “2015 Plan”), which provides for the issuance of incentive awards of up to 10,000,000 shares of our Common Stock to officers, key employees, consultants and directors. The 2015 Plan provides that no greater than 3,333,333 shares may be awarded prior to the first anniversary of the 2015 Plan’s adoption, which occurred on March 5, 2015. See “Market Price of and Dividends on Common Equity and Related Stockholder Matters—Securities Authorized for Issuance under Equity Compensation Plans” below for more information about the 2015 Plan.
Departure and Appointment of Directors and Officers
Under our Certificate of Incorporation, our Board of Directors is authorized to consist of between one and eleven members, as determined from time to time by our Board. In connection with the Merger, our Board size was fixed at five members, subject to increase or decrease as further determined by the Board.
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Effective as of the closing of the Merger, Peter de Svastich, our sole director before the Merger, who was also our sole executive officer prior to the Merger, resigned his position as a director and executive officer of our Company and Steve Hoffman and Michael Demurjian were appointed to our Board of Directors. In addition, effective as of the closing of the Merger, Steve Hoffman was appointed as our Chief Executive Officer, Chief Science Officer and President, Michael Demurjian was appointed as our Chief Operating Officer and Executive Vice President and Akber Pabani was appointed as our Chief Financial Officer and Treasurer. Messrs. Hoffman and Demurjian served as the sole directors and executive officers of Tyme and were Tyme’s principal stockholders.
During the negotiations of the terms of the Merger Agreement and amendments to the Bridge Note, it was agreed that, in addition to the requirement of Messrs. Hoffman and Demurjian be appointed to our post-Merger Board of Directors and their executive positions with our Company, Tyme had the right to designate three independent directors to our Board and a list of potential director-candidates was provided to GEM and the holder of Bridge Note. Prior to the funding in January of 2015 of the final $960,000 of the loan evidenced by the Bridge Note, Tyme placed into escrow 25 shares of its Common Stock which escrowed shares were returned to Tyme for cancelation upon Tyme providing the Bridge Note holder with letters from at least three of a list of potential director-candidates of their willingness to join our Board following the Merger, our obtaining appropriate directors’ and officers’ insurance (“D&O insurance”) and other events occurring (certain of such events not being within our or Tyme’s control). Neither GEM nor any of its affiliates has any right to appoint or nominate any person to serve as a director of our Company.
Following the consummation of the Merger, we expanded our Board of Directors by three members, each of whom we believe meets the the NASDAQ Stock Market definition of independent director. These three new members are Patrick LePore, Dr. Gerald Sokol and Timothy Tyson.
See “Management – Directors and Executive Officers” below for information about our new directors and executive officers.
Lock-up Agreements and Other Restrictions
In connection with the Merger, each of Steve Hoffman, our Chief Executive Officer, Chief Science Officer and President and Michael Demurjian, our Chief Operating Officer and Executive Officer, who own, in the aggregate, 56,555,600 shares or approximately 65.8% of our Common Stock issued and outstanding immediately following the closing of the Merger, PPO and the other transactions contemplated by the Merger Agreement (each, a “Restricted Holder”), entered into separate Lock-Up Agreements with our Company, pursuant to which the Restricted Holders are restricted, for a period of twelve months from the date of the Merger (extendable in the case of certain public and private sales of our Common Stock by our Company), from certain sales or dispositions of our Common Stock held by them, except in certain limited circumstances (the “Lock-Up”). The Restricted Holders’ Tyme Merger Registrable Shares and an additional 1 million shares owned by each Restricted Holder are excluded from the Lock-Up.
Further, under the Lock-Up Agreements, each Restricted Holder has agreed to be subject to restrictions on engaging in certain transactions, including effecting or agreeing to effect short sales, whether or not against the box, establishing any “put equivalent position” with respect to our Common Stock, borrowing or pre-borrowing any shares of our Common Stock or granting other rights (including put or call options) with respect to our Common Stock or with respect to any security that includes, relates to or derives any significant part of its value from our Common Stock or otherwise seeks to hedge the Restricted Holder’s position in our Common Stock.
All descriptions of the Lock-Up Agreements are qualified in their entireties by reference to the texts thereof filed as exhibits hereto, which are incorporated herein by reference.
Pro Forma Ownership
Immediately after giving effect to (i) the Merger and (ii) the surrender and cancellation of 13,000,200 shares of our Common Stock in the Split-Off Transaction, (iii) the surrender for cancellation of 26,276,600 shares of our Common Stock in accordance with the terms of the Merger Agreement, (iv) the closing of the PPO and (v) the conversion of the Bridge Note, there were 86 million shares of our Common Stock issued and outstanding, as follows:
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the pre-Merger stockholders of Tyme hold 68 million shares of our Common Stock; |
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the pre-Merger stockholders of our Company hold 12.724 million shares of our Common Stock; |
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investors in the PPO hold 2.716 million shares of our Common Stock; |
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the holder of the Bridge Note received 2.31 million shares of our Common Stock upon the conversion of the Bridge Note; and |
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a consultant to our Company received 250,000 shares of our Common Stock upon entering into a consulting agreement with us. |
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In addition, to the shares of our Common Stock issued and outstanding immediately following the closing of the Merger, our 2015 Plan authorizes issuance of up to 10,000,000 shares of our Common Stock as incentive awards to our directors, executive officers, consultants and employees. As of the date of filing this Current Report on Form 8-K, no options or other awards have been granted under the 2015 Plan.
No other securities convertible into or exercisable or exchangeable for our Common Stock are outstanding.
Our common stock is quoted on the OTC Markets (OTC QB) under the symbol “TYMI.”
Accounting Treatment; Change of Control
The Merger is being accounted for as a “reverse merger,” and Tyme is deemed to be the acquirer in the Merger. Consequently, the assets and liabilities and the historical operations that will be reflected in the financial statements prior to the Merger will be those of Tyme and will be recorded at the historical cost basis of Tyme and the consolidated financial statements after completion of the Merger will include the assets and liabilities of Tyme, historical operations of Tyme and operations of our Company and its subsidiaries, on a consolidated basis from the closing date of the Merger. As a result of the issuance of the shares of our Common Stock pursuant to the Merger, a change in control of the Company occurred as of the date of consummation of the Merger. Except as described in this Current Report on Form 8-K, no arrangements or understandings exist among present or former controlling stockholders with respect to the election of members of our Board of Directors and, to our knowledge, no other arrangements exist that might result in a change of control of the Company.
We continue to be a “smaller reporting company,” as defined under the Exchange Act, following the Merger. We believe that the Merger resulted in our Company ceasing to be a “shell company” (as such term is defined in Rule 12b-2 under the Exchange Act).
DESCRIPTION OF BUSINESS
Immediately following the Merger, the business of Tyme became our business.
History
As described above and in our prior periodic Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, we were incorporated in Florida as Global Group Enterprises Corp. on November 22, 2011. Our initial intention was to distill, bottle, market and distribute alcoholic beverages (primarily an ultra-premium vodka), but we never acted on such intention, other than initial planning. Effective as of September 18, 2014, we reincorporated in the State of Delaware by merging with and into Tyme Technologies, Inc., our newly-formed, wholly-owned Delaware subsidiary, which was the surviving corporation in such merger and our successor-in-interest. As a result of the Reincorporation, among other things,
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we changed our jurisdiction of incorporation from Florida to Delaware; |
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we changed our name from Global Group Enterprises Corp. to Tyme Technologies, Inc.; |
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each share of Global Group Enterprises Corp.’s common stock outstanding at the time of the Reincorporation was automatically converted into 4.3334 issued and outstanding and fully paid and non-assessable shares of the surviving corporation’s common stock, with the result that the aggregate 12,000,000 shares of Global Group Enterprises Corp.’s common stock outstanding immediately prior to the Reincorporation were converted into an aggregate of 52,000,800 shares of our common stock; and |
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we increased our authorized capital stock from 250 million shares of common stock, par value $0.0001 per share, to 300 million shares of common stock, par value $0.0001 per share and 10 million shares of “blank check” preferred stock, par value $0.0001 per share. |
As a result of the Merger, we have acquired the business of Tyme and its subsidiaries. Tyme was incorporated on July 26, 2013 under the laws of the State of Delaware.
Our principal executive offices are located at 48 Wall Street - Suite 1100, New York, New York 10005. Our telephone number is 646-205-1603. Our website address is www.tymetechnologiesinc.com. The information contained on our website is not incorporated by reference into this Current Report on Form 8-K.
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Our Business
Tyme Inc., is a clinical-stage pharmaceutical company focused on discovering and developing highly targeted cancer therapeutics for a broad range of oncology indications. We are currently developing for use in humans SM-88, our proprietary drug cocktail – which we believe to be a first-in-class drug that harnesses the body’s own immune defenses to fight tumor cells. Our drug is based on a mechanism designed to utilize oxidative stress, among other techniques, to selectively kill cancer cells.
SM-88 is a novel combination of four currently marketed drugs that synergistically target the unique metabolic features of cancer cells, thus providing a selective method of altering the susceptibility of cancer cells to oxidative stress. This selectivity is underscored by evidence indicating that, to date, the SM-88 drug cocktail has been shown to be nontoxic to noncancerous cells, unlike most current anticancer drugs and treatments. SM-88’s therapeutic potential is based on its ability to increase the availability of free radicals at the cancer site and promote their entry into the cell by stripping the cancer cells of their normal barriers to these toxic electrons. The active components of SM-88 are all administered in low doses and are generally considered safe for their approved indications in areas other than cancer treatment.
We believe, based on SM-88’s mechanism of action and proof-of-concept clinical data, that our drug may ultimately improve overall response rates, clinical outcomes and survival rates in breast cancer patients and could eventually become a cornerstone of modern, targeted oncology care. Based on its novel proposed mechanism of action, SM-88 may prove beneficial to breast cancer patients who have relapsed following traditional cancer therapies failing at improving long-term survival rates.
We have focused our research and development efforts on a proprietary platform technology, for which we retain global intellectual property and commercial rights, for use in creating drugs to treat the unmet medical needs of oncology patients. This population includes patients with limited life expectancy and scarce therapeutic options, such as those with refractory cancer (i.e. , cancer that is unresponsive to treatment with standard therapies), those who are undergoing salvage therapy or patients who have relapsed. We believe this development strategy may allow for faster regulatory approval and may likely require smaller clinical trials, as compared to those indications with more therapeutic options and larger patient populations.
Our initial proof-of-concept clinical trial demonstrated that our drug was well-tolerated by patients and has the potential to shrink tumors and/or slow tumor growth. Promising and exciting results were shown in the 30 enrolled subjects eligible for efficacy evaluation in a proof-of-concept institutional review board (IRB)-approved clinical trial.
We are currently finalizing our regulatory and drug development program for SM-88 and working towards the initiation of our first phase II clinical trial. At this time, based on the positive results experienced by the breast cancer subjects in the proof-of-concept trial, advanced metastatic breast cancer is being considered as the initial indication for the phase II trial.
Our Strengths
We believe we can become a leader in developing cancer therapies with our platform technology for the following reasons:
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Our initial drug candidate, SM-88, is believed to be a first-in-class immuno-modulating-electrochemical-response-modifier cancer therapy; |
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Our SM-88 cocktail has demonstrated its potential as an aggressive combination treatment, with significant antitumor activity that has not, to date, shown any toxic side effects at current therapeutic dose levels; |
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We have a growing pipeline of drug candidates based on our technology platform that are focused on key cancer indications; |
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We retain global commercial rights for the drug candidates in our product pipeline; |
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Our management team has a strong track record in the development and commercialization of new technologies and discoveries; and |
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We have a technology base and patent portfolio in the field of targeted electrochemical immuno-oncology. |
Our Strategy
Our goal is to develop and commercialize targeted electrochemical immuno-oncology therapies aimed at improving and extending patients’ lives. Key elements of our strategy to achieve this goal are to:
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Successfully advance SM-88 through clinical development and commercial launch. We intend to pursue a worldwide development and commercialization plan for SM-88. |
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Continue to invest in our technology platform and IP portfolio to further build our electrochemical immuno-oncology therapy pipeline. Our development plan is focused on continued advancement of our technology and an investigation of other oncology indications for our technology platform beyond the indications targeted by our SM-88 drug product. |
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Further establish research and development (R&D) capabilities in the U.S. We plan to expand our R&D efforts to encompass other indications within the oncology field that will benefit from our technology platform, to investigate other uses and patient populations and to conduct further mechanism studies that could potentially pave the way for adding further drugs to our pipeline. We also intend to extend our R&D program, subject to available funds, to encompass pediatric indications, where the FDA offers added exclusivity rights. Furthermore, in the future, we may expand our R&D program to investigate other possible oncology treatment uses for our drugs. |
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Build a balanced portfolio of proprietary and partnered programs. We plan to independently develop and commercialize multiple drug candidates, initially for human indications within the oncology field. For targets outside our core areas of interest or where a partner can contribute specific expertise, we intend to evaluate potential collaborations with strategic partners and/or potential acquisitions of other companies who can augment our expertise and technology, as well as a means to acquire rights or ownership of additional IP. We also contemplate exploring global development partners and arrangements, where appropriate. |
Current Status
To date, we have financed our operations primarily through loans from third parties and private sales of convertible debt, as well as loans and equity contributions from existing stockholders. Through September 30, 2014, we raised $2.226 million through the issuance of convertible loans, including the sale of the convertible Bridge Note in the original principal amount of $1.1 million. In November 2014, the holder of the Bridge Note advanced us an additional $250,000 and the Bridge Note was amended and restated to reflect a principal amount of $1.35 million. In January of 2015, the holder of the Bridge Note advanced us an additional $960,000 and the Bridge Note was further amended and restated to reflect a principal amount of $2.31 million. In March of 2015, we completed a private offering of our Common Stock for gross proceeds of $6.79 million, of which $4.29 million was received in cash and the remaining $2.5 million was tendered in the form of a note in the principal amount of $2.5 million. In connection with the consummation of the PPO, the Bridge Note was converted into 2.31 million shares of our Common Stock. Based on our current plans, we do not anticipate generating product or royalty revenues unless and until we obtain marketing approval for and commercialize one or more of our drug candidates.
We have generated losses since we began drug development in 2011. For the years ending December 31, 2013 and 2012, we incurred net losses of approximately $1.058 million and $888,000, respectively. For the nine months ending September 30, 2014 and 2013, we incurred net losses of approximately $1.196 million and $657,000, respectively. As of September 30, 2014, we had an accumulated deficit of approximately $2.707 million. We expect to continue to incur losses as we continue our drug development program and will incur losses until at least such time as we gain approval to market one or more of our drugs. Our near-term future profitability is dependent upon the successful development, approval and commercialization of SM-88 and achieving a level of revenues adequate to support operations. We may never achieve profitability and unless and/or until we do, we will continue to need to raise additional funds or be forced to limit or curtail our R&D efforts. We intend to fund future operations through additional equity and debt financings and we also may seek additional capital through arrangements with strategic partners or from other sources.
Based on our operating plan, our existing working capital as of September 30, 2014 is not sufficient to meet the cash requirements to fund planned operations without additional financing. Although we have raised an aggregate of $9.1 million in gross proceeds from the sale of the Bridge Note and equity securities since July 1, 2014, there can be no assurances that additional financing will be available to us on satisfactory terms or at all. These conditions raise substantial doubts about our ability to continue operations and we will be required to raise additional funds, alternative means of financial support or both, in order to continue operations. The accompanying financial statements have been prepared assuming that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business.
In order to comply with laws governing the sales and marketing of drugs within the U.S., we must comply with the rules and regulations of the U.S. Food and Drug Administration. These rules and regulations are time consuming, detailed and complex and require substantial financial commitment in order to maintain compliance. We also would be required to comply with the laws, rules and regulations of other countries and regions, including those enacted in the European Union (“EU”), before we could market and sell our drugs in such countries and regions. In order to further our efforts we completed a proof-of-concept clinical trial for our first drug candidate, SM-88, in December 2012. We are now preparing to file an IND for SM-88. The IND is the next step in the FDA regulatory approval process.
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The timeline for filing an IND for SM-88 with the FDA cannot be stated at this time with any degree of certainty. The timing is subject to many factors, many of which are beyond our control.
We plan on initiating a comprehensive, closely monitored, phase II clinical trial in patients with advanced metastatic breast cancer who have failed the usual standard-of-care therapies or have exhausted conventional treatments. We plan to review interim data during the course of this clinical trial to confirm that our product development activities are in line with our internal development and commercialization plans.
Commercialization Plans
We have not yet established a sales, marketing or product distribution infrastructure because our lead drug is still in an early stage of development and regulatory approval.
In anticipation of receiving regulatory approvals to market SM-88 or any other product, we may build a focused sales and marketing organization in the U.S. to sell our products at the appropriate time, if and when, marketing approval is granted. We believe that such an organization will be able to effectively target the community of oncologists who are on the front line in treating the patient populations for which SM-88 is being developed. We may at such time also build the necessary medical communications team for any products we market ourselves. These responsibilities would include developing educational initiatives regarding our regulatory-approved drugs and technology platform and establishing relationships with thought leaders in the specific fields of medicine and oncology. Along with the above capabilities, we may also build the commercial infrastructure required to support sales and marketing, including, but not limited to: sales support, sales management, internal marketing, distribution support, national account management team, key management account support, managed care organizations, group purchasing account management, government account management, oncology group management, specialty pharmacy management, international sales and distribution.
To develop the appropriate commercial infrastructure, we will have to invest significant financial and managerial resources, some of which will need to be in place prior to any confirmation that SM-88 or any other product we develop, has received marketing approval. At this time, we do not have the funding to support such an infrastructure.
Alternatively or in combination with our own marketing efforts, we may elect to enter into licensing, distribution or other marketing arrangements in the U.S.
Outside the U.S., we will explore all options, including, but not limited to: developing our own sales and marketing organization or entering into licensing, distribution or other marketing arrangements with third parties to commercialize any of our drug candidates once they obtain marketing approval.
Thinking forward, outside of the U.S., we may elect to utilize strategic partners, distributors or contract sales forces to assist in the commercialization of our products, if any.
Background - Tyme
Tyme Inc. was formed in July of 2013. At that time, we acquired two-thirds of the outstanding membership interest in Luminant Biosciences, LLC, a Delaware limited liability company, which was formed in August of 2011 and conducted the initial R&D of our therapeutic platform. In May of 2014, we acquired the remaining minority interest in Luminant. Since January 1, 2014, the majority of our R&D activities and other business efforts have been conducted by Tyme Inc. and all of our patent and patent application rights are held by Tyme Inc. Throughout this description of our Company and business, references to “us,” “we,” “our” and similar terminology refer to our Company in its entirety, including Tyme and its Luminant wholly-owned subsidiary, unless the context implies otherwise.
Platform Technology
We believe we have developed a novel approach for selectively killing cancer cells that is not predicated on any single-agent or agents. Rather, it is an approach in which multiple compounds are used in combination to achieve a cascade of therapeutic events. Our therapeutic platform technology uses both approved drugs as well as an active compound, which the FDA may ultimately categorize as a new chemical entity. We have received one patent and have applied for additional patents regarding these compounds and the methodology that could be used to create future drug products based on our technology platform.
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Our approach is intended to take advantage of the deregulated energy state of tumors to selectively kill cancer cells using electrochemical pathways. While mechanism of action studies are being designed and tested, our IP and drug research program deals with a multi-part process. It is proposed that the high-energy needs of rapidly proliferating tumor cells may be harnessed as a means of stopping cancer cell growth, reducing the size of tumors and eventually destroying those cells. A normal cell uses a process called oxidative phosphorylation to generate approximately 32-high-energy molecules (adenosine triphosphate) from glucose to provide energy for the cell. In contrast, cancer cells use a process called glycolysis that only generates approximately two such high-energy molecules from glucose and requires the additional metabolism of lipids (fats) for energy. This results in a very high-energy requirement for the cancer cells. Cancer cells reproduce rapidly and must synthesize large amounts of proteins to drive their proliferation and, accordingly, their amino acid needs are also quite high. Our approach is to use tumor cells’ own exaggerated hunger against them. Our approach is to essentially change the metabolic uptake of the cancer cell. Our SM-88 drug is designed to exploit a cancer’s weakness in a manner that we believe has never before been exploited.
Clinical Trial Study
We recently completed a 30 subject, single-center, open-label, proof-of-concept clinical trial of SM-88 for the treatment of advanced metastatic cancer.
The purpose of our proof-of-concept study was to determine the safety, tolerability and efficacy of SM-88 in subjects with advanced metastatic cancer. Goals of the study were to:
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Assess Progression-Free Survival (“PFS”) in patients treated with SM-88; |
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Assess secondary measures of efficacy including Objective Response Rate, Duration of Response and Overall Survival; |
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Evaluate safety and tolerability of SM-88; and |
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Explore Patient Reported Outcomes, including health-related Quality-of-Life (“QoL”) and disease/treatment-related symptoms. |
Between January and December 2012, 30 subjects with stage IV cancer and distant metastasis, including bone and central nervous system involvement, were included in the trial. The patient population was comprised of patients who failed all available anticancer treatments.
Cancer types were: 43% breast cancer with metastases (15% each had metastases to: bone, lung, bone/lymph;) 20% had metastases to lung; (8% each had metastases to: lung, lymph, bone/brain/lung, bone/brain/spine, bone/liver, bone/brain; liver/bones/lymph), 10% pancreatic cancer with metastases, 6.6% bile duct cancer, 6.6% had prostate cancer with bone metastasis, 3.3% had colon cancer, 3.3% had tongue cancer, 3.3% had cancer of the appendix and 3.3% had thyroid cancer.
Subjects received between one to ten cycles of treatment with SM-88, each cycle consisting of daily administration, five days per week for six weeks. The therapy was well-tolerated with all drug-related AEs occurring within the first cycle of treatment, with the exception of hyperpigmentation, which eventually occurred in all subjects. Drug-related AEs in Cycle 1 were mild to moderate, self-limiting and did not require therapy. They are presented in the following table.
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During Cycle 1, 24 (80.0%) subjects experienced at least one AE that was considered by the investigator to be possibly, probably or definitely related to SM-88. The majority of these AEs were fatigue, which was reported as related in 15 (50.0%) subjects. Other AEs reported as related to SM-88 in greater than 10% of subjects were hyperpigmentation (8 subjects, 26.7%) and pain (4 subjects, 13.3%). No serious adverse events (SAE) were reported during Cycle 1 and there were no subject discontinuations due to an AE.
Overall, 28 (93.3%) subjects experienced at least one AE during the first 6-week cycle. The most commonly reported AEs were fatigue, which was reported by 20 (66.7%) subjects, AEs related to pigmentation (hyperpigmentation [9 subjects/30.0%] or pigment change [2 subjects/6.7%]) and AEs related to pain (pain [9 subjects/30.0%], tumor pain [2 subjects/6.7%], abdominal pain [1 subject/3.3%], bone pain [1 subject/3.3%], flank pain [1 subject/3.3%] or neck pain [2 subjects/6.7%]). Other AEs reported in greater than 10% of subjects were nausea (6 [20.0%] subjects), lethargy (4 [13.3%] subjects), diarrhea (3 [10.0%] subjects) and headache (3 [10.0%] subjects).
Most AEs of fatigue started within two weeks of the onset of treatment and had durations ranging from 1.5 to 3 weeks. Two of those events resolved within one day and approximately one-third were still ongoing at the end of treatment. Three of the events were reported as moderate in severity and the rest were mild.
The primary endpoint for the study was PFS and 25 of the 30 randomized subjects had evaluable data to contribute to this analysis. Subjects with missing data for the PFS analysis included subjects whom: either had no evaluable baseline scans, had no measurable tumors on Baseline scans or had no follow-up scans. For subjects who did provide data, scans were not always obtained on a regular schedule during the study and in some cases, the interval between tumor assessments differed from subject to subject.
The last assessment of tumor responses was performed on November 15, 2013. At that time, 25 of the 30 treated subjects were evaluable and their Response Evaluation Criteria In Solid Tumors (RECIST1.1) status is presented below.
RECIST Results |
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Number of Subjects n = 25 |
Complete Response |
2 (8%) |
Partial Response |
3 (12%) |
Stable Disease |
18 (72%) |
Progressive Disease |
2 (8%) |
Virtually all subjects experienced dramatic and rapid improvements in Eastern Cooperative Oncology Group Performance Status (ECOG PS), European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire and self-reported pain scores during Cycle 1.
A measureable and dramatic improvement in self-reported pain was seen in all subjects. As shown in the pain score table below for all treated subjects, at the end of Cycle 1, an additional eight subjects no longer experienced pain after treatment with SM-88.
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We believe that SM-88 is a promising treatment for advanced metastatic cancer. It was well-tolerated among 30 subjects with a variety of cancers in our proof-of-concept clinical trial, including 14 subjects with stage IV breast cancer. We believe that our drug is not only unique, but thus far has shown no significant side effects except for cutaneous hyperpigmentation.
We believe that the results of the proof-of-concept clinical trial indicate that SM-88 holds promise as a successful monotherapy and likely has utility in combinations with both cytotoxic and current immuno-therapies. We further believe that the magnitude of the positive clinical response in this end-stage cancer population, as well as the amelioration of disease-related symptoms, an increase in performance status and QoL, provides a solid rationale for further development of SM-88 as a potential cancer treatment.
Target Markets
Cancer
Cancer is a term used for a variety of diseases in which abnormal cells divide without control and are able to invade other tissues. Cancer is not just one disease but many diseases. Cancer cells can spread to other parts of the body through the blood and lymph systems. In normal tissues, the rates of new cell growth and cell death are tightly regulated and kept in balance. In cancerous tissues, this balance is disrupted as a result of mutations, causing unregulated cell growth that leads to tumor formation. While tumors can grow slowly or rapidly, the dividing cells will nevertheless accumulate and the normal organization of the tissue will become disrupted. Cancers subsequently can spread throughout the body by processes known as invasion and metastasis. Once cancer spreads to sites beyond the primary tumor, it may be incurable. Cancer cells that arise in the lymphatic system and bone marrow are referred to as hematological malignancies. Cancer cells that arise in other tissues or organs are referred to as solid tumors.
The American Cancer Society (“ACS”) estimates that solid tumor cancers will account for approximately 1.5 million or 91% of new cancer cases diagnosed annually and will account for approximately 500,000 cancer-related deaths in the U.S. annually. For 2014, the ACS estimates that in the U.S. there will be approximately 1.66 million new cases of cancer and 585,000 deaths related to all cancers (solid and hematological).
Despite significant improvements in cancer diagnosis and treatment, cancer rates continue to increase globally and are a leading cause of death. According to the International Agency for Research on Cancer, the specialized cancer agency of the World Health Organization, annual cancer rates around the world are projected to increase by over 56% from 14.1 million cases in 2012 to 22 million new cases in the year 2030. According to the CDC, cancer is the second leading cause of death in the U.S., exceeded only by heart disease. The overall five-year survival expectancy is currently approximately 66% and there are an estimated 13 million people currently suffering from cancer in the U.S.
Metastatic Breast Cancer (MBC)
The American Cancer Society estimated that over 230,000 new cases of invasive breast cancer would be diagnosed among women in the U.S. during 2013, along with over 2,000 new cases in men. Breast cancer is the second most frequently diagnosed cancer in women, after skin cancer. Furthermore, an estimated 40,000 breast cancer deaths were expected to be seen in 2013. Breast cancer ranks second as a cause of cancer death in women, after lung cancer. After taking into account tumor size, extent of spread and other characteristics of the tumor, as well as patient preference, treatment usually involves breast-conserving surgery (surgical removal of the tumor and surrounding tissue) or mastectomy (surgical removal of the breast). Treatment may also involve radiation therapy, chemotherapy (before or after surgery), hormone therapy (e.g., selective estrogen response modifiers, aromatase inhibitors and ovarian ablation) and/or targeted therapy.
In 2012, approximately 330,000 patients with breast cancer were treated with drugs in the U.S. and the top five countries (Germany, France, Italy, Spain and United Kingdom) of the EU. Half of these patients were from the U.S. and approximately 100,000 of these patients were treated for advanced or metastatic cancer with first, second or third-line therapy.
Cancer Costs in the U.S.
Of the nation’s 10 most expensive medical conditions, cancer has the highest per person-estimated cost of treatment. According to a National Institute of Health analysis, medical costs associated with cancer reached $125 billion in 2010 and are projected to increase another 27% by 2020, to at least $158 billion in the U.S.
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When estimating projections for the cost of cancer in the U.S. from 2010-2020, cancer prevalence was estimated by phase of care (initial year following diagnosis, continuing and last year of life) and tumor site, for 13 cancers in men and 16 cancers in women and projected through 2020. Cancer prevalence was calculated from cancer incidence and survival models estimated from Surveillance, Epidemiology and End Results (SEER) Program data. Annualized net costs were estimated from recent SEER Medicare linkage data, which included claims through 2006 among beneficiaries aged 65 years and older with a cancer diagnosis.
The table below provides estimates of expenditures on cancer treatment in 2010 and projected for 2020.
Note: This is based on a study that estimated and projected the national cost of cancer care, segregated by cancer site, through the year 2020 using the most recently available U.S. population projections, cancer incidence, survival and cost of care data.
Data Source: Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the Cost of Cancer Care in the U.S.: 2010-2020 . J Natl Cancer Inst . 2011 Jan.
Patients with cancer who received chemotherapy averaged $111,000 per year in total medical and pharmacutical costs. In contrast, the average annual per capita medical cost (including pharmaceuticals) for nononcology patients was less than $4,000. The per patient annual cost for patients with cancer receiving chemotherapy was, on average, approximately four times the cost of patients with cancer not receiving chemotherapy. These costs were significantly higher than the averages for other patients with common chronic diseases and patients without cancer.
After matching the demographics of patients without cancer to those with cancer, patients with cancer receiving chemotherapy incurred six times the annual costs of patients with diabetes and 26 times the costs of patients without cancer. The majority of costs incurred by patients with cancer receiving chemotherapy occurred in the outpatient setting. Outpatient costs included chemotherapy drugs, infusions, physician visits, lab, radiology and ambulatory surgery.
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Worldwide Rates of Cancer
There were an estimated 14.1 million cancer cases reported around the world in 2012, comprising 7.4 million cases in men and 6.7 million in women. This caseload is expected to increase to 24 million by 2035. The age-standardized rate for all cancers (excluding non-melanoma skin cancer) for men and women combined was 182 per 100,000 in 2012. The rate was higher for men (205 per 100,000) than women (165 per 100,000). The highest rates of cancer for both men and women was found in Denmark, with 338 people per 100,000 being diagnosed in 2012. The age-standardized rate was at least 300 per 100,000 for nine other countries (Denmark, France, Australia, Belgium, Norway, U.S., Ireland, Republic of Korea and The Netherlands).
Cancer Costs Worldwide
Reports indicate that, in the U.S., $322 billion dollars was spent on healthcare in 2011 and GMR Data estimates that, in the U.S., $31.8 billion was spent in the oncology market in 2012, capturing 40.5% of the worldwide oncology market. Following the U.S. was Japan; spending $8.9 billion dollars in 2012, capturing 11.2% of the market. In addition, the European mainstays of the pharmaceutical sector, the United Kingdom, Germany, France, Spain and Italy, comprised 25% of the global oncology market in 2012.
Staging
Stages of Cancer
Most types of cancer are classified into four stages, with an additional Stage 0 to distinguish those forms that may later lead to cancer (“pre-cancer” stage). The diagram below illustrates the progression of the disease:
Data Source: WWW.MD-HEALTH.COM. Accessed 29 August 2014.
Stage 0 . Also known as carcinoma in situ, this is an early form of cancer where there is a flat lesion but no invasion of malignant cells into the surrounding tissue. Although this can develop into full-blown cancer, some doctors do not consider this as cancer but “pre-cancer.”
Stage I . Tumors in this stage are usually smaller than 2 centimeters (cm) and are localized to their site of origin. Lymph nodes are not affected and there is no sign of metastasis (spreading to other parts of the body).
Stage II . Tumors in this stage measure 2-5 cm, but are still localized to their site of origin since they have not invaded other tissues or metastasized. Local lymph nodes may be affected. Stage II tumors are considered to be locally advanced tumors.
Stage III . Tumors in this stage are fairly large, measuring more than 5 cm. This late, locally advanced stage affects nearby lymph nodes and it may be difficult to differentiate from stage II cancer.
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Stage IV . Tumors in this stage may be of any size, affecting nearby lymph nodes and showing evidence of metastasis to other organs or regions of the body. A secondary cancer may develop during this stage. The overall physical and mental health of the patient may be affected and the historical survival rate is very low.
Survival
Stage IV cancer usually carries a grim prognosis, as compared to earlier stages of the disease. The five-year survival rate for patients in this stage may depend on different factors such as the type of cancer, overall general health, the type of treatment used and will power to overcome the disease.
The five-year survival rate is expressed as the percentage of patients who will likely live up to 5 years after diagnosis of the disease, based on research performed in patients with the same type and stage of cancer. Therefore, a 60% five-year survival rate indicates that it is estimated that 60 out of every 100 patients will live for five years after diagnosis while the rest (40 of 100) will most likely die.
The five-year survival rate is just an estimate and not an exact number, since many factors influence the progression of one’s disease. The following table summarizes the five-year survival rates of different types of stage IV cancers:
Cancer Treatments
The most common methods of treating patients with cancer are surgery, radiation and drug therapy. For patients with localized disease, surgery and radiation therapy are particularly effective. Drug therapies are generally used by physicians for treating patients with metastatic cancer or for cancers that cannot otherwise be treated through surgery, such as most hematological malignancies. The goal of the various drug therapies is to damage and kill cancer cells or to interfere with the molecular and cellular processes that control the development, growth and survival of cancer cells. In many cases, drug therapy entails the administration of a cocktail of drugs. Over the past several decades, drug therapy has evolved from non-specific drugs that kill both healthy and cancerous cells, to drugs that target specific molecular pathways involved in cancer.
An early approach to pharmacological cancer treatment was to develop drugs, referred to as chemotherapeutic or cytotoxic drugs, which kill rapidly proliferating cancer cells through non-specific mechanisms, such as disrupting cell metabolism or causing damage to cellular components required for tumor survival and rapid growth. While these drugs have been effective in the treatment of some cancers, cytotoxic drug therapies act in an indiscriminate manner, killing healthy cells along with cancerous cells. Due to their mechanism of action, many cytotoxic drugs have a narrow therapeutic window or a dose range above which the toxicity causes unacceptable or even fatal levels of damage and below which the drugs are not effective in eradicating cancer cells.
The next approach to pharmacological cancer treatment was to develop drugs such as monoclonal antibodies, referred to as targeted therapeutics, which are antibodies that are derived from a single-parental cell clone, that target specific biological molecules in the human body that play a role in rapid cell growth and the spread of cancer. Included in this category are small molecule drugs as well as large molecule drugs, also known as biologics. With heightened vigilance and new diagnostic tests, targeted therapies (including monoclonal antibodies such as Herceptin ® , Rituxan ® , Erbitux ® and Avastin ® , as well as small molecules such as Nexavar ® and Tarceva ® ) have resulted in improvements in overall survival for many cancer patients. More recently, antibodies have been developed that are optimized regarding their effector function, also known as F C optimized antibody drugs, such as obinutuzumab. These molecules are designed to engage NK-cells and macrophages more effectively in the elimination of cancer cells.
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Cancer immunotherapy plays an increasing role among emerging cancer drug therapies. The intention of the cancer immunotherapy is to harness the body’s own immune system to fight tumor cells or, in some cases, re-establish or remove certain blockades or promote certain signaling cascades. There are different approaches, such as vaccinations, checkpoint inhibitors, immunomodulators, T-cell and NK-cell engagers like bispecific antibodies or cellular therapies involving the induction of a patient’s own T-cells to express chimeric antigen receptors. Ipilimumab (Yervoy ® ) and sipuleucel-T (Provenge ® ) were the first cancer immunotherapies to enter the market.
As an example of how immunotherapy is part of standard treatments, postmenopausal women with early-stage breast cancer that is positive for hormone receptors, may benefit from treatment with an aromatase inhibitor (e.g., letrozole, anastrozole or exemestane) or tamoxifen. For women whose cancer tests positive for HER2/neu, approved targeted therapies include trastuzumab (Herceptin; Genentech) and for advanced disease, lapatinib (Tykerb ® ; GSK) and pertuzumab (Perjeta ® ; Genentech).
Of note, in 2013, the FDA approved Kadcyla (ado-trastuzumab emtansine) from Roche-Genentech, as a new therapy for patients with HER2-positive, late-stage MBC. Kadcyla is intended for patients who were previously treated with trastuzumab, another anti-HER2 therapy and taxanes. The safety and effectiveness of Kadcyla were evaluated in a clinical study of 991 patients randomly assigned to receive Kadcyla or lapatinib plus capecitabine (Xeloda; Roche-Genentech). Results showed that patients treated with Kadcyla had a median PFS of 9.6 months compared to 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months in the lapatinib plus capecitabine group.
Revenue/Payment Structure within the Healthcare Industry
Pharmaceutical Coverage, Pricing and Reimbursement
In the U.S. and other countries, the level of sales of any product for which we receive regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payers, including government health administrative authorities, managed care providers, private health insurers and other organizations. Increasingly, third-party payers examine the medical necessity and cost effectiveness of medical products and services, in addition to their safety and efficacy and, accordingly, significant uncertainty exists as to the reimbursement status of newly approved therapeutics. Third-party reimbursement is necessary for us to adequately enable us to realize an appropriate return on our investment in research and product development, but may not be available for our products.
The division of competencies within the EU provides its Member States the power to organize their own social security systems, which includes health care policies to promote the financial stability of their health care insurance systems. According to Article 168 of the Treaty on the Functioning of the EU, “Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organization and delivery of health services and medical care.”
In this context, the national authorities are free to set the prices of medicinal products and to designate the treatments that they wish to reimburse under their own social security systems. However, the EU has defined a common procedural framework through the adoption of Council Directive 89/105/EEC, which is generally known as the “Transparency Directive.” This instrument aims to ensure that national pricing and reimbursement decisions are made in a transparent manner and do not disrupt the operation of the internal market.
The Pharmaceutical Pricing and Reimbursement systems established by Member States of the EU are usually quite complex. Each country uses different schemes and policies, adapted to fit its own economic and health needs. We would have to develop or access special expertise in this field to prepare health economic dossiers on our medicinal products if we would market our products, if and when approved, in the EU.
Significant uncertainty exists as to the coverage and reimbursement status of SM-88 in the U.S. and international markets. Commercial sale of SM-88 will depend, in part, on the availability of reimbursement from third-party payers. The process for determining whether a third-party payer will provide coverage for a drug product may be separate from the process for setting the price or reimbursement rate. Third-party payers may limit coverage to the specific drug products on an approved list or formulary, which might not include all of the FDA-approved drugs for a particular indication. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain FDA approval. SM-88 may not be considered as medically necessary or cost-effective by one or more third party payers. A decision by a third-party payer to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.
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In 2003, the U.S. government enacted legislation providing a partial prescription drug benefit for Medicare beneficiaries, which became effective at the beginning of 2006. Government payment for some of the costs of prescription drugs may increase demand for any products for which we receive marketing approval. However, to obtain payments under this program, we would be required to sell products to Medicare recipients through prescription drug plans operating pursuant to this legislation. These plans will likely negotiate discounted prices for our drug.
The Healthcare Reform Law of 2010 substantially changes the way healthcare is financed in the U.S. by both government and private insurers. Among other cost containment measures, the Healthcare Reform Law establishes:
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An annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents; |
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A new Medicare Part D coverage gap discount program, in which pharmaceutical manufacturers who wish to have their drugs covered under Part D must offer discounts to eligible beneficiaries during their coverage gap period (the “donut hole”); and |
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A new formula that increases the rebates a manufacturer must pay under the Medicaid Drug Rebate Program. |
We expect that federal, state and local governments in the U.S. will continue to consider legislation to limit the growth of healthcare costs, including the cost of prescription drugs. Future legislation could limit payments for pharmaceuticals such as SM-88.
Different pricing and reimbursement schemes exist in other countries. In the EU, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular drug to currently available therapies. Other Member States allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on healthcare costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within that country.
The marketability of SM-88, if and when approved, may suffer if government and third-party payers fail to provide adequate coverage and reimbursement. In addition, an increasing emphasis on managed care in the U.S. has increased and we expect will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for SM-88, less favorable coverage policies and reimbursement rates could be implemented in the future.
Competition
Our competition comes from other commercial and research enterprises working in the field of cancer research. Those pharmaceutical and biotechnology companies, academic institutions and government research institutes around the globe that are working towards new treatments in the field of oncology, collectively form the competitive nature in cancer R&D.
We expect SM-88 to compete with products manufactured by other companies in highly competitive markets throughout the world.
Important competitive factors include patient safety, effectiveness, QoL and ease of use of products; price and demonstrated cost-effectiveness; marketing effectiveness; and research and development of new products and processes. Most new products we intend to market, assuming regulatory approval, will and must compete with other products already on the market as well as products that are later developed by existing or new competitors. If competitors introduce new products or delivery systems with therapeutic or cost advantages, our products would be subject to progressive price reductions, decreased volume of sales or both. Increasingly, to obtain favorable reimbursement and formulary positioning with government payers, managed care organizations and pharmacy benefits managers, we would be required to demonstrate that our products offer not only medical benefits but also more value as compared with other treatment regimens.
The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. While we believe that our technology, development and regulatory plans and scientific knowledge provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. Any drugs that we successfully develop and commercialize will compete with existing therapies and new potential therapies that may become available in the future.
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Our products, if approved for sale, would eventually all be subject to competition from generic drug manufacturers. Manufacturers of generic pharmaceuticals generally invest far less than R&D companies such as us. We anticipate that any manufacturer of a generic version of our drugs will invest far less than we have in the past and intend to do in the future in R&D and marketing our products, including SM-88. They therefore, have the advantage in that they can price their drugs much lower than our brand-name drugs. Accordingly, when the time comes for our brand-name drug to lose market exclusivity, we anticipate that each of such products will face intense price competition from generic forms of the product. Additionally, in many countries outside the U.S., IP protection is weak or nonexistent and we would be forced to compete with generic or counterfeit versions of our products in such counties whether or not we hold legal exclusivity.
The most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy, hormone therapy and targeted drug therapy. Our products once approved, would compete not only with other drugs, but also with such other types of therapies and treatments.
There are a variety of available drug therapies marketed for cancer. In many cases, these drugs are administered in combination to enhance efficacy. While SM-88 may compete with many existing drug and other therapies, to the extent it is ultimately used in combination with or as an adjunct to these therapies, our drug will not be competitive with them. Some of the currently approved drug therapies are branded and subject to patent protection and others are available on a generic basis. Many of these approved drugs are well-established therapies and widely accepted by physicians, patients and third-party payers. In general, although there has been considerable progress over the past few decades in the treatment of cancer with currently marketed therapies providing benefits to many patients, these therapies all are limited to some extent in their efficacy and frequency of AEs and none are successful in treating all patients. As a result, the level of morbidity and mortality from cancer remains high.
In addition to currently marketed therapies, there are also a number of medicines in late-stage clinical development to treat cancer. These medicines in development may provide efficacy, safety, convenience and other benefits that are not provided by currently marketed therapies. As a result, they may provide significant competition for SM-88.
Intellectual Property
Overview
We will strive to protect and enhance our proprietary technology, inventions and improvements that are commercially important to the development of our business, including through seeking, maintaining and defending patent rights, whether developed internally or licensed from third parties. We also intend to rely on trade secrets related to our proprietary technology platform and our know-how, continuing technological innovation and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of cancer treatment, which may be important for the development of our business. We additionally may rely on regulatory protection afforded through data exclusivity, market exclusivity and patent term extensions, where available.
Our commercial success may depend, in part, on our ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to our business, defend and enforce our patents, preserve the confidentiality of our trade secrets and operate without infringing the valid enforceable patents and proprietary rights of third parties. Our ability to stop third parties from making, using, selling, offering to sell or importing our products may depend on the extent to which we have rights under valid and enforceable licenses, patents or trade secrets that cover these activities. With respect to both licensed and Company-owned IP, we cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted to us in the future will be commercially useful in protecting our commercial products and methods of manufacturing such products, as well as being held valid if challenged.
Licensed IP
Currently, we already have one patent issued in the U.S., as well as four patent applications pending. We have begun the process of pursuing foreign patent applications corresponding to two of these patent applications and intend to pursue foreign patent applications corresponding to the others. Our policy is to file patent applications to protect technology, inventions and improvements to inventions that are commercially important to the development of our business. We have and will continue to seek U.S. and international patent protection for a variety of technologies, including: pharmaceutical compositions, methods for treating diseases of interest, methods for manufacturing the pharmaceutical compositions and research tools and methods. We also intend to seek patent protection or rely upon trade secret rights to protect other technologies that may be used to discover and validate targets and that may be used to identify and develop novel products. We will also seek protection, in part, through confidentiality and proprietary information agreements.
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We believe we have no need to license any technologies for SM-88 to be commercially viable. We believe our Company owns all the IP necessary for our SM-88 to perform as intended and to be commercially marketed, once all applicable regulatory requirements have been obtained. Additionally, we believe the drug substances utilized in SM-88 are not covered by any patents that would impede our use of such drug substances.
Regulatory Process
Government Regulation and Product Approval
Government authorities in all major pharmaceutical markets extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing and import and export of pharmaceutical products, such as those we are developing. Although our initial focus will be in the U.S. and Europe, we will develop and seek marketing approval for our products in other countries and territories, such as Canada and Japan and for markets that follow the leading authorities, such as Brazil and South Korea. The processes for obtaining regulatory approvals in the U.S., Europe and in other countries, along with subsequent compliance with applicable statutes and regulations, will require the expenditure of substantial time and financial resources.
FDA Approval Process
SM-88 is subject to regulation in the U.S. by the FDA as a drug product. The FDA subjects drug products to extensive pre- and post-market regulation. The Public Health Service Act (“PHSA”), the Federal Food, Drug and Cosmetic Act and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling and the import and export of drugs. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications (“NDAs”), withdrawal of approvals, clinical holds, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or fines or civil or criminal penalties.
The PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The PHSA also provides authority to the FDA to immediately suspend licenses in situations where there exists a danger to public health, to prepare or procure products in the event of shortages and critical public health needs and to authorize the creation and enforcement of regulations to prevent the introduction or spread of communicable diseases in the U.S. and between states.
The drug development process required by the FDA before a new drug may be marketed in the U.S. is long, expensive and inherently uncertain. Drug development in the U.S. typically involves preclinical laboratory and animal testing, the submission to the FDA of an IND, which must become effective before clinical testing may commence and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Developing the data to satisfy FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.
Preclinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product. The conducting of the preclinical tests must comply with federal regulations and requirements, including good laboratory practices (“GLP”). The results of preclinical testing are submitted to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing and controls (“CMC”) and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.
An IND must become effective before U.S. clinical trials may begin. A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented on nor questioned the IND submission within this 30-day period, the clinical trial proposed in the IND may begin.
Clinical trials involve the administration of the investigational new drug to healthy volunteers or subjects with the condition under investigation, all under the supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practices (“GCP”), an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors; and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the ongoing IND file.
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The FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial is not being conducted in accordance with FDA requirements or presents an unacceptable risk to clinical trial subjects. The study protocol and informed consent information for subjects in clinical trials must be submitted to an IRB for review and approval. An IRB may also require the clinical trial at a clinical site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements or may impose other conditions to assure subject safety. The study sponsor may also suspend a clinical trial at any time on various grounds, including a determination that the subjects are being exposed to an unacceptable health risk.
Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap or be combined. In phase I, the drug is initially introduced into healthy human subjects and is tested to assess pharmacokinetics, pharmacological actions, adverse events (AEs) associated with increasing doses and, if possible, early evidence of effectiveness. In the case of some products targeted for severe or life-threatening diseases, such as cancer treatments, initial human testing may be conducted in the intended patient population. Phase II usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage, as well as identification of common adverse effects and safety risks. If a compound demonstrates evidence of effectiveness and an acceptable safety profile in phase II, phase III trials are initiated to obtain additional information about clinical efficacy and safety in a larger number of subjects, typically at geographically dispersed clinical trial sites. Phase III clinical trials are intended to establish data sufficient to demonstrate substantial evidence of the efficacy and safety of the product to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug. Trials conducted outside of the U.S. under similar, GCP-compliant conditions in accordance with local applicable laws may also be acceptable to the FDA in support of product licensing.
Sponsors of clinical trials for investigational drugs must publicly disclose certain clinical trial information, including detailed trial design and trial results, in FDA public databases. These requirements are subject to specific timelines and apply to most controlled clinical trials of FDA-regulated products.
After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. The FDA review and approval of the NDA is required before marketing of the product may begin in the U.S. The NDA must include the results of all preclinical, clinical and other testing and a compilation of data relating to the product’s pharmacology and CMC and must demonstrate the safety and efficacy of the product based on these results. The NDA must also contain extensive manufacturing information. The cost of preparing and submitting an NDA is substantial and is in addition to the costs of conducting clinical trials. Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee, as well as annual product and establishment user fees, which may total several million dollars and are typically increased annually.
The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that the NDA is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of NDAs. Most such applications for standard review drugs are reviewed within 10 months from the date the application is accepted for filing. Although the FDA often meets its user fee performance goals, it can extend these timelines if necessary and its review may not occur on a timely basis at all. The FDA usually refers applications for novel drugs, which present complex questions of safety or efficacy, to an advisory committee - typically a panel that includes clinicians and other experts - for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the drug product unless it verifies that compliance with current good manufacturing practice (“cGMP”) standards is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication(s) being studied.
After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional nonclinical or clinical testing or supplemental information, in order for the FDA to reconsider the application. If or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information that was included. The FDA approval is never guaranteed and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied.
Under the PHSA, the FDA may approve a NDA if it determines that the product is safe, pure and potent and the facility where the product will be manufactured meets standards designed to ensure that it continues to be safe, pure and potent. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. The approval for a drug may be significantly more limited than requested in the application, including limitations on the specific diseases and dosages or the indications for use, which could restrict the commercial value of the product. The FDA may also require that certain contraindications,
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warnings or precautions be included in the product labeling. In addition, as a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy (“REMS”) to further ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals and elements to assure safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and the use of patient registries. The requirement for a REMS or use of a companion diagnostic with a drug can materially affect the potential market and profitability of the drug. Moreover, product approval may require, as a condition of approval, substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.
FDA Fast Track Program
The FDA’s Fast Track program, a provision of the FDA Modernization Act of 1997, is designed to facilitate interactions between a sponsoring company and the FDA before and during submission of a NDA for an investigational agent that, alone or in combination with one or more other drugs, is intended to treat a serious or life-threatening disease or condition and which demonstrates the potential to address an unmet medical need for that disease or condition. Under the Fast Track program, the FDA may consider reviewing portions of a marketing application before the sponsor submits the complete application if the FDA determines, after a preliminary evaluation of the clinical data, that a fast track product may be effective. A Fast Track designation provides the opportunity for more frequent interactions with the FDA and a fast track product could be eligible for priority review if supported by clinical data at the time of submission of the NDA.
Based on the initial results of our clinical trial in subjects with late-stage breast cancer, SM-88 has shown to slow disease progression in some cases, as well as PFS in many subjects with advanced breast cancer. Accordingly, we believe SM-88 may ultimately qualify for FDA fast track designation. We intend to engage the FDA in future discussions concerning SM-88 qualification for FDA Fast Track designation. However, there can be no assurance that such designation will be granted.
Priority Review/Standard Review (U.S.) and Accelerated Review (EU)
The FDA may grant a New Drug Application a priority review designation based both upon the request of an applicant and the results of the Phase III clinical trial(s) submitted in the NDA. This designation sets the target date at six months for FDA action on the application. Priority review is granted where preliminary trial results indicate that a product, if approved, has the potential to provide a safe and effective therapy for a situation where no satisfactory alternative therapy exists or where the product is possibly a significant improvement over existing marketed products. If these criteria are not met for priority review, the NDA is subject to the standard FDA review period of ten months. However, priority review designation does not change the scientific/medical standard for regulatory approval or the quality of evidence necessary to support approval.
Under the Centralized Procedure in the European Union, the maximum timeframe for the evaluation of a marketing authorization application is 210 days, which excludes clock stops when additional written or oral information needs to be provided by the applicant in response to questions asked by The Committee for Medicinal Products for Human Use (“CHMP”). Accelerated evaluation might be granted by the CHMP in exceptional cases, such as when a medicinal product is expected to be a major public health interest, as defined by three cumulative criteria: the seriousness of the disease to be treated ( e.g. , heavily disabling or life-threatening); the absence or insufficiency of an appropriate alternative therapeutic approach; and an anticipation of high therapeutic benefit. Under these circumstances the European Medicines Agency (“EMA”) ensures that the opinion of the CHMP is delivered within 150 days, excluding clock stops.
There can be no assurance that we would be able to satisfy any of these requirements to conduct preclinical or clinical trials or receive any regulatory approvals including priority or accelerated evaluation.
Breakthrough Therapy Approvals
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (“FDASIA”) was signed into law. FDASIA provides a new designation for an expedited FDA review process called Breakthrough Therapy Designation. A breakthrough therapy is a drug that is intended alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. If a drug is designated as a breakthrough therapy, the FDA will expedite the development and review of such drug for trial and market approval. All requests for Breakthrough Therapy Designation will be reviewed within 60 days of receipt and FDA will either grant or deny the request.
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As with the Fast Track program, promising results from early phase clinical studies indicate that SM-88 may qualify as an FDA Breakthrough Therapy designation while the clinical testing program continues. When appropriate, we intend to hold discussions with the FDA regarding SM-88’s qualification for Breakthrough Therapy designation. There can be no assurance that such designation will be granted.
The Hatch-Waxman Act
Under the Hatch-Waxman Act, newly approved drugs and indications may benefit from a statutory period of non-patent marketing exclusivity. The Hatch-Waxman Act provides five-year marketing exclusivity to the first applicant to gain approval of an NDA for a new chemical entity, meaning that the FDA has not previously approved any other new drug containing the same active moiety. The Hatch-Waxman Act prohibits having an effective approval date for an abbreviated new drug application (“ANDA”) or a Section 505(b)(2) NDA for another version of such drug during the five-year exclusive period; however, submission of an ANDA or Section 505(b)(2) NDA containing a paragraph IV certification is permitted after four years, which may trigger a 30-month stay of approval of the ANDA or Section 505(b)(2) NDA. Protection under the Hatch-Waxman Act will not prevent the submission or approval of another “full” NDA; however, the applicant would be required to conduct its own preclinical and adequate and well-controlled clinical trials to demonstrate safety and effectiveness. The Hatch-Waxman Act also provides three years of marketing exclusivity for the approval of new and supplemental NDAs, including Section 505(b)(2) NDAs, for, among other things, new indications, dosages or strengths of an existing drug, if new clinical investigations that were conducted or sponsored by the applicant are determined by the FDA to be essential to the approval of the application.
In addition to non-patent marketing exclusivity, the Hatch-Waxman Act amended the Food, Drug and Cosmetic Act (“FDCA”) to require each NDA sponsor to submit with its application information on any patent that claims the active pharmaceutical ingredient, drug product (formulation and composition) and method-of-use for which the applicant submitted the NDA and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use or sale of the drug. Generic applicants that wish to rely on the approval of a drug listed in the Orange Book must certify to each listed patent. The Orange Book is a listing of all drug products that have been approved by the FDA and their generic equivalences. We intend to submit for Orange Book listing all relevant patents for SM-88 and to vigorously defend any Orange Book-listed patents for our approved products.
The Hatch-Waxman Act also permits a patent term extension of up to five years as compensation for the patent term lost during product development and the FDA regulatory review process. However, a patent term extension cannot extend the remaining term of a patent beyond a total of 14 years after the FDA approves a marketing application. The patent term extension period is generally equal to the sum of one-half the time between the effective date of an IND and the submission date of an NDA and all of the time between the submission date of an NDA and the approval of that application, up to a total of five years. Only one patent applicable to a regulatory review period that represents the first commercial marketing of that drug is eligible for the extension and it must be applied for prior to expiration of the patent. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for patent term extension. We will consider applying for a patent term extension for some of our patents, to add patent life beyond the expiration date, depending on our ability to meet certain legal requirements permitting such extension and the expected length of clinical trials and other factors involved in the submission of an NDA. There can be no assurance that such an extension, if applied for, will be granted.
Advertising and Promotion
Once an NDA is approved, a product will be subject to continuing post-approval regulatory requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the internet. Failure to comply with these regulations can result in significant penalties, including the issuance of warning letters directing a company to correct deviations from FDA standards, a requirement that future advertising and promotional materials be pre-cleared by the FDA and federal and state civil and criminal investigations and prosecutions.
Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. Changes to some of the conditions established in an approved application, including changes to indications, labeling or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing original and resubmitted NDAs.
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AE Reporting and cGMP Compliance
AE reporting and submission of periodic reports are required following FDA approval of an NDA. The FDA also may require post-marketing testing, known as phase IV testing, REMS and surveillance to monitor the effects of an approved product or the FDA may place conditions on an approval that could restrict the distribution or use of the product. In addition, manufacture, packaging, labeling, storage and distribution procedures must continue to conform to cGMPs after approval. Drug manufacturers and certain manufacturing subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with cGMPs. Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain compliance with cGMPs. Regulatory authorities may withdraw product approvals, request product recalls or impose marketing restrictions through labeling changes or product removals if a company fails to comply with regulatory standards, if the product encounters problems following initial marketing or if previously unrecognized problems are subsequently discovered.
Orphan Drug
Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition; generally, a disease or condition that affects fewer than 200,000 individuals in the U.S. Orphan drug designation must be requested before submitting a NDA. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not necessarily convey any advantage in or shorten the duration of, the regulatory review and approval process. The first NDA applicant to receive FDA approval for a particular product to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for the product for treatment of the specified indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug for the same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition or the same drug for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA application user fee. It is not our current intent to pursue orphan drug designation for SM-88.
Other Healthcare Laws and Compliance Requirements
In the U.S., our activities are potentially subject to regulation by federal, state and local authorities in addition to the FDA, including the Centers for Medicare and Medicaid Services, other divisions of the U.S. Department of Health and Human Services (for example, the Office of Inspector General), the U.S. Department of Justice and individual U.S. Attorney offices within the Department of Justice and state and local governments.
EU Approval Process
The EMA is a decentralized scientific agency of the EU. It coordinates the evaluation and monitoring of centrally authorized medicinal products. It is responsible for the scientific evaluation of applications for EU marketing authorizations, as well as the development of technical guidance and the provision of scientific advice to sponsors. The EMA decentralizes its scientific assessment of medicines by working through a network of about 4,500 experts throughout the EU, nominated by the Member States. The EMA draws on resources of over 40 National Competent Authorities of European Member States.
The process regarding regulatory approval of medicinal products in the EU follows roughly the same lines as in the U.S. and likewise generally involves satisfactorily completing each of the following:
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preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable European GLP regulations; |
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submission to the relevant national authorities of a clinical trial application (“CTA”) for each trial in humans, which must be approved before the trial may begin; |
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performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication; |
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submission to the relevant competent authorities of a Marketing Authorization Application (“MAA”), which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labelling; |
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satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced cGMPs; |
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potential audits of the nonclinical and clinical trial sites that generated the data in support of the MAA; and |
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review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product. |
Preclinical Studies
The conduct of the preclinical tests and formulation of the compounds for testing must comply with the relevant European regulations and requirements. Preclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animal studies in order to assess the potential safety and efficacy of the product. The results of the preclinical tests, together with relevant manufacturing information and analytical data, are submitted as part of the CTA.
Clinical Trial Approval
Pursuant to the Clinical Trials Directive 2001/20/EC, as amended, a system for the approval of clinical trials in the EU has been implemented through national legislation of the Member States. Under this system, approval must be obtained from the competent national authority of each European Member State in which a study is planned to be conducted. To this end, a CTA is submitted, which must be supported by an investigational medicinal product dossier (IMPD) and further supporting information prescribed by the Clinical Trials Directive and other applicable guidance documents. Furthermore, a clinical trial may only be started after a competent ethics committee has issued a favorable opinion on the clinical trial application in that country.
Manufacturing and import into the EU of investigational medicinal products is subject to the holding of appropriate authorizations and must be carried out in accordance with cGMPs.
Health Authority Interactions
During the development of a medicinal product, frequent interactions with the EU regulators are vital to make sure all relevant input and guidelines/regulations are taken into account in the overall program.
Pediatric Studies
Regulation (EC) 1901/2006, which came into force in the EU on January 26, 2007, aims to facilitate the development and accessibility of medical products for use in children without subjecting children to unnecessary trials or delaying the authorization of medicinal products for use in adults. The regulation established the Pediatric Committee (“PDCO”), which is responsible for coordinating the EMA’s activities regarding medicines for children. The PDCO’s main role is to determine which studies that marketing authorization applicants need to complete in the pediatric population as part of the so-called Pediatric Investigation Plans (“PIP”). All applications for marketing authorization for new medicines that were not authorized in the EU before January 26, 2007 have to include either the results of studies carried out in children of different ages (as agreed with the PDCO) or proof that a waiver or a deferral of these studies has been obtained from the PDCO. As indicated, the PDCO determines what pediatric studies are necessary and describes them in a PIP. This requirement for pediatric studies also applies when a company wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorized. The PDCO can grant deferrals for some medicines, allowing a company to delay development of the medicine in children until there is enough information to demonstrate its effectiveness and safety in adults and can also grant waivers when development of a medicine in children is not needed or is not appropriate, such as for diseases that only affect the elderly population.
Before an MAA can be filed or an existing marketing authorization can be varied, the EMA checks that companies are in compliance with the agreed studies and measures listed in each relevant PIP.
Regulation (EC) 1901/2006 also introduced several incentives for the development of medicines for children in the EU:
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medicines that have been authorized across the EU in compliance with an agreed PIP are eligible for an extension of their patent protection by six months (this is the case even when the pediatric studies’ results are negative); |
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for orphan medicines, the incentive is an additional two years of market exclusivity, extending the typical 10-year period to 12 years; |
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scientific advice and protocol assistance at the EMA are free of charge for questions relating to the development of medicines for children; and |
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medicines developed specifically for children that are already authorized but are not protected by a patent or supplementary protection certificate, may be eligible for a pediatric use marketing authorization (PUMA); and |
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if a PUMA is granted, the product will benefit from 10 years of market protection as an incentive for the development of the product for use in children. |
MAA
Authorization to market a product in the EU member states proceeds under one of four procedures: a centralized authorization procedure, a mutual recognition procedure, a decentralized procedure or a national procedure.
Centralized Authorization Procedure
Certain drugs, including medicinal products developed by means of biotechnological processes, must be approved via the centralized authorization procedure for marketing authorization. A successful application under the centralized authorization procedure results in a marketing authorization from the European Commission, which is automatically valid in all EU member states. The other European Economic Area member states (namely Norway, Iceland and Liechtenstein) are also obligated to recognize the Commission decision. The EMA and the European Commission administer the centralized authorization procedure.
Under the centralized authorization procedure, the Committee for Medicinal Products for Human Use (“CHMP”) serves as the scientific committee that renders opinions about the safety, efficacy and quality of human products on behalf of the EMA. The CHMP is composed of experts nominated by each member state’s national drug authority, with one of them appointed to act as Rapporteur for the co-ordination of the evaluation with the possible assistance of a further member of the Committee acting as a Co-Rapporteur. After approval, the Rapporteur(s) continue to monitor the product throughout its life cycle. The CHMP is required to issue an opinion within 210 days of receipt of a valid application, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data. The process is complex and involves extensive consultation with the regulatory authorities of member states and a number of experts. Once the procedure is completed, a European Public Assessment Report is produced. If the CHMP concludes that the quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. The CHMP’s opinion is sent to the European Commission, which uses the opinion as the basis for its decision whether or not to grant a marketing authorization. If the opinion is negative, information is given as to the grounds on which this conclusion was reached.
After a drug has been authorized and launched, it is a condition of maintaining the marketing authorization that all aspects relating to its quality, safety and efficacy must be kept under review. Sanctions may be imposed for failure to adhere to the conditions of the marketing authorization. In extreme cases, the authorization may be revoked, resulting in withdrawal of the product from sale.
Mutual Recognition Procedure and Decentralized National Procedure
Under a Mutual Recognition Procedure (“MRP”) or a Decentralized Procedure (“DCP”), the applicant must select which and how many EU member states in which to seek approval. In the case of an MRP, the applicant must initially receive national approval in one EU member state. This will be the so-called reference member state (“RMS”) for the MRP. Then, the applicant seeks approval for the product in other EU member states, the so-called concerned member states (“CMS”) in a second step.
For the DCP, the applicant will approach all chosen Member States at the same time. To do so, the applicant will identify the RMS that will assess the submitted MAA and provide the other selected Member States with the conclusions and results of the assessment. In principle, the applicant can choose any EU Member State as the RMS; however, in almost all Member States, the applicant needs to send a request for a time slot when the applicant will be allowed to submit the application. Depending on the Member State selected as RMS, the interval between submission of the request to the actual submission date can be two years or longer.
Accelerated Assessment Procedure
When an application is submitted for a marketing authorization in respect of a drug for human use, which is of major interest from the point of view of public health and in particular, from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment. Under the accelerated assessment procedure, the CHMP is required to issue an opinion within 150 days of receipt of a valid application, subject to clock stops. We believe that SM-88 may qualify for this provision and we will take advantage of this provision, if appropriate.
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Conditional Approval
Under EU regulations, a medicine that would fulfill an unmet medical need may, if its immediate availability is in the interest of public health, be granted a conditional marketing authorization on the basis of less complete clinical data than are normally required, subject to specific obligations being imposed on the authorization holder. These specific obligations are to be reviewed annually by the EMA. The list of these obligations is to be made publicly accessible. Such an authorization shall be valid for one year, on a renewable basis.
Period of Authorization and Renewals
A marketing authorization is initially valid for five years and may then be renewed on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the authorizing member state. To this end, the marketing authorization holder is to provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variants introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid. Once renewed, the marketing authorization shall be valid for an unlimited period, unless the Commission or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal. Any authorization which is not followed by the actual placing of the drug on the European market (in case of centralized procedure) or on the market of the authorizing Member State within three years after authorization shall cease to be valid (the so-called sunset clause).
Orphan Drug Designation
EU regulations also provide for an orphan drug designation. This designation is granted if its sponsor can establish:
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that the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the EU when the application is made; or |
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that the product is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the EU and that without incentives it is unlikely that the marketing of the drug in the EU would generate sufficient return to justify the necessary investment; and |
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that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the EU or, if such method exists, the drug will be of significant benefit to those affected by that condition. |
An application for designation as an orphan product can be made any time prior to the filing of an application for approval to market the product. Marketing authorization for an orphan drug leads to a ten-year period of market exclusivity. This period may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan drug designation, for example because the product is sufficiently profitable not to justify continued market exclusivity. Market exclusivity can be revoked only in very selected cases, such as consent from the marketing authorization holder, inability to supply sufficient quantities of the product, demonstration of “clinically relevant superiority” by a similar medicinal product or, after a review by the Committee for Orphan Medicinal Products, requested by a Member State in the fifth year of the marketing exclusivity period (if the designation criteria are believed to no longer apply). Medicinal products designated as orphan drugs are eligible for incentives made available by the EU and by its Member States to support research into and the development and availability of orphan drugs. It is not our current intention to pursue orphan drug designation for SM-88.
Regulatory Data Protection
Without prejudice to the law on the protection of industrial and commercial property, marketing authorizations for new medicinal products in the EU benefit from an 8+2+1 year period of regulatory protection.
This regime consists of a regulatory data protection period of eight years plus a concurrent market exclusivity of ten years plus an additional market exclusivity of one further year if, during the first eight years of those ten years, the marketing approval holder obtains an approval for one or more new therapeutic indications which, during the scientific evaluation prior to their approval, are determined to bring a significant clinical benefit in comparison with existing therapies. Under the current rules, a third party may reference the preclinical and clinical data of the reference product beginning eight years after first approval, but the third party may market a generic version only after ten (or eleven) years have lapsed.
Additional regulatory data protection can be applied for when an applicant has complied with all requirements as set forth in an approved PIP.
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International Conference on Harmonization (ICH)
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) is a project that brings together the regulatory authorities of Europe, Japan and the U.S. and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration. Harmonization would lead to a more economical use of human, animal and material resources, the elimination of unnecessary delay in the global development and availability of new medicines, while maintaining safeguards on quality, safety, efficacy and regulatory obligations to protect public health.
ICH guidelines have been adopted as law in many countries, but are only used as guidance in the U.S. by the FDA. In many areas of drug regulation, ICH has resulted in comparable requirements, for instance with respect to the Common Technical Document, which has become the core document for filings for market authorization in several jurisdictions. In this manner, ICH has facilitated a more efficient path to markets.
Pharmaceutical Coverage, Pricing and Reimbursement
As previously noted, in the U.S. and other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payers, including government health administrative authorities, managed care providers, private health insurers and other organizations. The division of competences within the EU leaves to its Member States the power to organize their own social security systems, including health care policies to promote the financial stability of their health care insurance systems.
In this context, each of the Member States’ national authorities are free to set the prices of medicinal products and to designate the treatments that they wish to reimburse under their social security system. However, the EU has defined a common procedural framework through the adoption what is generally known as the “Transparency Directive.” This directive aims to ensure that national pricing and reimbursement decisions are made in a transparent manner and do not disrupt the operation of the internal market.
The pharmaceutical pricing and reimbursement systems established by Member States are usually quite complex. Each country uses different schemes and policies, adapted to its own economic and health needs. We would have to develop or access special expertise in this field to prepare health economic dossiers on our medicinal products if we would market our products, if and when approved, in the EU.
Manufacturing
We do not own or operate and currently have no near term plans to establish, any manufacturing facilities. We currently rely on and expect to continue to rely on, third party contract manufacturers for supplies of SM-88 for preclinical and clinical testing, as well as for the initial commercial manufacture of any products that we may market following regulatory approval.
We currently purchase all our drug substance and drug products from contract manufacturers and intend to continue to do so on an as-needed purchase order basis. We do not have long-term supply arrangements in place at this time. We intend to identify and qualify any further necessary contract manufacturers to provide all active pharmaceutical ingredients (“API”) and finished drug product services during the IND stages and prior to submission of an NDA to the FDA.
Our current intention is that, during the course of the IND program through the End-of-Phase 2 (“EOP2”), we will scale-up the manufacturing, CMC and GMP program towards commercial manufacturing. The overall CMC program includes the development of production specifications, producing and validating standards and the development of suitable analytical methods for test and release, as well as stability testing. Before and during the use of contract manufacturers, we (or qualified designee) will conduct audits to ensure compliance with the mutually agreed process descriptions and cGMP regulations. Our manufacturers themselves must comply with their in-house quality assurance programs and be available for inspections by regulatory agencies, including the FDA and European drug regulatory agencies. During the development of our drug candidates, we will scale the manufacturing process to a suitable size. Such scaling up involves several steps and may involve modification of the process, in which case modifications to our CMC sections will occur, with continuous submissions to the FDA and EU regulatory authorities.
SM-88 is a combination drug that is comprised of four active ingredients. The components of SM-88 are all administered in low doses and are generally considered safe for the indications for which they have previously received regulatory approval. Such approvals have been in areas other than cancer treatment. The drug substances that comprise SM-88 are organic compounds of low
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molecular weight, generally called small molecules. They can be manufactured in reliable and reproducible synthetic processes from readily available starting materials. The chemistry is amenable to scale-up and we believe does not require unusual equipment in the manufacturing process.
One component of SM-88 is a derivation of an existing FDA-approved drug that has been modified to contribute to the functionality of SM-88. This drug substance is being manufactured by an FDA-audited contract manufacturer and holder of an FDA Drug Master File. This manufacturer currently is our sole supplier of this drug substance. To our knowledge, the current manufacturer of this drug substance is the only FDA-approved supplier of this drug. We believe this cGMP contract manufacturer has sufficient capacity to meet our projected needs into the near future. In the event of a catastrophic event or if this contract manufacturer is unable to meet our needs, we will need to find an alternative source. This will likely result in delays for the clinical development program. It is not impossible to find a substitute for this supplier in the event that it becomes necessary, but it would be costly in terms of development time. We do not currently have arrangements in place for a redundant supply of the drug substance.
The remaining three active pharmaceutical ingredients (“APIs”) in SM-88 are available from several contract manufacturers, each holding Drug Master Files at the FDA for their respective API’s. We believe that the loss of or the inability of, any of these sources to provide our required ingredients would not have any substantive delaying effect on our research program, clinical trials or future commercial sale of SM-88, as, we believe, these other sources are readily available.
Employees
As of March 6, 2015, we have five full-time employees. Within our staff, two employees are engaged in R&D and three in business development, finance, legal, human resources, facilities, information technology and general management and administration. None of our employees are represented by labor unions or covered by collective bargaining agreements. Where necessary, we have entered into consulting contracts to provide us with subject matter expertise. We believe there is available a sufficient number of contractors with appropriate subject matter expertise for our current and near term needs.
Facilities
Our principal executive offices are located at 48 Wall Street - Suite 1100, New York, New York 10005, where we lease and occupy approximately 1,100 square feet of office space. We lease these offices under a three-month lease that provides for automatic renewals, unless either party gives notice of non-renewal. The current term of our lease expires on March 31, 2015.
We believe that our existing facilities are adequate for our current administrative needs. When our current lease term expires, we may exercise our renewal option or look for additional or alternate space for our operations. We believe that suitable additional or alternative space will be available in the future on commercially reasonable terms.
We will rely on clinical research centers, hospitals, contract research organizations and other parties for suitable space and facilities to conduct our clinical trials.
We will explore, in the future, establishing a dedicated technical facility, when we believe the need for such a facility has arisen. No assurance can be given that such a facility can be located without difficulty or at a cost favorable to us.
RISK FACTORS
An investment in our securities is highly speculative and involves a high degree of risk. We face a variety of risks that may affect our operations or financial results and many of those risks are driven by factors that we cannot control or predict. Before investing in the securities of our Company, prospective investors should carefully consider the following risks and discussions of other risks contained elsewhere in this Current Report on Form 8-K, together with the financial statements (including notes thereto) and other information contained in this Form 8-K. If any of the following risks actually occurs, our business, prospects, financial condition and results of operations could be materially adversely affected. In such a case, the trading price of our securities would likely decline and investors in our Company may lose all or a part of their investment. Only those investors who can bear the risk of loss of their entire investment should consider an investment in our securities.
This Form 8-K contains certain forward-looking statements relating to future events and financial performance of our Company. Prospective investors are cautioned that such statements are only predictions and involve risks and uncertainties and that actual events or results may differ materially. In evaluating such statements, prospective investors should specifically consider the various factors identified in this Form 8-K, including the matters set forth below, which could cause actual results to differ materially from those indicated by such forward-looking statements.
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Prospective investors should consider carefully whether an investment in the Company is suitable for them in light of the information contained in this Form 8-K and the financial resources available to them. The risks described below do not purport to be all the risks to which our Company could be exposed. This section is a summary of certain risks and is not set out in any particular order of priority. They are the risks that we presently believe are material to the business, operations and financial condition of our Company. Additional risks of which we are not presently aware of or which we presently deem immaterial may also impair our Company’s business, operations, financial condition or results of operations.
Risks Related to Our Business and the Development and Commercialization of Our Drug Candidates.
Our proprietary lead drug, SM-88, is in the early stages of clinical development. We are currently finalizing our regulatory and drug development program for SM-88 and working towards the initiation of our first phase II clinical trial. Clinical drug development is expensive, time-consuming and uncertain and we may ultimately not be able to obtain regulatory approval for the commercialization of our lead candidate.
The risk of failure for drugs in clinical development is high and it is impossible to predict when our lead drug candidate for the treatment of cancer, SM-88, will prove effective or safe in humans or will receive regulatory approval for any form of cancer or any other indication.
The research, testing, manufacturing, labeling, approval, selling, marketing and distribution of drug products are subject to extensive regulation by the U.S. Food and Drug Administration, the European Medicines Agency, national competent authorities in Europe and other non-U.S. regulatory authorities, which establish regulations that differ from country to country. We are not permitted to market SM-88 and any other drug product we may develop in the U.S. or in other countries until we receive approval of a New Drug Application from the FDA or marketing approval from applicable regulatory authorities outside the U.S. Since SM-88 is in the early stages of development, it is subject to the risk of failure inherent in the drug development process. To date, we have not submitted an application for or received marketing approval for, SM-88. We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA or EMA. Obtaining approval of a NDA or a Marketing Authorization Application (“MAA”) can be a lengthy, expensive and uncertain process. In addition, failure to comply with the FDA, EMA and/or other non-U.S. regulatory requirements prior to regulatory approval, could subject our Company to administrative or judicially imposed sanctions, which include but are not limited to:
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restrictions on our ability to conduct clinical trials, including issuing full or partial clinical holds or other regulatory objections to ongoing or planned trials; |
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recalls; |
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restrictions on the use of drugs, manufacturers or our planned manufacturing process; |
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warning letters; |
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clinical investigator disqualification; |
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civil and criminal penalties; |
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injunctions; |
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suspension or withdrawal of regulatory approvals; |
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drug seizures, detentions or import/export bans or restrictions; |
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voluntary or mandatory drug recalls and publicity requirements; |
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total or partial suspension of drug; |
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imposition of restrictions on operations, including costly new manufacturing requirements; and |
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refusal to approve pending NDAs or supplements to approved NDAs in the U.S. and refusal to approve marketing approvals in other jurisdictions, such as a MAA in the EU. |
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The FDA, EMA and other non-U.S. regulatory authorities also have substantial discretion in the drug approval process. Generally, the number of nonclinical and clinical trials that will be required for regulatory approval varies depending on the drug candidate, the disease or condition that the drug candidate is designed to address and the regulations applicable to any particular drug candidate. Regulatory agencies can delay, limit or deny approval of a drug for many reasons, which include but are not limited to:
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the drug candidate may be deemed unsafe or ineffective; |
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current results may not continue to confirm the positive results from earlier nonclinical or clinical trials; |
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failure to select optimal drug doses and suitable trial endpoints; |
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populations studied did not reflect populations likely to use the drug; |
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mortality rates in clinical trials are shown to be numerically higher in subjects treated with SM-88 that in those treated with comparator drugs; |
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regulatory agencies may not find the data from nonclinical and clinical trials sufficient or well-controlled; |
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regulatory agencies might not approve or might require changes to manufacturing processes or facilities; and |
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regulatory agencies may change their approval policies or adopt new regulations. |
Any delay in obtaining or failure to obtain, required approvals could materially adversely affect our ability to generate revenue from SM-88, which would likely result in significant harm to our financial position and adversely impact our share price. Furthermore, any regulatory approval to market SM-88 may be subject to limitations on the indicated uses for which we may market the drug. These limitations may limit the size of the market for SM-88 and any other drug product we may develop.
We have no history of conducting large-scale or pivotal clinical trials or commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.
Our operations to date have been limited to financing and staffing our Company and developing our technology platform, SM-88 and other potential drug candidates. We have not yet developed our commercialization strategy and marketing plan. Accordingly, we have not been given the opportunity to demonstrate our ability to successfully complete a large-scale or pivotal clinical trial, obtain marketing approval, manufacture product on a commercial scale or conduct sales and marketing activities. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.
If clinical trials for SM-88 are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our drug on a timely basis, which would require us to incur additional costs and delay revenue.
SM-88 is in the early stages of development. We are working towards conducting our first phase II clinical trial and its initiation is subject to numerous factors that can cause interruption or delay, many of which are beyond our control. Should we experience any interruption or delay, our future plans and expected future revenue will be adversely affected and could result in our inability to continue our operations.
We anticipate commencing a phase II clinical trial with SM-88 in patients in 2015, with plans to review interim data in order to confirm that our development plans are in line. In addition, we plan to conduct nonclinical trials and develop our pharmacology and toxicology program for SM-88. The commencement of these planned trials could be substantially delayed or prevented due to several factors, which include but are not limited to:
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further discussions with the FDA, the EMA or other regulatory agencies regarding the scope or design of our clinical trials; |
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the limited number of and competition for, suitable sites to conduct our clinical trials, many of which may already be engaged in other clinical trial programs, including trials for the same indication as SM-88; |
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delay or failure to obtain regulatory approval or agreement to commence a clinical trial in any of the countries where enrollment is planned; |
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inability to obtain sufficient funds required to execute our clinical and regulatory development plans; |
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clinical holds on or other regulatory objections to, a new or ongoing clinical trial; |
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delay or failure in the testing, validation, manufacture and delivery of sufficient supplies of SM-88 for our clinical trials; |
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delay or failure to reach agreement on acceptable clinical trial terms or clinical trial protocols with prospective investigational sites or clinical research organizations (“CRO”), the terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs; and |
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delay or failure to obtain institutional review board or independent ethics committee (“IEC”) approval to conduct a clinical trial at a prospective investigational site. |
Additionally, many factors could substantially delay or prevent the timely completion of our planned clinical trials due to several factors, which include but are not limited to:
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slower than expected rate of subject recruitment and enrollment; |
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slower than projected IRB/IEC review and approval; |
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the Data Monitoring Committee (“DMC”) of the FDA requires the clinical trial be delayed or stopped or requests major or minor modifications to the clinical trial; |
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failure of subjects to complete their full participation in clinical trial or return for post-treatment follow-up; |
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unforeseen safety issues, including severe or unexpected drug-related adverse effects experienced by subjects, including the possibility of death; |
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lack of SM-88 efficacy during the clinical trials; |
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poor trial design for one or more of our clinical trials; |
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withdrawal of participation by a principal investigator in one or more of our clinical trials; |
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inability or unwillingness of subjects or clinical investigators to comply with clinical trial procedures; |
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resolution of data discrepancies; |
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inadequate CRO management and/or monitoring in one or more of our clinical trials; |
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the need to repeat, reconstruct or terminate a clinical trial due to inconclusive or negative results or unforeseen complications in testing; and |
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a request by the FDA to abandon our current drug development programs. |
Changes in regulatory requirements and guidance may also occur and we may need to significantly amend ongoing clinical trial protocols or revise planned prospective clinical trial protocols to reflect such changes mandated by regulatory authorities. Amendments may require us to renegotiate terms with CROs or resubmit clinical trial protocols to IRBs or IEUs for re-review, which may impact the costs, timing or successful completion of a clinical trial. Our clinical trials may be suspended or terminated at any time by the FDA, the EMA, other regulatory authorities or the IRB/IEC overseeing the clinical trial, due to a number of factors, which include but are not limited to:
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failure to conduct the clinical trial in accordance with regulatory requirements or compliance with the clinical protocol; |
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unforeseen safety issues or any determination that a clinical trial presents unacceptable health risks to subjects; |
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lack of adequate funding to continue the clinical trial due to higher or additional unforeseen costs or other business decisions; and |
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upon a breach or pursuant to the terms of any agreement with or for any other reason by, current or future collaborators that have responsibility for the clinical development of SM-88. |
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Any failure or significant delay in clinical and regulatory development plans for SM-88 or any other drug candidate we may pursue would likely adversely affect our ability to obtain regulatory approval for the drug and would diminish our ability to generate revenue.
The results of previous clinical trials may not be predictive of future results, our progress in trials for one drug candidate may not be indicative of progress in trials for other drug candidates and the results of our current and planned clinical trials may not satisfy the requirements of the FDA, the EMA or other non-U.S. regulatory authorities.
We currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. Before obtaining marketing approval from regulatory authorities for the sale of SM-88 as a cancer therapy, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our drug in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and has a risk of uncertainty as to its outcome. Clinical failure can occur at any stage of clinical development and the outcome of early clinical trials may not be predictive of the success of later clinical trials. Additionally, interim results of a clinical trial do not necessarily predict final trial results. In addition, nonclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that have believed their drug performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products.
Drug candidates that have shown promising results in early clinical trials may still suffer significant setbacks in subsequent registration clinical trials. A number of companies in the pharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier clinical trials.
Clinical trials may also produce negative or inconclusive results and we may decide or regulators may require us, to conduct additional clinical or nonclinical testing. We will be required to demonstrate with substantial evidence through well-controlled clinical trials that SM-88 is safe and effective for use in diverse populations before we can seek regulatory approvals for its commercial sale.
In addition, the design of a clinical trial can determine whether its results will support approval of a drug. Flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. We may be unable to design and execute a clinical trial to support regulatory approval.
In some instances, there may be significant variability in safety and/or efficacy results between different trials of the same drug due to numerous factors, including amendment to trial protocols, variability in size and type of the patient populations, adherence to the dosing regimen and other trial procedures and the rate of dropout among clinical trial subjects. We do not know whether any of the clinical trials in our development plan will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval to market SM-88.
There is always the possibility that SM-88 may not gain regulatory approval even if it achieves its primary endpoints in its phase III clinical trials, which may only be initiated if we are successful in complying with all regulatory requirements necessary to commence phase III clinical trials. The FDA, the EMA or other non-U.S. regulatory authorities may disagree with our trial design and/or our interpretation of data from nonclinical and clinical trials. In addition, any of these regulatory authorities may change requirements for the approval of a drug even after reviewing and providing comments or advice on a protocol for a clinical trial. In addition, any of these regulatory authorities may also approve a drug for fewer or more limited indications than requested or may grant approval that is contingent on the performance of costly post-marketing clinical trials. Further, the FDA, the EMA or other non-U.S. regulatory authorities may not accept the labeling claims that we believe would be necessary or desirable for the successful commercialization of SM-88.
Even if SM-88 obtains regulatory approval, it will be subject to continual regulatory review.
If marketing authorization is obtained for our lead drug candidate, SM-88, the drug will continue to be under review by regulatory authorities and, therefore, authorization could be subsequently withdrawn or restricted at any time there is a safety issue. We will be subject to ongoing obligations and oversight by regulatory authorities, including adverse event (AE) reporting requirements, marketing restrictions and, potentially, other post-marketing obligations, all of which may result in significant expense and limit our ability to commercialize our drug product.
If there are changes in the application of legislation or regulatory policies or if problems are discovered with SM-88 or our manufacture(s) or if we or one of our distributors, licensees or co-marketers fails to comply with regulatory requirements, the regulators could take various actions. These include imposing fines on us, imposing restrictions on the drug or its manufacture and requiring us to recall or remove the drug from the market. The regulators could also suspend or withdraw our marketing
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authorizations, requiring us to conduct additional clinical trials, change our drug labeling or submit additional applications for marketing authorization. If any of these events occurs, our ability to sell SM-88 may be impaired and we may incur substantial additional expense to comply with regulatory requirements, which could adversely affect our business, financial condition and the result of our operations.
We may not be successful in our efforts to use and expand our technology platform to build a pipeline of drug candidates.
A key element of our business strategy is to further develop and expand our technology platform so that we can build a steady pipeline that we ultimately hope will be successful in the treatment of a variety of cancers, as well as other diseases that affect health and quality of life. Although our discovery and development efforts to date have resulted in the development of SM-88, we may not be able to develop additional drugs that are safe and effective. Even if we are successful in continuing to build our pipeline, the potential drug candidates that we discover may not be suitable for further clinical development. There is always the potential that they produce harmful adverse effects or possess other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance. If we do not continue the steady development and commercialization of products utilizing our technology platform, we will face difficulty in obtaining revenues in future periods, which could result in significant harm to our financial position and adversely affect our share price.
We have a growing pipeline of drug candidates based on our technology platform that are focused on key cancer indications. To date, the FDA and other regulatory authorities have not approved products that utilize this technology platform.
In the future, we plan to develop additional drug candidates based on our proprietary technology platform. This platform incorporates novel technologies and methods and actions. The approval of the drug candidates in our pipeline is less certain than approval of drugs that do not employ such novel technologies or methods of action. We intend to work closely with the FDA, the EMA and other non-U.S. regulatory authorities to perform the requisite scientific analyses and evaluation of our methods to obtain regulatory approval for these future drug candidates. For example, final assays and specifications of our future drug candidates have yet to be developed and the FDA, EMA or other non-U.S. regulatory authorities may require additional analyses to evaluate this aspect of our technology. It is possible that the validation process may take time and significant expenditures of resources, require independent third-party analyses or not be accepted by the FDA, the EMA and other non-U.S. regulatory authorities. Delays or failure to obtain regulatory approval of any of our future drug candidates could adversely affect our business prospects.
Even if we obtain marketing approval for SM-88 in a major pharmaceutical market such as the U.S. or Europe, we may never obtain approval or commercialize in other major markets, which would limit our ability to realize the drug’s full market potential.
In order to market any products in a country or territory, we must establish and comply with numerous and varying regulatory requirements of such countries or territories regarding safety and efficacy. Clinical trials conducted in one country may not be acceptable for review by regulatory authorities in other countries and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures differ among countries and can involve additional testing and validation as well as varying administrative review periods. Seeking regulatory approvals in multiple countries could result in significant delays, difficulties and costs and may require additional nonclinical or clinical trials, which would be costly and time-consuming or even delay or prevent the introduction of SM-88 in those countries. In addition, our failure to obtain regulatory approval in one country may delay or have negative effects on the process for regulatory approval in other countries. We do not have any drug candidates approved for sale in any jurisdiction, including international markets and we do not have experience in obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, our target market will be reduced and our ability to realize the full market potential of SM-88 will be harmed.
In the U.S., we may seek fast track or breakthrough designation for SM-88. There is no assurance that the FDA will grant either designation and even if it does, such designation may not actually lead to a faster development process, regulatory review or approval compared to conventional FDA procedures and does not increase the likelihood that SM-88 will receive marketing approval in the U.S.
The fast track program, a provision of the FDA Modernization Act of 1997, is designed to facilitate interactions between a sponsor and the FDA before and during submission of a NDA for an investigational agent that, alone or in combination with one or more drugs, is intended to treat a serious or life-threatening disease or condition and which demonstrates the potential to address an unmet medical need for that disease or condition. Under the fast track program, the FDA may consider reviewing portions of a marketing application before the sponsor submits the complete application, if the FDA determines, after a preliminary evaluation of the clinical data, that a fast track drug may be effective. A fast track designation provides the opportunity for more frequent interactions with the FDA and could make the drug eligible for priority review if supported by clinical data at the time of submission of the NDA.
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The FDA is authorized to designate a new drug as a breakthrough therapy if it finds that the drug is intended, alone or in combination with one or more drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For products designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Products designated as breakthrough therapies by the FDA are also eligible for accelerated approval.
The FDA has broad discretion whether or not to grant fast track or breakthrough designation. Accordingly, even if we believe SM-88 meets the criteria for fast track or breakthrough designation, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of fast track or breakthrough designation for a drug candidate may not result in a faster development process, review or approval compared to drug candidates considered for approval under conventional FDA procedures and, in any event, does not assure ultimate approval by the FDA. The FDA may even withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.
Should we choose to pursue orphan drug designation, we may be unable to obtain orphan drug designation or exclusivity for SM-88. If our competitors are able to obtain orphan drug exclusivity for their products in the same indications for which we are developing SM-88, we may not be able to have our products approved by the applicable regulatory authority for a significant period of time. Conversely, if we obtain orphan drug exclusivity for SM-88 or any other drug we may develop, we may not be able to benefit from the associated marketing exclusivity.
Regulatory authorities in some jurisdictions, including the U.S. and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate SM-88 as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the U.S. In the European Union, the European Commission may designate a drug candidate as an orphan medicinal drug if it is a medicine for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affects not more than five in 10,000 persons in the EU or it is unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development. If SM-88 were to receive orphan drug designation, this orphan drug status may not ensure that we have market exclusivity in a particular market and there is no assurance we will be able to receive orphan drug designation for SM-88. Further, the granting of a request for orphan drug designation does not alter the standard regulatory requirements and process for obtaining marketing approval.
Generally, if a drug candidate with an orphan drug designation receives the first marketing approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which, subject to certain exceptions, precludes the FDA from approving the marketing application of another drug for the same indication for that time period or precludes the EMA and other national drug regulators in the EU, from accepting the marketing application for another medicinal drug for the same indication. The applicable period is seven years in the U.S. and ten years in the EU. The EU period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. In the EU orphan exclusivity may also be extended for an additional two years ( i.e ., a maximum of 12 years’ orphan exclusivity) if the drug is approved based on a dossier that includes pediatric clinical trial data generated in accordance with an approved pediatric investigation plan. Orphan drug exclusivity may be lost in the U.S. if the FDA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.
Even if we obtain orphan drug exclusivity for SM-88, that exclusivity may not effectively protect the drug from competition because exclusivity can be suspended under certain circumstances. In the U.S., even after an orphan drug is approved, the FDA can subsequently approve another drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In the EU orphan exclusivity will not prevent a marketing authorization from being granted for a similar drug in the same indication if the new drug is safer, more effective or otherwise clinically superior to the first drug or if the marketing authorization holder of the first drug is unable to supply sufficient quantities of the drug.
SM-88 and any other drug product we may develop may have serious adverse, undesirable or unacceptable side effects, which may delay or prevent marketing approval. If such side effects are identified during the development of SM-88 or following approval, if any, we may need to abandon our development of SM-88 and any other drug product, the commercial profile of any approved label may be limited and/or we may be subject to other significant negative consequences following marketing approval, if any.
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Although SM-88 and any other drug products we may develop will undergo safety testing to the extent possible and agreed to with regulatory authorities, not all adverse effects of drugs can be predicted or anticipated. SM-88, our proprietary drug cocktail – which we believe is a first-in-class drug that harness the body’s own immune defenses to fight tumor cells - is based on a mechanism designed to utilize oxidative stress, among other techniques, to selectively kill cancer cells, yet is powerful and could lead to serious side effects that we only discover in clinical trials. Unforeseen side effects from SM-88 and any other drug product we may develop could arise either during clinical development or, if such side effects are sporadic, after it has been approved by regulatory authorities and the approved drug has been marketed, resulting in the exposure of additional patients. While our proof-of-concept clinical trial for SM-88 demonstrated a favorable safety profile, the results from future trials of SM-88 may not confirm these results. Any new therapy to kill cancer tumors is risky and may have unintended consequences. We have not fully demonstrated that SM-88 is safe in humans and we may not be able to do so.
Furthermore, we are initially developing SM-88 for patients with cancer for whom no other therapies have succeeded and survival times are frequently short. Therefore, we expect that certain subjects may die during the clinical trials and it may be difficult to ascertain whether such deaths are attributable to the underlying disease, complications from the disease, SM-88 or a combination of such factors.
The results of future clinical trials may show that SM-88 causes undesirable or unacceptable side effects, which could interrupt, delay or halt our clinical trials and result in delay of or failure to obtain, marketing approval from the FDA, the European Commission and other non-U.S. regulatory authorities or result in marketing approval from the FDA, the European Commission and other non-U.S. regulatory authorities with restrictive label warnings or potential drug liability claims.
If SM-88 receives marketing approval and it is later identified as undesirable or has unacceptable side effects, we are at risk for the following actions:
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regulatory authorities may require us to take SM-88 off the market; |
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regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies; |
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regulatory authorities may require post-market clinical trials to assess possible serious risks associated with SM-88, which will require us to provide the FDA with additional data; |
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we may be required to change the way SM-88 is administered, conduct additional clinical trials or change the labeling of the drug; |
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we may be subject to limitations on how we may promote SM-88; |
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sales of SM-88 may decrease significantly; |
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we may be subject to litigation or drug liability claims; and |
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our reputation may suffer. |
Any of these events could prevent us from achieving or maintaining market acceptance of SM-88 or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of SM-88.
We depend on continued patient enrollment into our clinical trials. If we are unable to enroll patients in our clinical trials, our research and development efforts could be materially adversely affected.
Successful and timely completion of clinical trials will require that we enroll and complete the trials with a sufficient number of evaluable subjects. Our clinical trials may be subject to delays resulting from the trials’ slower enrollment or subject withdrawal. Subject enrollment depends on many factors, including the size and nature of the patient population, eligibility criteria for the clinical trial, the proximity of patients to clinical sites, the design of the clinical protocol, the availability of competing clinical trials for the same population of subjects, the availability of new drugs approved for metastatic breast cancer and clinicians’ and patients’ perceptions as to the potential advantages of SM-88 and any other drug product we may develop in relation to other available therapies.
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These factors may make it difficult for us to enroll enough patients to complete our clinical trials in a timely and cost-effective manner. Delays in the completion of any clinical trial for SM-88 and any other drug product we may develop will increase our costs, slow down our drug development and delay or potentially jeopardize our ability to commence drug sales and generate revenue. In addition, some of the factors that cause or lead to, a delay in the completion of clinical trials may also ultimately lead to the denial of regulatory approval of SM-88 and any other drug product we may develop.
Even if approved, if SM-88 does not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, our revenue generated from its sales will be limited.
The commercial success of our SM-88 and any other drug product we may develop will depend upon its acceptance among physicians, patients and the overall medical community. The degree of market acceptance of SM-88, which would be applicable to any other drug product we may develop, will depend on a number of factors, which include but are not limited to:
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limitations or warnings contained in the approved labeling for SM-88; |
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changes in the standard of care for metastatic breast cancer for SM-88; |
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limitations in the approved clinical indications for SM-88; |
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demonstrated clinical safety and efficacy of SM-88 compared to other drugs; |
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lack of significant adverse effects; |
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limitations on how we promote SM-88; |
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sales, marketing and distribution support; |
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availability and extent of reimbursement from managed care plans and other third-party payors; |
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timing of market introduction and perceived effectiveness of competitive drugs; |
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the degree of cost-effectiveness of SM-88; |
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availability of alternative therapies at similar or lower cost, including generic and over-the-counter drugs; |
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the extent to which SM-88 is approved for inclusion on formularies of hospitals and managed care organizations; |
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whether SM-88 is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for metastatic breast cancer; |
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adverse publicity about SM-88 or favorable publicity about competitive drugs; |
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convenience and ease of administration; and |
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potential drug liability claims. |
If SM-88 is approved but does not achieve an adequate level of acceptance by physicians, patients and the overall medical community, we may not generate sufficient revenue to become profitable or to sustain operations. In addition, efforts to educate the medical community and third-party payors on the benefits of SM-88 may require significant resources and may never be successful.
We are subject to manufacturing risks that could substantially increase our costs and limit the supply of SM-88 and any other drug product we may develop.
The process of manufacturing SM-88 is complex, highly regulated and subject to several risks, which include but are not limited to:
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We do not have experience in manufacturing SM-88 in bulk quantity or at commercial scale. We plan to contract with external manufacturers to develop a larger scale process for manufacturing SM-88 in parallel with our phase II trial of SM-88. We may not succeed in the scaling up of our process or we may need a larger manufacturing process for SM-88 than what we have planned. Any changes to our manufacturing processes may result in the need to obtain additional regulatory approvals. Difficulties in achieving commercial-scale production or the need for additional regulatory approvals could delay the development and regulatory approval of SM-88 and ultimately affect our success. |
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The process of manufacturing drugs, such as SM-88, is extremely susceptible to loss due to contamination, equipment failure or improper installation or operation of equipment, vendor or operator error, inconsistency in yields, variability in drug characteristics and difficulties in scaling the production process. Even minor deviations from normal manufacturing processes could result in reduced production yields, drug defects and other supply disruptions. If microbial, viral or other contaminations are discovered in SM-88 or in the manufacturing facilities in which SM-88 is made, such manufacturing facilities may need to be closed for an extended time to investigate and remedy the contamination. |
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A shortage of one or more SM-88 drug substance(s) or ingredients. |
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The manufacturing facilities in which SM-88 is made could have delays in manufacturing due to delays created by other sponsor company drug manufacturing runs, which could affect our manufacturing runs. |
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An unforeseen increase in ingredients procurement or other manufacturing costs. |
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The manufacturing facilities in which SM-88 is made could be adversely affected by equipment failures, labor shortages, labor strikes, natural disasters, power failures, lack of phone or internet services, riots, crime, act of foreign enemies, war, nationalization, government sanction, blockage, embargo, any extraordinary event or circumstance beyond control and numerous other factors. |
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We and our manufacturing partners must comply with applicable current Good Manufacturing Practice and local and state regulations and guidelines. We or our manufacturing partners may encounter difficulties in achieving quality controls and quality assurance and may experience shortages in qualified personnel. We and our manufacturing partners will be subject to inspections by the FDA and comparable agencies in other jurisdictions to confirm compliance with applicable regulatory requirements. Any failure to follow cGMPs or other regulatory requirements or delay, interruption or other issues that arise in the manufacture, fill-finish, packaging or storage of SM-88 that result from a failure at the facilities or the facilities or operations of third parties to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and commercialize SM-88. This could lead to significant delays in the availability of our drug for clinical trials or the termination or clinical hold on a trial or the delay or prevention of a filing or approval of marketing applications for SM-88. Significant noncompliance could also result in the imposition of sanctions, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approvals for SM-88, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could damage our reputation. If we and/or our manufacturing partners are not able to maintain regulatory compliance, we may not be permitted to market SM-88 and/or may be subject to drug recalls, seizures, injunctions or criminal prosecution. |
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Any adverse developments affecting manufacturing operations for SM-88, if any are approved, may result in shipment delays, inventory shortages, lot inspection failures, drug withdrawals or recalls or other interruptions in the supply of SM-88. We may also have to take inventory write-offs and incur other charges and expenses for products that fail to meet regulator-approved manufacturing specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives; and |
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Drug products that have been produced and stored for later use may degrade, become contaminated or suffer other quality defects, which could cause the affected products to no longer be suitable for its intended use in clinical trials or other development activities. If the defective drug cannot be replaced in a timely fashion, we may incur significant delays in our development programs that could adversely affect the value of SM-88. |
One component of SM-88 is a derivation of an existing FDA-approved drug that has been modified to contribute to the functionality of SM-88. This drug substance is being manufactured by a FDA-approved, third-party and to date that manufacturer is our sole supplier of this drug substance. To our knowledge, the current manufacturer of this drug substance is the only FDA-approved supplier of the existing drug in the U.S. We believe this cGMP manufacturer has sufficient capacity to meet our projected needs into the near future. In the event of a catastrophic event or this manufacturer is unable to meet our needs, we will, due to the nature of the drug
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substance and the modifications required for this drug substance, need to find an alternative source of supply, which will likely result in time delays in the clinical development process. We believe that replacement for this supplier, in the event it becomes necessary, is not impossible, but would cost us in development time. Currently, we do not have an arrangement in place for a secondary supplier for this drug substance.
We currently have no marketing, sales or distribution infrastructure. If we are unable to develop sales, marketing and distribution capabilities on our own or through collaborations or if we fail to achieve adequate pricing and/or reimbursement, we will not be successful in commercializing SM-88 and any other drug product we may develop.
We currently have no marketing, sales and distribution capabilities because our lead drug candidate, SM-88, is still in clinical development. If SM-88 is approved, we intend either to have established a sales and marketing organization with technical expertise and supporting distribution capabilities to commercialize our drug or to have outsourced this function or portions, to one or more an experienced third-parties. Either of these options is expensive and time-consuming. Some of these costs may be incurred well in advance of any regulatory approvals for SM-88. In addition, we may not be able to hire a sales force that is sufficient in size or has adequate expertise in the medical markets that we intend to target. Any failure or delay in the development of our internal sales, marketing and distribution capabilities or to outsource these functions, in whole or part, would adversely affect the commercialization of our products.
To the extent that we enter into collaborative agreements for marketing, sales and/or distribution, our revenue may be lower than if we directly marketed and sold SM-88. In addition, any revenue we receive will depend in whole or in part upon the efforts and success of these third-party collaborators, which are likely not to be entirely within our control. If we are unable to enter into these arrangements on acceptable terms or at all, we may not be able to successfully commercialize SM-88. If we are not successful in commercializing SM-88, either on our own or through collaborations with one or more third parties, our future revenues will suffer, we may incur significant and additional losses and we may be forced to curtail operations.
SM-88 and any other drug product we may develop will face significant competition and, if competitors develop and market products that are more effective, safer or less expensive than our drug, our commercial opportunity will be negatively impacted.
The anticancer treatment industry is highly competitive and subject to rapid and significant technological changes. We are currently developing SM-88 to compete with other drugs that currently exist or are being developed. Drugs we may develop in the future are also likely to face competition from other drugs, some of which we may not be currently be aware of. In marketing our products, we will have domestic and international competitors, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities and other research institutions. Many of our competitors have significantly greater financial, manufacturing, marketing, drug development, technical and human resources than we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, patient recruitment and manufacturing pharmaceutical products. These companies also have significantly greater research and marketing capabilities than we do and may also have products that have been approved or are in more advanced stages of development or collaborative arrangements in our target markets with leading companies and research institutions. Established pharmaceutical companies also may invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make SM-88 and any other drug product we may develop obsolete. Some or all of these factors may contribute to our competitors succeeding in obtaining patent protection and/or marketing approval or developing and commercializing products in our field before we do.
There is a large number of companies working to develop and/or market various types of anticancer treatments. These treatments consist both of small molecule drugs, as well as biological drugs that work by using next-generation technology platforms to address specific cancer targets. These treatments are often combined with one another in an attempt to maximize a response rate. In addition, several companies are developing drugs that work by targeting multiple specificities using a single recombinant molecule, as we are.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe effects, are more convenient or are less expensive than SM-88. Our competitors also may obtain FDA, EU or other non-U.S. regulatory approval for their products more rapidly than we may, which could result in our competitors establishing a strong market position before we are able to enter the market. Even if SM-88 achieves marketing approval, it may be priced at a significant premium over competitive products, if any have been approved by then, resulting in our product’s reduced competitiveness.
In addition, our future ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of similar or biosimilar products.
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In addition, in March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act or collectively, the Health Care Reform Law, a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of health care spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. The Health Care Reform Law also created a new regulatory scheme authorizing the FDA to approve biosimilars. Under the Health Care Reform Law, a manufacturer may submit an application for licensure of a biologic product that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product,” without the need to submit a full package of nonclinical and clinical data. Under this new statutory scheme, an application for a biosimilar product may not be submitted to the FDA until four years following approval of the reference product. The FDA may not approve a biosimilar product until 12 years from the date on which the reference product was approved. Even if a product is considered to be a reference product eligible for exclusivity, another company could market a competing version of that product if the FDA approves a full NDA for such product containing the sponsor’s own nonclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. Furthermore, recent legislation has proposed that the 12-year exclusivity period for each a reference product may be reduced to seven years.
Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, recruiting clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to or necessary for, SM-88. In addition, the biopharmaceutical industry is characterized by rapid technological changes. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our technologies or product candidates obsolete, less competitive or not economical.
Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization of SM-88 and may affect the price we set. Our successful commercialization will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement and pricing policies.
In the U.S., the EU, its Member States and some other foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system. These changes could prevent or delay marketing approval of SM-88 and any other drug product we may develop, restrict or regulate post-approval activities and affect our ability to sell and recognize revenue from SM-88 or any other drug product we may develop. Among policy makers and payors in the U.S. and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing health care costs, improving quality and/or expanding access to health care.
In the U.S., the Medicare Prescription Drug, Improvement and Modernization Act of 2003 or the Medicare Modernization Act, changed the way Medicare covers and pays for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology based on average sale prices for physician-administered drugs. In addition, this legislation provided authority for limiting the number of drugs that will be covered in any therapeutic class. Cost-reduction initiatives and other provisions of this legislation could decrease the coverage and price that we receive for any approved products. While the Medicare Modernization Act applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from the Medicare Modernization Act may result in a similar reduction in payments from private payors.
In addition, the Health Care Reform Law, among other things, increased rebates a manufacturer must pay to the Medicaid program, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, established a new Medicare Part D coverage gap discount program in which manufacturers must provide 50% point-of-sale discounts on products covered under Part D and implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain health care services through bundled payment models. Further, the new law imposed a significant annual fee on companies that manufacture or import branded prescription drug products. Substantial new provisions affecting compliance were enacted, which may affect our business practices with health care practitioners. The goal of the Health Care Reform Law is to reduce the cost of health care and substantially change the way health care is financed by both governmental and private insurers. While we cannot predict what impact on federal reimbursement policies this legislation will have in general or on our business specifically, the Health Care Reform Law may result in downward pressure on pharmaceutical reimbursement, which could negatively affect market acceptance of and the price we may charge for, any products we develop that receive regulatory approval. We also cannot predict the impact of the Health Care Reform Law on our business or financial condition, as many of the Health Care Reform Law reforms require the promulgation of detailed regulations implementing the statutory provisions, which has not yet occurred.
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Moreover, other legislative changes have also been proposed and adopted in the U.S. since the Health Care Reform Law was enacted. On August 2, 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012 or the ATRA, which, among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other health care funding, which could have a material adverse effect on our customers and accordingly, our future results from operations.
The delivery of health care in the EU, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context. In general, however, the health care budgetary constraints in most EU Member States have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of SM-88 and any other drug product we may develop, restrict or regulate post-approval activities and affect our ability to commercialize any products for which we obtain marketing approval.
If any drug liability lawsuits are successfully brought against us or any of our collaborators, we may incur substantial liabilities and may be required to limit commercialization of SM-88 and any other drug product we may develop.
We face an inherent risk of drug liability lawsuits related to the testing of SM-88 and any other drug product we may develop in seriously ill patients and will face an even greater risk of liability lawsuits if SM-88 is approved by regulatory authorities and introduced commercially. Drug liability claims may be brought against us or our collaborators, if any, by subjects enrolled in our clinical trials, patients, health care providers or others using, administering or selling SM-88. If we cannot successfully defend ourselves against any such claims, we may incur substantial liabilities. Regardless of their merit or eventual outcome, liability claims may result in, but are not limited to:
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decreased demand for SM-88; |
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injury to our reputation; |
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withdrawal of subjects in our clinical trials; |
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withdrawal of clinical trial sites or entire trial programs; |
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increased regulatory scrutiny; |
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significant litigation costs; |
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substantial monetary awards to or costly settlements with patients or other claimants; |
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drug recalls or a change in the indications for which they may be used; |
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loss of revenue; |
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diversion of management and scientific resources from our business operations; and |
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the inability to commercialize SM-88. |
If SM-88 is approved for commercial sale, we will be highly dependent upon consumer perception and the safety and quality of SM-88. We could be adversely affected if we are subject to negative publicity or if SM-88 proves to be or is asserted to be, harmful to patients. Because of our dependence upon consumer perceptions, any adverse publicity associated with illness or other adverse effects resulting from patients’ use or misuse of SM-88 could have a material adverse impact on our financial condition or results of operations.
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When necessary, we intend to obtain clinical trial insurance for the SM-88 phase II clinical trial. We also intend to obtain drug liability insurance coverage at appropriate levels for our operations, which will vary as the level of our operations vary during our growth from a R&D company to a company manufacturing and marketing drugs to the public. Our planned insurance coverage may not be adequate to cover all liabilities that we may incur. We also may need to increase our insurance coverage when we begin the commercialization of SM-88. Insurance coverage is becoming increasingly expensive. As a result, we may be unable to obtain or maintain sufficient liability insurance at a reasonable cost to protect us against losses that could have a material adverse effect on our business. A successful drug liability claim or series of claims brought against us, particularly if judgments exceed any insurance coverage we may have, could decrease our cash resources and adversely affect our business, financial condition and results of operations and could possibly cause us to cease our operations in their entirety.
Our management lacks experience in obtaining FDA approval of products, which could result in delays or the failure to obtain required regulatory approval of our products .
Although they have experience in creating and marketing various products, neither of our two executive officers have ever organized, managed or completed FDA-required submissions and clinical trials concerning new drug products. While we intend to retain employees, advisors and consultants with experience in the FDA approval process and have retained and utilized a number of such advisors and consultants in the past, the lack of experience by our chief executive and operating officers could result in delays in obtaining necessary regulatory approvals, both in conducting clinical trials and final marketing approvals, additional costs and the possibility that approvals will not be obtained due to the failure to comply with the regulatory approval process, such delays, costs and/or failure would likely adversely affect our business, financial condition and results of operations and could possibly cause us to cease our operations in their entirety.
Risks Related to our Financial Condition and Need for Additional Capital
We have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We have no products approved for commercial sale and to date we have not generated any revenue or profit from drug sales. We may never achieve or sustain profitability.
We are a clinical-stage pharmaceutical company with a limited operating history. We have incurred significant losses since our inception. As of September 30, 2014, our accumulated deficit (unaudited) was approximately $2.71 million. Our losses have resulted principally from expenses incurred in the discovery and development of SM-88 and from general and administrative expenses incurred while building our business infrastructure. We expect to continue to incur losses for the near future. Furthermore, we expect these losses to increase as we continue our research and development of and seek regulatory approval for, our drug candidate SM-88, prepare for and begin to commercialize SM-88 or any other approved products and add infrastructure and personnel to support our drug development efforts and operations as a public company. The net losses and negative cash flows incurred to date, together with expected future losses, have had and likely will continue to have, an adverse effect on our stockholders’ equity and working capital. The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.
Because of the numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of increased expenses or when or if, we will be able to achieve profitability. For example, our expenses could increase if FDA or EMA require us to conduct supplemental clinical trials not included in our current development plan or if there are any delays in completing our planned clinical trials or in the development of SM-88 or any other drug product we may pursue.
To become and remain profitable, we must succeed in the development and commercialization of drugs with significant market potential. This will require us to be successful in a range of challenging activities for which we are only in the preliminary stages, including developing SM-88, obtaining regulatory approval and manufacturing, marketing and selling SM-88. We may never succeed with these activities or generate revenue from drug sales that is significant enough to achieve profitability. Our ability to generate future revenue from drug sales depends heavily on our success in many areas, which include but are not limited to:
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completing research and clinical development of SM-88, including successful completion of required clinical trials; |
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obtaining marketing approval for SM-88; |
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developing a sustainable and scalable manufacturing process for SM-88 and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount and quality) drugs to support clinical development and the market demand for SM-88, if approved; |
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launching and commercializing SM-88, either directly or with a collaborator or distributor; |
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establishing sales, marketing and distribution capabilities in the U.S. and in other markets, such as the EU; |
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obtaining market acceptance of SM-88 as a viable treatment option; |
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addressing any competing technological and market developments; |
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identifying, assessing, acquiring and/or developing new drug candidates; |
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negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; |
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maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and |
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attracting, hiring and retaining qualified personnel. |
Even if SM-88 or another drug candidate that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercialization. Because of the numerous risks and uncertainties with drug development, we are unable to accurately predict the timing or amount of increased expenses or when or if, we will be able to achieve profitability. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our failure to become or remain profitable would depress our market value and could impair our ability to raise capital, expand our business, develop other drug candidates or continue our operations. A decline in the value of our Company could also cause investors in our Common Stock (or other securities we may issue in the future) to lose all or part of their investment.
We will require substantial additional funding, which may not be available to us on acceptable terms or at all and, if not available, may require us to delay, scale back or cease our drug development programs or operations.
In addition to SM-88, we seek to advance multiple drug candidates through the research and clinical development process. The completion of the development and the potential commercialization of SM-88 or any other drug product, should it receive approval, will require substantial funds. We believe that our available cash and cash equivalents will be sufficient to fund our anticipated level of operations for at least the next nine months, but there can be no assurance that this will be the case. Our future financing requirements will depend on many factors, some of which are beyond our control, which include but are not limited to:
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Until we can generate sufficient drug and royalty revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. Additional financing may not be available to us when we need it or financings may not be available on favorable terms. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our drug candidates, technologies, future revenue streams or research programs and/or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interests of our existing stockholders will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights, including without limitation the issuance of additional shares of our Common Stock to the purchasers in the PPO and the Bridge Note purchaser if we raise funds within the next two years at a per share price less than the per share price of shares sold in the PPO. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain adequate financing when needed and on favorable terms, we may have to delay, reduce the scope of or suspend one or more of our clinical trials or research and development programs or our commercialization efforts.
We may expend our limited resources to pursue SM-88 for the treatment of metastatic breast cancer and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.
Because we have limited financial and managerial resources, we currently are focusing our research programs on SM-88 for the treatment of metastatic breast cancer. As a result, we may forego or delay pursuit of opportunities with other drug candidates or other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and drug candidates for specific indications may not yield any commercially viable products.
If we do not accurately evaluate the commercial potential or target market for SM-88 or any other drug candidate, we may relinquish valuable rights through collaboration, licensing or other royalty arrangements in cases where it would have been advantageous for us to retain sole development and commercialization rights.
If we do not achieve our projected development goals in the periods we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline.
Over the course of our development efforts, we will estimate the successful completion of various scientific, clinical, regulatory and other drug development goals, which we refer to as milestones. These milestones may include the commencement or completion of clinical trials and the submission of planned regulatory filings. Occasionally, we may publicly announce the expected timing of some of these milestones. For example, throughout this Current Report on Form 8-K, we state that we plan to begin phase II trials sometime in the immediate future. All of these milestones will be based on a variety of assumptions. The actual timing of achieving these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet these milestones as publicly announced, the commercialization of our products may be delayed and, as a result, our stock price may decline.
Risks Related to our Reliance on Third Parties
We rely on third parties to conduct our clinical trials and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of these trials.
We will not independently conduct clinical trials for SM-88 and may not do so for any other drug product we may develop. We will rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators to perform these functions. Our reliance on these third parties for clinical development activities reduces our control over these activities but does not relieve us of our responsibilities. For example, the FDA requires us to comply with standards, commonly referred to as good clinical practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible, accurate and that the rights, integrity and confidentiality of subjects in clinical trials are protected, even though we are not in control of these processes. These third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain or may be delayed in obtaining, regulatory approvals for SM-88 or other products we may develop and will not be able to or may be delayed in our efforts to, successfully commercialize SM-88 and any other drug product we may develop.
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We will also rely on other third parties to store and distribute supplies for our clinical trials. Any performance failure on the part of our existing or future distributors could delay clinical development or regulatory approval of SM-88, producing additional losses and depriving us of potential revenue.
We intend to rely on third-party contract manufacturing organizations to manufacture and supply SM-88 for us. If one of our suppliers or manufacturers fails to perform adequately or fulfill our needs, we may be required to incur significant costs and devote significant efforts to find new suppliers or manufacturers. We may also face delays in the development and commercialization of SM-88 and any other drug product we may develop.
We currently have limited experience in and we do not own facilities for, clinical-scale manufacturing of SM-88 and we rely upon third-party contract manufacturing organizations to manufacture and supply drug for our clinical trials. The manufacture of pharmaceutical products in compliance with the FDA’s cGMP requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, including difficulties with production costs and yields, quality control, including drug stability, quality assurance testing, shortages of qualified personnel, as well as compliance with strictly enforced cGMP requirements and other federal and state regulatory requirements and foreign regulations. If our manufacturers were to encounter any of these difficulties or otherwise fail to comply with their obligations to us or under applicable regulations, it would jeopardize our ability to supply investigational drug for our clinical trials. Any delay or interruption in the supply of clinical trial materials could delay the completion of our clinical trials, increase the costs associated with maintaining our clinical development programs and, depending upon the period of delay, require us to commence new trials at significant additional expense or terminate the ongoing trials.
All manufacturers used to formulate the components of SM-88 must comply with cGMP requirements, which are enforced by the FDA through its facilities inspection program. These requirements include, among other things, quality control, quality assurance and the documentation and maintenance of records. Manufacturers of our drug candidates may be unable to comply with cGMP requirements and/or with other FDA, state and foreign regulatory requirements. The FDA or similar foreign regulatory agencies may also implement new standards at any time or change their interpretation and enforcement of existing standards for manufacture, packaging or testing of drug products. We have little control over our manufacturers’ compliance with these regulations and standards and a failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in drug approval, drug seizure or recall or withdrawal of a drug approval. If the safety of any drug supplied is compromised due to our manufacturers’ failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize SM-88 and as a result, may be held liable for any injuries sustained. Any of these factors could cause a delay of clinical trial completion, regulatory submission, approval or commercialization of SM-88, increase our costs or impair our reputation.
We currently rely on single-source suppliers for each of the drug components in SM-88. Supplies are obtained under individual purchase orders and we do not have any long-term supply agreements in place at this time. Although we believe alternative sources of supplies exist, the number of third-party suppliers with the necessary manufacturing and regulatory expertise and facilities is limited, could be more expensive and it could take a significant amount of time to source, any of which would adversely affect our business. New suppliers of SM-88 would be required to qualify under applicable regulatory requirements and would need to have sufficient rights under applicable IP laws to the method of manufacturing the drug candidate. Obtaining the necessary FDA approvals or other qualifications under applicable regulatory requirements and ensuring non-infringement of third-party IP rights could result in a significant interruption of supplies and could require the new manufacturer(s) to bear significant additional costs which may be passed on to us.
Our reliance on third parties may require us to share our trade secrets, which increase the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
Because we rely on third parties to assist in the research, development and manufacture of SM-88, we must, at times, share trade secrets with them. We will seek to protect our proprietary technology in part by initially entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with our advisors, employees and third-party contractors prior to disclosing any proprietary information. These agreements typically limit the rights of third parties to use or disclose our confidential information, which include our trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets will become known by our competitors, are inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s independent discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and could have a material adverse effect on our business.
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In addition, these agreements would typically restrict the ability of our advisors, employees, third-party contractors and consultants to publish data that could potentially relate to our trade secrets, even though our agreements may contain certain limited publication rights. For example, any academic institution that we may collaborate with in the future can be, based on customary practice, expected to be granted rights to publish data arising out of such collaboration, provided that we are notified in advance and given the opportunity to delay publication for a limited time period in order for us to secure patent protection of IP rights arising from the collaboration, in addition to the opportunity to remove confidential or trade secret information from any such publication. In the future, we may also conduct joint research and develop programs that may require us to share trade secrets under the terms of such research. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.
We may enter into license agreements with third parties, with respect to SM-88 any other drug products we may develop, that may place the development of SM-88 and any other drug products we may develop partially or entirely outside of our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us and, if our collaborations are not successful, SM-88 and any other drug products we may develop may not reach their full market potential.
For financial and efficiency reasons, we may enter into licensing or collaboration agreements with third parties. Collaborations, if any are entered into, involving SM-88 and any other drug products we may develop, will be and are subject to numerous risks, which may include, but are not limited to:
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collaborators may have significant discretion in determining the efforts and resources that they will apply to collaborations; |
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collaborators may not perform their obligations as expected; |
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collaborators may not pursue development and commercialization of SM-88 or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; |
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collaborators may delay clinical trials, provide insufficient funding for a clinical program, stop a clinical trial, abandon SM-88, repeat or conduct new clinical trials or require a new formulation of SM-88 clinical testing; |
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collaborators could independently develop or develop with third parties, products that compete directly or indirectly with SM-88; |
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a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities; |
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we could grant exclusive rights to our collaborators that would prevent us from collaborating with others; |
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collaborators may not properly maintain or defend our IP rights or may use our IP or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our IP or proprietary information or expose us to potential liability; |
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collaborators may not aggressively or adequately pursue litigation against ANDA filers or may settle such litigation on unfavorable terms; |
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disputes may arise between us and a collaborator that causes the delay or termination of the research, development or commercialization of SM-88 and any other drug product we may develop or results in costly litigation or arbitration that diverts management attention and resources; |
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collaborations may be terminated, sometimes at-will, without penalty; |
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collaborators may own or co-own IP covering our products that results from our collaborating with them and, in such cases, we would not have the exclusive right to commercialize such IP; and |
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a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings. |
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Risks Related to the Operation of our Business
Our future operational success depends on our ability to retain our key executives and to attract, retain and motivate qualified personnel.
We are highly dependent on our chief executive officer, chief operating officer and the other members of our executive and scientific teams. Our executives may terminate their employment with us at any time. The loss of the services of any of these people could impede the achievement of our research, development and commercialization objectives.
Recruiting and retaining qualified scientific, clinical, administrative, operations, manufacturing and sales and marketing personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development, preparing filings and communicating with the FDA and other regulatory authorities and commercialization strategies. Our consultants and advisors may be employed or contracted by businesses in addition to ours and may have commitments with other entities that may limit their availability to us.
To date, our drug discovery process and development program has been led by Steve Hoffman, our chief executive officer who was Tyme’s chief executive office prior to the Merger. He has been instrumental in providing scientific, technical and business expertise and therefore we will need to establish an appropriately valued key man life insurance policy for him. We intend to obtain and thereafter maintain “key person” insurance on Mr. Hoffman but not for any other executives or employees. We may not be able to obtain the insurance on Mr. Hoffman at favorable rates or at all. Any insurance proceeds we may receive under this “key person” insurance may not adequately compensate us for the loss of Mr. Hoffman’s services. Development of SM-88 could ultimately continue without Mr. Hoffman’s contributions, but future development of SM-88 and all other drug products in our pipeline, would be adversely affected without his continued involvement.
We expect to expand our development, regulatory and marketing capabilities and, as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
As of March 6, 2014, we had five employees. Over the next several years, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, continue to expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. Our current management has limited experience in managing a company which had the research and development and operational growth we anticipate for our Company. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
We are an “emerging growth company,” and we cannot be certain whether the reduced reporting requirements applicable to emerging growth companies will make our Common Stock less attractive to investors.
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act or the JOBS Act, which was enacted in April 2012. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 or the Sarbanes-Oxley Act’s reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an emerging growth company for up to two more years, although circumstances could cause us to lose that status earlier. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of our initial public offering of securities, which occurred in March 2012, (b) in which we have total annual gross revenue of at least $1.0 billion or (c) in which we are deemed to be a large accelerated filer, which means the market value of our Common Stock that is held by non-affiliates exceeds $700 million as of the prior June 30th and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. We cannot predict if investors will find our Common Stock less attractive because we may rely on these exemptions. If some investors find our Common Stock less attractive as a result, there may be a less active trading market for our Common Stock and our stock price may suffer or be more volatile.
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Business disruptions (domestic and/or international) could seriously harm our future revenue and financial condition and increase our costs and expenses.
Our operations could be subject to equipment failures, labor shortages, labor strikes, earthquakes, power shortages, telecommunications failures, floods, hurricanes, typhoons, fires, extreme weather conditions, terrorist activities, medical epidemics, riots, crime, act of foreign enemies, war, nationalization, government sanction, blockage, embargo and other natural or manmade disasters or business interruptions. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and could increase our costs and expenses.
Our corporate headquarters is located in New York. Our current and future, third-party collaborators, future partners, supplies, CROs and investigational sites are or will be, located throughout the U.S. or internationally and may be located near major high-risk terrorist targets, earthquake faults, flood and fire zones. The ultimate impact on us, our significant partners and suppliers as well as our and their general infrastructures being located near major high-risk terrorist targets, earthquake faults, flood and fire zones and being consolidated in certain geographical areas is unknown, but our operations and financial condition could suffer in the event of a major terrorist attack, earthquake, fire, flood or other natural or manmade disaster.
Our business is also subject to risks associated with conducting international business. If we obtain approval to commercialize any approved products outside of the U.S., a variety of risks associated with international operations could materially adversely affect our business. Some of our third-party collaborators, future partners, suppliers, CROs and investigational sites could be located outside the U.S. Accordingly, our future success could be harmed by a variety of factors, which include but are not limited to:
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economic weakness, including inflation or political instability in particular non-U.S. economies and markets; |
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differing regulatory requirements for drug approvals in non-U.S. countries; |
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potentially reduced protection for IP rights; |
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difficulties in compliance with non-U.S. laws and regulations; |
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changes in non-U.S. regulations and customs, tariffs and trade barriers; |
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changes in non-U.S. currency exchange rates and currency controls; |
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changes in a specific country’s or region’s political or economic environment; |
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trade protection measures, import/export licensing requirements or other restrictive actions by U.S. or non-U.S. governments; |
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negative consequences from changes in tax laws; |
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
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workforce uncertainty in countries where labor unrest is more common than in the U.S.; |
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difficulties associated with staffing and managing international operations, including differing labor relations; |
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
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business interruptions resulting from geo-political actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods and fires. |
Our internal computer systems or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug development program.
Despite the implementation of security measures, our internal computer systems and those of our CROs and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we believe we have not experienced any such system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development program. For example, the loss of clinical data from completed or ongoing clinical trials for SM-88 could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of SM-88 could be delayed.
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Risks Related to Intellectual Property
Our ability to successfully commercialize our technology and drug candidate may be materially adversely affected if we are unable to obtain and maintain effective IP.
Our success is largely dependent on our ability to obtain and maintain patent and other IP protection in the U.S. and in other countries with respect to our proprietary technology and drug candidates. In some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications or to maintain or enforce the patents, covering technology or products that we license to third parties or, conversely, that we may license from third parties. Therefore, if we are subject to patent infringement, we cannot be certain that these patents and applications will be prosecuted and enforced in a manner consistent with the best interests of our business. In addition, if third parties who license patents to us or from us fail to maintain such patents or lose rights to those patents, licensing rights may be reduced or eliminated.
We have sought to protect our proprietary position by filing patent applications in the U.S. and abroad related to our novel technologies and products that are important to our business. This process is expensive and time-consuming and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protection in all relevant markets. It is also possible that we fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Our pending and future patent applications may be insufficient to protect our technology or products, completely or in part. In addition, existing and any future patents we obtain may not be extensive enough to prevent others from using our technologies or from developing competing drugs and technologies.
The patent position of specialty pharmaceutical and biotechnology companies generally is highly uncertain and involves complex legal and factual questions for which many legal principles remain unresolved. In recent years, patent rights have been the subject of significant litigation and, as a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may result in patents not being issued to us in the U.S. or in other countries. Changes in either the patent laws or interpretation of patent laws in the U.S. and other countries may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the U.S. Publications of discoveries in scientific literature often lag behind the actual discoveries and patent applications in the U.S. and other countries are typically not published until 18 months after filing or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications or that we were the first to file for patent protection of such inventions. In addition, the United States Patent and Trademark Office or USPTO, might require that the term of a patent issuing from a pending patent application be disclaimed and limited to the term of another patent that is commonly owned or names a common inventor. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights is highly uncertain.
Recent or future patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. In March of 2013, under the recently enacted Leahy-Smith America Invents Act or America Invents Act, the U.S. moved from a “first to invent” to a “first-to-file” system. Under a “first-to-file” system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the invention earlier. The America Invents Act includes a number of other significant changes to U.S. patent law, including provisions that affect the way patent applications are prosecuted, redefine prior art and establish a new post-grant review system. The effects of these changes are currently unclear as the USPTO only recently developed new regulations and procedures in connection with the America Invents Act and many of the substantive changes to patent law, including the “first-to-file” provisions, only became effective in 2013. In addition, the courts have yet to address any of these provisions and the applicability of the Act and new regulations on specific patents discussed herein have not been determined and would need to be reviewed. However, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition. We may become involved in opposition, interference, derivation, inter parties review or other proceedings that challenge our patent rights or the patent rights of others and the outcome of any proceedings are highly uncertain. An adverse determination in any such proceeding could reduce the scope of or invalidate, our patent rights, allowing third parties to commercialize our technology or drug products and compete directly with us, without payment to us or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or drugs in a non-infringing manner. The issuance of a patent is not conclusive as to its scope, validity or enforceability and our owned and licensed patents may be challenged
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in the courts or patent offices in the U.S. and abroad. Such challenges may result in the patent claims of our owned or licensed patents being narrowed, invalidated or held unenforceable. This could limit our ability to stop or prevent us from stopping others from using or commercializing similar or identical technology and drugs or limit the duration of the patent protection of our technology and drug. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting our drug might expire before or shortly after SM-88 or any other drug product we develop is commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to our drug products or otherwise provide us with a competitive advantage.
We may not be able to protect our IP rights throughout the world.
Filing, prosecuting and defending patents for SM-88 or any other drug product we may develop throughout the world would be prohibitively expensive. Competitors may use our technologies in countries where we have not obtained patent protection to develop their own drugs and, further, may export otherwise infringing products to territories where we have patent protection but where enforcement is not as strong as in the U.S. These products may compete with our drug products in countries where we do not have any issued patents and our patent claims or other IP rights may not be effective or sufficient to prevent them from so competing. Many companies have encountered significant problems in protecting and defending IP rights in foreign countries. The legal systems of a number of countries, particularly certain developing countries, do not favor the enforcement of patents and other IP protection, including those relating to biopharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products against third parties in violation of our proprietary rights. Further, the initiation of proceedings to enforce or protect our patent rights in foreign countries could result in substantial cost and divert our efforts and attention from other aspects of our business.
Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for noncompliance with these requirements.
The USPTO and various non-U.S. patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during and following the patent prosecution process. Our failure to comply with such requirements could result in abandonment or lapse of a patent or patent application, which would result in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would have been the case if our patents were in force.
We may become involved in lawsuits or other proceedings to protect or enforce our patents or other IP, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe or otherwise violate our patents, trademarks, copyrights or other IP. To counter infringement or unauthorized use, we or our licensees may be required to file infringement claims, which can be expensive and time-consuming. For example, if we need to file patent infringement lawsuits in the future against manufacturers of generic pharmaceuticals that have filed Abbreviated New Drug Applications with the FDA seeking approval to manufacture and sell generic versions of SM-88 or any other drug product we may develop, we anticipate that the prosecution of such lawsuits will require a significant amount of time and attention from our chief executive officer, chief financial officer and other senior executives. In addition, in a patent infringement proceeding, a court may decide that our patent is invalid or unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in the litigation or proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Such a result could limit our ability to prevent others from using or commercializing similar or identical technology and drugs, limit our ability to prevent others from launching generic versions of our drug products and could limit the duration of patent protection for our products, all of which could have a material adverse effect on our business. A successful challenge to our patents could reduce or eliminate our right to receive royalties. Furthermore, because of the substantial amount of discovery required in connection with IP litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation.
Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.
Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. Other entities may have or obtain patents or proprietary rights that could limit our ability to make, use, sell, offer for sale or import/export SM-88, or any other approved drug, or impair our competitive position.
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Patents could be issued to third parties that we may ultimately be found to infringe. Third parties may have or obtain valid and enforceable patents or proprietary rights that could block us from developing drug candidates using our technology. Our failure to obtain a license to any technology that we require may materially harm our business, financial condition and results of operations. Moreover, our failure to maintain a license to any technology that we require for our drug products may also materially harm our business, financial condition and results of operations. Furthermore, we would be exposed to a threat of litigation.
In the pharmaceutical industry, significant litigation and other proceedings regarding patents, patent applications, trademarks and other IP rights have become commonplace. The types of situations in which we may become a party to such litigation or proceedings include:
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we or our collaborators, may initiate litigation or other proceedings against third parties seeking to invalidate the patents held by those third parties or to obtain a judgment that our drugs or processes do not infringe those third parties’ patents; |
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if our competitors file patent applications that claim technology also claimed by us or our licensors or collaborators, we or our licensors or collaborators may be required to participate in interference or opposition proceedings to determine the priority of invention, which could jeopardize our patent rights and potentially provide a third-party with a dominant patent position; |
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if third parties initiate litigation claiming that our processes or products infringe their patent or other IP rights, we and our licensors or collaborators will need to defend against such proceedings; and |
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if a license to necessary drug technology is terminated, the licensor may initiate litigation claiming that our processes or products infringe or misappropriate their patent or other IP rights and/or that we breached our obligations under the license agreement and we and our collaborators would need to defend against such proceedings. |
These lawsuits would likely be costly and could affect our results of operations and divert the attention of our management and scientific personnel. There is a risk that a court would decide that we or our collaborators are infringing the third party’s patents and would order us or our collaborators to stop the activities covered by the patents. In that event, we or our collaborators may not have a viable alternative to the technology protected by the patent and may need to halt work on the affected drug candidate or cease commercialization of an approved product. In addition, there is a risk that a court will order us or our collaborators to pay the other party damages. An adverse outcome in any litigation or other proceeding could subject us to significant liabilities to third parties and require us to cease using the technology that is at issue or to license the technology from third parties. We may not be able to obtain any required licenses on commercially acceptable terms or at all. Any of these outcomes could have a material adverse effect on our business.
The pharmaceutical and biotechnology industries have produced a significant number of patents and it may not always be clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts and the interpretation is not always uniform or predictable. If we are sued for patent infringement, we would need to demonstrate that our products or methods do not infringe the patent claims of the relevant patent or that the patent claims are invalid. We may not be able to do this because proving invalidity is difficult. For example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and divert management’s time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing SM-88 or any other drug candidate to market and be precluded from manufacturing or selling one or more of our drug products.
As noted previously, the cost of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the cost of such litigation and proceedings more effectively than we can because of their substantially greater resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.
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We may not be successful in obtaining or maintaining necessary rights to IP through acquisitions and in-licenses.
Because our drugs may require the use of proprietary rights held by third parties, the growth of our business will likely depend in part on our ability to acquire, in-license, maintain or use these proprietary rights. In addition, our drug products may require specific formulations to work effectively and efficiently and the rights to these formulations may be held by others. We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party IP rights from third parties that we identify as necessary for one or more of our drug candidates. The licensing and acquisition of third-party IP rights is a competitive area and a number of more established companies are also pursuing strategies to license or acquire third-party IP rights that we may consider attractive. These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.
For example, we may sometimes need to collaborate with U.S. and non-U.S. academic institutions to accelerate our nonclinical research or development under written agreements with these institutions. Typically, these institutions could provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from our collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable to do so, the institution may offer the IP rights to other parties, potentially blocking our ability to pursue the applicable drug candidate or program.
In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party IP rights on terms that would allow us to make an appropriate return on our investment. If we are unable to successfully obtain a license to third-party IP rights necessary for the development of our drug products, we may have to abandon its development and therefore, our business and financial condition could suffer.
We may be unable to protect the confidentiality of our trade secrets, thus harming our business and competitive position.
In addition to our patented technology and drug, we rely upon trade secrets, including unpatented know-how, technology and other proprietary information to develop and maintain our competitive position, which we seek to protect, in part, by confidentiality agreements with our current and future employees, as well as our collaborators and consultants. We also have agreements with our employees and selected consultants that obligate them to assign their inventions to us. However, while it is our policy to require our employees and contractors who may be involved in the conception or development of IP to execute such agreements, we may be unsuccessful in executing such an agreement with each party who in fact conceives or develops IP that we regard as our own. In addition, it is possible that technology relevant to our business will be independently developed by a person that is not a party to such an agreement. While to our knowledge the confidentiality of our trade secrets has not been compromised, if the employees, consultants or collaborators that are parties to these agreements breach or violate the terms of these agreements, we may not have adequate remedies for any such breach or violation and we could lose our trade secrets through such breaches or violations. Further, our trade secrets could be disclosed, misappropriated or otherwise become known or be independently discovered by our competitors. In addition, IP laws in foreign countries may not protect our IP to the same extent as the laws of the U.S. If our trade secrets are disclosed or misappropriated, it would harm our ability to protect our rights and adversely affect our business.
We may be subject to claims that our employees and outside contractors have wrongfully used or disclosed IP from their former employers and clients. IP litigation or proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
Although we will try to ensure that our employees and outside contractors do not use the proprietary information or the know-how of others in their work for us and we have no knowledge of any instances of wrongful use or disclosure by our employees and outside contractors to date, we may be subject to claims that we or these employees and outside contractors have used or disclosed IP, including trade secrets or other proprietary information from their former employers or clients. Litigation may be necessary to defend our Company against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable IP rights or personnel. Even if we are successful in defending against such claims, litigation or other legal proceedings relating to IP claims may cause us to incur significant expenses and could distract our scientific and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. Should this occur and securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Common Stock. This type of litigation or proceeding could substantially increase our operating losses and reduce resources available to us for development activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other IP-related proceedings could adversely affect our ability to compete in the marketplace.
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If we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation for extending the term of patents covering SM-88 and any other drug product we may develop, our business may be materially harmed.
Depending upon the timing, duration and conditions of FDA marketing approval of SM-88 and any other drug product we may develop in the future, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments and similar legislation in the EU. The Hatch-Waxman Amendments permit a patent term extension of up to five years for a patent covering an approved drug as compensation for effective patent term lost during drug development and the FDA regulatory review process. However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that drug will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue could be materially reduced.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
Our registered or unregistered trademarks or trade names, to the extent we obtain and use them, may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other IP may be ineffective and could result in substantial costs and a diversion of resources and could adversely affect our financial condition or results of operations.
Risks Related to Government Regulations
Health care reform measures could hinder or prevent the commercial success of SM-88 any other drug product we may develop.
In the U.S., there have been and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system that could affect our future revenue and profitability and the future revenue and profitability of our potential customers. Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, one of the most significant health care reform measures in decades, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act was enacted in 2010. PPACA contains a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement changes and fraud and abuse measures, all of which will affect existing government healthcare programs and will result in the development of new programs. PPACA, among other things:
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imposes a non-deductible annual fee on entities that manufacture or import certain branded prescription drugs; |
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increases the minimum level of Medicaid rebates payable by manufacturers of brand-name drugs from 15.1% to 23.1%; |
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requires collection of rebates for drugs paid by Medicaid managed care organizations; |
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provides for a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable branded drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. |
While the U.S. Supreme Court upheld most of the constitutional elements of PPACA in June 2012, other legal challenges are still pending final adjudication in several jurisdictions. In addition, Congress has also proposed a number of legislative initiatives, including possible repeal of PPACA. At this time, it remains unclear whether there will be any changes made to PPACA, whether to certain provisions or its entirety. We can provide no assurance that PPACA, as currently enacted or as amended in the future, will not adversely affect our business and financial results and we cannot predict how future federal or state legislative or administrative changes relating to health care reform will affect our business.
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The continuing efforts of the government, insurance companies, managed care organizations and other payors of health care services to contain or reduce costs of health care may, among other things, adversely affect:
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our ability to set a price we believe is fair for our drug products; |
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our ability to generate revenue and achieve or maintain profitability; and |
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the availability of capital. |
If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be, applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business. The regulations that may affect our ability to operate include, but are not limited to:
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the federal healthcare program Anti-Kickback Statute, which prohibits knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, in exchange for or to induce either the referral of an individual for or the purchase order, lease or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs; |
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the federal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting or causing to be presented, false or fraudulent claims for payment or approval or knowingly using false statements, to obtain payment from the federal government and which may apply to entities like us which provide coding and billing advice to customers; |
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the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which created new federal criminal statutes that prohibit knowingly and willfully executing or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by or under the custody or control of, any healthcare benefit program, regardless of the payor ( e.g ., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of or payment for, healthcare benefits, items or services relating to healthcare matters; |
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the federal physician self-referral law, commonly known as the Stark Law, which prohibits a physician from making a referral to an entity for certain designated health services reimbursed by Medicare or Medicaid if the physician or a member of the physician’s family has a financial relationship with the entity and which also prohibits the submission of any claims for reimbursement for designated health services furnished pursuant to a prohibited referral; |
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the federal transparency requirements under PPACA require manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the U.S. Department of Health and Human Services or HHS, information related to physician payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as certain ownership and investment interests held by physicians and their immediate family members; |
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) and their respective implementing regulations, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; and |
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state law equivalents of each of the above federal laws, such as anti-kickback, false claims and transparency laws which may be broader in scope and apply to items or services reimbursed by any third-party payor, including commercial insurers. |
PPACA, among other things, amended the intent standard of the federal Anti-Kickback Statute and criminal healthcare fraud statutes to a stricter standard such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, PPACA codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act.
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If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil, criminal and/or administrative penalties, damages, fines, disgorgement and possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these or other laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.
Because we and our suppliers, are subject to environmental, health and safety laws and regulations, we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities, which may adversely affect our business and financial condition.
Our operations, including our discovery, development, testing, research and manufacturing activities, are subject to numerous environmental, health and safety laws and regulations. These laws and regulations govern, among other things, the controlled use, handling, release and disposal of and the maintenance of a registry for, hazardous materials and biological materials, such as chemical solvents, human cells, carcinogenic compounds, mutagenic compounds and compounds that have a toxic effect on reproduction, laboratory procedures and exposure to blood-borne pathogens. If we fail to comply with such laws and regulations, we could be subject to fines or other sanctions.
As with other companies engaged in activities similar to ours, we face a risk of environmental liability inherent in our current and historical activities, including liability relating to release of or exposure to, hazardous or biological materials. Environmental, health and safety laws and regulations are becoming more stringent. We may be required to incur substantial expenses in connection with future environmental compliance or remediation activities, in which case, our production and development efforts may be interrupted or delayed and our financial condition and results of operations may be materially adversely affected.
The third parties with whom we contract to manufacture SM-88 and any other drug products we may develop are also subject to these and other environmental, health and safety laws and regulations. Liabilities they incur pursuant to these laws and regulations could result in significant costs or, in certain circumstances, an interruption in operations, any of which could adversely affect our business and financial condition if we are unable to find an alternate supplier in a timely manner.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA or EMA regulations, to provide accurate information to the FDA or EMA or intentional failures to report financial information or data accurately or to disclose unauthorized activities to us. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation and subjects. We have adopted a code of conduct, but it is not always possible to identify and deter employee misconduct. The precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.
If generic manufacturers use litigation and regulatory means to obtain approval for generic versions of products on which our future revenue depends, our business will suffer.
Under the U.S. Food, Drug and Cosmetic Act (“FDCA”), the FDA can approve an ANDA for a generic version of a branded drug without the ANDA applicant undertaking the clinical testing necessary to obtain approval to market a new drug. In place of such clinical trials, an ANDA applicant usually needs only to submit data demonstrating that its drug has the same active ingredient(s) and is bioequivalent to the branded product, in addition to any data necessary to establish that any difference in strength, dosage form, inactive ingredients or delivery mechanism does not result in different safety or efficacy profiles, as compared to the reference drug.
FDCA requires that an applicant for approval of a generic form of a branded drug certify either that its generic drug does not infringe any of the patents listed by the owner of the branded drug in the Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book or that those patents are not enforceable. This process is known as a Paragraph IV Challenge. Upon receipt of the Paragraph IV notice, the owner has 45 days to bring a patent infringement suit in federal district court against the company seeking ANDA approval of a drug covered by one of the owner’s patents. The discovery, trial and appeals process in such
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suits can take several years. If this type of suit is commenced, FDCA provides a 30-month stay on the FDA’s approval of the competitor’s application. This type of litigation is often time-consuming, costly and may result in generic competition if the patents at issue are not upheld or if the generic competitor is found not to infringe upon the owner’s patents. If the litigation is resolved in favor of the ANDA applicant or the challenged patent expires during the 30-month stay period, the stay is lifted and the FDA may thereafter approve the application based on the usual standards for approval of ANDAs.
For various strategic and commercial reasons, manufacturers of generic medications frequently file ANDAs shortly after FDA approval of a branded drug regardless of the perceived strength and validity of the patents associated with such products. Based on these past practices, we believe it is likely that one or more such generic manufacturers will file ANDAs with respect to SM-88, if approved by the FDA, prior to the expiration of the patents related to those compounds.
The filing of an ANDA as described above with respect to any of our products could have an adverse impact on our stock price. Moreover, if any such ANDAs were to be approved and the patents covering the relevant products were not upheld in litigation or if a generic competitor were found not to infringe these patents, the resulting generic competition would negatively affect our business, financial condition and results of operations.
The marketing of SM-88, if approved, will be limited to use for the treatment of specific cancer indications and, if we want to expand the indications for which these drug candidates may be marketed, additional regulatory approvals will need to be obtained, which may not be granted.
We are currently seeking regulatory approval of SM-88 for the treatment of metastatic breast cancer. If SM-88 is approved, the FDA will restrict our ability to market or advertise SM-88 for other indications, which could limit physician and patient adoption. We may attempt to develop, promote and commercialize new treatment indications and protocols for future indications for SM-88, but we cannot predict when or if the approval required to do so will be received. In addition, we would be required to conduct additional clinical trials to support approvals for additional indications for SM-88, which would be time-consuming and expensive and may produce results that do not support regulatory approvals. If we do not obtain additional regulatory approvals, our ability to expand our business will be limited.
If SM-88 is approved for marketing and we are found to have improperly promoted off-label uses or if physicians misuse our products or use our products off-label, we may become subject to prohibitions on the sale or marketing of our products, significant fines, penalties, sanctions and drug liability claims. Additionally, our image and reputation within the industry and marketplace could be harmed.
The FDA and other regulatory agencies strictly regulate the marketing and promotional claims that are made about approved drugs. In particular, a drug may not be promoted for use or indications that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. For example, if we receive marketing approval for SM-88 for the treatment of metastatic breast cancer, the first indication we are pursuing, we cannot prevent physicians from using SM-88 for their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses prior to FDA approval for an additional indication, we may receive warning letters and become subject to significant liability, which would materially harm our business. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would materially harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred and our reputation could be damaged. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we are deemed by the FDA to have engaged in the promotion of our products for off-label use, we could be subject to FDA prohibitions on the sale or marketing of our products or significant fines and penalties and the imposition of these sanctions could also affect our reputation and position within the industry.
Physicians may also misuse our products, potentially leading to adverse results, side effects or injury, which may lead to drug liability claims. If our products are misused, we may become subject to costly litigation by our customers or their patients. Drug liability claims could divert management’s attention from our core business, be expensive to defend and result in sizable damage awards against us that may not be covered by liability insurance. Furthermore, the use of our products for indications other than those approved by the FDA may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients. Any of these events could harm our business and results of operations and cause our stock price to decline.
Additionally, as with an existing number of previously approved therapeutics to treat cancer, the FDA may require us to educate health care providers and patients about the proper use and administration of SM-88 or any other drug products we develop in the future and obtain FDA approval to market.
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Being a public company is expensive and administratively burdensome.
As a public reporting company, we are subject to the information and reporting requirements of the Securities Act, the Exchange Act and other federal securities laws, rules and regulations related thereto, including compliance with the Sarbanes-Oxley Act. Complying with these laws and regulations requires the time and attention of our Board of Directors and management and increases our expenses. Among other things, we are required to:
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maintain and evaluate a system of internal controls over financial reporting in compliance with the requirements of Section 404 of the Sarbanes-Oxley Act and the related rules and regulations of the SEC and the Public Company Accounting Oversight Board; |
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maintain policies relating to disclosure controls and procedures; |
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prepare and distribute periodic reports, proxy statements, Forms 8-K and other reports and filings in compliance with our obligations under federal securities laws; |
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institute a more comprehensive compliance function, including with respect to corporate governance; and |
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involve, to a greater degree, our outside legal counsel and accountants in the above activities and incur additional expenses relating to such involvement. |
The costs of preparing and filing annual and quarterly reports and Forms 8-K, proxy statements and other information with the SEC and furnishing annual reports containing audited financial statements to stockholders is expensive and much greater than that of a privately-held company and compliance with these rules and regulations may require us to hire additional financial reporting, internal controls and other finance personnel and will involve a material increase in regulatory, legal and accounting expenses and the attention of management. There can be no assurance that we will be able to comply with the applicable regulations in a timely manner, if at all. In addition, being a public company makes it more expensive for us to obtain director and officer liability insurance. In the future, we may be required to accept reduced coverage or incur substantially higher costs to obtain this coverage. These factors could also make it more difficult for us to attract and retain qualified executives and members of our Board of Directors, particularly directors willing to serve on an audit committee which we expect to establish in the future.
Any failure to maintain effective internal control over our financial reporting could materially adversely affect us.
Section 404 of the Sarbanes-Oxley Act of 2002 requires us to include in our Annual Reports on Form 10-K an assessment by management of the effectiveness of our internal control over financial reporting. In addition, at such time, if any, as we are no longer a “smaller reporting company,” our independent registered public accounting firm will have to attest to and report on management’s assessment of the effectiveness of such internal control over financial reporting. Based upon an evaluation conducted in connection with the preparation of Tyme’s audited financial statements at and for the year ended December 31, 2013 and our quarterly financial statements at and for the period ended September 30, 2014 and 2013, our current management (which includes the sole directors and executive offices of Tyme prior to the Merger) concluded that our disclosure controls and procedures were not effective as of such dates to ensure that information required to be disclosed in the periodic reports that we file or submit under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Specifically, our management determined that there were control deficiencies, although not constituting material weaknesses, including those relating to segregation of duties over cash disbursements, oversight of our outside accounting firm by management, disclosures and the presentation of the original draft of our financial statements to our auditors failing to include necessary items to reflect the financial impact of all transactions involving Tyme during the subject accounting periods and maintaining complete books and records. Our independent public accountants, in conducting an audit of Tyme’s financial statements as of December 31, 2013, identified several control deficiencies that they believed constituted a significant deficiencies and less severe control deficiencies, individually and in aggregate. In addition, at the present time, we do not have an audit committee.
We intend to implement a number of changes in our internal control over financial reporting. Since the date of Tyme’s latest financial statements, we have retained a Chief Financial Officer with substantial experience and appropriate technical knowledge and have begun analyzing our controls and procedures. With the additional funding provided by the PPO and retention of a CFO, we intend to segregate duties regarding processing disbursements, enact procedures aimed at timely and efficiently maintaining our books and records and financial statement preparations, as well as analyzing both financial and operational transactional activities including verifying that all amounts are properly calculated, required disclosures are properly included and amounts properly presented in our financial statements.
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We must perform system and process evaluation and testing of our internal control over financial reporting to allow management and (if required in future) our independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting, as required by Section 404. Our compliance with Section 404 may require that we incur substantial accounting expenses and expend significant management efforts. We currently do not have an internal audit group and we will need to retain the services of additional accounting and financial staff or consultants with appropriate public company experience and technical accounting knowledge to satisfy the ongoing requirements of Section 404. We intend to review the effectiveness of our internal controls and procedures and make any changes management determines appropriate, including to achieve compliance with Section 404 by the date on which we are required to so comply.
While we intend to diligently and thoroughly document, review, test and improve our internal control over financial reporting in order to ensure compliance with Section 404 in the future, management may not be able to conclude that our internal control over financial reporting is effective. Furthermore, even if management were to reach such a conclusion, if our independent registered public accounting firm is not satisfied with the adequacy of our internal control over financial reporting or if the independent auditors interpret the requirements, rules or regulations differently than we do, then they may decline to attest to management’s assessment or may issue an auditor’s report that is qualified. Any of these events could result in a loss of investor confidence in the reliability of our financial statements, which in turn could negatively affect the price of our Common Stock.
Risks Related to Ownership of Our Common Stock
Our share price is likely to be volatile due to factors beyond our control. There is the possibility that the market price of our Common Stock may drop below the price paid.
All readers of this Current Report on Form 8-K should consider an investment in our Common Stock as risky and invest only if the investor can withstand a significant loss and wide fluctuations in the market value of an investment. Investors may be unable to sell their shares of our Common Stock at or above, the price they paid due to fluctuations in the market price of our Common Stock arising from changes in our operating performance or prospects. In addition, the stock market has recently experienced significant volatility, particularly with respect to pharmaceutical, biotechnology and other life sciences company stocks. The volatility of pharmaceutical, biotechnology and other life sciences company stocks often does not relate to the operating performance of the companies represented by the stock. Some of the factors that may cause the market price of our Common Stock to fluctuate include, but are not limited to:
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results and timing of our clinical trials and clinical trials of our competitors’ products; |
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the failure or discontinuation of any of our development programs; |
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issues in manufacturing SM-88 or any future drugs we may develop and receive governmental approval; |
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regulatory developments or enforcement in the U.S. and non-U.S. countries with respect to SM-88 or our competitors’ products; |
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failure to achieve pricing and/or reimbursement levels expected by us or the market; |
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competition from existing products or new products that may emerge; |
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developments or disputes concerning patents or other proprietary rights; |
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introduction of technological innovations or new commercial products by us or our competitors; |
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announcements by us, our collaborators or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; |
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changes in estimates or recommendations by securities analysts, if any cover our Common Stock; |
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fluctuations in the valuation of companies perceived by investors to be comparable to us; |
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public concern over SM-88 or any future drugs we may develop and receive governmental approval; |
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litigation; |
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future sales of our Common Stock; |
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share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; |
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additions or departures of key personnel; |
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changes in the structure of healthcare payment systems in the U.S. or overseas; |
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the failure of SM-88, if approved or any other approved drug product we may develop, to achieve commercial success; |
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economic and other external factors or other disasters or crises; |
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period-to-period fluctuations in our financial condition and results of operations, including the timing of receipt of any milestone or other payments under commercialization or licensing agreements; |
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general market conditions and market conditions for biopharmaceutical stocks; and |
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overall fluctuations in U.S. equity markets. |
In addition, in the past, when the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit and divert the time and attention of our management, which could seriously harm our business.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish substantial rights.
Until such time, if ever, as we can generate substantial revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, grants and license and development agreements in connection with any collaborations. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, then stockholders’ ownership interests will be diluted and the terms of these new securities may include liquidation or other preferences that adversely affect rights of holders of our Common Stock. Debt financing, if available at all, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, drug candidates, future revenue streams or grant licenses on terms that are not favorable to us. We cannot give any assurance that we will be able to obtain additional funding if and when necessary or on satisfactory terms. If we are unable to obtain adequate financing on a timely basis, we could be required to delay, scale back or eliminate one or more of our development programs or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.
Future issuances of our Common Stock or rights to purchase Common Stock pursuant to our equity incentive plans or outstanding warrants could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.
Our Board of Directors authorized to grant equity awards, including stock options, to our employees, directors and consultants, covering up to 10 million shares of our Common Stock, pursuant to our 2015 Equity Incentive Plan. We plan to register the shares available for issuance or subject to outstanding awards under our 2015 Plan. Future issuances, as well as the possibility of future issuances, under our 2015 Plan or other equity incentive plans could cause the market price of our Common Stock to decrease.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
The trading market for our Common Stock will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently and may never, publish research on our Company. If no securities or industry analysts commence coverage of our Company, the trading price for our stock would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. In addition, if our operating results fail to meet the forecast of analysts, our stock price would likely decline. Further, if one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.
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Provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Provisions in our corporate charter and our bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our Common Stock, thereby depressing the market price of our Common Stock. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board of Directors. Because our Board is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. Among others, these provisions include that:
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our Board of Directors has the right to expand the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our Board; |
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our certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; |
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stockholders must provide advance notice and additional disclosures in order to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and |
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our Board of Directors may issue, without stockholder approval, shares of undesignated preferred stock; the ability to issue undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to acquire us. |
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
Investors could lose all of their investment in our Company .
An investment in our securities is speculative and involves a high degree of risk. Potential investors should be aware that the value of an investment in our Company may go down as well as up. In addition, there can be no certainty that the market value of an investment in our Company will fully reflect its underlying value. Investors could lose their entire investment in our Company.
Investors may experience dilution of their ownership interests because of the future issuance of additional shares of our common or preferred stock or other securities that are convertible into or exercisable for our common or preferred stock .
In the future, we may issue our authorized but previously unissued equity securities, resulting in the dilution of the ownership interests of our stockholders at the time of such issuances. The Company will be authorized to issue an aggregate of 300 million shares of Common Stock and 10 million shares of “blank check” preferred stock. We may issue additional shares of our Common Stock or other securities that are convertible into or exercisable for our Common Stock in connection with hiring or retaining employees, future acquisitions, future sales of our securities for capital raising purposes or for other business purposes. The future issuance of any such additional shares of our Common Stock may create downward pressure on the trading price of our Common Stock. We will need to raise additional capital in the near future to meet our working capital needs and there can be no assurance that we will not be required to issue additional shares, warrants or other convertible securities in the future in conjunction with these capital raising efforts, including at a price (or exercise prices) below the price a stockholder at the time of such securities issuance paid for such stockholder’s stock.
The ability of our Board of Directors to issue additional stock may prevent or make more difficult certain transactions, including a sale or merger of the Company. Our Board of Directors is authorized to issue up to 10 million shares of preferred stock with powers, rights and preferences designated by it. (See “Preferred Stock” in the section of this Current Report on Form 8-K titled “Description of Securities.”) Shares of voting or convertible preferred stock could be issued or rights to purchase such shares could be issued, to create voting impediments or to frustrate persons seeking to effect a takeover or otherwise gain control of the Company. The ability of our Board to issue such additional shares of preferred stock, with rights and preferences it deems advisable, could discourage an
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attempt by a party to acquire control of the Company by tender offer or other means. Such issuances could therefore deprive stockholders of benefits that could result from such an attempt, such as the realization of a premium over the market price for their shares in a tender offer or the temporary increase in market price that such an attempt could cause. Moreover, the issuance of such additional shares of preferred stock to persons friendly to our Board of Directors could make it more difficult to remove incumbent managers and directors from office even if such change were to be favorable to stockholders generally.
There currently is no public market for our Common Stock and there can be no assurance that a public market will ever develop. Failure to develop or maintain a trading market could negatively affect the value of our Common Stock and make it difficult or impossible for a holder of shares of our Common Stock to sell such shares.
There is currently no public market for shares of our Common Stock and one may never develop. Our Common Stock is quoted on the QM tier of OTC Markets. The OTC Markets is a thinly traded market and lacks the liquidity of certain other public markets with which some investors may have more experience. We may not ever be able to satisfy the listing requirements for our Common Stock to be listed on a national securities exchange, which is often a more widely-traded and liquid market. Some, but not all, of the factors which may delay or prevent the listing of our Common Stock on a more widely-traded and liquid market include the following:
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our stockholders’ equity may be insufficient; |
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the market value of our outstanding securities may be too low; |
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our net income from operations may be too low; |
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our Common Stock may not be sufficiently widely held; |
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we may not be able to secure market makers for our Common Stock; and |
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we may fail to meet other rules and requirements mandated by the several exchanges and markets to have our Common Stock listed. |
Should we fail to satisfy the initial listing standards of the national exchanges or our Common Stock is otherwise rejected for listing and remains listed on the OTC Markets or is suspended from the OTC Markets, the trading price of our Common Stock could suffer and the trading market for our Common Stock may be less liquid and our Common Stock price may be subject to increased volatility.
Our Common Stock may be subject to the “penny stock” rules of the SEC and the trading market in the securities is limited, which makes transactions in the stock cumbersome and may reduce the value of an investment in the stock.
Rule 15g-9 under the Exchange Act establishes the definition of a “penny stock,” which, for the purposes relevant to us, is any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions. For any transaction involving a penny stock, unless exempt, the rules require:
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that a broker or dealer approve a person’s account for transactions in penny stocks; and |
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the broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased. |
In order to approve a person’s account for transactions in penny stocks, the broker or dealer must:
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obtain financial information and investment experience objectives of the person; |
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make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks; and |
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deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market, which, in highlight form: |
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sets forth the basis on which the broker or dealer made the suitability determination; and |
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confirms that the broker or dealer received a signed, written agreement from the investor prior to the transaction. |
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Disclosure also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker or dealer and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.
Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of our Common Stock and cause a decline in the market value of our Common Stock.
Our stock may be traded infrequently and in low volumes, so investors may be unable to sell their shares at or near the quoted bid prices if they need to sell their shares.
Until our Common Stock is listed on a national securities exchange such as the New York Stock Exchange or the Nasdaq Stock Market, we expect our Common Stock to remain eligible for quotation on the OTC Markets or on another over-the-counter quotation system. In those venues, however, the shares of our Common Stock may trade infrequently and in low volumes, meaning that the number of persons interested in purchasing our Common Stock at or near bid prices at any given time may be relatively small or non-existent. An investor may find it difficult to obtain accurate quotations as to the market value of our Common Stock or to sell the investor’s shares at or near bid prices or at all. In addition, if we fail to meet the criteria set forth in SEC regulations, various requirements would be imposed by law on broker-dealers who sell our securities to persons other than established customers and accredited investors. Consequently, such regulations may deter broker-dealers from recommending or selling our Common Stock, which may further affect the liquidity of our Common Stock. This would also make it more difficult for us to raise capital.
We do not anticipate paying dividends on our Common Stock.
Cash dividends have never been declared or paid on our Common Stock and we do not anticipate such a declaration or payment for the foreseeable future. We expect to use future earnings, if any, to fund business growth. Therefore, stockholders will likely not receive any funds absent a sale of their shares of Common Stock. If we do not pay dividends, our Common Stock may be less valuable because a return on an investment in shares of our Common Stock will only occur if our stock price appreciates. We cannot assure stockholders of a positive return on their investment when they sell their shares, nor can we assure that stockholders will not lose the entire amount of their investment.
The ownership interests in our Company held by two of our executive officers and directors could allow them to significantly influence corporate decision-making in a manner that may not reflect the interests of all of our stockholders.
Steve Hoffman, our chief executive officer and a director and Michael Demurjian, our chief operating officer and a director, each own of record approximately 32.9%, of our Common Stock as of the completion of the Merger and PPO. As a result, these individuals are positioned to exercise significant influence over the our Company’s management and affairs, including, but not limited to, electing our Board of Directors and exercising managerial influence and voting rights in connection with fundamental corporate transactions to take action that may not reflect the best interests of all of the stockholders of our Company.
MARKET, INDUSTRY AND OTHER DATA
We obtained the industry, market and other data throughout this prospectus from our own internal estimates and research and from industry publications and research, surveys and trials conducted by other third parties. These data involve a number of assumptions and limitations and readers of this Current Report on Form 8-K are cautioned not to give undue weight to such estimates.
Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, readers of this Form 8-K should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
The following Management’s Discussion and Analysis should be read in conjunction with the historical financial statements and the related notes thereto contained in this Current Report on Form 8-K. The Management’s Discussion and Analysis contains forward-looking statements, such as statements of our plans, objectives, expectations and intentions. Any statements that are not statements of
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historical fact are forward-looking statements. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like and/or future tense or conditional constructions (“will,” “may,” “could,” “should,” etc.) or similar expressions, identify certain of these forward-looking statements. These forward-looking statements are subject to risks and uncertainties, including those under “Risk Factors” in this Form 8-K, that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. Our Company’s actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. We do not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Form 8-K.
As the result of the Merger and Split-Off Transaction and the change in business and operations of our Company resulting from such events, a discussion of the past financial results of our Company is not pertinent and under applicable accounting principles the historical financial results of Tyme, the acquirer in the Merger for accounting purposes, prior to the Merger are considered the historical financial results of our Company.
The following discussion highlights Tyme’s results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described and provides information that management believes is relevant for an assessment and understanding of the statements of financial condition and results of operations presented herein. The following discussion and analysis are based on Tyme’s audited and unaudited financial statements contained in this Form 8-K, which we have prepared in accordance with accounting principles generally accepted in the United States, commonly referred to as “U.S. GAAP.” You should read the discussion and analysis together with such financial statements and the related notes thereto.
Basis of Presentation
The audited consolidated financial statements of Tyme for the fiscal years ended December 31, 2013 and 2012 and the unaudited condensed consolidated financial statements of Tyme for the three and nine months ended September 30, 2014 and 2013, include a summary of our significant accounting policies and should be read in conjunction with the discussion below. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in these audited financial statements. All such adjustments are of a normal recurring nature.
Overview
Tyme is a clinical-stage, research and development pharmaceutical company focused on discovering and developing highly targeted cancer therapeutics for a broad range of oncology indications in humans. We are currently developing as our first drug product, subject to regulatory approval, SM-88, which we believe to be a first-in-class drug that harness the body’s own immune defenses to fight tumor cells. Our drug is based on a mechanism designed to utilize oxidative stress, among other techniques, to selectively kill cancer cells.
We believe that the net proceeds from the PPO, together with our existing cash as of September 30, 2014 including the remaining funds from Tyme’s issuance and funding of the Bridge Note that was converted into shares of our Common Stock upon consummation of the Merger and PPO, will enable us to fund our planned operating expenses and capital expenditure requirements for a currently forecast period of approximately the next nine months. This forecast period could vary and is subject to numerous factors, including actual research and development results and general and administrative costs and expenses differing from our current estimates of such future results and expenditures. We will need to secure additional funding in the future, from one or more equity or debt financings, collaborations or other sources, in order to carry out all of our planned research and development and potential commercialization activities.
Financial Overview
Revenue
We have not generated any revenue from commercial product sales since we commenced operations. In the future, if any of our product candidates are approved for commercial sale, we may generate revenue from product sales or, alternatively, we may choose to select a collaborator or licensee to commercialize our product candidates and receive revenues through such arrangements.
Progressing any, as yet speculative revenues, will require that we develop not only a viable and regulatory-approved product candidate, but that we also build the necessary operational skills and secure appropriate employees and consultants to either commercialize directly or collaborate with partners. We have yet to fully develop such skills, retain appropriate employees and consultants or enter into any collaborations (if we deem entry into such collaborations to be beneficial to us).
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Research and Development Expenses
Our research and development costs are expensed as incurred and are primarily comprised of external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), independent clinical trial site operators and consultants and employee-related expenses including salaries and benefits. We do not currently utilize a formal time allocation system to capture expenses on a project-by-project basis as the majority of our past and planned expenses have been and will be in support of the development of our lead product candidate, SM-88, as well as our technology platform and IP portfolio and the further enhancement of our research and development activities.
Research and development activities are central to our business model. We plan to increase our research and development expenses for the foreseeable future. Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including the timing of the initiation of clinical trials and enrollment of patients in clinical trials. Research and development expenses are expected to increase as we advance the clinical development of SM-88 and further advance our technology platform and any other drug candidates we may choose to develop. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts, when we will incur and recognize these costs that will be necessary to complete the development efforts or the period, if any, in which material net cash inflows may commence from any of our product candidates.
Additionally, we will incur substantial costs beyond our present and future clinical trials in order to file with the FDA Investigational New Drug Applications and, thereafter, New Drug Applications for our product candidates, including SM-88, and, in each case, the nature, design, size and cost of further studies and trials will depend in large part on the outcome of preceding studies and trials and discussions with regulators. The cost of the nonclinical and clinical work may be substantially different from what we anticipate, due to factors outside our controls. We currently do not have the funds to support all expected and required R&D activities and will need to raise such funds through public or private offers of debt and or equity securities. No definitive plans are in place at this time with respect to any offering of our securities and we can give no assurance that any such offerings will be successful, on terms favorable to our Company or will raise sufficient funds that are needed at any time during the periods the R&D activities are planned.
It is difficult to determine with certainty the costs and duration of our current or future clinical trials and pre-clinical studies or if, when or to what extent we will generate revenues from the commercialization and sale of our product candidate if we obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates. The duration, costs and timing of our clinical trials will depend on a variety of factors that include but are not limited to:
• |
per patient trial costs; |
|
|
• |
the number of patients that participate in the trials; |
|
|
• |
the number of sites included in the trials; |
|
|
• |
the countries in which the trials are conducted; |
|
|
• |
the length of time required to enroll eligible patients; |
|
|
• |
the number of doses that patients receive; |
|
|
• |
the drop-out or discontinuation rates of patients; |
|
|
• |
potential additional safety monitoring or other studies requested by regulatory agencies; |
|
|
• |
the duration of patient follow-up; |
|
|
• |
the efficacy and safety profile of the drug candidates; |
|
|
• |
slower than expected rate of subject recruitment and enrollment; |
|
|
• |
slower than projected Institutional Review Board, Independent Ethics Committee, and other regulatory review and approval; |
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• |
the Data Monitoring Committee of the FDA requires one or more of our clinical trials to be stopped; |
|
|
• |
failure of subjects to complete their full participation in one or more of our clinical trials or return for post-treatment follow-up; |
|
|
• |
unforeseen safety issues, including severe or unexpected drug-related adverse effects experienced by subjects, including the possibility of death; |
|
|
• |
withdrawal of participation by a principal investigator in one or more of our clinical trials; |
|
|
• |
inability or unwillingness of subjects or clinical investigators to comply with clinical trial procedures; |
|
|
• |
resolution of data discrepancies; |
|
|
• |
inadequate CRO, management and/or monitoring in one or more of our clinical trials; |
|
|
• |
the need to repeat, reconstruct or terminate one or more of our clinical trials due to inconclusive or negative results or unforeseen complications in testing; and |
|
|
• |
a request by the FDA to abandon one of more of our current drug development programs. |
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. The full extent of costs we may incur is highly speculative and not defined.
General and Administrative Expenses
General and administrative (“G&A”) expenses consist primarily of salaries and related costs for executive and other administrative personnel and consultants, including, travel expenses and expenses related to business development activities. Other general and administrative expenses include professional fees for legal, patent review, consulting and accounting services. General and administrative expenses are expensed when incurred.
We expect that our general and administrative expenses will increase in the future as a result of new employee hiring, stock based compensation, retaining and utilizing outside consultants, the scaling of operations to support more advanced clinical trials and building the appropriate infrastructure for our responsibilities as a public company including establishing necessary financial controls and procedures for compliance with the requirements established by and under the Sarbanes–Oxley Act. We anticipate that our incremental costs per year associated with being a publicly traded company may be substantial and it is possible that our actual incremental costs will be higher than we currently estimate. These increases will likely include increased costs for insurance, hiring of additional personnel, board and outside consultant compensations, outside consultants, investor relations, legal, accounting and audit services, among other expenses.
Interest Expense
Interest expense represents, non-cash interest expense incurred on the convertible debt we have issued.
Results of Operations
Revenues
We do not anticipate recognizing any revenues until such time as one of our products has been approved for marketing by appropriate regulatory authorities or we enter into collaboration or licensing arrangement, none of which is anticipated to occur in the near future.
The following table summarizes certain information in our Unaudited Condensed Consolidated Statement of Operations for the Three and Nine Months ended September 30, 2014 and 2013.
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|
|
(Unaudited) |
|
(Unaudited) |
|
||||||||
|
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
|
||||||||
|
|
2014 |
|
2013 |
|
2014 |
|
2013 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
286,979 |
|
$ |
167,494 |
|
$ |
431,274 |
|
$ |
455,944 |
|
General and administrative |
|
|
601,473 |
|
|
126,003 |
|
|
719,851 |
|
|
198,634 |
|
Total operating expenses |
|
|
888,452 |
|
|
293,494 |
|
|
1,151,125 |
|
|
654,578 |
|
Loss from operations |
|
|
(888,452 |
) |
|
(293,497 |
) |
|
(1,151,125 |
) |
|
(654,578 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
30,544 |
|
|
2,037 |
|
|
44,509 |
|
|
2,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(918,996 |
) |
|
(295,534 |
) |
|
(1,195,634 |
) |
|
(656,615 |
) |
Loss attributable to non-controlling interests |
|
|
(83 |
) |
|
(68,213 |
) |
|
(10,956 |
) |
|
(188,573 |
) |
Loss attributable to controlling interests |
|
$ |
(918,913 |
) |
$ |
(227,321 |
) |
$ |
(1,184,678 |
) |
$ |
(468,042 |
) |
Comparison for the three months ended September 30, 2014 and 2013
We did not recognize any revenues for the three months ended September 30, 2014 and 2013.
Research and Development Expenses
Our R&D expenses for the three months ended September 30, 2014 increased by $119,485 or 71%, to $286,979 from $167,494 for the three months ended September 30, 2013. The increase between the three-month periods was primarily due to a scaling of our proof of concept activities as we not only worked with patients, but purchase the supplies of the necessary therapeutics to accomplish our work during the proof of concept phase.
All R&D expenditures have been incurred in respect of our lead drug candidate, SM-88, its platform. We expect to incur further and larger amounts of R&D expenditures as we plan to prepare for and look to execute on a Phase II clinical trial of SM-88 upon regulatory approval to proceed with such trial. Future R&D expenditures are subject to successfully raising the required capital and securing the necessary people and processes to direct our activities.
General and Administrative Expenses
Our G&A expenses for the three months ended September 30, 2014 increased by $475,470 or 377%, to $601,473 from $126,003 for the three months ended September 30, 2013. The increase between the three-month periods was due to increased legal and accounting activities associated with our plans to seek further investment funds and preparations to complete the Merger and associated filings with the SEC. We also incurred increased expenses associated with employing senior management to lead key operational activities.
We expect our G&A expenses, subject to securing ongoing funding, to increase as our operations grow. Key ongoing drivers for our G&A expenses may include legal, accounting, auditing and other costs associated with our planned R&D activities in support of contracts and potential patent related activities internationally; costs associated with migrating to a public company; corporate office expenses and further costs associated with hiring employees.
Interest Expense
Our interest expense was $30,544 for the three months ended September 30, 2014 as compared to interest expense of $2,037 for the three months ended September 30, 2013. The increase was primarily due to interest expense incurred on the USVC convertible debt, funded in part during the 2013 three-month period and the Bridge Note originally issued in July 2014. The USVC debt was converted into equity in August 2014 and the Bridge Note was converted into equity contemporaneous with the consummation of the Merger in March of 2015.
Comparison for the Nine Months Ended September 30, 2014 and 2013
We did not recognize any revenues for the nine months ended September 30, 2014 and 2013.
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Research and Development Expenses
Our R&D expenses for the nine months ended September 30, 2014 decreased by $24,670 or 5%, to $431,274 from $455,944 for the nine months ended September 30, 2013. The decrease between the nine-month periods was primarily due to a consistent pace of progress in our proof of concept activities.
All R&D expenditures have been incurred in respect of our lead drug candidate, SM-88. We expect to incur further and larger amounts of R&D expenditures as we plan to prepare for and execute on a Phase II clinical trial of our lead drug candidate SM-88. Future R&D expenditures are subject to successfully raising the required capital and securing the necessary people and processes to direct our activities.
General and Administrative Expenses
Our general and administrative expenses for the nine months ended September 30, 2014 increased by $521,217 or 262%, to $719,851 from $198,634 for the nine months ended September 30, 2013. The increase between the nine-month periods was due to increased legal and accounting activities associated with our plans to seek further investment funds, preparations to complete the Merger and associated filings with the SEC and expenses related to filling domestic and international patent applications. We also incurred increased expenses associated with employing senior management to lead key operational activities.
We expect our G&A expenses, subject to securing ongoing funding, to increase as our operations grow. Key ongoing drivers for our G&A expenses may include legal , accounting, auditing and other costs associated with our planned R&D activities in support of contracts and potential patent related activities internationally, costs associated with migrating to a public company, corporate office expenses and further costs associated with hiring employees.
Interest Expense
Our interest expense was $44,509 for the nine months ended September 30, 2014 as compared to interest expense of $2,037 for the nine months ended September 30, 2013. The increase was primarily due to interest expense incurred on the USVC debt and Bridge Note. The USVC debt was converted into equity in August of 2014 and the Bridge Note was converted into equity contemporaneous with the consummation of the Merger in December 2014.
Comparison for the Year Ended December 31, 2012 and 2013
The following table summarizes certain information for our Audited Condensed Consolidated Statement of Operations for fiscal years ended December 31, 2013 and 2012.
|
|
2013 |
|
2012 |
|
||
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
$ |
744,717 |
|
$ |
602,981 |
|
General and administrative |
|
|
307,100 |
|
|
284,598 |
|
Total operating expenses |
|
|
1,051,817 |
|
|
887,579 |
|
Loss from operations |
|
|
(1,051,817 |
) |
|
(887,579 |
) |
|
|
|
|
|
|
|
|
Interest expense |
|
|
5,855 |
|
|
— |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(1,057,672 |
) |
|
(887,579 |
) |
Loss attributable to non-controlling interests |
|
|
285,847 |
|
|
295,860 |
|
Loss attributable to controlling interests |
|
$ |
(771,825 |
) |
$ |
(591,719 |
) |
We did not recognize any revenues for our fiscal years ended December 31, 2013 and 2012.
Research and Development Expenses
Our R&D expenses for our fiscal year ended December 31, 2013 increased by $141,736 or 24%, to $744,717 from $602,981 for our fiscal year ended December 31, 2012. The increase between the fiscal years was primarily due to increased clinical development activities relating to our lead drug candidate, SM-88. All R&D expenditures relate to the development of our lead drug candidate, SM-88, its platform. We expect to incur further additional expenditures in respect of our R&D activities subject to securing necessary financial funding and hiring the necessary employees with the required skills to execute on our R&D plans.
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Subject to securing the necessary capital, future clinical trials will drive material levels of expenditure, which are likely to be significantly greater than the expenditures we incurred in 2013 or 2012. There is no certainty at all that envisaged increased R&D expenditures will translate successfully into a regulatory-approved and commercially viable therapeutic product.
General and Administrative Expenses
Our G&A expenses for our fiscal year ended December 31, 2013 increased by $22,502, or 8%, to $307,100 from $284,598 for our fiscal year ended December 31, 2012. The increase was primarily due to an increase in consulting and legal fees relating to patent research and regulatory filings. We expect our G&A expenses to increase as we scale up our operations and move into further complex areas of the clinical trial process. Key drivers of G&A will relate to legal costs, costs associated with conducting our operations as a public company, corporate office expenses and the hiring of personnel, including consultants, to both execute and manage our operational activities.
Interest Expense
Our interest expense increased was $5,855 for our fiscal year ended December 31, 2013 as compared to $0 for our fiscal year ended December 31, 2012. The increase was primarily due to interest payable on the convertible debt we issued commencing in 2013. The USVC debt was converted into equity in August of 2014.
Liquidity and Capital Resources
We have incurred losses and negative cash flows from operations since inception and have an accumulated deficit of $2,707,424 as of September 30, 2014. We incurred net losses of $1,057,672 and $887,579 for the years ended December 31, 2013 and December 31, 2012, respectively and net losses of $1,195,634 and $656,615 for the nine months ended September 30, 2014 and September 30, 2013, respectively. We anticipate incurring additional losses until such time, if ever, that we can generate significant revenues from our lead drug candidate, SM-88, which currently is in development and/or any other drug candidates we may develop.
Historically, we have financed our operations primarily through capital contributions and issuance of convertible debt. From inception through September 30, 2014, we have received proceeds of $2,663,000 from capital contributions and $2,226,000 from the issuance of convertible notes. The total proceeds from capital contributions and convertible debt issuance totaling $4,889,000 were reduced by amounts advanced to stockholders and members of $1,455,838. At September 30, 2014, we had cash of $289,628.
In the second quarter of 2013, we began receiving funds from the issuance of another note. The total amount borrowed under this note was $1.126 million, of which $200,000 was funded in 2014 and $926,000 was funded in 2013.
During the third quarter of 2014, we received $1.1 million of proceeds from the issuance of a Bridge Note. In November of 2014, the holder of the Bridge Note loaned our Company an additional $250,000 and the Bridge Note was amended and restated to reflect the increased principal amount of $1.35 million. In January of 2015, the holder of such note loaned Tyme an additional $960,000 and the note was further amended and restated to reflect a principal amount of $2.31 million. In February of 2015, the note was further amended to reflect a change in its mandatory conversion feature to a fixed amount, as further discussed below. The note as amended and restated is referred to in this Current Report on Form 8-K as the “Bridge Note.”
We believe that the net proceeds from the PPO, together with our existing cash as of September 30, 2014 including the remaining funds from Tyme’s issuance of the Bridge Note that was converted in shares of our Common Stock upon consummation of the Merger and PPO, will enable us to fund our planned operating expenses and capital expenditure requirements for an estimated nine months. We will need to secure additional funding in the future, from one or more equity or debt financings, collaborations or other sources, in order to carry out all of our planned research and development and potential commercialization activities.
Cash Flows
The following is a summary of cash flows for the years ended December 31, 2013 and 2012 and the nine months ended September 30, 2014 and 2013:
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|
(Unaudited) |
|
|
|
||||||||
|
Nine Months Ended September 30, |
|
Year Ended December 31, |
|
||||||||
|
2014 |
|
2013 |
|
2013 |
|
2012 |
|
||||
Net Cash Used in Operating Activities |
$ |
(975,682 |
) |
$ |
(738,888 |
) |
$ |
(1,199,246 |
) |
$ |
(706,696 |
) |
Net Cash Used in Investing Activities |
$ |
(2,710 |
) |
$ |
(12,473 |
) |
$ |
(19,953 |
) |
$ |
(2,200 |
) |
Net Cash Provided by Financing Activities |
$ |
1,175,400 |
|
$ |
895,348 |
|
$ |
1,311,819 |
|
$ |
705,343 |
|
Net Cash Increase (Decrease) in Cash |
$ |
197,008 |
|
$ |
143,987 |
|
$ |
92,620 |
|
$ |
(3,553 |
) |
Operating Activities
Net cash used in operating activities was $975,682 for the nine months ended September 30, 2014, consisting primarily of a net loss of $1,195,634 offset by non-cash depreciation expense of $3,635 and a net change in operating assets and liabilities of $216,317. The change in operating assets and liabilities was driven by an increase in prepaid assets of $8,725 and a decrease in accounts payable and other current liabilities of $225,042. The decrease in accounts payable and accrued expenses was primarily due to the timing and volume of our payment of costs related to ongoing development of our product candidate.
Net cash used in operating activities was $738,888 for the nine months ended September 30, 2013, consisting primarily of a net loss of $656,615, offset by non-cash depreciation expense of $376 and a net change in operating assets and liabilities of $82,469. The change in operating assets and liabilities was driven by an increase in prepaid assets of $110,080 and a decrease in accounts payable and other current liabilities of $27,431. The net decrease in operating assets and liabilities was primarily due to the timing and volume of our payment of costs related to ongoing development of our product candidate.
Net cash used in operating activities was $1,199,246 for the year ended December 31, 2013, consisting primarily of a net loss of $1,057,672 offset by non-cash depreciation expense of $514 and a net change in operating assets and liabilities of $142,088. The net change in operating assets and liabilities comprised an increase in prepaid assets of $110,080 as we made advance payments to secure supplies required for our proof of concept activities and an increase in accounts payable and other current liabilities of $32,008, which was associated with the timing of payments made to our clinical partners in the ordinary course of business.
Net cash used in operating activities was $706,696 for the year ended December 31, 2012 and consisted primarily of a net loss of $887,579 offset by non-cash depreciation expense of $210 and a net change in operating assets and liabilities of $180,673. The change in operating activities and liabilities comprised a decrease in prepaid assets of $11,103 due to the timing of payments made in the ordinary course of business and an increase in accounts payable and other current liabilities of $169,570. The increase in accounts payable and other current liabilities was primarily due to the timing of our payments of costs related to ongoing development of our product candidate.
Investing Activities
Cash used in investing activities during the nine months ended September 30, 2014 decreased by $9,763 or 78%, to $2,710, as compared to $12,473 during the nine months ended September 30, 2013. The decrease was driven primarily by a reduction in the purchases of equipment.
Cash used in investing activities during the year ended December 31, 2013 increased by $17,753, to $19,953, as compared to $2,200 during the year ended December 31, 2012. The increase was driven primarily due to equipment purchases. We currently envision making office equipment purchases, principally computers and printers, in the near future as our R&D efforts continue and become more complex and in connection with our becoming a public company.
Financing Activities
Cash provided by financing activities during the nine months ended September 30, 2014 increased by $280,052 or 31%, to $1,175,400 from $895,348 for the nine months ended September 30, 2013. The net proceeds of $1,175,400 were primarily driven by proceeds from the sale of the Bridge Note of $1,100,000, proceeds from the issuance of a convertible note totaling $200,000 and proceeds from capital contributions of $25,000. The gross proceeds of $1,325,000 were reduced by advances made to stockholders/members totaling $149,600.
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Cash provided by financing activities during the year ended December 31, 2013 increased by $606,476 or 86%, to $1,311,819 as compared to $705,343 during the year ended December 31, 2012. The net proceeds of $1,311,819 were primarily driven by proceeds in 2013 from the issuance of convertible notes of $926,000 and proceeds from capital contributions of $1,096,400. The gross proceeds of $2,022,400 in the year ended December 31, 2013 were reduced by advances made to stockholders/members totaling $710,581.
Ongoing and enhanced net inflows of financing, which are not guaranteed, will be critical to our ability to execute our plans to engage in R&D and other operational activities. There is no reliable and consistent established framework in place for us to receive financing.
Critical Accounting Policies and Significant Judgments and Estimates
We base this Management’s Discussion and Analysis of Financial Condition and Results of Operations on our financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our financial statements. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Readers should consider their evaluations of our financial condition and results of operations with these policies, judgments and estimates in mind.
While we describe our significant accounting policies in the notes to our financial statements appearing elsewhere in this Current Report on Form 8-K, we believe the following accounting policies are the most critical to the judgments and estimates we use in the preparation of our financial statements.
Clinical Trial Expense Accruals
As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. As we migrate to a more complex Phase II and later clinical trial phases, we envisage that our clinical trial accrual process will account for expenses resulting from our obligations under contracts with vendors, consultants and CROs and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which will vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts.
Our objective is to reflect the appropriate clinical trial expenses in our financial statements by matching the appropriate expenses with the period in which services and efforts are expended. We will account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial. We will determine accrual estimates through financial models that take into account discussion with applicable personnel and outside service providers as to the progress or state of completion of trials. During the course of a clinical trial, we will adjust our clinical expense recognition if actual results differ from our estimates. We will make estimates of our accrued expenses as of each balance sheet date in our financial statements based on the facts and circumstances known to us at that time. Our clinical trial accrual and prepaid assets are dependent, in part, upon the receipt of timely and accurate reporting from CROs and other third-party vendors. Although we do not expect our estimates to differ materially from amounts we actually incur, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low for any particular period.
Convertible Debt
We have issued convertible debt to help fund our growth and operations. We evaluate the features of our convertible debt in accordance with under FASB ASC Topic 470-20, Debt with Conversion and Other Options and 815-15, Derivatives and Hedging, Embedded Derivatives. The evaluation is done at the time of issuance of convertible debt.
We evaluated each issuance of its convertible debt and determined the embedded conversion features qualify for a scope exception for derivative instruments that are both indexed to our own stock and classified in stockholders equity. These embedded features therefore are not separately recorded as derivative instruments under ASC 815.
We account for potential beneficial conversion features under ASC 470-20, Debt with Conversion and Other Options. At the time of each of the issuances of convertible debt, our common stock into which each of the convertible debt issuances is convertible had an estimated fair value less than the effective conversion prices of the convertible debt. Therefore, there was no intrinsic value on the respective commitment dates, which required separate recognition and amortization.
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ASC 820, Fair Value Measurement (ASC 820), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of our Company. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.
ASC 820 identifies fair value as the exchange price or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following:
• |
Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access. |
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• |
Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. |
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• |
Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement. |
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by us in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Items measured at fair value on a recurring basis include money market funds. The fair value of our stock, which is an element of the intrinsic value calculation for conversion feature embedded in our convertible debt was made at the time of issuance and is non-recurring. In the absence of publicly quoted stock price, our evaluation of the fair market value of our stock and the convertible feature of the convertible debt issues has required management to consider all three levels of fair value measurement noted above.
In the absence of a public trading market for our Common Stock, we must develop an estimate of the fair value of our Common Stock. We determined the fair value of our Common Stock based on values assigned by potential investors and other various objective and subjective factors including external market conditions affecting the biopharmaceutical industry, trends within the biopharmaceutical industry, our results of operations and financial position, the status of our research and development efforts and progress of our clinical programs, our stage of development and business strategy, the lack of an active public market for our Common Stock and the likelihood of achieving a liquidity event such as the Merger or PPO in light of prevailing market conditions.
As we make further progress in our maturing as a public company and should we need to issue other convertible instruments, we will utilize the process and methodologies detailed above. During the periods presented, we have not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs.
Operating and Capital Expenditure Requirements
We have not achieved profitability since our inception and we expect to continue to incur net losses for the foreseeable future. We expect our cash expenditures to increase in the near term as we fund our planned clinical trials for our product candidate. As a result of the Merger, we will be a publicly traded company and will incur significant legal, accounting and other expenses that we were not required to incur as a private company. In addition, the Sarbanes-Oxley Act, as well as rules adopted by the SEC, requires public companies to implement specified corporate governance practices that were inapplicable to us as a private company. We expect these rules and regulations will increase our legal and financial compliance costs and will make certain activities more time-consuming and costly. At the current time, we are unable to estimate these costs.
We believe that the net proceeds from the PPO, together with our existing cash as of September 30, 2014 and remaining proceeds of our sale of the Bridge Note, will enable us to fund our planned operating expenses and capital expenditure requirements for at least the next nine months. However, we will need to raise funds in the future to pay for our operations in general and our planned clinical trials. In order to meet these additional cash requirements, we may seek to issue additional equity or convertible debt securities that may result in dilution to our then current stockholders. If we raise additional funds through the issuance of preferred stock or convertible debt securities, these securities could have rights senior to those of our Common Stock and could contain covenants that restrict our operations, ability to seek further financing and distributions on our Common Stock. There can be no assurance that we will be able to obtain additional equity or debt financing on terms acceptable to us, if at all. Our failure to obtain sufficient funds on acceptable terms when needed could have a negative impact on our business, results of operations and financial condition.
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Our future capital requirements will depend on many factors, including:
• |
the results of our pre-clinical studies and clinical trials; |
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• |
the development, regulatory approval and commercialization of our product candidate, SM-88; |
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• |
the scope, progress, results and costs of researching and developing our current product candidates or any other future product candidates and conducting pre-clinical studies and clinical trials; |
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• |
the timing of and the costs involved in, obtaining regulatory approvals for our current product candidates or any other future product candidates; |
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• |
the cost of commercialization activities if our current product candidates or any other future product candidates are approved for sale, including marketing, sales and distribution costs; |
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• |
the cost of manufacturing our current product candidates or any other future product candidates for pre-clinical studies, clinical trials and, if approved, commercial sale; |
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• |
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements; |
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• |
the results of any product liability, infringement or other lawsuits related to our current product candidates or future approved products, if any; |
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• |
the expenses needed to attract and retain skilled personnel; |
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• |
the costs associated with being a public company; |
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• |
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and |
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• |
the timing, receipt and amount of sales of or royalties on, future approved products, if any. |
In addition, the probability of success for our product candidates will depend on numerous factors, including regulatory approval, competition, manufacturing capability, commercial viability and the effects of significant and changing government regulations. Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved for sale, among physicians, patients, healthcare payors and the medical community. We will determine which commercializing programs to pursue and how much to fund each program in response to the scientific and clinical success of our product candidates, as well as an assessment of our product candidates’ commercial potential.
Please see “Risk Factors” above for additional risks associated with our substantial capital requirements.
Contractual Obligations and Commitments
At our current stage of development and at a stage where we have yet to secure material and recurring amounts of financial funding, we do not have any significant contractual obligations. We will plan to enter into longer term obligations once we have a credible level of clarity on the financial resources consistently available to us.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as defined by applicable SEC regulations.
Quantitative and Qualitative Disclosure About Market Risk
We are exposed to market risks in the ordinary course of our business. These market risks are principally limited to interest rate fluctuations.
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We had cash and cash equivalents of $289,628 at September 30, 2014, consisting primarily of funds in cash and money market accounts. The primary objective of our investment activities is to preserve principal and liquidity while maximizing income without significantly increasing risk. We do not enter into investments for trading or speculative purposes. Due to the short-term nature of our investment portfolio, we do not believe an immediate 1.0% increase in interest rates would have a material effect on the fair market value of our portfolio and, accordingly, we do not expect a sudden change in market interest rates to materially affect our operating results or cash flows.
We do not believe that inflation and changing prices had a significant impact on our results of operations for any periods presented herein.
JOBS Act
For as long as we remain an “emerging growth company” under the recently enacted JOBS Act, we will, among other things:
• |
be exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act, which requires that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting; |
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• |
be permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Exchange Act and instead provide a reduced level of disclosure concerning executive compensation; and |
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• |
be exempt from any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements. |
Although we are still evaluating the JOBS Act, we currently intend to take advantage of some or all of the reduced regulatory and reporting requirements that will be available to us so long as we qualify as an “emerging growth company.” Among other things, this means that our independent registered public accounting firm will not be required to provide an attestation report on the effectiveness of our internal control over financial reporting so long as we qualify as an emerging growth company, which may increase the risk that weaknesses or deficiencies in our internal control over financial reporting go undetected. Likewise, so long as we qualify as an emerging growth company, we may elect not to provide you with certain information, including certain financial information and certain information regarding compensation of our executive officers, that we would otherwise have been required to provide in filings we make with the SEC, which may make it more difficult for investors and securities analysts to evaluate our Company. As a result, investor confidence in our company and the market price of our Common Stock may be materially and adversely affected.
Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of new or revised accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
Off-Balance Sheet Arrangements
The Company did not engage in any “off-balance sheet arrangements” (as that term is defined in Item 303(a)(4)(ii) of Regulation S-K) as of September 30, 2014.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission and generally includes voting or investment power with respect to securities. In accordance with SEC rules, shares of our Common Stock which may be acquired upon exercise of stock options or warrants which are currently exercisable or which become exercisable within 60 days of the date of the table below are deemed beneficially owned by the holders of such options and warrants and are deemed outstanding for the purpose of computing the percentage of ownership of such person, but are not treated as outstanding for the purpose of computing the percentage of ownership of any other person.
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The following table sets forth information with respect to the beneficial ownership of our Common Stock as of the date of the closing of the Merger, March 5, 2015 (the “Determination Date”), after giving effect to the Merger, Split-Off Transaction, PPO, conversion of the Bridge Note, surrender of 26,276,600 shares by the Pre-Merger Company Stockholders pursuant to the Merger Agreement and the issuance of 250,000 shares to a consultant, by (i) each stockholder known by us to be the beneficial owner of more than 5% of our Common Stock, (ii) each of our directors and executive officers and (iii) all of our directors and executive officers as a group. To the best of our knowledge, except as otherwise indicated and subject to community property laws, where applicable, each of the persons named in the table has sole voting and investment power with respect to the shares of our Common Stock beneficially owned by such person. To our knowledge, none of the shares listed below are held under a voting trust or similar agreement, except as noted. Other than the Merger, to our knowledge, there is no arrangement, including any pledge by any person of securities of the Company or any of its parents, the operation of which may at a subsequent date result in a change in control of the Company. Our Common Stock is our only class of voting securities currently outstanding.
The following table assumes that all of the 8.5 million shares of our Common Stock held in escrow pursuant to the PPO Note Escrow Agreement and Adjustment Shares Escrow Agreement and the 6.4 million shares of our Common Stock issued to the pre-Merger Tyme Stockholders in connection with the Merger but held in escrow pursuant to the Indemnification Shares Escrow Agreement will be released to the owners of such shares and not surrendered for cancellation.
Unless otherwise indicated in the following table, the address for each person named in the table is c/o Tyme Technologies, Inc., 48 Wall Street – Suite 1100, New York, New York 10005.
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Amount and Nature of Beneficial Ownership |
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Name and Address of Beneficial Owner |
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Number |
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Percentage |
Steve Hoffman (1) |
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28,277,800 |
(2) |
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32.9% |
Michael Demurjian (3) |
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28,277,800 |
(2) |
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32.9% |
Akber Pabani (4) |
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0 |
|
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0.0% |
GEM Global Yield Fund LLC SCS (5) |
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8,596,540 |
(6) |
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9.9% |
U.S. VC Partners, LLC (7) |
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4,984,400 |
|
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5.8% |
Patrick G. LePore (8) |
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0 |
(9) |
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0.0% |
Dr. Gerald Sokol (8) |
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0 |
(9) |
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0.0% |
Timothy C. Tyson (8) |
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0 |
(9) |
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0.0% |
All directors and executive officers as a group (6 persons) |
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56,555,600 |
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65.8% |
__________
(1) |
Mr. Hoffman is a director, Chief Executive Officer, Chief Science Officer and President of our Company. |
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(2) |
Includes 1,413,890 shares of our Common Stock held in escrow pursuant to the Indemnification Shares Escrow Agreement. |
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(3) |
Mr. Demurjian is a director, Chief Operating Officer and Executive Vice President of our Company. |
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(4) |
Mr. Pabani is Chief Financial Officer and Treasurer of our Company. |
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(5) |
The address for GEM is 590 Madison Avenue – 36 th Floor, New York, New York 10022. Christopher Brown is the manager of GEM and was the holder of the Bridge Note. Mr. Brown designated GEM to receive the Conversation Shares upon the conversion of the Bridge Note which occurred contemporaneously with the closing of the Merger and PPO. |
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(6) |
Includes 5 million shares of our Common Stock held in escrow pursuant to the PPO Note Pledge Agreement and 3.5 million shares held in escrow pursuant to the Adjustment Shares Escrow Agreement. GEM would receive additional shares of our Common Stock, if all of the Qualified Offering Shares are issued. |
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(7) |
The address of U.S. VC Partners, L.P. is 900 Third Avenue - 19th Floor, New York, New York 10022. |
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(8) |
Patrick G. LePore, Dr. Gerald Sokol and Timothy C. Tyson each serve as a director of our Company. |
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(9) |
Under our independent director compensation policy, each of our independent directors will be entitled to receive shares of our Common Stock effective the last day of each calendar quarter, provided such independent director is serving on our Board of Directors on such date. The number of shares each independent director is entitled to receive shall be based upon the market price of our Common Stock on the effective issuance date. The first issuance of shares under our independent director compensation policy will occur as of March 31, 2015. Until such date, we will be unable to determine the number of shares each independent director shall then be entitled to receive under our independent director compensation policy. |
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DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
Directors and Executive Officers
Set forth below are the names of and certain information regarding our current executive officers and directors, each of whom was appointed effective as of the closing of the Merger:
Name |
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Age |
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Position(s) |
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Date Elected to Our
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Steve Hoffman |
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52 |
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Director and Chief Executive Officer |
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March 5, 2015 * |
Michael Demurjian |
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48 |
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Director and Chief Operating Officer |
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March 5, 2015 * |
Patrick G. LePore |
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59 |
|
Director |
|
March 10, 2015 |
Dr. Gerald Sokol |
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71 |
|
Director |
|
March 10, 2015 |
Timothy C. Tyson |
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62 |
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Director |
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March 10, 2015 |
Akber Pabani |
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49 |
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Chief Financial Officer |
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N/A |
__________
* Messrs. Hoffman and Demurjian served as the sole directors of Tyme since its formation on July 26, 2013.
During the negotiations that resulted in the terms of the Merger Agreement, the parties, including representatives of GEM, agreed that Steve Hoffman and Michael Demurjian would become directors of our Company following the consummation of the Merger and that Tyme would have the right to designate three individuals to serve as independent directors on our Board after the consummation of the Merger from a list of director candidates provided GEM and the holder of the Bridge Note. As a result of such negotiations and in accordance with the terms of the Merger Agreement, Messrs. Hoffman and Demurjian became our sole directors upon consummation of the Merger. Neither GEM nor any of its affiliates has any right to appoint or nominate any person to serve as a director of our Company. Following the consummation of the Merger, we expanded our Board of Directors by three members, each of whom we believe meets the NASDAQ Stock Market definition of independent director. These three new members are Patrick LePore, Dr. Gerald Sokol and Timothy Tyson.
In the future, our directors are to be elected at our Company’s annual stockholders’ meetings, each to serve until the next annual meeting of our stockholders and until their respective successors are elected and qualified. Directors are to be elected by a plurality of the votes cast at the annual meeting of our stockholders and hold office until the expiration of the term for which he or she was elected and until a successor has been elected and qualified.
A majority of the number of directors then serving on our Board of Directors constitutes a quorum for the purpose of the transaction of business at a meeting of our Board. Directors must be present at the meeting for the purpose of determining a quorum. However, any action required or permitted to be taken by our Board may be taken without a meeting if all members of the Board of Directors consent in writing to the action.
Executive officers are appointed by our Board and serve at its pleasure.
The principal occupation and business experience during the past five years for our executive officers and directors is as follows:
Steve Hoffman has served as Chief Executive Officer of Tyme since its formation in July 2013 and as a manager of Luminant since its formation in September 2011. In such roles and continuing with his position as Chief Executive Officer, Chief Science Officer and President of our Company, he supervises the development of our product candidates. He has over 25 years of holding a variety of senior management positions with companies in the chemistry, aerospace and laser optics fields. Prior to the establishment of Luminant, Mr. Hoffman was a co-founder and, from 1993 to 2007, Chief Technology Officer of Mikronite Technologies Group Inc., a developer, licensor and marketer of material surfacing technologies for various manufacturing processes and applications. At Mikronite, Mr. Hoffman supervised its implementation of proprietary technology. He has received numerous patents and has pending other patent applications, including a patent and three patent applications that have been assigned to our Company. His efforts on behalf of Mikronite were recognized by The Home Depot and Lowe’s with a Best New Product award and an Innovative Technology award from the New Jersey Manufacturers Association. Mr. Hoffman attended New York University and Rutgers University with a concentration in mechanical engineering from 1980 to 1984 and continued his studies under the direct supervision of the chairman of the physics department at the University of Michigan specializing in physics and electro-optics.
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Michael Demurjian has served as Chief Operating Officer of Tyme since its formation in July 2013 and as a manager of Luminant since its formation in September 2011. In such roles and continuing with his position as Chief Operating Officer and Executive Vice President of our Company, he leads the research teams in development, studies and data collection for our submissions to regulatory authorities, including the FDA. Prior to the establishment of Luminant, Mr. Demurjian was a co-founder and, from 1993 to 2007, Director of Marketing of Mikronite Technologies Group, Inc., a developer, licensor and marketer of material surfacing technologies for various manufacturing processes and applications. At Mikronite, Mr. Demurjian established all marketing activities and functions, marketing research and analysis, marketing strategy, implementation planning, project, process and vendor management organizational management and leadership. His efforts on behalf of Mikronite were recognized by The Home Depot and Lowe’s with a Best New Product award and an Innovative Technology award from the New Jersey Manufacturers Association. Mr. Demurjian received a BA in Economics from New York University in 1986.
Akber Pabani was appointed Chief Financial Officer of Tyme on March 5, 2015 and became our Chief Financial Officer upon the consummation of the Merger. Mr. Pabani served as Chief Financial Officer of Y-Prime Inc., a start-up healthcare information technology company focused on clinical trial, software, information services and SaaS contracts, from 2012 to February 2014. From 2008 to 2011, he was Vice-President – Finance of Moksha8 Pharmaceuticals Inc., a specialty pharmaceutical company. Mr. Pabani served in various executive positions, including as Vice President – Finance, at Mars Electronics International and affiliated companies during 2003 through 2007, Finance Director for the United Kingdom and Ireland region of a financial services division of Electronic Data Systems Inc. during 2001 through 2003 and held various financial positions with Eastman Kodak from 1991 through 2000. He also performed audit and consulting assignments for a number of publicly-quoted companies while a CPA with Grant Thornton from 1987 through 1990. Mr. Pabani received his BA in Economics from the University of Kent (United Kingdom) in 1987, became a Chartered Accountant (England and Wales) in 1990, received his MBA from London Business School in 1998 and qualified as a CPA in 2007.
Patrick G. LePore served as Chairman, CEO and President of Par Pharmaceuticals, Inc. (NYSE: PRX) from September 2006 through November 2012. Par is a healthcare company focusing on the development, licensing, manufacturing and distributing of generic and branded drugs, with facilities in New York, California and Chennai, India. Through Mr. LePore’s leadership, Par increased its value and market presence during his tenure culminating in its sale to Texas Pacific Group (TPG) in a going private transaction. Mr. LePore transitioned to Chairman of the new company beginning in November 2012. Mr. LePore’s leadership in the pharmaceutical industry has spanned both private and public sectors with board and operational experience in each. His experience includes building and running a large pharmaceutical service business as well as a fully integrated manufacturing business. Mr. LePore’s unique background makes him one of a handful of pharmaceutical executives with an in depth knowledge of the brand, generics and pharmaceutical service industries. He began his career with Hoffmann La Roche and then founded Boron LePore and Associates, a medical communications company, which he took public in 1997 and was eventually sold to Cardinal Health in 2002. As an accomplished and respected life science executive, Mr. LePore has extensive experience in all areas of executive management including human resources, executive development, strategic planning, mergers and acquisition, business development, investor relations and corporate governance. He also brings over 30 years of industry relationships and an impeccable reputation among his colleagues. Throughout his career, Mr. LePore has served on nonprofit and corporate boards. In addition to chairing the Par board, he is currently the Chairman of Agene Bio and serves on the boards of PharMerica (NYSE:PMC) and Villanova University. A graduate of Villanova University, he holds an MBA from Farleigh Dickinson University.
Gerald H. Sokol , MD, MSc, FCP, attained his medical degree from Indiana University’s Combined Degree Program in Experimental Medicine with a Masters Degree in Pharmacology and an MD. He interned in Medicine at Temple University and attended the U.S. Public Health Service Hospital in affiliation with the National Cancer Institute, Johns Hopkins and the University of Maryland completing training in Internal Medicine. He then completed training at the Massachusetts General Hospital, Harvard Medical School in Radiation Oncology, Medical Oncology and Clinical Pharmacology attaining Board Certification in Internal Medicine, Medical Oncology, Radiation Oncology, Clinical Pharmacology, and later Quality Assurance and Utilization Review. He also is certified in Skin Cancer Medicine from the University of Queensland. Dr Sokol has been Chief of Radiation Oncology at the University of South Florida’s Tampa General Hospital and has built or contributed to building over ten cancer centers. He is a board member and partner of Florida Cancer Specialists and Research Institute. Dr Sokol is a decorated retired Captain in the US Navy and served as Commanding Officer of the unit at the Uniformed Services University. Dr. Sokol currently holds professorships in Medicine and Pharmacology at that institution. While maintaining a medical practice, Dr. Sokol served on the review staff of the FDA for over 27 years as a senior regulatory scientist and officer composing over 300 white papers, IND and NDA reviews and opinion papers. Dr. Sokol has authored or coauthored over 100 books, book chapter, abstracts and papers on a multitude of clinical issues. He is a lifetime fellow and board member of the American Cancer Society and a fellow of the American College of Clinical Pharmacology.
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Timothy C. Tyson serves as the President of Alkaloida Chemical Company Zrt. Mr. Tyson served as Interim Chief Executive Officer of Caldera Pharmaceuticals, Inc. from September 23, 2014 to November 21, 2014. He served as Interim Chief Executive Officer and Executive Chairman of Aptuitand at Laurus Labs Private Limite since August 2008. He has over 30 years of remarkable corporate career in the pharmaceutical industry. He served as Acting Chief Executive Officer of Aptuit LLC since September 2008. He served as the President of ICN Hungary Co., Ltd. (also called as ICN Hungary Ltd.). Mr. Tyson served as the Chief Executive Officer of Valeant Pharmaceuticals International (formerly, ICN Pharmaceuticals Inc.) from January 1, 2005 to February 1, 2008. He served as President of Valeant Pharmaceuticals International from November 2002 to February 1, 2008 and served as its Chief Operating Officer from November 2002 to December 2004. He served as President of Global Manufacturing and Supply for GlaxoSmithKline plc. from June 1998 to November 2002. From 1997 to 1998, Mr. Tyson served as GlaxoSmithKline’s Vice President and General Manager of Business Operations. During his 14-year tenure at GlaxoSmithKline, he served in a variety of roles with broad international and domestic responsibilities, including significant management experience running two divisions: Glaxo Dermatology and Cerenex Pharmaceuticals. He was responsible for managing all sales and marketing for the U.S. operations, where he launched over 30 new products. Prior to his tenure at GlaxoSmithKline, Mr. Tyson served in a number of executive positions at Bristol-Myers Company in Operations and Research and Development. Prior to his tenure at Bristol-Myers, he served as a Manufacturing Manager for Procter & Gamble. He served as an Officer in the United States Army from 1974 to 1979 and spent 14 years in the United States Army Reserves. He has been Independent Non-Executive Chairman of Caldera Pharmaceuticals since April 1, 2014 and has been a director since October 2013. He has been Chairman of the Board of Aptuit LLC since August 2008 and its Manager since August 2008. He has been Independent Director of Marken Limited since March 05, 2013. He serves as a Director of Alkaloida Chemical Company Zrt. He serves as Director of ICN Hungary Co., Ltd., and Valeant Pharmaceuticals. He served as a Director of Ventaira Pharmaceuticals, Inc. He serves as Director for the Pharmaceutical Research and Manufacturing Association; BICOM; the Chief Executive Officer Roundtable for the University of California at Irvine; the Dean’s Executive Forum at Cal State Fullerton; the Chief Executive Officer Council on Cancer; the Health Sector Advisory Board at Duke University; the Leadership Forum of the International Society of Pharmaceutical Engineers and as a visiting lecturer at Cambridge University. Mr. Tyson serves on the board of directors for a number of non-profit organizations. He served as a Director of Valeant Pharmaceuticals International from 2004 to February 1, 2008. In 2002, Mr. Tyson received a Bicentennial Leadership Award from the United States Military Academy at West Point and was named 2007 Alumnus of the Year at Jacksonville State University. Mr. Tyson received a Master in Business Administration and Master in Public Administration from Jacksonville State University in 1979 and 1976, respectively. He is also a 1974 graduate of the United States Military Academy at West Point.
Director Independence
We are not currently subject to listing requirements of any national securities exchange or inter-dealer quotation system which has requirements that a majority of the board of directors of a listed/quoted company be “independent” and, as a result, we are not at this time required to have our Board of Directors comprised of a majority of “independent directors.” Our Board was recently expanded by the addition of three independent directors, Patrick G. LePore, Dr. Gerald Sokol and Timothy C. Tyson, each of whom we believe meets the Nasdaq Stock Market definition of independent director.
Family Relationships
There are no family relationships among our directors or executive officers.
Involvement in Certain Legal Proceedings
None of our directors or executive officers has been involved in any of the following events during the past ten years:
• |
any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time; |
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• |
any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offences); |
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• |
being subject to any order, judgment or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his or her involvement in any type of business, securities or banking activities; or |
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• |
being found by a court of competent jurisdiction (in a civil action), the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law and the judgment has not been reversed, suspended or vacated. |
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Board Committees
We have not established an executive, audit, compensation, nominating or any other committee of our Board of Directors. Our Board of Directors may designate from among its members an executive committee and/or one or more other committees in the future and adopt appropriate charters for such committees. Further, we do not have a policy with regard to the consideration of any director-candidates recommended by our stockholders. To date, no stockholder has made any such recommendations. Our entire Board of Directors performs all functions that could otherwise be performed by committees. In connection with and following the Merger, our board underwent a complete change in membership. We intend to address in the near future the establishment of various Board committees, including the possible creation of separate audit, compensation and nominating committees.
Audit Committee Financial Expert
We have no separate audit committee at this time. Our entire Board of Directors oversees our audits and auditing procedures. Our Board has at this time not determined whether any director is an “audit committee financial expert” within the meaning of Item 407(d)(5) of SEC Regulation S-K.
Compensation Committee Interlocks and Insider Participation
We have no separate compensation committee at this time. No executive officer of our Company has served as a director or member of the compensation committee (or other committee serving an equivalent function) of any other entity, one of whose executive officers served as director of our Company during 2013.
Code of Ethics
The Company currently has not adopted a written code of ethics.
EXECUTIVE COMPENSATION
General
The following table sets forth, with respect to our fiscal years ended December 31, 2014 and 2013, all compensation earned by or paid to all persons who served as Chief Executive Officer of Tyme or our Company at any time during our fiscal year ended December 31, 2014 and such other executive officer and other employees of our Company who were employed by Tyme or our Company as of the close of business on December 31, 2014 and whose total annual salary and bonus earned during our fiscal year ended December 31, 2014 exceeded $100,000. No compensation in the form of stock, options or other equity were granted or issued to any of the persons set forth in the following table during the periods indicated as compensation.
SUMMARY COMPENSATION TABLE
Name and Principal Position |
|
Year (1) |
|
Salary |
|
All Other
|
|
Total |
|
|||
Peter de Svastich, CEO and President |
|
2014 |
|
$ |
0 |
|
$ |
0 |
|
$ |
0 |
|
of our Company (2) |
|
2013 |
|
|
N/A |
|
|
N/A |
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steve Hoffman, CEO of Tyme and |
|
2014 |
|
$ |
225,000 |
|
|
(4) |
|
$ |
225,000 |
|
currently CEO of our Company (3) |
|
2013 |
|
$ |
0 |
|
|
(4) |
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Demurjian, COO of Tyme and |
|
2014 |
|
$ |
225,000 |
|
|
(6) |
|
$ |
225,000 |
|
currently COO of our Company (5) |
|
2013 |
|
$ |
0 |
|
|
(6) |
|
$ |
0 |
|
_________
(1) |
Prior to the consummation of the Merger, our fiscal year ended on November 30 th of each calendar year. In connection with the consummation of the Merger, our fiscal year was changed so as to end on December 31 st of each calendar year to conform with the fiscal year historically used by Tyme. The compensation and other information contained for Peter de Svastich, the sole CEO and President of our Company throughout 2014, contained in the table is with respect to our fiscal years ended November 30, 2014 and 2013. Information in the table concerning Steve Hoffman and Michael Demurjian is with respect to Tyme’s fiscal years ended December 31, 2014 and 2013. |
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(2) |
Mr. Svastich served as our Chief Executive Officer and President from April 26, 2013 to the date of the consummation of the Merger on February March 5, 2015. |
|
|
(3) |
Mr. Hoffman served as President and Chief Executive Officer of Tyme since its incorporation on July 26, 2013 and became our Chief Executive Officer upon the consummation of the Merger on March 5, 2015. |
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|
(4) |
During 2012, Mr. Hoffman received advances from Luminant, a subsidiary of Tyme, totaling $250,000. During 2013, Mr. Hoffman received additional advances from Luminant totaling $250,000. In 2014, the rights to receive repayment of these advances was assigned to a third party in connection with such third party’s sale to Mr. Hoffman of one-half of the third party’s membership interest in Luminant, which acquired membership interest Mr. Hoffman then assigned and contributed to Tyme. Mr. Hoffman remains obligated to repay the amount of the advances to such third party. |
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|
|
In addition, during 2013, Tyme made advances to Mr. Hoffman totaling $103,072. Prior to the consummation of the Merger and in order for our Company to be in compliance with applicable laws regarding loans by public entities to their executive officers and directors, the amount of the advances was recognized by Mr. Hoffman as income and we recognized an expense equal to the amount of such 2013 advances. Mr. Hoffman did not otherwise receive any compensation from Tyme or our Company during 2013 and 2014, other than salary totaling $225,000 in 2014 (as reflected in the table) and his other benefits consisted solely of Tyme or Luminant reimbursing him for health insurance premiums for him ($2,875 in 2013 and $6,919 in 2014). |
|
|
(5) |
Mr. Demurjian served as Vice President and Chief Operating Officer of Tyme from its incorporation on July 26, 2013 and became our Chief Operating Officer upon the consummation of the Merger on March 5, 2015. |
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|
(6) |
During 2012, Mr. Demurjian received advances from Luminant, a subsidiary of Tyme, totaling $273,657. During 2013, Mr. Demurjian received additional advances from Luminant totaling $254,416. In 2014, the rights to receive repayment of these advances was assigned to a third party in connection with such third party’s sale to Mr. Demurjian of one-half of the third party’s membership interest in Luminant, which acquired membership interest Mr. Demurjian then assigned and contributed to Tyme. Mr. Demurjian remains obligated to repay the amount of the advances to such third party. |
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|
In addition, during 2013, Tyme made advances to Mr. Demurjian totaling $102,293. Prior to the consummation of the Merger and in order for our Company to be in compliance with applicable laws regarding loans by public entities to their executive officers and directors, the amount of the advances was recognized by Mr. Demurjian as income and we recognized an expense equal to the amount of such 2013 advances. Mr. Demurjian did not otherwise receive any compensation from Tyme or our Company during 2013 and 2014, other than salary totaling $225,000 in 2014 (as reflected in the table) and his other benefits consisted solely of Tyme or Luminant reimbursing him for health insurance premiums for him and his family ($8,920 in 2013 and $16,144 in 2014). |
We have no plans in place and have never maintained any plans that provide for the payment of retirement benefits or benefits that will be paid primarily following retirement including, but not limited to, tax qualified deferred benefit plans, supplemental executive retirement plans, tax-qualified deferred contribution plans and nonqualified deferred contribution plans.
Except as indicated below and our employment agreements with Messrs. Hoffman and Demurjian discussed in the section titled “Employment Agreements” below, we have no contracts, agreements, plans or arrangements, whether written or unwritten, that provide for payments to the named executive officers listed above.
Outstanding Equity Awards at Fiscal Year-End
We have one compensation plan approved by our stockholders, our 2015 Equity Incentive Plan (the “2015 Plan”). As of end of our last completed fiscal year and through the date of this Current Report on Form 8-K, we had not granted any awards under the 2015 Plan.
Employment Agreements
We have entered into employment agreements with each of Steve Hoffman, our Chief Executive Officer and Chief Science Officer and Michael Demurjian, our Chief Operating Officer. Under these agreements, which were effective as of the consummation of the Merger, Messrs. Hoffman and Demurjian will each be entitled to an annual base salary of $450,000 and such performance bonuses as our board of directors may determine, from time to time, in its sole discretion. The base salaries will be reviewed annually
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(commencing in 2016) by our board of directors; provided that the base salaries may not be decreased from their then current levels due to any board review. The employment agreements each have a term of five years; provided, however, that commencing on the first anniversary of the effective date of the agreements and on each anniversary thereafter, the term shall automatically be extended by one year, such that, at any time during the term of the agreement, the remaining employment term shall never be less than four years and one day. If the executive is terminated without “Cause” or for “Good Reason,” the executive will be entitled to receive his base salary plus any accrued but unpaid performance bonus, with the base salary payable at the same intervals as the base salary would have been payable if the termination had not occurred. If the employment is terminated for “Cause,” or in the case of the executive’s death or disability, the executive will only be entitled to his base salary through the termination date, plus any accrued and unpaid performance bonus as of the termination date. “Cause” is defined in the employment agreements as: (i) a breach by the executive of the agreement, (ii) the executive’s conviction of, guilty plea to or confession of guilt of, a felony involving us, (iii) materially fraudulent, dishonest or illegal conduct by the executive in the performance of services for or on behalf of us or any of our affiliates, (iv) any conduct by the executive in material violation of any company policy, (v) any conduct by the executive that is materially detrimental to the reputation of our Company or any of our affiliates, (vi) the executive’s misappropriation of our or any of our affiliates’ funds, (vii) the executive’s gross negligence or willful misconduct or willful failure to comply with written directions of our board of directors which directions are within the scope of the executive’s duties, (viii) the executive’s engaging in conduct involving an act of moral turpitude or (ix) a breach of the executive’s duty of loyalty to us or our affiliates. “Good Reason” is defined in each of the employment agreements as our failure to make all payments due the executive under the employment agreement after notice thereof.
All descriptions of Messrs. Hoffman’s and Demurjian’s Employment Agreements herein are qualified in their entireties by reference to the texts thereof filed as exhibits hereto, which are incorporated herein by reference.
Director Compensation
Prior to the consummation of the Merger, none of our directors or directors of Tyme received any cash compensation for their service as members of our Board of Directors, but they were reimbursed for reasonable out-of-pocket expenses incurred in connection with their duties as directors.
Our Board currently consists of five persons, including two directors who also serve as two of our executive officers, Steve Hoffman and Michael Demurjian. We believe that each of the three other directors meet the independent director standards of the NASDAQ Stock Market. Our Board has established a director compensation policy, effective as of March 10, 2015, pursuant to which we will compensate our independent directors at the annual rate of $100,000, of which 50% will be paid in cash quarterly in arrears and 50% in the form of restricted shares of our Common Stock to be issued under the 2015 Plan on a quarterly basis, also in arrears.
Science Advisory Board
We intend to establish a Science Advisory Board, consisting of persons with experience in the oncology, pharmaceutical and health industries. Members of this Advisory Board would provide advice to us, individually and as a group at meetings organized by our Company, subject to availability and their individual obligations to their employees and clients, as applicable. We intend to grant to each Advisory Board member at the time he/she joins the Advisory Board with an award, granted under the 2015 Plan, of an option to purchase 50,000 shares of our Common Stock, such option to have a term of five years, have an exercise price equal to the closing price of our Common Stock on the date of grant and vest over a three-year period commencing on the first anniversary of the date of grant.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
SEC rules require us to disclose any transaction or currently proposed transaction in which our Company is a participant and in which any related person has or will have a direct or indirect material interest involving the lesser of $120,000 or one percent (1%) of the average of the Company’s total assets as of the end of last two completed fiscal years. A related person is any executive officer, director, nominee for director or holder of 5% or more of the Company’s common stock or an immediate family member of any of those persons.
The descriptions set forth above under the captions “The Merger and Related Transactions - Merger Agreement,” “- Split-Off,” “- the PPO,” “- Registration Rights,” “- Voting Agreement,” “- 2014 Equity Incentive Plan,” “- Lock-up Agreements and Other Restrictions” and “Executive Compensation -Employment Agreements” and “- Director Compensation” and below under “Description of Securities - Options” are incorporated herein by reference.
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In addition, we note the following additional related party transactions:
• |
In connection with the incorporation of Tyme, Steve Hoffman and Michael Demurjian assigned and contributed to Tyme all of their membership interests in Luminant, each of such membership interests constituting one-third of the entire membership interests in Luminant then outstanding. Mr. Hoffman was the Chief Executive Officer of pre-Merger Tyme and is our current Chief Executive Officer and Chief Science Officer, a director of our Company and the beneficial owner of over 5% of our Common Stock currently outstanding. Mr. Demurjian was the Chief Operating Officer of pre-Merger Tyme and is our current Chief Operating Officer, a director of our Company and the beneficial owner of over 5% of our Common Stock currently outstanding. |
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|
• |
During 2012, Mr. Hoffman received advances from Luminant, a subsidiary of Tyme, totaling $250,000. During 2013, Mr. Hoffman received additional advances from Luminant totaling $250,000. In 2014, the rights to receive repayment of these advances was assigned to a third party in connection with such third party’s sale to Mr. Hoffman of one-half of the third party’s membership interest in Luminant, which acquired membership interest Mr. Hoffman then assigned and contributed to Tyme. Mr. Hoffman remains obligated to repay the amount of the advances to such third party. Such Luminant membership interest represented one-sixth of the total membership interests in Luminant outstanding as of its acquisition by Mr. Hoffman and subsequent assignment and contribution to Tyme. |
|
|
• |
Tyme made advances to Mr. Hoffman totaling $103,972 in 2013 and $37,600 in 2014. Prior to the consummation of the Merger and in order for our Company to be in compliance with applicable laws regarding loans by public entities to their executive officers and directors, the amount of the advances was recognized by Mr. Hoffman as income and we recognized an expense equal to the amount of such 2013 and 2014 advances. |
|
|
• |
During 2012, Mr. Demurjian received advances from Luminant, a subsidiary of Tyme, totaling $273,657. During 2013, Mr. Demurjian received additional advances from Luminant totaling $254,416. In 2014, the rights to receive repayment of these advances was assigned to a third party in connection with such third party’s sale to Mr. Demurjian of one-half of the third party’s membership interest in Luminant, which acquired membership interest Mr. Demurjian then assigned and contributed to Tyme. Mr. Demurjian remains obligated to repay the amount of the advances to such third party. Such Luminant membership interest represented one-sixth of the total membership interests in Luminant outstanding as of its acquisition by Mr. Demurjian and subsequent assignment and contribution to Tyme. |
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• |
Tyme made advances to Mr. Demurjian totaling $102,293 in 2013 and $112,000 in 2014. Prior to the consummation of the Merger and in order for our Company to be in compliance with applicable laws regarding loans by public entities to their executive officers and directors, the amount of the advances was recognized by Mr. Demurjian as income and we recognized an expense equal to the amount of such 2013 and 2014 advances. |
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• |
As a condition to Tyme’s July 2014 sale of the original Bridge Note, our Chief Executive Officer, Steve Hoffman, assigned to Tyme all of his interest in certain patents and patent applications and Tyme granted Mr. Hoffman a perpetual, non-royalty license rights with respect to such patents and patent applications in all fields other than in connection with the treatment of cancer. |
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• |
In 2013, Tyme borrowed funds totaling $1.26 million from U.S. VC Partners, L.P. (“USVC”). In August 2014, USVC converted this debt into 106.6 shares of Tyme common stock. Contemporaneously with such conversion and issuance of the 106.6 shares, Messrs. Hoffman and Demurjian each assigned and contributed to Tyme 53.3 shares of Tyme common stock that they owned such that no dilution was recognized by any of the other stockholders of Tyme. USVC currently owns a total of 4,984,400 shares of our Common Stock as a result of the conversion of its shares of Tyme common stock into shares of our Common Stock in the Merger. Such shares of our Common Stock owned by USVC represent approximately 5.8% of our Common Stock as of the date of this Current Report on Form 8-K. |
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• |
Christopher Brown is the Manager of GEM and was the holder of the Bridge Note. Mr. Brown designated GEM to receive the Conversation Shares upon the conversion of the Bridge Note which occurred contemporaneously with the closing of the Merger and PPO. |
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• |
GEM has deposited with an escrow agent 5 million shares of our Common Stock which are subject to forfeiture under the PPO Note Escrow Agreement. GEM also has deposited with an escrow agent an additional 3.5 million shares of our Common Stock which are subject to forfeiture under the Adjustment Shares Escrow Agreement. |
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• |
GEM purchased all of the 2.716 million shares of our Common Stock sold in the PPO. |
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• |
All of the 26,276,600 Merger Related Surrendered Shares were surrendered for cancelation by GEM. |
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• |
On November 22, 2011 we issued 39,000,600 shares of our Common Stock to our then-sole director and officer, Andrew Keck, for an aggregate purchase price of $9,000. |
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• |
On February 27, 2013, GEM purchased a controlling interest in our Company. At the closing of that 2013 transaction, we entered into a Consulting Agreement with Andrew Keck, our then sole officer and director, pursuant to which Mr. Keck agreed to continue to provide services to us that are ordinarily and customarily performed by a chief executive officer for two months. In consideration for the services to be rendered by Mr. Keck, we agreed to pay Mr. Keck a monthly fee of $750, commencing on February 27, 2013. GEM made the two $750 payments to Mr. Keck on our behalf. The $1,500 advance was non-interest bearing and due on demand. In connection with the consummation of the Merger such debt was forgiven. |
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• |
GEM made additional advances to our Company during our fiscal years ended November 30, 2014 and 2013 of $57,670 (with respect to the 2014 fiscal year) and $31,501 (with respect to the 2013 fiscal year). In connection with the consummation of the Merger all of such debt was forgiven. |
MARKET PRICE OF AND DIVIDENDS ON COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market Information
Our Common Stock is currently quoted on the OTC Markets, QB Tier, under the symbol “TYMI.” Previously and until September 26, 2014, our Common Stock was quoted on the OTC Markets, QB Tier, under the symbol “GGET.” There is currently no trading market for our Common Stock and there is no assurance that a regular trading market will ever develop. OTC Markets securities are not listed and traded on the floor of an organized national or regional stock exchange. Instead, OTC Markets securities transactions are conducted through a telephone and computer network connecting dealers. OTC Markets issuers are traditionally smaller companies that do not meet the financial and other listing requirements of a regional or national stock exchange.
To have our Common Stock listed on any of the public trading markets, including the OTC Markets, we will require a market maker to sponsor our securities. We have not yet engaged any market maker to sponsor our securities and there is no guarantee that our securities will meet the requirements for quotation or that our securities will be accepted for listing on the OTC Markets. This could prevent us from developing a trading market for our Common Stock.
Holders
As of March 10, 2015, we have 86 million shares of Common Stock outstanding held by 16 stockholders of record.
Dividend Policy
We have never paid any cash dividends on our capital stock and do not anticipate paying any cash dividends on our Common Stock in the foreseeable future. We intend to retain future earnings to fund ongoing operations and future capital requirements. Any future determination to pay cash dividends will be at the discretion of our Board of Directors and will be dependent upon financial condition, results of operations, capital requirements and such other factors as the Board of Directors deems relevant.
Securities Authorized for Issuance under Equity Compensation Plans
The Company had no equity compensation plans as of the end of our fiscal year 2014.
2015 Equity Incentive Plan
On March 5, 2015, our Board of Directors adopted and our stockholders approved our Company’s 2015 Equity Incentive Plan (the “2015 Plan”), which reserves a total of 10 million shares of our Common Stock for issuance under the 2015 Plan.
We believe that the 2015 Plan is integral to our compensation strategies and programs. There is an ongoing “battle for talent” within the industry in which we operate and within the overall domestic employment market. In order to retain and secure employees in this intensely competitive employment environment, we believe that we must have competitive compensation programs, particularly with respect to equity-based awards. The use of stock options and other stock awards among public companies is widely prevalent. We believe that the 2015 Plan will give us more flexibility to keep pace with our competitors.
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We expect to use stock options as our most widely used form of long-term incentives for our directors, executive officers, employees and consultants. The 2015 Plan also will permit stock bonus grants, restricted stock grants, performance stock grants, stock appreciation rights grants and other types of awards.
We have not granted any stock options or other awards under the 2015 Plan through the date of this Current Report on Form 8-K.
Plan Summary
A summary of the principal features of the 2015 Plan is provided below, but is qualified in its entirety by reference to the actual 2015 Plan. A copy of the 2015 Plan has been attached as an exhibit to this Current Report on Form 8-K.
Purposes
The purposes of the 2015 Plan are to:
• |
enable us and our subsidiaries and affiliates to attract and retain highly qualified personnel who will contribute to our success and |
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• |
provide incentives to participants in the 2015 Plan that are linked directly to increases in stockholder value which will therefore inure to the benefit of all of our stockholders. |
Shares Available for Issuance
The maximum number of shares of our Common Stock that initially may be issued under the 2015 Plan is 10 million. The number of shares that may be granted pursuant to the 2015 Plan and the exercise prices of and number of shares subject to outstanding options and other awards will be proportionately adjusted, subject to any required action by our board of directors or stockholders and compliance with applicable securities laws, in the event of a stock dividend, recapitalization, stock split, reverse stock split, subdivision, combination, reclassification or similar change in our capital structure involving our common stock. No more than an aggregate of 3,333,333 shares of our Common Stock may be awarded during the twelve months following the 2015 Plan’s adoption by our stockholders, which occurred on March 5, 2015.
Administration
The 2015 Plan will be administered by of our Board of Directors or a committee of our Board in which each member will be an independent director. Throughout the remainder of this discussion of the 2015 Plan, the term “administrator” refers to our Board or the committee delegated authority to administer the 2015 Plan.
The 2015 Plan provides for the administrator to have full authority, in its discretion, to:
• |
select the persons to whom awards will be granted, |
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• |
grant awards, |
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• |
determine the number of shares to be covered by each award, |
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• |
determine the type, nature, amount, pricing, timing and other terms of each award and |
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• |
interpret, construe and implement the provisions of the 2015 Plan, including the authority to adopt rules and regulations. |
Eligibility
Participation in the 2015 Plan is limited to our, our subsidiaries and affiliates’:
• |
employees, including officers, |
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• |
directors, |
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• |
consultants and |
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• |
advisors. |
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Types of Awards
Under the 2015 Plan, the administrator is authorized to award:
• |
stock options, |
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• |
stock bonuses, |
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• |
restricted stock, |
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• |
stock appreciation rights, commonly referred to as “SARs,” |
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• |
performance grants and |
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• |
other types of awards. |
Stock Options
The administrator is authorized to grant stock options, which may be either incentive stock options qualifying for favorable tax treatment under the Internal Revenue Code, referred to as “ISOs,” or nonqualified stock options, referred to as “NSOs.” The exercise price of all options awarded under the 2015 Plan must be no less than 100% of the fair market value of our common stock on the date of the grant. For purposes of the 2015 Plan, fair market value shall be equal to the closing market price of our Common Stock. In the absence of a market price, fair market value shall be determined in such manner as the administrator may deem equitable or as required by applicable law or regulation.
At the time of grant, the administrator will determine when options are exercisable and when they expire. In absence of such determination, each option will have a ten year term, with one quarter of the shares subject to the option becoming exercisable on the first anniversary of the option grant and with an additional one-quarter becoming exercisable on each of the next three anniversary dates. The term of an option cannot exceed ten years, except in the case of an ISO granted to a person who beneficially owns 10% or more of the total combined voting power of all of our equity securities, referred to as a “10% stockholder.” An ISO granted to a 10% stockholder cannot have a term exceeding five years, nor may such an ISO be exercisable at less than 110% of the fair market value of our common stock on the date of grant. ISOs may not be granted more than ten years after the date of adoption of the 2015 Plan by our Board of Directors.
The aggregate fair market value of shares first exercisable in any calendar year by an individual holding ISOs, whether under the 2015 Plan or any other plan of our company, may not exceed $100,000. In such an event, the shares in excess of such $100,000 limitation shall be deemed granted as an NSO.
Payment for shares purchased upon exercise of a stock option must be made in full at the time of purchase. Payment may be made in cash or at the option of the administrator:
• |
by reduction of indebtedness we owe to the optionee, |
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• |
by the transfer to us of shares of our Common Stock owned by the participant for at least six months or obtained in the public market and which are valued at fair market value on the date of transfer, |
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• |
in the case of employees other than executive officers, by interest bearing promissory note, |
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• |
except with respect to ISOs or where otherwise prohibited by applicable law and provided a public market for our common stock exists, by “cashless exercise,” or |
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• |
through a “same day sale” or “margin” commitment by a broker-dealer that is a member of the Financial Industry Regulatory Authority. |
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Restricted Stock Grants
Restricted stock consists of shares of our common stock which are sold or granted to a participant, but are subject to substantial risk of forfeiture and to restrictions on their sale or other transfer by the participant. The administrator determines the eligible participants to whom and the time or times at which, grants of restricted stock will be made, the number of shares to be granted, the price to be paid, if any, the time within which the shares covered by such grants will be subject to forfeiture, the time at which the restrictions will terminate and all other terms and conditions of the grants. Restrictions could include, but are not limited to, performance criteria, continuous service with us, the passage of time or other restrictions. In the case of a 10% stockholder, restricted stock will only be issued at fair market value.
Any performance criteria may be used to measure our performance as a whole or the performance of any of our subsidiaries, affiliates or business units. Any performance criteria may be adjusted to include or exclude extraordinary items.
SARs
An SAR is a right, denominated in shares, to receive an amount, payable in shares, in cash or a combination of shares and cash, that is equal to the excess of: (a) the fair market value of our Common Stock on the date of exercise of the right over (b) the fair market value of our common stock on the date of grant of the right, multiplied by the number of shares for which the right is exercised. SARs may be awarded either in combination with the grant of an option or other type of award or individually.
Stock Bonus Awards
The administrator may award shares of our Common Stock to participants without payment therefor, as additional compensation for service to us, our subsidiaries or our affiliates.
Performance Grants
The 2015 Plan authorizes the administrator to award performance grants. Performance grant awards are earned over a performance period determined by the administrator at the time of the award. There may be more than one performance award in existence at any one time and the performance periods may differ or overlap. Further, performance grants can be awarded separately or in tandem with other awards.
At the time a performance grant is awarded, the administrator will establish minimum and maximum performance goals over the performance period. The portion of the performance award earned by the participant will be determined by the administrator, based on the degree to which the performance goals are achieved. No performance grants will be earned by the participant unless the minimum performance goals are met.
Amendment of the 2015 Plan
Except as may be required for compliance with Rule 16b-3 under the Exchange Act and Sections 162(m) or 422 of the Internal Revenue Code, our Board of Directors has the right and power to amend the 2015 Plan; provided , however , that our Board may not amend the 2015 Plan in a manner which would impair or adversely affect the rights of the holder of an outstanding award without such holder’s consent. If the Code or any other applicable statute, rule or regulation, including, but not limited to, those of any securities exchange, requires stockholder approval with respect to the 2015 Plan or any type of amendment thereto, then, to the extent so required, stockholder approval will be obtained.
Termination of the 2015 Plan
Subject to earlier termination by our board of directors, the 2015 Plan will terminate on March 5, 2025. Termination of the 2015 Plan will not, in any manner, impair or adversely affect any award outstanding at the time of termination.
Administrator’s Right to Modify Benefits
Any award granted may be converted, modified, forfeited or canceled, in whole or in part, by the administrator if and to the extent permitted in the 2015 Plan or applicable agreement entered into in connection with an award grant or with the consent of the participant to whom such award was granted.
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Change in Control
An award agreement may provide that, upon a “change in control,” all or any portion of the award shall automatically become immediately vested and exercisable, that restrictions relating to the award shall lapse or that the award shall become immediately payable.
A change of control will be deemed to have occurred if:
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any person (other than a current stockholder or holder of rights entitling the holder to acquire our securities) acquires beneficial ownership of 50% or more of the voting power of our then-outstanding voting securities, |
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members of our current board cease to constitute a majority of our board without the approval of our current board (or those elected with the approval of the directors on the board at the time of such member’s election) or |
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we are a party to a merger, consolidation, liquidation, dissolution or sale of all or substantially all of our assets, other than a merger in which we are the surviving corporation and such merger does not result in any other manner in a change in control. |
The Merger has been expressly excluded from a transaction which would trigger a change of control under the 2015 Plan.
Reusage
If a stock option expires or is terminated, surrendered or canceled without having been fully exercised or if restricted stock or SARs are forfeited or terminated without the issuance of all of the shares subject to such award, the shares covered by such awards again will be available for use under the 2015 Plan. Shares covered by an award granted under the 2015 Plan will not be counted as used unless and until they are actually and unconditionally issued and delivered to a participant. The number of shares which are transferred to us by a participant to pay the exercise or purchase price of an award will be subtracted from the number of shares issued with respect to such award for the purpose of counting shares used. Shares covered by an award granted under the 2015 Plan which is settled in cash will not be counted as used.
Termination of Options
Upon the termination of an optionee’s employment or other service with us, the optionee will have three months to exercise options to the extent exercisable as of the date of termination, except where such termination is for cause, in which event the option will expire immediately. However, if, the termination is due to the optionee’s death or disability, then the optionee or the optionee’s estate or legal representative shall have the right to exercise any vested options for twelve months after such death or disability. The administrator, in its discretion, may delay the termination of such an option, but only for up to the earlier of: (x) five years from such termination or (y) the option’s original expiration date.
Federal Income Tax Consequences
The following is a general summary, as of the date of this Current Report on Form 8-K, of the federal income tax consequences to us and participants under the 2015 Plan. Federal tax laws may change and the federal, state and local tax consequences for any such participant will depend upon his, her or its individual circumstances. Each participant shall be encouraged to seek the advice of a qualified tax advisor regarding the tax consequences of participation in the 2015 Plan.
ISOs
An optionee generally does not recognize taxable income upon the grant or upon the exercise of an ISO.
If an optionee sells ISO shares before having held them for at least one year after the date of exercise and two years after the date of grant, the optionee recognizes ordinary income to the extent of the lesser of: (x) the gain realized upon the sale or (y) the difference between the fair market value of the shares on the date of exercise and the exercise price. Any additional gain is treated as long-term or short-term capital gain depending upon how long the optionee has held the ISO shares prior to disposing of them in a disqualifying disposition. In the year of disposition, we will receive a federal income tax deduction in an amount equal to the ordinary income which the optionee recognizes as a result of the disposition.
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If an optionee sells ISO shares after having held them for at least one year from exercise and two years from the date of grant, the optionee recognizes income in an amount equal to the difference, if any, between the fair market value of those shares on the date of sale and the exercise price of the ISO shares. Such income will be taxed at long-term capital gains rates. In such an event, we will not be entitled to a federal income tax deduction. The holding period requirements generally are waived when an optionee dies.
The exercise of an ISO may, in some cases, trigger liability for the alternative minimum tax.
NSOs
An optionee does not recognize taxable income upon the grant of an NSO. Upon the exercise of an NSO, the optionee recognizes ordinary income to the extent the fair market value of the shares received upon exercise of the NSO on the date of exercise exceeds the exercise price, unless the optionee is subject to the provisions of Section 16 of the Securities Exchange Act of 1934. We will receive an income tax deduction in an amount equal to the ordinary income which the optionee recognizes upon the exercise of the stock option. If an optionee sells shares received upon the exercise of an NSO, the optionee recognizes capital gain income to the extent the sales proceeds exceed the fair market value of such shares on the date of exercise. If the optionee is subject to Section 16, absent an election to be taxed at the time of exercise, the optionee will be taxed when the insider trading restrictions of Section 16 lapse and then based upon the value of the shares at the time the trading restrictions lapse.
Restricted Stock
A participant who receives an award of restricted stock does not generally recognize taxable income at the time of the award or payment. Instead, the participant recognizes ordinary income in the taxable year in which his or her interest in the shares becomes either: (x) freely transferable or (y) no longer subject to substantial risk of forfeiture. On the date restrictions lapse, the participant includes in taxable income the fair market value of the shares less the cash, if any, paid for the shares.
A participant may elect to recognize income at the time he or she receives restricted stock in an amount equal to the fair market value of the restricted stock, less any cash paid for the shares, on the date of the award.
We will receive a compensation expense deduction in the taxable year in which restrictions lapse or in the taxable year of the award if, at that time, the participant had filed a timely election to accelerate recognition of income.
Other Benefits
In the case of an exercise of an SAR or an award of a performance grant or stock bonus, the participant will generally recognize ordinary income in an amount equal to any cash received and the fair market value of any shares received on the date of payment or delivery. In that taxable year, we will receive a federal income tax deduction in an amount equal to the ordinary income which the participant has recognized.
Million Dollar Deduction Limit
We may not deduct compensation of more than $1 million that is paid to an individual who, on the last day of the taxable year, is either our chief executive officer or is among one of the four other most highly-compensated officers for that taxable year. The limitation on deductions does not apply to certain types of compensation, including qualified performance-based compensation. We believe that awards in the form of stock options constitute qualified performance-based compensation and, as such, will be exempt from the $1 million limitation on deductible compensation.
Registration and Effect of Stock Issuance
We intend to register under the Securities Act the shares of our common stock issuable under the 2015 Plan. This will make such shares immediately eligible for resale in the public market.
The issuance of shares of our common stock under the 2015 Plan will dilute the voting power of our stockholders.
Miscellaneous
A new benefits table is not provided because no grants have been made under the 2015 Plan and all benefits are discretionary. Accordingly, benefits are not determinable with respect to our chief executive officers, other named executive officers, all current executive officers as a group, all current directors and all executive officer as a group and all employees, including all current officers who are not executive officers, as a group.
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DESCRIPTION OF SECURITIES
We have authorized capital stock consisting of 300 million shares of Common Stock and 10 million shares of preferred stock. As of the date of this Current Report on Form 8-K, we had 86 million shares of our Common Stock and no shares of preferred stock issued and outstanding.
Common Stock
The holders of outstanding shares of our Common Stock are entitled to receive dividends out of assets or funds legally available for the payment of dividends at such times and in such amounts as our Board of Directors from time to time may determine. Holders of our Common Stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders. There is no cumulative voting of the election of directors then standing for election. Holders of our Common Stock are not entitled to pre-emptive rights and shares of our Common Stock are not subject to conversion or redemption. Upon liquidation, dissolution or winding up of our Company, the assets legally available for distribution to stockholders are distributable ratably among the holders of our Common Stock after payment of liquidation preferences, if any, on any outstanding payment of other claims of creditors. Each outstanding share of our Common Stock that is issued and outstanding is duly and validly issued, fully paid and non-assessable.
Preferred Stock
Shares of our preferred stock may be issued from time to time in one or more series and/or classes, each of which will have such distinctive designation or title as shall be determined by our Board of Directors prior to the issuance of any shares of such series or class. Our preferred stock will have such voting powers, full or limited or no voting powers and such preferences and relative, participating, optional or other special rights and such qualifications, limitations or restrictions thereof, as shall be stated in such resolution or resolutions providing for the issue of such series or class of preferred stock as may be adopted from time to time by our Board of Directors prior to the issuance of any shares thereof. No shares of our preferred stock are currently issued or outstanding and our Board has not, as of the date of this Current Report on Form 8-K, designated any class or series of preferred stock for use in the future.
While we do not currently have any plans for the issuance of shares of our preferred stock, the issuance of preferred stock could adversely affect the rights of the holders of our Common Stock and, therefore, reduce the value of our Common Stock. It is not possible to state the actual effect of the issuance of any shares of preferred stock on the rights of holders of our Common Stock until our Board determines the specific rights of the holders of such shares of preferred stock; however, these effects may include:
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restricting dividends on our Common Stock; |
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diluting the voting power of our Common Stock; |
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impairing the liquidation rights of our Common Stock; and/or |
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delaying or preventing a change in control of our Company without further action by our stockholders. |
Other than in connection with shares of preferred stock (as explained above), which preferred stock is not currently designated nor contemplated by us, we do not believe that any provision of our charter or By-Laws would delay, defer or prevent a change in control.
Options
No options or other awards have been granted to date under our 2015 Plan or otherwise. Accordingly, as of the date of this Current Report on Form 8-K, we have outstanding no options or warrants to purchase shares of our Common Stock.
Registration Rights
See Item 2.01, “Completion of Acquisition or Disposition of Assets - The Merger and Related Transactions - Registration Rights” for a description of the registration rights granted to investors in the PPO, the designee of the former holder of the Bridge Note, the holders of the Tyme Stockholders Registrable Shares and a consultant, which description is incorporated herein by reference.
Other Convertible Securities
As of the date of this Current Report on Form 8-K, other than the securities described above, our Company does not have any outstanding convertible or derivative securities.
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Transfer Agent
The transfer agent for our Common Stock is Continental Stock Transfer & Trust Company. The transfer agent’s address is 17 Battery Place - 8 th Floor, New York, New York 10004 and its telephone number is (212) 509-4000.
LEGAL PROCEEDINGS
From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm business.
We are currently not aware of any pending legal proceedings to which we are a party or of which any of our property is the subject, nor are we aware of any such proceedings that are contemplated by any governmental authority.
INDEMNIFICATION OF DIRECTORS AND OFFICERS
Delaware Law allows us to indemnify our officers and directors from certain liabilities. Pursuant to our Certificate of Incorporation, we shall indemnify, to the fullest extent permitted by applicable law any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative in nature by reason of the fact that he or she is or was a director, officer, employee or agent of our Company or, while a director, officer, employee or agent of our Company, is or was serving at the request of our Company as a director, officer, trustee, employee or agent of or in any other capacity with another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, against expenses (including attorneys’ fees), judgments, fines, penalties and amounts paid in settlement in connection with such action, suit or proceeding.
Pursuant to our Certificate of Incorporation, we shall advance to a director, officer, employee or agent of our Company expenses incurred in connection with defending any action, suit or proceeding referred to above or in our By-Laws at any time before the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of the indemnified person to repay such amount if it shall ultimately be determined that he or she is not entitled to be indemnified by us as authorized in our Certificate of Incorporation or as provided in the By-Laws.
The indemnification and other rights provided for in our Certificate of Incorporation shall not be exclusive of any provision with respect to indemnification or the payment of expenses in our By-Laws or any other contract or agreement between us and any officer, director, employee or agent of our Company or any other person.
Other than discussed above, neither our Certificate of Incorporation or By-Laws includes any specific indemnification provisions for our officers or directors against liability under the Securities Act. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of our Company pursuant to the foregoing provisions or otherwise, our Company has been advised that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
Item 3.02 |
Unregistered Sales of Equity Securities |
The Bridge Note and the PPO
The information regarding the Bridge Notes and the PPO set forth in Item 2.01, “Completion of Acquisition or Disposition of Assets - The Merger and Related Transactions - The Bridge Financing” and ” - The PPO” are incorporated herein by reference.
Shares Issued in Connection with the Merger
On March 5, 2015, pursuant to the terms of the Merger Agreement, all of the issued and outstanding shares of Tyme common stock were exchanged for 68 million shares of our Common Stock. This transaction was exempt from registration under Section 4(2) of the Securities Act as not involving any public offering. None of the securities were sold through an underwriter and, accordingly, there were no underwriting discounts or commissions involved.
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Consultant’s Shares
We retained a consultant to provide investor relations services to us, effective as of the consummation of the Merger. In connection with such retention, we issued to the consultant 250,000 shares of our Common Stock. This transaction was exempt from registration under Section 4(2) of the Securities Act as not involving any public offering. None of the securities were sold through an underwriter and, accordingly, there were no underwriting discounts or commissions involved.
Sales of Unregistered Securities of Tyme
On July 26, 2013, Tyme issued to each of Steve Hoffman and Michael Demurjian 1,000 shares of Tyme’s common stock (34 million shares of our Common Stock) in exchange for their assignment to Tyme of all of their membership interests in Luminant. Each of such assigned membership interests represented one-third of the then outstanding membership interests of Luminant. Each of these issuances was exempt from registration under Section 4(2) of the Securities Act as transactions by an issuer not involving any public offering.
Effective as of August 28, 2014, U.S. VC Partners, LLC (“USVC”) converted its convertible promissory note in the amended principal amount of $1.126 million into 102.6 shares of Tyme’s common stock (3,624,400 shares of our Common Stock). This issuance was exempt from registration under Section 4(2) of the Securities Act as a transaction by an issuer not involving any public offering.
Subsequent to their acquisitions of their individual shares of Tyme’s common stock, at various times between July 2013 and August 2014, each of Messrs. Hoffman and Demurjian sold and transferred certain of their shares to a total of eight persons or entities, as well as each surrendering to us for cancellation 53.3 shares of Tyme’s common stock (1,812,200 shares of our Common Stock) in connection with the issuance to USVC of 102.6 shares of Tyme’s common stock (3,624,400 shares of our Common Stock) upon USVC’s conversion of Tyme’s $1.126 million debt owed to it, resulting in their ownership of shares of our Common Stock as reflected in the “Principal Stockholders Table” set forth above. Each of such sales and transfers was exempt from registration under Section 4(1) of the Securities Act as transactions by a person other than the issuer, underwriter or dealer and Section 4(2) of the Securities Act as transactions by an issuer not involving any public offering.
Item 4.01 |
Changes in Registrant’s Certifying Accountant. |
On March 6, 2015, DKM Certified Public Accountants (“DKM”) was dismissed as our independent registered public accounting firm. On the same date, WithumSmith+Brown, PC (“WSB”) was engaged as our new independent registered public accounting firm. WSB acted as the independent registered public accounting firm of Tyme, with respect to Tyme’s fiscal year ended December 31, 2013 and Luminant, with respect to Luminant’s fiscal years ended December 31, 2013, 2012 and 2011, and has been engaged to act as Tyme’s independent registered public accounting firm for Tyme’s fiscal year ended December 31, 2014. Our Board of Directors approved the dismissal of DKM and approved the engagement of WSB as our independent registered public accounting firm to be effective upon consummation of the Merger, which occurred on March 5, 2015.
None of the reports of DKM on our financial statements for either of the past two years or subsequent interim period contained an adverse opinion or disclaimer of opinion or was qualified or modified as to uncertainty, audit scope or accounting principles, except that our audited financial statements contained in our Annual Reports on Form 10-K for the fiscal years ended November 30, 2014 and 2013 included a going concern qualification in the reports.
During our Company’s two most recent fiscal years ended November 30, 2014 and 2013 and the subsequent interim periods preceding their dismissal, there were no disagreements with DKM, whether or not resolved, on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure, which, if not resolved to the satisfaction of DKM would have caused them to make reference to the subject matter of the disagreement in connection with their reports on our Company’s financial statements.
The Company provided DKM with a copy of the disclosures it is making in this Current Report on Form 8-K and has requested that DKM furnish it with a letter addressed to the SEC stating whether they agree with the above statements. The letter furnished by DKM has been made an exhibit to this Form 8-K.
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During the two most recent fiscal years and the interim periods preceding the engagement and through the date of this Form 8-K, neither the Company nor anyone on its behalf has previously consulted with WSB regarding either (a) the application of accounting principles to a specified transaction, either completed or proposed; or the type of audit opinion that might be rendered on our Company’s financial statements and neither a written report was provided nor oral advice was provided to the Company that WSB concluded was an important factor considered by the Company in reaching a decision as to the accounting, auditing or financial reporting issue; or (b) any matter that was either the subject of a disagreement (as defined in paragraph 304(a)(1)(iv) of Regulation S-K and the related instructions thereto) or a reportable event (as described in paragraph 304(a)(1)(v)) of Regulation S-K).
Item 5.01 |
Changes in Control of Registrant. |
The information regarding change of control of the Company in connection with the Merger set forth in Item 2.01, “Completion of Acquisition or Disposition of Assets—The Merger and Related Transactions” is incorporated herein by reference.
Item 5.02 |
Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers. |
The information regarding departure and election of directors and departure and appointment of principal officers of the Company in connection with the Merger set forth in Item 2.01, “Completion of Acquisition or Disposition of Assets - The Merger and Related Transactions” is incorporated herein by reference.
Item 5.03 |
Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year. |
On March 5, 2015, we changed our fiscal year from a fiscal year ending on November 30 th of each year, which was used in our most recent filing with the SEC, to one ending on December 31st of each year, which is the fiscal year end of Tyme. We intend to file a Form 10-K with respect to our fiscal year ended December 31, 2014 within the time period required of a smaller reporting company and, thereafter, file our periodic reports based on the new fiscal year.
Item 5.06 |
Change in Shell Company Status. |
Prior to the Merger, we were a “shell company” (as such term is defined in Rule 12b-2 promulgated under the Exchange Act). As a result of the Merger, we have ceased to be a shell company. The information contained in this Current Report on Form 8-K, together with the information contained in our Annual Report on Form 10-K for the fiscal year ended November 30, 2013 and our subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as filed with the SEC, constitute the current “Form 10 information” necessary to satisfy the conditions contained in Rule 144(i)(2) under the Securities Act.
Item 9.01 |
Financial Statements and Exhibits. |
(a) Financial statements of business acquired.
In accordance with Item 9.01(a) of Form 8-K, Tyme’s audited financial statements as of and for the fiscal years ended December 31, 2013 and 2012 and Tyme’s unaudited condensed financial statements as of and for the three and nine months ended, September 30, 2014 and 2013 and the accompanying notes, are included in this Current Report in Form 8-K beginning on Page F-1.
(b) Pro forma financial information.
In accordance with Item 9.01(b) of Form 8-K, unaudited pro forma condensed combined financial information as of and for the fiscal years ended, December 31, 2013 and as of and for the nine months ended September 30, 2014 and 2013 and the accompanying notes, are included in this Current Report on Form 8-K beginning on Page F-28.
(d) Exhibits
In reviewing the agreements included or incorporated by reference as exhibits to this Current Report on Form 8-K, please remember that they are included to provide the reader with information regarding their terms and are not intended to provide any other factual or disclosure information about our Company or the other parties to the agreements. The agreements may contain representations and warranties by each of the parties to the applicable agreement. These representations and warranties have been made solely for the benefit of the parties to the applicable agreement and:
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should not in all instances be treated as categorical statements of fact, but rather as a way of allocating the risk to one of the parties if those statements prove to be inaccurate; |
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have been qualified by disclosures that were made to the other party in connection with the negotiation of the applicable agreement, which disclosures are not necessarily reflected in the agreement; |
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may apply standards of materiality in a way that is different from what may be viewed as material to readers of this Form 8-K or other investors; and |
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were made only as of the date of the applicable agreement or such other date or dates as may be specified in the agreement and are subject to more recent developments. |
Accordingly, such representations and warranties may not describe the actual state of affairs as of the date they were made or at any other time. Additional information about our Company may be found elsewhere in this Form 8-K and our other public filings, which are available without charge through the SEC’s website at http://www.sec.gov.
Exhibit
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Description |
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2.1* |
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Agreement and Plan of Merger and Reorganization, dated as of March 5, 2015, by and among Tyme Technologies, Tyme Acquisition Corp., Tyme, Inc. and other signatories thereto. |
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2.2 |
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Agreement and Plan of Merger, dated September 12, 2014, between Global Group Enterprises Corp. and Tyme Technologies, Inc. [Incorporated by reference to Exhibit 2.1 to our Current Report on Form 8-K (Date of Report: September 12, 2014), filed with the SEC on September 19, 2014.] |
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3.1 |
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Amended and Restated Certificate of Incorporation of Tyme Technologies, Inc. [Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K (Date of Report: September 12, 2014), filed with the SEC on September 19, 2014.] |
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3.2 |
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Articles of Merger of Global Group Enterprises Corp. with and into Tyme Technologies, Inc., filed with the Secretary of State of the State of Florida on September 18, 2014. [Incorporated by reference to Exhibit 3.3 to our Current Report on Form 8-K (Date of Report: September 12, 2014), filed with the SEC on September 19, 2014.] |
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3.3 |
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Certificate of Merger of Global Group Enterprises Corp. with and into Tyme Technologies, Inc., filed with the Secretary of State of the State of Delaware on September 18, 2014. [Incorporated by reference to Exhibit 3.4 to our Current Report on Form 8-K (Date of Report: September 12, 2014), filed with the SEC on September 19, 2014.] |
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3.4* |
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Certificate of Merger of Tyme Acquisition Corp. with and into Tyme Inc., filed with the Secretary of State of the State of Delaware on March 5, 2015. |
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3.5 |
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By-Laws of Tyme Technologies, Inc. [Incorporated by reference to Exhibit 3.2 to our Current Report on Form 8-K (Date of Report: September 12, 2014), filed with the SEC on September 19, 2014.] |
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10.1* |
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Split-Off Agreement, dated as of March 5, 2015, among Global Group Enterprises Corp., Tyme Technologies, Inc. and Andrew Keck. |
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10.2* |
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General Release Agreement, dated as of March 5, 2015, among Global Group Enterprises Corp., Tyme Technologies, Inc. and Andrew Keck. |
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10.3* |
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Lock-Up and No Shorting Agreement, dated as of March 5, 2015, between Tyme Technologies, Inc. and Steven Hoffman. |
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10.4* |
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Lock-Up and No Shorting Agreement, dated as of March 5, 2015, between Tyme Technologies, Inc. and Michael Demurjian. |
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FINANCIAL STATEMENTS
Table of Contents
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Tyme Inc. |
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Report of Independent Registered Public Accounting Firm |
F-1 |
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Audited Consolidated Financial Statements for the Fiscal Years Ended December 31, 2013 and 2012 |
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Balance Sheets |
F-2 |
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Statement of Operations |
F-3 |
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Statement of Stockholders’ Equity |
F-4 |
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Statement of Cash Flows |
F-5 |
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Notes to Financial Statements |
F-6 |
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Consolidated Financial Statements for the Three and Nine Months Ended September 30, 2014 (Unaudited) |
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Balance Sheets |
F-14 |
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Statement of Operations |
F-15 |
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Statement of Stockholders’ Equity |
F-16 |
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Statement of Cash Flows |
F-17 |
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Notes to Financial Statements |
F-18 |
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Pro Forma Financial Information (Unaudited) |
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Unaudited Pro Forma Combined Consolidated Financial Data Information |
F-28 |
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Pro Forma Balance Sheet as of September 30, 2014 |
F-29 |
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Pro Forma Statements of Operations as of November 30, 2014 and December 31, 2013 |
F-30 |
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Pro Forma Statements of Operations as of August 31, 2014 and September 30, 2013 |
F-31 |
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Notes to Pro Forma Financial Information |
F-32 |
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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of
Tyme Inc. and Subsidiary
We have audited the accompanying consolidated balance sheets of Tyme Inc. and Subsidiary (the “Company”) as of December 31, 2013 and 2012, and the related statements of operations, changes in stockholders’ deficit, and cash flows for the years then ended. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Tyme Inc. and Subsidiary as of December 31, 2013 and 2012, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred losses and negative cash flows since inception and has a stockholders’ deficit of $850,281 as of December 31, 2013. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its product candidates currently in development. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plan in regards to these matters is also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
As disclosed in Note 2 to the financial statements, the Company elected to early adopt amended guidance related to Accounting Standards Codification Topic 915, Development Stage Entities, which eliminates the requirements to present inception-to-date information for the consolidated statement of operations, cash flows, and stockholders’ equity, along with certain other disclosures which were historically required for development stage entities. Our opinion has not been modified with respect to this matter.
/s/ WithumSmith+Brown, PC
New Brunswick, New Jersey
November 14, 2014
F - 1
TYME INC. AND SUBSIDIARY
Consolidated Balance Sheets
December 31, 2013 and 2012
|
|
2013 |
|
2012 |
|
||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash |
|
$ |
92,620 |
|
$ |
— |
|
Prepaid assets |
|
|
110,180 |
|
|
100 |
|
Total current assets |
|
|
202,800 |
|
|
100 |
|
|
|
|
|
|
|
|
|
Property and equipment, net of accumulated depreciation of $724 and $210, respectively |
|
|
21,429 |
|
|
1,990 |
|
Total assets |
|
$ |
224,229 |
|
$ |
2,090 |
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts payable and other current liabilities |
|
$ |
148,510 |
|
$ |
180,518 |
|
Current maturities of convertible notes |
|
|
347,249 |
|
|
— |
|
Total current liabilities |
|
|
495,759 |
|
|
180,518 |
|
|
|
|
|
|
|
|
|
Convertible notes less current maturities |
|
|
578,751 |
|
|
— |
|
Total liabilities |
|
|
1,074,510 |
|
|
180,518 |
|
|
|
|
|
|
|
|
|
Commitments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ deficit |
|
|
|
|
|
|
|
Common stock, $0.001 par value, 1,000,000 shares authorized, 2,000 shares issued and outstanding at December 31, 2013 |
|
|
2 |
|
|
— |
|
Additional paid in capital |
|
|
2,008 |
|
|
2,010 |
|
Accumulated deficit |
|
|
(1,522,746 |
) |
|
(750,921 |
) |
Total Tyme Inc stockholders’ deficit |
|
|
(1,520,736 |
) |
|
(748,911 |
) |
|
|
|
|
|
|
|
|
Noncontrolling interests |
|
|
1,976,693 |
|
|
1,166,140 |
|
Due from stockholders/members |
|
|
(1,306,238 |
) |
|
(595,657 |
) |
Total stockholders’ deficit |
|
|
(850,281 |
) |
|
(178,428 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
224,229 |
|
$ |
2,090 |
|
The Notes to Consolidated Financial Statements are an integral part of this statement.
F - 2
TYME INC. AND SUBSIDIARY
Consolidated Statements of Operations
Years ended December 31, 2013 and 2012
|
|
2013 |
|
2012 |
|
||
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
$ |
744,717 |
|
$ |
602,981 |
|
General and administrative |
|
|
307,100 |
|
|
284,598 |
|
Total operating expenses |
|
|
1,051,817 |
|
|
887,579 |
|
Loss from operations |
|
|
(1,051,817 |
) |
|
(887,579 |
) |
|
|
|
|
|
|
|
|
Interest expense |
|
|
5,855 |
|
|
— |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(1,057,672 |
) |
|
(887,579 |
) |
Loss attributable to noncontrolling interests |
|
|
285,847 |
|
|
295,860 |
|
Loss attributable to controlling interests |
|
$ |
(771,825 |
) |
$ |
(591,719 |
) |
The Notes to Consolidated Financial Statements are an integral part of this statement.
F - 3
TYME INC. AND SUBSIDIARY
Consolidated Statements of Stockholders’ Deficit
Years Ended December 31, 2013 and 2012
|
|
|
Additional |
|
|
|
Non |
|
Due from |
|
Total |
|
||||||||
|
Common stock |
|
Paid-in- |
|
Accumulated |
|
Controlling |
|
Stockholders/ |
|
Stockholders’ |
|
||||||||
|
Shares |
|
Amount |
|
capital |
|
deficit |
|
interests |
|
Members |
|
Deficit |
|
||||||
Balance January 1, 2012 |
— |
|
$ |
— |
|
$ |
2,010 |
|
$ |
(159,202 |
) |
$ |
233,000 |
|
$ |
(72,000 |
) |
$ |
3,808 |
|
Capital Contributions |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,229,000 |
|
|
— |
|
|
1,229,000 |
|
Advances to stockholders/members |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(523,657 |
) |
|
(523,657 |
) |
Net Loss |
— |
|
|
— |
|
|
— |
|
|
(591,719 |
) |
|
(295,860 |
) |
|
— |
|
|
(887,579 |
) |
Balance , December 31, 2012 |
— |
|
|
— |
|
|
2,010 |
|
|
(750,921 |
) |
|
1,166,140 |
|
|
(595,657 |
) |
|
(178,428 |
) |
Shares Issued |
2,000 |
|
|
2 |
|
|
(2 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Capital Contributions |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,096,400 |
|
|
— |
|
|
1,096,400 |
|
Advances to stockholders/members |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(710,581 |
) |
|
(710,581 |
) |
Net Loss |
— |
|
|
— |
|
|
— |
|
|
(771,825 |
) |
|
(285,847 |
) |
|
— |
|
|
(1,057,672 |
) |
Balance, December 31, 2013 |
2,000 |
|
$ |
2 |
|
$ |
2,008 |
|
$ |
(1,522,746 |
) |
$ |
1,976,693 |
|
$ |
(1,306,238 |
) |
$ |
(850,281 |
) |
The Notes to Consolidated Financial Statements are an integral part of this statement.
F - 4
TYME INC. AND SUBSIDIARY
Consolidated Statements of Cash Flows
Years Ended December 31, 2013 and 2012
|
|
2013 |
|
2012 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,057,672 |
) |
$ |
(887,579 |
) |
Adjustments to reconcile net loss to net cash from operating activities |
|
|
|
|
|
|
|
Depreciation |
|
|
514 |
|
|
210 |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
Prepaid assets |
|
|
(110,080 |
) |
|
11,103 |
|
Accounts payable and other current liabilities |
|
|
(32,008 |
) |
|
169,570 |
|
Net cash used in operating activities |
|
|
(1,199,246 |
) |
|
(706,696 |
) |
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(19,953 |
) |
|
(2,200 |
) |
Net cash used in investing activities |
|
|
(19,953 |
) |
|
(2,200 |
) |
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
Capital contributions |
|
|
1,096,400 |
|
|
1,229,000 |
|
Changes in due from stockholders/members |
|
|
(710,581 |
) |
|
(523,657 |
) |
Proceeds from issuance of convertible notes |
|
|
926,000 |
|
|
— |
|
Net cash provided by financing activities |
|
|
1,311,819 |
|
|
705,343 |
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash |
|
|
92,620 |
|
|
(3,553 |
) |
|
|
|
|
|
|
|
|
Cash - beginning of year |
|
|
— |
|
|
3,553 |
|
|
|
|
|
|
|
|
|
Cash - end of year |
|
$ |
92,620 |
|
$ |
— |
|
|
|
|
|
|
|
|
|
Supplemental Cash Flow Information: |
|
|
|
|
|
|
|
Cash paid for interest and income taxes are as follows: |
|
|
|
|
|
|
|
Interest |
|
$ |
— |
|
$ |
— |
|
Income taxes |
|
$ |
— |
|
$ |
— |
|
|
|
|
|
|
|
|
|
Noncash investing and financing activities: |
|
|
|
|
|
|
|
Issuance of common stock as a result of contribution of member interest in Luminant Biosciences LLC |
|
$ |
2 |
|
$ |
— |
|
The Notes to Consolidated Financial Statements are an integral part of this statement.
F - 5
TYME INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements
December 31, 2013 and 2012
(1) Background and Nature of Business
Tyme Inc. and Subsidiary (the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications. Tyme Inc. (“Tyme”) was incorporated in Delaware in 2013 and its operations to date have been directed primarily toward developing business strategies, research and development activities and preparing for clinical trials for its product candidates. The Company has focused its research and development efforts on a proprietary platform technology for which it retains global intellectual property (IP) and commercial rights.
The Company is currently formulating its regulatory and drug development program for SM-88, working towards the initiation of its first phase II clinical trial.
Assignment of Interest in Luminant
On July 26, 2013, the founding stockholders (“the Founders”) of the Company entered into a Founder Contribution and Exchange Agreement under which the Founders contributed their membership units in Luminant Biosciences, LLC. (“Luminant”) to the Company in exchange for 2,000 shares of common stock, par value $0.001 per share (the “Company Common Stock”) of the Company. As a result of the transaction, as of December 31, 2013, Luminant Biosciences, LLC is 66 2/3% owned by the Company. The two Founders are two executive officers of the Company and collectively own more than 50 percent of the Company’s outstanding stock as of December 31, 2013. Since this transaction is among entities under common control, no gain or loss is recognized in the consolidated financial statements and the carrying amounts of the net assets are eliminated in consolidation.
Going Concern
The Company has incurred losses and negative cash flows from operations since inception and has an accumulated deficit of $850 thousand as of December 31, 2013. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its product candidates currently in development. The Company’s primary sources of liquidity to date has been the issuance of a convertible promissory note on August 2, 2013 and contributed capital by a member of Luminant. The Company received $926 thousand from the issuance of a convertible promissory note in 2013 and approximately $2.6 million of historical capital contributions in Luminant by one of its members. Substantial additional financing will be needed by the Company to fund its operations, gain regulatory approval of and to commercially develop its technologies and product candidates. There can be no assurance that such financing will be available when needed or on acceptable terms. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
Management is currently evaluating different strategies to obtain the required funding of future operations. These strategies may include, but are not limited to: additional funding from current or new investors, borrowings of debt, a public offering of the Company’s equity or debt securities, and/or a merger with a publically traded company with available cash and liquid assets. There can be no assurance that these future funding efforts will be successful.
The Company is subject to those risks associated with any specialty pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change, and is largely dependent on the services of its employees and consultants.
F - 6
TYME INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (Continued)
December 31, 2013 and 2012
(2) Summary of Significant Accounting Policies
Basis of Presentation
On July 26, 2013, the controlling members of Luminant elected to transfer their membership units in Luminant to a newly formed company, Tyme Inc., in exchange for 2,000 shares of Company Common Stock (see Note 1). The Company has evaluated this transaction in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and has concluded that this transaction represents a recapitalization of entities under common control. Accordingly, the consolidated financial statements presented herein have been adjusted to reflect this recapitalization, by reporting assets, liabilities and equity at their carrying values and operations as of beginning of the year of the earliest comparative financial statements. The Company’s consolidated financial statements have been prepared in conformity with U.S. GAAP and include the accounts of Tyme Inc. and its subsidiary Luminant Biosciences, LLC. All significant intercompany accounts have been eliminated in consolidation.
Since its inception, the Company has not generated any significant revenues related to its operations. In June 2014, the Financial Accounting Standards Board released Accounting Standards Update No. 2014-10, which amended Topic 915 of the Accounting Standards Codification, Development Stage Entities, to eliminate the requirements to present inception-to-date information for the consolidated statement of operations, cash flows, and stockholders’ equity, along with certain other disclosures, which were historically required for development stage entities. This guidance is effective for annual reporting periods beginning after December 15, 2014 (for both public and nonpublic entities) and interim reporting periods beginning after December 15, 2014 for public entities and interim reporting periods beginning after December 15, 2015 for other entities. Early application of this amended guidance is permitted, provided that the entity’s financial statements have either not yet been issued (for public business entities) or made available for issuance (for other entities). The Company has evaluated this amended guidance and has elected to early adopt the amended guidance. This early adoption has no impact on the consolidated financial condition, results of operations, or cash flows of the Company.
Use of Estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Significant items subject to such estimation include the stated value of the Company underlying the conversion feature of the outstanding convertible notes payable. Actual results could differ from such estimates.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, including accounts payable and accrued expenses approximates fair value given their short-term nature. The carrying amount of the convertible promissory notes payable approximates fair value because the interest rates on these instruments are reflective of rates that the Company could obtain on unaffiliated third party debt with similar terms and conditions.
Prepaid Assets
Prepaid assets represents expenditures made in advance of when the economic benefit of the cost will be realized, and which will be expensed in future periods with the passage of time or when a triggering event occurs.
Property and Equipment, Net
Property and equipment are recorded at cost and are depreciated on a straight-line basis over their estimated useful lives. The Company estimates a life of five to seven years for equipment and furniture and fixtures. Upon sale or retirement, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in operating expenses. Repairs and maintenance costs are expensed as incurred.
F - 7
TYME INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (Continued)
December 31, 2013 and 2012
(2) Summary of Significant Accounting Policies (Continued)
Impairment of Long-Lived Assets
The Company assesses the recoverability of its long-lived assets, which include fixed assets whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the years ended December 31, 2013 and 2012, the Company determined that there was no impairment of its long-lived assets.
Research and Development
Research and development costs are expensed as incurred and are primarily comprised of, but not limited to, external research and development expenses incurred under arrangements with third parties, such as contract research organizations (CROs), contract manufacturing organizations (CMOs) and consultants that conduct clinical and preclinical studies, costs associated with preclinical and development activities, costs associated with regulatory operations, depreciation expense for assets used in research and development activities and employee related expenses including salaries and benefits for research and development personnel. Costs for certain development activities, such as clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expense, which are reported in prepaid assets or accounts payable and other current liabilities.
Noncontrolling Interests
Noncontrolling interests represents the minority member’s interest in the Company’s subsidiary, Luminant (see Note 1). At December 31, 2013, the Company owned 66 2/3 percent of Luminant representing 66 2/3 percent of the voting control which requires that Luminant’s operations be included in the consolidated financial statements. The 33 1/3 percent interest of Luminant that is not owned by the Company is shown as noncontrolling interests in the 2013 and 2012 consolidated statement of operations and consolidated balance sheet.
Income Taxes
The Company’s subsidiary, Luminant, operates as a limited liability corporation for federal and state income tax purposes. Accordingly, the taxable income or loss of Luminant passes to the individual members rather than pay taxes at the corporate level through the date the Founders contributed their 66 2/3 ownership in Luminant to the Company and accordingly there is no provision for income or deferred taxes for the year ended December 31, 2012.
From the date of inception July 26, 2013 through December 31, 2013, the Company operates as a C-Corporation and includes in its income its share of the income of Luminant. Deferred tax assets or liabilities are recorded for temporary differences between financial reporting and tax basis of assets and liabilities, using enacted rates in effect for the year in which the differences are expected to reverse.
A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. The Company has provided a full valuation allowance on its deferred tax assets that consists of cumulative net operating losses of $666 thousand for the period from inception (July 26, 2013) to December 31, 2013. Due to its cumulative loss position, history of operating losses and losses expected to be incurred in the foreseeable future, a full valuation allowance was considered necessary (Note 6).
F - 8
TYME INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (Continued)
December 31, 2013 and 2012
(2) Summary of Significant Accounting Policies (Continued)
Income Taxes (Continued)
The utilization of net operating losses for Federal income tax purposes sustained by the Company could be substantially limited annually if there were an “ownership change” (as defined by Section 382 of the Internal Revenue Code of 1986, as amended). If it were determined that there is a change in ownership, or if the Company undergoes a change of ownership in the future, the utilization of the Company’s net operating loss carry-forward may be materially limited. This could result in a reduction in equal amounts to the deferred tax assets and the related valuation reserves.
The Company is required to evaluate uncertain tax positions taken or expected to be taken in the course of preparing the Company’s consolidated financial statements to determine whether the tax positions are more likely than not of being sustained by the applicable tax authority. Tax positions with respect to tax at the Company level deemed not to meet the “more-likely than-not” threshold would be recorded as a tax expense in the current year. The Company has concluded that no provision for uncertain tax positions is required in the Company’s consolidated financial statements.
The Company had no unrecognized tax benefits at December 31, 2013 and 2012. The tax years which currently remain subject to examination by major tax jurisdictions as of December 31, 2013 are the years ended December 31, 2011 through 2013. In addition, the Company had no income tax related penalties or interest for periods presented in these consolidated financial statements.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views their operations and manages their business in one segment.
(3) Property and Equipment, Net
Property and equipment consisted of equipment and furniture and fixtures that had a net book value of $21,429 and $1,990 as of December 31, 2013 and 2012, respectively. Depreciation expense was $514 and $210 for the years ended December 31, 2013 and 2012, respectively.
(4) Accounts Payable and Other Current Liabilities
Accounts payable and other current liabilities consisted of the following:
|
|
December 31, |
|
||||
|
|
2013 |
|
2012 |
|
||
Interest |
|
$ |
5,855 |
|
$ |
— |
|
Legal |
|
|
67,908 |
|
|
161,502 |
|
Consulting |
|
|
7,730 |
|
|
— |
|
Research and development |
|
|
58,750 |
|
|
11,000 |
|
Other |
|
|
8,267 |
|
|
8,016 |
|
|
|
$ |
148,510 |
|
$ |
180,518 |
|
F - 9
TYME INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (Continued)
December 31, 2013 and 2012
(5) Convertible Notes Payable
On August 2, 2013, the Company entered into a Convertible Promissory Note Agreement (“Convertible Notes”) to be funded in a series of loans up to a maximum principal amount of $997,000. As of December 31, 2013, the Company received $926,000 in proceeds under the Convertible Notes. The Convertible Notes accrue interest at a rate of 2.5% per year. Principal repayments commence on April 30, 2014 equal to 1/24th of the then outstanding balance, with the entire principal amount due and payable on April 30, 2016.
If, prior to April 30, 2014, the Company enters into any financing transaction with the lender or an affiliate thereof, upon the closing the outstanding principal balance of the Convertible Notes shall automatically convert on a dollar for dollar basis into the securities being issued and sold at a conversion price equal to the purchase price per share implied by a pre-investment valuation of the Company equal to $20 million, (“Conversion Price”), Further, if the Company enters into an agreement with a third party, other than the lender or affiliate thereof, into any debt or equity financing, exclusive license of any portion of the IP Rights, a sale of substantially all of the assets of the Company, or subsidiary thereof, or any transaction or series of transactions resulting in the current stockholders holding less than a majority of the voting interests, then, at the lender’s option, effective immediately prior to closing of the third party transaction the outstanding principal balance of the Convertible Notes shall be converted on a dollar for dollar basis into shares of Company Common Stock. In the case of conversion of principal under either scenario, the Company would have no further obligations or liabilities under the Convertible Notes.
In connection with the issuance of the Convertible Notes the Company determined that the conversion feature was not an embedded derivative requiring bifurcation and separate accounting treatment as the conversion feature was indexed to the Company’s own stock. The Company also determined the conversion feature did not result in a beneficial conversion feature requiring separate accounting treatment because the conversion rate approximated the fair value of the Company Common Stock at the commitment date.
The Company recorded interest expense of $5,855 during 2013, on the Convertible Notes. This amount is included in Accounts payable and other current liabilities. The Convertible Notes outstanding principal and accrued interest balance at December 31, 2013 was $931,855. As of December 31, 2013, future maturities of the Convertible Notes are $347,250 in 2014, $463,000 in 2015 and $115,750 in 2016.
In January 2014, the lender increased the aggregate principal amount of the Convertible Notes from $997 thousand to $1.126 million and advanced funds to the Company to the effect, that the total amount funded to the Company was equal to the increased principal amount of the Convertible Notes. On August 28, 2014, the Company was notified by the lender that the lender was exercising the conversion feature in the Convertible Notes (See Note 10).
(6) Income Taxes
No provision for U.S. federal or state income taxes has been recorded as the Company has incurred net operating losses since inception. Significant components of the Company’s net deferred income tax assets as of December 31, 2013 and 2012 consist of the following:
|
|
|
2013 |
|
|
2012 |
|
Net deferred tax assets |
|
|
|
|
|
|
|
Tax loss carry-forwards |
|
$ |
266,000 |
|
$ |
— |
|
Other assets |
|
|
— |
|
|
— |
|
Research and development credits |
|
|
— |
|
|
— |
|
Other liabilities |
|
|
— |
|
|
— |
|
Valuation allowance |
|
|
(266,000 |
) |
|
— |
|
|
|
|
|
|
|
|
|
Total net deferred income taxes |
|
$ |
— |
|
$ |
— |
|
F - 10
TYME INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (Continued)
December 31, 2013 and 2012
(6) Income Taxes (Continued)
A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 2013 and 2012 is as follows:
|
|
2013 |
|
|
2012 |
|
||
U.S. federal tax rate |
|
|
35.00 |
% |
|
|
— |
% |
State tax rate |
|
|
5.00 |
% |
|
|
— |
% |
Valuation allowance |
|
|
(40.00 |
)% |
|
|
— |
% |
|
|
|
|
|
|
|
|
|
|
|
|
— |
% |
|
|
— |
% |
Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carry-forward period. Due to the Company’s history of operating losses, the deferred tax assets arising from the aforementioned future tax benefits are currently not likely to be realized and, accordingly, are offset by a full valuation allowance. The income tax provision varies from the expected provision determined by applying the federal statutory income tax rate to income (loss).
As of December 31, 2013, the Company has net operating loss carry-forwards of approximately $ 666 thousand available to offset federal and state income tax, which expire through 2033. Utilization of the net operating loss carry-forwards may be subject to a substantial annual limitation due to the ownership change limitations provided by the Internal Revenue Code of 1986, as amended, or the IRC, and similar state provisions. The effect of an ownership change could be an imposition of an annual limitation on the use of net operating loss carry-forwards attributable to periods before the change.
(7) Stockholders’ Deficit
Common Stock
Authorized, Issued and Outstanding
The Company is authorized to issue 1,000,000 shares of common stock, with a par value of $0.001, of which 2,000 shares were issued and outstanding at December 31, 2013. As a result of the recapitalization as described in Note 2, stockholders’ deficiency has been presented to reflect this recapitalization as of the earliest period presented in these consolidated financial statements.
Voting
Each holder of Company Common Stock is entitled to one vote for each share thereof held by such holder at all meetings of stockholders (and written action in lieu of meetings). The number of authorized shares of Company Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of majority of the combined number of issued and outstanding shares of the Company.
Dividends
Dividends may be declared and paid on the Company Common Stock from funds lawfully available therefore, as and when determined by the board of directors.
Liquidation
In the event of the liquidation, dissolution, or winding-up of the Company, holders of Company Common Stock will be entitled to receive all assets of the Company available for distribution to its stockholders.
F - 11
TYME INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (Continued)
December 31, 2013 and 2012
(8) Commitments
Contract Service Providers
In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development and clinical research activities. Substantially all of these arrangements are on an as needed basis.
(9) Related Party Transactions
Due from Stockholders/Members
The Company obtains from and grants cash advances to certain of its stockholders. These net advances are non-interest bearing and have no terms for repayment. The amounts due as of December 31, 2013 and 2012 were $1,306,238 and $595,657, respectively. Such amounts have been reflected as a reduction of stockholders’ equity. For financial statement presentation, $20,000 has been reclassified from accounts payable relating to amounts owed to stockholders in arriving at the amount presented for 2013. Certain amounts due at December 31, 2013 have been satisfied subsequent to year end (see Note 10).
(10) Subsequent Events
The Company evaluates events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. For its consolidated financial statements as of December 31, 2013 and for the year then ended, the Company evaluated subsequent events through the date of the issuance of the consolidated financial statements. There are no subsequent events to be recognized or reported are as follows:
During January 2014, the Convertible Notes which provided for funding in a series of loans up to a maximum principal amount of $997,000 was increased to a maximum principal amount of $1,126,000 and the lender made additional advances under the Convertible Notes totaling $200,000.
In May 2014, certain stockholders of the Company individually purchased 100 percent of the noncontrolling interest in the Company’s subsidiary, Luminant, which in turn was contributed to the Company by them in satisfaction of certain outstanding amounts included in due from stockholders/members as of December 31, 2013.
On June 6, 2014, the Company entered into a Term Sheet (the “GEM Term Sheet”) whereby GEM Global Yield Fund, LLC SCS and/or its affiliates and assigns (GEM) will assist the Company and Global Group Enterprises Corp., a U.S. publicly traded company, in connection with a merger and private placement offering (PPO). The proposed date of the merger and the First PPO was to be August 31, 2014. This date has since been extended to November 15, 2014. The GEM Term Sheet also contemplated a fifteen month bridge loan which would convert into Company Common Stock upon completion of the PPO.
On July 3, 2014, a stockholder conveyed personal ownership of certain patents relating to the field of cancer treatment to the Company, which were filed and disclosed in the US Patent Office. On July 9, 2014 the Company entered into a License Agreement with this stockholder as the stockholder desired to retain the right to certain assigned patents to use and commercialize the patents in all other fields other than the treatment of cancer. Pursuant to the License Agreement, the Company has granted the stockholder an exclusive, worldwide, royalty-free license to develop, make, have made, use, sell, offer to sell, import, export and distribute products or services in fields other than the treatment of cancer. This license is to include the right to sublicense to any third party so long as such sublicense is consistent with the terms of the License Agreement and contains terms reasonably sufficient for the third party to satisfy its obligations thereunder.
F - 12
TYME INC. AND SUBSIDIARY
Notes to Consolidated Financial Statements (Continued)
December 31, 2013 and 2012
(10) Subsequent Events (Continued)
On July 11, 2014, the Company entered into a Securities Purchase Agreement (SPA) and received $1,100,000 in proceeds from the issuance of a convertible promissory note (the “Bridge Note”) from an investor who is an affiliate of GEM. The Bridge Note bears interest at a rate of 10% per year, maturing fifteen months from the date of issue and is secured by all assets of the Company. The Bridge Note is mandatorily convertible upon the closing of the PPO. The Company issued in the name of the purchaser of the Bridge Note but placed into escrow 100 shares of Company Common Stock. These shares currently are not deemed outstanding, but will either be delivered to the Bridge Note purchaser or returned to the Company for cancellation pursuant to the terms of the Termination Shares Escrow Agreement, dated as of July 3, 2014.
On August 28, 2014, the lender converted its Convertible Notes in the aggregate principal amount of $1.126 million into 106.6 shares of the Company’s Common Stock. Simultaneous with the issuance of the 106.6 shares to the Lender, the two principal stockholders of the Company, as capital contributions, surrendered to the Company for cancellation an aggregate of 106.6 shares of Company Common Stock. The net effect of such issuance and cancellations resulted ins no change in the total number of shares of Company Common Stock issued (2,100) and outstanding (2,000).
F - 13
TYME INC. AND SUBSIDIARY
Consolidated Balance Sheets
|
|
September 30, |
|
December 31, |
|
||
|
|
2014 |
|
2013 |
|
||
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash |
|
$ |
289,628 |
|
$ |
92,620 |
|
Prepaid assets |
|
|
118,905 |
|
|
110,180 |
|
Total current assets |
|
|
408,533 |
|
|
202,800 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
20,503 |
|
|
21,429 |
|
Total assets |
|
$ |
429,036 |
|
$ |
224,229 |
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Deficiency |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and other current liabilities |
|
$ |
347,309 |
|
$ |
148,510 |
|
Current maturities of convertible notes |
|
|
— |
|
|
347,249 |
|
Current maturities of senior secured bridge notes |
|
|
1,100,000 |
|
|
— |
|
Total current liabilities |
|
|
1,447,309 |
|
|
495,759 |
|
|
|
|
|
|
|
|
|
Convertible notes less current maturities |
|
|
— |
|
|
578,751 |
|
Total liabilities |
|
|
1,447,309 |
|
|
1,074,510 |
|
|
|
|
|
|
|
|
|
Commitments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ deficit |
|
|
|
|
|
|
|
Common stock, $0.001 par value, 1,000,000 shares authorized, 2,100 shares issued and 2,000 shares outstanding at September 30, 2014 and 2,000 shares issued and outstanding at December 31, 2013, respectively |
|
|
2 |
|
|
2 |
|
Additional paid in capital |
|
|
2,044,914 |
|
|
2,008 |
|
Accumulated deficit |
|
|
(2,707,424 |
) |
|
(1,522,746 |
) |
Total Tyme Inc stockholders’ deficit |
|
|
(662,508 |
) |
|
(1,520,736 |
) |
|
|
|
|
|
|
|
|
Noncontrolling interests |
|
|
— |
|
|
1,976,693 |
|
Due from stockholders/members |
|
|
(355,765 |
) |
|
(1,306,238 |
) |
Total stockholders’ deficit |
|
|
(1,018,273 |
) |
|
(850,281 |
) |
Total liabilities and stockholders’ deficiency |
|
$ |
429,036 |
|
$ |
224,229 |
|
See accompanying notes to condensed financial statements.
F - 14
TYME INC. AND SUBSIDIARY
Consolidated Statements of Operations
|
|
(Unaudited) |
|
(Unaudited) |
|
||||||||
|
|
For the three months ended
|
|
For the nine months ended
|
|
||||||||
|
|
2014 |
|
2013 |
|
2014 |
|
2013 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
286,979 |
|
$ |
167,494 |
|
$ |
431,274 |
|
$ |
455,944 |
|
General and administrative |
|
|
601,473 |
|
|
126,003 |
|
|
719,851 |
|
|
198,634 |
|
Total operating expenses |
|
|
888,452 |
|
|
293,497 |
|
|
1,151,125 |
|
|
654,578 |
|
Loss from operations |
|
|
(888,452 |
) |
|
(293,497 |
) |
|
(1,151,125 |
) |
|
(654,578 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
30,544 |
|
|
2,037 |
|
|
44,509 |
|
|
2,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(918,996 |
) |
|
(295,534 |
) |
|
(1,195,634 |
) |
|
(656,615 |
) |
Loss attributable to noncontrolling interests |
|
|
(83 |
) |
|
(68,213 |
) |
|
(10,956 |
) |
|
(188,573 |
) |
Loss attributable to controlling interests |
|
$ |
(918,913 |
) |
$ |
(227,321 |
) |
$ |
(1,184,678 |
) |
$ |
(468,042 |
) |
See accompanying notes to condensed financial statements.
F - 15
TYME INC. AND SUBSIDIARY
Consolidated Statements of Changes in Stockholders’ Deficiency
For the periods ended September 30, 2014
(Unaudited)
|
|
|
|
|
|
Additional |
|
|
|
Non |
|
Due from |
|
Total |
|
|||||
|
Common stock |
|
paid-in- |
|
Accumulated |
|
Controlling |
|
stockholders/ |
|
stockholders’ |
|
||||||||
|
Shares |
|
Amount |
|
capital |
|
deficit |
|
interests |
|
members |
|
deficiency |
|
||||||
Balance, January 1, 2013 |
— |
|
$ |
— |
|
$ |
2,010 |
|
$ |
(750,921 |
) |
$ |
1,166,140 |
|
$ |
(595,657 |
) |
$ |
(178,428 |
) |
Shares issued |
2,000 |
|
|
2 |
|
|
(2 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Capital contributions |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,096,400 |
|
|
— |
|
|
1,096,400 |
|
Advances to stockholders/members |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(710,581 |
) |
|
(710,581 |
) |
Net loss |
— |
|
|
— |
|
|
— |
|
|
(771,825 |
) |
|
(285,847 |
) |
|
— |
|
|
(1,057,672 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2013 |
2,000 |
|
|
2 |
|
|
2,008 |
|
|
(1,522,746 |
) |
|
1,976,693 |
|
|
(1,306,238 |
) |
|
(850,281 |
) |
Conversion of $1.126 million plus interest of conversion debt into 106.6 shares of common stock |
106.6 |
|
|
— |
|
|
1,152,242 |
|
|
— |
|
|
— |
|
|
— |
|
|
1,152,242 |
|
Surrender of common stock by two principal shareholders of the Company for cancellation of 106.6 shares of Company common stock |
(106.6 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Capital contributions |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
25,000 |
|
|
— |
|
|
25,000 |
|
Advances to stockholders/members |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(149,600 |
) |
|
(149,600 |
) |
Luminant stockholder loans assigned in buyout of noncontrolling interests by certain stockholders of Tyme |
— |
|
|
— |
|
|
(1,100,073 |
) |
|
— |
|
|
— |
|
|
1,100,073 |
|
|
— |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
(1,184,678 |
) |
|
(10,956 |
) |
|
— |
|
|
(1,195,634 |
) |
Contribution of noncontrolling interest |
— |
|
|
— |
|
|
1,990,737 |
|
|
— |
|
|
(1,990,737 |
) |
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, September 30, 2014 |
2,000 |
|
$ |
2 |
|
$ |
2,044,914 |
|
$ |
(2,707,424 |
) |
$ |
— |
|
$ |
(355,765 |
) |
$ |
(1,018,273 |
) |
See accompanying notes to condensed financial statements.
F - 16
TYME INC. AND SUBSIDIARY
Consolidated Statements of Cash Flows
(Unaudited)
|
|
For the nine months ended
|
|
||||
|
|
2014 |
|
2013 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,195,634 |
) |
$ |
(656,615 |
) |
Adjustments to reconcile net loss to net cash from operating activities: |
|
|
|
|
|
|
|
Depreciation |
|
|
3,635 |
|
|
376 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Prepaid assets |
|
|
(8,725 |
) |
|
(110,080 |
) |
Accounts payable and other current liabilities |
|
|
225,042 |
|
|
27,431 |
|
Net cash used in operating activities |
|
|
(975,682 |
) |
|
(738,888 |
) |
|
|
|
|
|
|
|
|
Cash flows from investing activity: |
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(2,710 |
) |
|
(12,473 |
) |
Net cash used in investing activities |
|
|
(2,710 |
) |
|
(12,473 |
) |
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
Capital contributions - noncontrolling interest |
|
|
25,000 |
|
|
831,400 |
|
Proceeds from issuance of convertible notes |
|
|
200,000 |
|
|
500,000 |
|
Proceeds from secured bridge note |
|
|
1,100,000 |
|
|
— |
|
Changes in due from stockholders/members |
|
|
(149,600 |
) |
|
(436,052 |
) |
Net cash provided by financing activities |
|
|
1,175,400 |
|
|
895,348 |
|
|
|
|
|
|
|
|
|
Net increase in cash |
|
|
197,008 |
|
|
143,987 |
|
|
|
|
|
|
|
|
|
Cash - beginning of year |
|
|
92,620 |
|
|
— |
|
|
|
|
|
|
|
|
|
Cash - end of year |
|
$ |
289,628 |
|
$ |
143,987 |
|
|
|
|
|
|
|
|
|
Supplemental Cash Flow Information: |
|
|
|
|
|
|
|
Cash paid for interest and income taxes are as follows: |
|
|
|
|
|
|
|
Interest |
|
$ |
— |
|
$ |
— |
|
Income taxes |
|
$ |
— |
|
$ |
— |
|
|
|
|
|
|
|
|
|
Noncash investing and financing activities: |
|
|
|
|
|
|
|
Issuance of common stock as a result of contribution of member interest in Luminant Biosciences LLC |
|
$ |
— |
|
$ |
2 |
|
Conversion of $1.126 million of convertible debt into 106.6 shares of common stock. Simultaneously, stockholders surrendered an equal amount of their own common stock, thereby having no change in the total number of shares outstanding. |
|
$ |
1,152,242 |
|
$ |
— |
|
Luminant stockholder loans assigned in buyout of noncontrolling interests by certain stockholders of Tyme |
|
$ |
1,100,703 |
|
$ |
— |
|
Contribution of noncontrolling interests by stockholders of Tyme |
|
$ |
1,990,737 |
|
$ |
— |
|
See accompanying notes to condensed financial statements.
F - 17
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements
September 30, 2014
(1) Background and Nature of Business
Tyme Inc. and Subsidiary (the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications. Tyme Inc. (“Tyme”) was incorporated in Delaware in 2013 and its operations to date have been directed primarily toward developing business strategies, research and development activities and preparing for clinical trials for its product candidates. The Company has focused its research and development efforts on a proprietary platform technology for which it retains global intellectual property (IP) and commercial rights.
The Company is currently formulating its regulatory and drug development program for SM-88, working towards the initiation of its first phase II clinical trial.
Assignment of Interest in Luminant
On July 26, 2013, the founding stockholders (“the Founders”) of the Company entered into a Founder Contribution and Exchange Agreement under which the Founders contributed their membership units in Luminant Biosciences, LLC. (“Luminant”) to the Company in exchange for 2,000 shares of common stock, par value $0.001 per share (the “Company Common Stock”) of the Company. As a result of the transaction, as of December 31, 2013, Luminant Biosciences, LLC is 66 2/3% owned by the Company. The two Founders are two executive officers of the Company and collectively own more than 50 percent of the Company’s outstanding stock as of December 31, 2013. Since this transaction is among entities under common control, no gain or loss is recognized in the consolidated financial statements and the carrying amounts of the net assets are eliminated in consolidation.
In May 2014, the Founders of the Company individually acquired the noncontrolling interest in Luminant and contributed it to the Company making Luminant a wholly owned subsidiary of the Company (See Noncontrolling Interests).
Term Sheet for Pending Merger
On June 6, 2014, the Company entered into a Term Sheet (the “GEM Term Sheet”) whereby GEM Global Yield Fund, LLC SCS and/or its affiliates and assigns (GEM) will assist the Company and Global Group Enterprises Corp., a U.S. publicly traded company, in connection with a merger and private placement offering (PPO). The proposed date of the merger and the First PPO was to be August 31, 2014. This date was extended to November 15, 2014. The GEM Term Sheet also contemplated a fifteen month bridge loan which would convert into Company Common Stock upon completion of a contemplated offering of securities. Such Bridge Loan was consummated as of July 11, 2014 (See Note 6).
(2) Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim financial statements of the Company have been prepared on the accrual basis of accounting in accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information. In the opinion of management, the accompanying financial statements of the Company, include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of September 30, 2014 and its results of operations and cash flows for the nine months ended September 30, 2014 and 2013. Operating results for the nine months ended September 30, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014. The interim financial statements, presented herein, do not contain the required disclosures under U.S. GAAP for annual financial statements. The accompanying unaudited interim financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2013.
F - 18
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(2) Summary of Significant Accounting Policies (continued)
Liquidity and Going Concern
The Company has incurred losses and negative cash flows from operations since inception (July 26, 2013) and has an accumulated deficit of approximately $1.0 million and $850 thousand as of September 30, 2014 and December 31, 2013, respectively. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its product candidates currently in development. The Company’s primary sources of liquidity to date has been the issuance of convertible promissory notes on August 2, 2013 and July 3, 2014 and contributed capital by the founders. The Company received approximately $2.2 million from the issuance of convertible promissory notes and approximately $2.7 million in of historical capital contributions in Luminant by one of its members. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its technologies and product candidates. There is no assurance that such financing will be available when needed or on acceptable terms. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded assets amounts or the amounts and classification of liabilities the might result from the outcome of this uncertainty.
Notwithstanding the Bridge Note and Merger as further discussed in Note 11, management is evaluating different strategies to obtain the required additional funding of future operations. These strategies may include, but are not limited to: additional funding from current or new investors, borrowings of debt, and/or a public offering of the Company’s equity or debt securities s. There can be no assurance that these future funding efforts will be successful.
The Company is subject to those risks associated with any specialty pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Significant items subject to such estimation include the stated value of the Company underlying the conversion feature of the outstanding convertible notes payable. Actual results could differ from such estimates.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, including accounts payable and accrued expenses approximates fair value given their short-term nature. The carrying amount of the convertible promissory notes payable approximates fair value because the interest rates on these instruments are reflective of rates that the Company could obtain on unaffiliated third party debt with similar terms and conditions.
Prepaid Assets
Prepaid assets represents expenditures made in advance of when the economic benefit of the cost will be realized, and which will be expensed in future periods with the passage of time or when a triggering event occurs.
F - 19
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(2) Summary of Significant Accounting Policies (continued)
Property and Equipment, Net
Property and equipment are recorded at cost and are depreciated on a straight-line basis over their estimated useful lives. The Company estimates a life of five to seven years for equipment and furniture and fixtures. Upon sale or retirement, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in operating expenses. Repairs and maintenance costs are expensed as incurred.
Intangible Assets
The Company’s intangible assets consist of patents and patent applications contributed by the founders. This intellectual property value has been recorded as a de Minimis amount of $2,000 and included in the respective stockholder receivable accounts since no monies have been transferred. The patents have not been amortized and have a useful life of twenty years.
Impairment of Long-Lived Assets
The Company assesses the recoverability of its long-lived assets, which include fixed assets whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the periods ended September 30, 2014 and 2013, the Company determined that there was no impairment of its long-lived assets.
Research and Development
Research and development costs are expensed as incurred and are primarily comprised of, but not limited to, external research and development expenses incurred under arrangements with third parties, such as contract research organizations (CROs), contract manufacturing organizations (CMOs) and consultants that conduct clinical and preclinical studies, costs associated with preclinical and development activities, costs associated with regulatory operations, depreciation expense for assets used in research and development activities and employee related expenses including salaries and benefits for research and development personnel. Costs for certain development activities, such as clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expense, which are reported in prepaid assets or accounts payable and other current liabilities.
Noncontrolling interest
Noncontrolling interests represents the minority member’s interest in the Company’s subsidiary, Luminant. At December 31, 2013, the Company owned 66 2/3 percent of Luminant representing 66 2/3 percent of the voting control, which requires that Luminant’s operations be included in the consolidated financial statements. The 33 1/3 percent interest of Luminant that is not owned by the Company is shown as noncontrolling interests in the 2014 and 2013 consolidated statement of operations and consolidated balance sheet.
In May 2014, certain stockholders of the Company individually purchased 100 percent of the noncontrolling interest in the Company’s subsidiary, Luminant, which in turn was contributed to the Company by them in satisfaction of certain outstanding amounts included in due from stockholders/members’ as of December 31, 2013. As the result of the contribution of the noncontrolling interest, Luminant became a wholly owned subsidiary of the Company.
F - 20
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(2) Summary of Significant Accounting Policies (continued)
Income Taxes
The Company’s subsidiary, Luminant, operates as a limited liability corporation for federal and state income tax purposes. Accordingly, the taxable income or loss of Luminant passes to the individual members rather than pay taxes at the corporate level through the date the Founders contributed their 66 2/3 ownership in Luminant to the Company and accordingly there is no provision for income or deferred taxes for the year ended December 31, 2013.
From the date of inception (July 26, 2013) through September 30, 2014, the Company operates as a C-Corporation and includes in its income its share of the income/loss of Luminant. Deferred tax assets or liabilities are recorded for temporary differences between financial reporting and tax basis of assets and liabilities, using enacted rates in effect for the year in which the differences are expected to reverse.
A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. The Company has provided a full valuation allowance on its deferred tax assets that consists of cumulative net operating losses of $1.829 million for the period from inception (July 26, 2013) to September 30, 2014. Due to its cumulative loss position, history of operating losses and losses expected to be incurred in the foreseeable future, a full valuation allowance was considered necessary.
The utilization of net operating losses for Federal income tax purposes sustained by the Company could be substantially limited annually if there were an “ownership change” (as defined by Section 382 of the Internal Revenue Code of 1986, as amended). If it were determined that there is a change in ownership, of if the Company undergoes a change of ownership in the future, the utilization of the Company’s net operating loss carry-forward may be materially limited. This could result in a reduction in equal amounts to the deferred tax assets and the related valuation reserves.
The Company is required to evaluate uncertain tax positions taken or expected to be taken in the course of preparing the Company’s consolidated financial statements to determine whether the tax positions are more likely than not of being sustained by the applicable tax authority. Tax positions with respect to tax at the Company level deemed not to meet the “more-likely than-not” threshold would be recorded as a tax expense in the current year. The Company has concluded that no provision for uncertain tax positions is required in the Company’s consolidated financial statements.
The Company had no unrecognized tax benefits at September 30, 2014 and 2013. The tax years which currently remain subject to examination by major tax jurisdictions as of September 30, 2014 are the years ended December 31, 2011 through 2013. In addition, the Company had no income tax related penalties or interest for periods presented in these consolidated financial statements.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views their operations and manages their business in one segment.
Concentration of Credit Risk
Financial instruments that potentially expose Tyme to concentration of credit risk consist primarily of cash. Cash is deposited with major banks and at times, such balances with any one financial institution may be in excess of FDIC insurance limits. The Company believes no significant concentration of credit risk exists.
F - 21
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(3) Property and Equipment, Net
Property and equipment, net consisted of the following:
|
September 30, |
|
December 31, |
|
||
|
2014 |
|
2013 |
|
||
|
(Unaudited) |
|
|
|
||
Furniture and fixtures |
$ |
2,200 |
|
$ |
2,200 |
|
Machinery and equipment |
|
22,662 |
|
|
1,200 |
|
Construction in process |
|
— |
|
|
18,753 |
|
|
|
24,862 |
|
|
22,153 |
|
Less: accumulated depreciation |
|
4,359 |
|
|
724 |
|
|
$ |
20,503 |
|
$ |
21,429 |
|
Depreciation expense was $3,635 and $-0- for the nine months ended September 30, 2014 and 2013, respectively. Depreciation expense was $1,073 and $139 for the three months ended September 30, 2014 and 2013, respectively.
(4) Intangible Assets
On July 3, 2014, a stockholder conveyed personal ownership of certain patents and patent applications relating to the field of cancer treatment to the Company, which were filed and disclosed in the US Patent Office. On July 9, 2014 the Company entered into a License Agreement with this stockholder as the stockholder desired to retain the right to certain assigned patents and patent applications to use and commercialize the patents in all other fields other than the treatment of cancer. Pursuant to the License Agreement, the Company has granted the stockholder an exclusive, worldwide, royalty-free license to develop, make, have made, use, sell, offer to sell, import, export and distribute products or services in fields other than the treatment of cancer. This license includes the right to sublicense to any third party so long as such sublicense is consistent with the terms of the License Agreement and contains terms reasonably sufficient for the third party to satisfy its obligations thereunder.
(5) Accounts Payable and Other Current Liabilities
Accounts payable and other current liabilities consisted of the following:
|
September 30, |
|
December 31, |
|
||
|
2014 |
|
2013 |
|
||
|
(Unaudited) |
|
|
|
||
Interest |
$ |
24,122 |
|
$ |
5,855 |
|
Legal |
|
206,025 |
|
|
67,908 |
|
Consulting |
|
7,730 |
|
|
7,730 |
|
Research and development |
|
58,750 |
|
|
58,750 |
|
Professional |
|
42,263 |
|
|
— |
|
Other |
|
8,419 |
|
|
8,267 |
|
|
$ |
347,309 |
|
$ |
148,510 |
|
F - 22
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(6) Debt
Convertible Notes Payable
On August 2, 2013, the Company entered into a Convertible Promissory Note Agreement (the” Convertible Note Agreement”) to be funded in a series of loans up to a maximum principal amount of $997,000 (“Convertible Notes”). As of December 31, 2013, the Company received $926,000 in proceeds under the Convertible Notes. The Convertible Notes accrue interest at a rate of 2.5% per year. Principal repayments were to commence on April 30, 2014 equal to 1/24th of the then outstanding balance, with the entire principal amount due and payable on April 30, 2016.
The Convertible Note Agreement provided that if, prior to April 30, 2014, the Company enters into any financing transaction with the lender or an affiliate thereof, upon the closing the outstanding principal balance of the Convertible Notes shall automatically convert on a dollar for dollar basis into the securities being issued and sold at a conversion price equal to the purchase price per share implied by a pre-investment valuation of the Company equal to $20 million (“Conversion Price”). The Convertible Note Agreement further provided that if the Company enters into an agreement with a third party, other than the lender or affiliate thereof, into any debt or equity financing, exclusive license of any portion of the IP Rights, a sale of substantially all of the assets of the Company, or subsidiary thereof, or any transaction or series of transactions resulting in the current stockholders holding less than a majority of the voting interests, then, at the lender’s option, effective immediately prior to closing of the third party transaction the outstanding principal balance of the Convertible Notes shall be converted on a dollar for dollar basis into shares of Company Common Stock. The Convertible Note Agreement provided that in the case of conversion of principal under either scenario, the Company would have no further obligations or liabilities under the Convertible Notes.
In January 2014, the lender increased the aggregate principal amount of the Convertible Notes from $997 thousand to $1.126 million and advanced funds to the Company to the effect, that the total amount funded to the Company was equal to the increased principal amount of the Convertible Notes.
On August 28, 2014, the lender converted the Convertible Notes in the aggregate principal amount of $1.126 million into 106.6 shares of the Company Common Stock. Simultaneous with the issuance of the 106.6 shares to the Lender, the two principal stockholders of the Company, as capital contributions, surrendered to the Company for cancellation an aggregate of 106.6 shares of Company Common Stock. The net effect of such issuance and cancellations resulted in no change in the total number of shares of Company Common Stock issued (2,100) and outstanding (2,000).
The Company recorded interest expense relating to these Convertible Notes of $20,387 and $2,037 during the nine months ended September 30, 2014 and 2013, respectively. The Company recorded interest expense relating to these Convertible Notes of $6,422 and $2,037 during the three months ended September 30, 2014 and 2013, respectively. The outstanding principal and accrued interest balance at September 30, 2014 and 2013 was $-0- and $502,037, respectively.
On July 11, 2014, the Company entered into a Securities Purchase Agreement (SPA) and received $1,100,000 in proceeds from the issuance of a convertible promissory note (the “Bridge Note”) from an investor who is an affiliate of GEM. The Bridge Note bears interest at a rate of 10% per year, maturing fifteen months from the date of issue and is secured by all assets of the Company. The Bridge Note is mandatorily convertible upon the closing of the PPO at the conversion price as defined in the merger agreement contemplated in the GEM Term Sheet. The Company issued in the name of the purchaser of the Bridge Note but placed into escrow 100 shares of Company Common Stock. These shares currently are not deemed outstanding, but will either be delivered to the Bridge Note purchaser or returned to the Company for cancellation pursuant to the terms of a Termination Shares Escrow Agreement, dated as of July 3, 2014 among the Company, the holder of the Bridge Note, and the escrow agents.
On November 24, 2014, the Bridge Note was amended and revised to increase the principal amount to $1.35 million. On January 15, 2015, the Bridge Notes was further amended and revised to increase the principal amount to $2.31 million (see Note 11).
The Company recorded interest expense of $24,122 and $-0- during the nine months ended September 30, 2014 and 2013, respectively, on this convertible promissory note. The Company recorded interest expense of $24,122 and $-0- during the three months ended September 30, 2014 and 2013, respectively, on this convertible promissory note. The outstanding principal and accrued interest balance at September 30, 2014 and 2013 was $1,124,122 and $-0-, respectively.
F - 23
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(7) Income Taxes
No provision for U.S. federal or state income taxes has been recorded as the Company has incurred net operating losses since inception. Significant components of the Company’s net deferred income tax assets as of September 30, 2014 and December 31, 2013 consist of the following:
|
|
September 30,
|
|
December 31,
|
|
||
|
|
(Unaudited) |
|
|
|
||
Net deferred tax assets |
|
|
|
|
|
|
|
Tax loss carry-forwards |
|
$ |
731,500 |
|
$ |
266,000 |
|
Other assets |
|
|
— |
|
|
— |
|
Research and development credits |
|
|
— |
|
|
— |
|
Other liabilities |
|
|
— |
|
|
— |
|
Valuation allowance |
|
|
(731,500 |
) |
|
(266,000 |
) |
|
|
|
|
|
|
|
|
Total net deferred income taxes |
|
$ |
— |
|
$ |
— |
|
A reconciliation of the statutory tax rates and the effective tax rates for the periods ended September 30, 2014 and December 2013 is as follows:
|
|
September 30,
|
|
|
December 31,
|
|
||
|
|
(Unaudited) |
|
|
|
|
||
U.S. federal tax rate |
|
|
35.00 |
% |
|
|
35.0 |
% |
State tax rate |
|
|
5.00 |
% |
|
|
5.0 |
% |
Valuation allowance |
|
|
(40.00 |
)% |
|
|
(40.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
— |
% |
|
|
— |
% |
Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carry-forward period. Due to the Company’s history of operating losses, the deferred tax assets arising from the aforementioned future tax benefits are currently not likely to be realized and, accordingly, are offset by a full valuation allowance. The income tax provision varies from the expected provision determined by applying the federal statutory income tax rate to income (loss).
As of September 30, 2014 and December 31, 2013, the Company has net operating loss carry-forwards of approximately $1.829 million available to offset federal and state income tax, which expire through 2033. Utilization of the net operating loss carry-forwards may be subject to a substantial annual limitation due to the ownership change limitations provided by the Internal Revenue Code of 1986, as amended, or the IRC, and similar state provisions. The effect of an ownership change could be an imposition of an annual limitation on the use of net operating loss carry-forwards attributable to periods before the change.
F - 24
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(8) Stockholders’ Deficit
Common Stock
Authorized, Issued and Outstanding
The Company is authorized to issue 1,000,000 shares of common stock, with a par value of $0.001, of which 2,100 and 2,000 shares were issued and 2,000 and 2,000 shares were outstanding at September 30, 2014 and December 31, 2013, respectively. As a result of the recapitalization, stockholders’ deficiency has been presented to reflect this recapitalization as of the earliest period presented in these consolidated financial statements.
Voting
Each holder of Company Common Stock is entitled to one vote for each share thereof held by such holder at all meetings of stockholders (and written action in lieu of meetings). The number of authorized shares of Company Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of majority of the combined number of issued and outstanding shares of the Company.
Dividends
Dividends may be declared and paid on the Company Common Stock from funds lawfully available therefore, as and when determined by the board of directors.
Liquidation
In the event of the liquidation, dissolution, or winding-up of the Company, holders of Company Common Stock will be entitled to receive all assets of the Company available for distribution to its stockholders.
(9) Commitments
Contract Service Providers
In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development and clinical research activities. Substantially all of these arrangements are on an as needed basis.
(10) Related Party Transactions
Due from Stockholders/Members
The Company obtains from and grants cash advances to certain of its stockholders. These net advances are non-interest bearing and have no terms for repayment. The amounts due as of September 30, 2014 and December 31, 2013 were $355,765 and $1,306,238, respectively. Such amounts have been reflected as a reduction of stockholders’ equity. For financial statement presentation, $20,000 has been reclassified from accounts payable relating to amounts owed to stockholders in arriving at the amount presented for September 30, 2014 and December 31, 2013.
In May 2014, certain stockholders of the Company individually purchased 100 percent of the noncontrolling interest in the Company’s subsidiary, Luminant, which in turn was contributed to the Company by them in satisfaction of certain outstanding amounts included in due from stockholders/members as of December 31, 2013.
F - 25
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(11) Subsequent Events
The Company evaluates events or transactions that occur after the balance sheet date but prior to the issuance of financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. For its interim financial statements as of September 30, 2014 and for the quarter then ended, the Company evaluated subsequent events through the date of the issuance of the financial statements. There are no subsequent events to be recognized or reported that are not already previously disclosed including the following:
On November 24, 2014, the holder of the Bridge Note loaned the Company an additional $250,000. In connection with the funding of such loan, the Bridge Note was amended and restated to reflect a principal amount of $1.35 million. On January 15, 2015, the holder of the Bridge Note loaned the Company a further $960,000. In connection with the funding of such further loan, the Bridge Note was amended and restated to reflect a principal amount of $2.31 million. On March 5, 2015, the Bridge Note was further amended and restated to the effect that the mandatory conversion feature was amended to a set fixed conversion amount such that, upon mandatory conversion, the Bridge Note holder would receive one share of a specified company’s common stock for each $1.00 of principal of the Bridge Note outstanding as of the date of the mandatory conversion. The Company has evaluated the modification to the conversion rate as an inducement to convert the Bridge Note and has concluded that it provided the holder of the Bridge Note an incremental value of $3.465 million which will be charged as interest expense at the time of modification.
On March 5, 2015, the Company consummated a reverse triangular merger (the “Merger”) whereby a newly formed subsidiary of Tyme Technologies, Inc. (“Parent”) merged with and into the Company. The Merger resulted in the Company becoming a wholly-owned subsidiary of Parent and the stockholders of the Company as of immediately prior to the effective time of the Merger, receiving, in the aggregate, common stock of Parent equal to approximately 79% of the total number of shares of Parent common stock outstanding immediately following such issuance to such former Company stockholders. Contemporaneous with the closing of the Merger, among other matters, Parent completed a private placement of 2.716 million shares of Parent common stock for gross proceeds of $6.79 million (of which, $4.29 million was tendered in cash and the remaining subscription price paid by the delivery of a three-month promissory note in the principal amount of
$2.5 million (“PPO Note”) and the Bridge Note was converted into 2.31 million shares of Parent common stock. Parent common stock was the only equity securities of Parent outstanding prior to and immediately following consummation of the Merger, Parent’s private placement and the Bridge Note conversion. The foregoing aggregate 79% ownership of the post-Merger Parent by the former Company stockholders was calculated giving effect to the issuances of Parent common stock in Parent’s private placement and the conversion of the Bridge Note.
The PPO Note is secured by the escrow of 5 million shares of the post-merger Parent Common Stock. To the extent that the PPO Note is not paid at or prior to the Maturity Date, the escrowed shares will be forfeited to us for cancellation at the rate of one share for every $0.50 of PPO Note principal not paid to us.
Another condition to consummating the Merger is that Parent will retain a firm (the “IR Firm”) to provide investor relations services to the post-Merger Parent and the Parent has allocated 250,000 shares (the “IR Firm Shares”) of the Parents Common Stock for issuance to such firm. The appropriate accounting for the IR Firm Shares, which represents in substance a payment to a service provider, will be reflected as a charge to operations.
The investors in the PPO, along with the Bridge Note holder who received the Bridge Note Conversion Shares upon the automatic conversion of the Bridge Note which occured simultaneous with the closing of the PPO, will have anti-dilution protection on the shares purchased in the PPO or Bridge Note Conversion Shares (as the case may be) such that, if within two years after the closing of the Merger, Parent shall issue additional shares of Common Stock or common stock equivalents, for a consideration per share less than $0.50 (the “Lower Price”), each such investor and holder will be entitled to receive from the post-Merger Parent, additional shares, (“Lower Price Shares”) of Parent common stock in an amount such that, when added to the number of shares initially purchased by such investor or received upon conversion of the Bridge Note, will equal the number of shares that such investor’s PPO subscription amount would have purchased or the Bridge Note holder would have received upon conversion of the Bridge Note at the Lower Price. Management has not completed its assessment of the embedded feature related to the price protection provision and therefore has not included any adjustment(s) that may be required as a result of that analysis.
F - 26
TYME INC. AND SUBSIDIARY
Notes to Unaudited Interim Consolidated Financial Statements (continued)
September 30, 2014
(11) Subsequent Events (continued)
In connection with the PPO, post-merger Parent entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the purchasers in the PPO, holder of the Bridge Note and the IR Firm, pursuant to which Parent agreed that promptly, but no later than 90 calendar days following the maturity date of the PPO Note (such maturity date being 90 calendar days after the closing of the PPO), the Parent will file a registration statement with the SEC (the “Registration Statement”) covering (a) all of the PPO Shares issued in the PPO, (b) the Bridge Note Conversion Shares issued upon conversion of the Bridge Note, (c) the Lower Price Shares, if any, (d) the IR Firm Shares and (e) any shares of the Parent Common Stock issued or issuable with respect to the PPO Shares, Conversion Shares and Lower Price Shares upon any stock split, dividend or other distribution, recapitalization or similar event (collectively, the “PPO/Bridge Note Conversion Registrable Shares”). The Registration Statement will also cover 9% of the total number of shares issued to the former stockholders of the Company in connection with the Merger. The Parent is required to use commercially reasonable efforts to ensure that the Registration Statement is declared effective within 180 calendar days of filing with the SEC. If the Parent is late in filing the Registration Statement or if the Registration Statement is not declared effective within 180 days of its filing with the SEC, liquidated damages payable in cash by the post-Merger Parent to the holders of the PPO/Bridge Note Conversion Registrable Shares that have not been so registered will commence to accrue at a rate equal to $0.01 per Conversion Share and $0.025 per PPO Share for each full month that (i) Parent is late in filing the Registration Statement or (ii) the Registration Statement is late in being declared effective by the SEC; provided, however, that in no event shall the aggregate of any such per share liquidated damages exceed $0.08 per Conversion Share and $0.20 per PPO Share. Management has not completed its assessment of the embedded feature related to the registration rights provision and therefore has not included any adjustment(s) that may be required as a result of that analysis.
At the point of Merger and since inception, Parent was essentially a “Public Reporting Shell” with no substantive business operations. As such, Parent had negligible revenues and operating profits that require separate identification.
The Merger will begin to establish a public forum for the Company. Subject to executing on our goals, Management envisages that the public forum may help the Company secure necessary future funding in the public markets as it develops further its principal business focus as a clinical-stage biopharmaceutical enterprise focused on the development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications.
The transaction costs associated with the Merger relate to professional fees incurred in respect of Legal, Accounting and Audit. All such transaction costs, being associated with the final merger and issuance of equity, will be expensed as incurred and total approximately $1 million.
For accounting purposes the acquisition of the Company by Parent was considered a reverse acquisition, an acquisition transaction where the acquired company, the Company, is considered the acquirer for accounting purposes, notwithstanding the form of the transaction. The primary reason the transaction was treated as a purchase by the Company rather than a purchase by Parent was because Parent was a Public Reporting Shell company with limited operations and the Company’s stockholders gaining control of the voting power and outstanding share of Parent. Consequently, reverse acquisition accounting will be applied to the transaction. No additional goodwill or intangible assets are anticipated to be recognized in conjunction with the completion of the transaction..
On February 27, 2015, consistent with the Merger Agreement terms, non-interest bearing advances made to stockholders totaling $355,765 (See Note 10. Related Party Transactions) were settled by bonus compensation due to such stockholders being retained by the Company in lieu of payment.
F - 27
UNAUDITED PRO FORMA COMBINED CONSOLIDATED FINANCIAL DATA INFORMATION
On June 6, 2014 Global Group Enterprise Corp. (“Global”) entered into a combination agreement contemplating a plan of arrangement with Tyme Inc. (“Tyme”). Global is a Florida corporation and Tyme is a Delaware corporation. Global formed a Delaware subsidiary, Tyme Technologies, Inc. (“Technologies”) the surviving company in the merger, to facilitate the plan of arrangement. On March 5, 2015 Technologies and Tyme completed the transaction contemplated by the plan of arrangement. The combined companies now operate under the name “Tyme Inc.”.
The unaudited pro forma combined consolidated statement of operations of Tyme has been prepared by management after giving effect to the reverse merger transaction between Tyme and Technologies. The unaudited pro forma combined consolidated balance sheet has been presented as of September 30, 2014 and gives effect to the transaction as if it occurred on that date. The unaudited combined consolidated statement of operations for the fiscal year ended December 31, 2013 and the nine months ended September 30, 2014 are presented as if the merger occurred at the beginning of the respective periods.
The unaudited pro forma combined consolidated balance sheet has been constructed from the audited balance sheet of Tyme as of September 30, 2014 prepared in accordance with U.S. Generally Accepted Accounting Principles and the audited balance sheet of Technologies as of August 31, 2014 prepared in accordance with U.S. Generally Accepted Accounting Principles.
The unaudited pro forma combined consolidated statement of operations for the year ended December 31, 2013 has been constructed using the following:
• Audited statement of operations for the year ended December 31, 2013 of Tyme
• Audited statement of operations for the year ended November 30, 2014 of Technologies
The unaudited pro forma combined consolidated statement of operations for the nine months ended September 30, 2014 has been constructed using the following:
• Unaudited interim statement of operations for the nine months ended September 30, 2014 of Tyme
• Unaudited interim statement of operations for the nine months ended August 31, 2014 of Technologies
The unaudited pro forma combined consolidated financial statements should be read in conjunction with the audited consolidated financial statements of Tyme as of and for the year ended December 31, 2013 and 2012 and the audited financial statements of Technologies for the year ended November 30, 2014 and 2013.
The unaudited pro forma combined consolidated financial statements are prepared for illustrative purposes only and, are not necessarily indicative of the actual financial position and result of operations that would have been for the periods presented, nor do such financial statements purport to represent the result of future periods. The pro forma adjustments are based upon available information.
It is management’s opinion that these pro forma financial statements include all known adjustments necessary for the fair presentation, in all material respects, of the proposed transaction described above in accordance with U.S. GAAP applied on a consistent basis with the Company’s accounting policies. At the time of the preparation of the pro forma financial statements, management has not completed its assessment of certain embedded features related to price protection and registration rights as contemplated in the merger agreement and therefore has not included pro forma adjustment(s) that may be required as a result of that analysis. No potential cost savings, non-recurring charges, or credits are anticipated by the Company’s management subsequent to completion of the transaction.
For accounting purposes the acquisition of Tyme by Technologies was considered a reverse acquisition, an acquisition transaction where the acquired company, Tyme is considered the acquirer for accounting purposes, notwithstanding the form of the transaction. The primary reason the transaction was treated as a purchase by Tyme rather than a purchase of Tyme, by Technologies was because Technologies was a shell company.
Consequently, reverse acquisition accounting was applied to the transaction. No additional goodwill or intangible assets were recognized on completion of the transaction. The capital structure, including the number and type of shares issued, appearing in the consolidated balance sheet reflects that of the legal parent, Technologies now known as Tyme, including the shares issued to affect the reverse acquisition. The assets, liabilities and dollar amounts attributable to share capital are those of Tyme. Future financial statements will present a continuation of as Tyme’s financial statements with the adjustments described above.
F - 28
Tyme Inc.
(Formerly Tyme Technologies, Inc.)
Pro Forma Combined Consolidated Balance Sheet
As of September 30, 2014
(Unaudited)
F - 29
Tyme Inc.
(Formerly Tyme Technologies, Inc.)
Pro Forma Combined Consolidated Statement of Operations
As of November 30, 2014 and December 31, 2013
(Audited)
|
Year Ended |
|
Year Ended |
|
|
|
|
|
|
|
|
|||||
|
November 30, |
|
December 31, |
|
|
|
|
|
|
Tyme Inc. |
|
|||||
|
2014 |
|
2013 |
|
|
|
|
|
|
Pro Forma |
|
|||||
|
Technologies |
|
Tyme |
|
Combined |
|
Adjustments |
|
|
(Unaudited) |
|
|||||
|
|
|
|
|
|
|
(Note 1) |
|
|
|
|
|||||
Revenue |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
— |
|
|
744,717 |
|
|
744,717 |
|
|
|
|
|
|
744,717 |
|
General and administrative |
|
14,653 |
|
|
307,100 |
|
|
321,753 |
|
|
141,472 |
|
e |
|
1,302,518 |
|
|
|
|
|
|
|
|
|
|
|
|
214,293 |
|
e |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
625,000 |
|
l |
|
|
|
Professional fees |
|
39,260 |
|
|
— |
|
|
39,260 |
|
|
— |
|
|
|
39,260 |
|
Total operating expenses |
|
53,913 |
|
|
1,051,817 |
|
|
1,105,730 |
|
|
980,765 |
|
|
|
2,086,495 |
|
Loss from operations |
|
(53,913 |
) |
|
(1,051,817 |
) |
|
(1,105,730 |
) |
|
(980,765 |
) |
|
|
(2,086,495 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
— |
|
|
5,855 |
|
|
5,855 |
|
|
67,173 |
|
f |
|
3,538,028 |
|
|
|
|
|
|
|
|
|
|
|
|
3,465,000 |
|
k |
|
|
|
Loss before income taxes |
|
(53,913 |
) |
|
(1,057,672 |
) |
|
(1,111,585 |
) |
|
(4,512,938 |
) |
|
|
(5,624,523 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(53,913 |
) |
|
(1,057,672 |
) |
|
(1,111,585 |
) |
|
(4,512,938 |
) |
|
|
(5,624,523 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss attributable to noncontrolling interests |
|
— |
|
|
(285,847 |
) |
|
(285,847 |
) |
|
285,847 |
|
g |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss attributable to controlling interests |
$ |
(53,913 |
) |
$ |
(771,825 |
) |
$ |
(825,738 |
) |
$ |
(4,798,785 |
) |
|
$ |
(5,624,523 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per common share |
$ |
(0.00 |
) |
$ |
(0.02 |
) |
$ |
(0.01 |
) |
|
|
|
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per common share |
$ |
(0.00 |
) |
$ |
(0.02 |
) |
$ |
(0.01 |
) |
|
|
|
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
12,724,000 |
* |
|
68,000,000 |
|
|
80,724,000 |
|
|
5,276,000 |
** |
|
|
86,000,000 |
|
Diluted |
|
12,724,000 |
* |
|
68,000,000 |
|
|
80,724,000 |
|
|
5,276,000 |
** |
|
|
86,000,000 |
|
* The shares reflected have been adjusted to the capital structure of Technologies in anticipation of the Merger.
** The shares indicated are the shares issued in conjunction with the pro forma adjustments reflected above.
F - 30
Tyme Inc.
(Formerly Tyme Technologies, Inc.)
Pro Forma Combined Consolidated Statement of Operations
As of August 31, 2014 and September 30, 2014
(Unaudited)
|
Nine Months |
|
Nine Months |
|
|
|
|
|
|
|
|
|||||
|
Ended |
|
Ended |
|
|
|
|
|
|
|
|
|||||
|
August 31, |
|
September 30, |
|
|
|
|
|
|
Tyme Inc. |
|
|||||
|
2014 |
|
2014 |
|
|
|
|
|
|
Pro Forma |
|
|||||
|
Technologies |
|
Tyme |
|
Combined |
|
Adjustments |
|
|
(Unaudited) |
|
|||||
|
|
|
|
|
|
|
(Note 1) |
|
|
|
|
|||||
Revenue |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
— |
|
|
431,274 |
|
|
431,274 |
|
|
|
|
|
|
431,274 |
|
General and administrative |
|
8,659 |
|
|
719,851 |
|
|
728,510 |
|
|
141,472 |
|
e |
|
1,709,275 |
|
|
|
|
|
|
|
|
|
|
|
|
214,293 |
|
e |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
625,000 |
|
l |
|
|
|
Professional fees |
|
31,343 |
|
|
— |
|
|
31,343 |
|
|
|
|
|
|
31,343 |
|
Total operating expenses |
|
40,002 |
|
|
1,151,125 |
|
|
1,191,127 |
|
|
980,765 |
|
|
|
2,171,892 |
|
Loss from operations |
|
(40,002 |
) |
|
(1,151,125 |
) |
|
(1,191,127 |
) |
|
(980,765 |
) |
|
|
(2,171,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
— |
|
|
44,509 |
|
|
44,509 |
|
|
67,173 |
|
f |
|
3,576,682 |
|
|
|
|
|
|
|
|
|
|
|
|
3,465,000 |
|
k |
|
|
|
Loss before income taxes |
|
(40,002 |
) |
|
(1,195,634 |
) |
|
(1,235,636 |
) |
|
(4,512,938 |
) |
|
|
(5,748,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(40,002 |
) |
|
(1,195,634 |
) |
|
(1,235,636 |
) |
|
(4,512,938 |
) |
|
|
(5,748,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss attributable to noncontrolling interests |
|
— |
|
|
(10,956 |
) |
|
(10,956 |
) |
|
10,956 |
|
g |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss attributable to controlling interests |
$ |
(40,002 |
) |
$ |
(1,184,678 |
) |
$ |
(1,224,680 |
) |
$ |
(4,523,894 |
) |
|
$ |
(5,748,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per common share |
$ |
(0.00 |
) |
$ |
(0.02 |
) |
$ |
(0.02 |
) |
|
|
|
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per common share |
$ |
(0.00 |
) |
$ |
(0.02 |
) |
$ |
(0.02 |
) |
|
|
|
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
12,724,000 |
* |
|
68,000,000 |
|
|
80,724,000 |
|
|
5,276,000 |
** |
|
|
86,000,000 |
|
Diluted |
|
12,724,000 |
* |
|
68,000,000 |
|
|
80,724,000 |
|
|
5,276,000 |
** |
|
|
86,000,000 |
|
* The shares reflected have been adjusted to the capital structure of Technologies in anticipation of the Merger.
** The shares indicated are the shares issued in conjunction with the pro forma adjustments reflected above.
F - 31
NOTES TO PRO FORMA FINANCIAL INFORMATION
1. PRO FORMA ADJUSTMENTS AND ASSUMPTIONS
The unaudited pro forma financial statements incorporate the following pro forma assumptions and adjustments:
|
a. |
Outstanding liabilities of Technologies have been assumed by certain stockholders of Technologies in a separate transaction in contemplation of the reverse merger with Tyme. |
|
|
|
|
b. |
Technologies historic deficit, common stock and additional paid in capital, after the adjustment for the assumption of outstanding liabilities by certain stockholders of Technologies, have been eliminated. |
|
|
|
|
c. |
On November 24, 2014, the Company received an additional $250,000 under an amendment to the Bridge Note. |
|
|
|
|
d. |
On January 15, 2015, the Company received an additional $960,000 under an amendment to the Bridge Note. |
|
|
|
|
e. |
Tyme’s amounts due from shareholders/members were distributed as compensation to such shareholders on February 27, 2015 and therefore have been reclassified. |
|
|
|
|
f. |
Additional interest relating to Bridge Note from October 1, 2014 through March 5, 2015 has been recorded as the Bridge Note was converted at the time of the Merger. |
|
|
|
|
g. |
Tyme acquired the noncontrolling interest in its subsidiary in May 2014 therefore all amounts related to noncontrolling interest have been eliminated. |
|
|
|
|
h. |
Contemporaneous with the closing of the Merger, Technologies completed a private placement of 2.716 million shares of common stock for gross proceeds of $6.79 million of which, $4.29 million was tendered in cash and the remaining subscription price will be paid by the delivery of a three-month promissory note in the principal amount of $2.5 million. The 2.716 million shares have been recorded at the $.0001 par value per share of Technologies common stock. |
|
|
|
|
i. |
Contemporaneous with the closing of the Merger, the Bridge Note converted to shares of common stock at a fixed conversion of one share of Technologies common stock for each $1.00 of principal of the Bridge Note outstanding as of the date of the conversion. All accrued interested, which in the event of conversion is not due or payable was converted to additional paid in capital for no additional share issuance. |
|
|
|
|
j. |
The 68,000,000 shares of common stock of Technologies issued to the shareholders of Tyme in exchange for the 2,000 shares of Tyme’s common stock outstanding at the date of the merger have been recorded at the $0.0001 par value per share of Technologies common stock. |
|
|
|
|
k. |
The $3.465 million represents the incremental value of the modification to the Bridge Note conversion rate as an inducement to convert the Bridge Note. |
|
|
|
|
l. |
Pursuant to a separate consulting agreement included in the merger agreement, 250,000 shares of Technologies’ common stock were issued to the consultant as part of its compensation under such consulting agreement. The fair value of the shares issued ($625,000) has been recorded as an operating expense with a corresponding offset to common stock and additional paid in capital. |
2. EARNINGS (LOSS) PER SHARE
Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible notes payable, which would result in the issuance or vesting of incremental shares of common stock. In computing the basic and diluted net loss per share, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation.
The unaudited pro forma net loss per share is computed using the weighted average number of shares of common stock outstanding after giving effect to the conversion of convertible notes, the issuance of shares sold in the PPO and shares issued in conjunction with a consulting agreement resulting in an aggregate of 86,000,000 shares of common stock, as if they had occurred at the beginning of the period.
F - 32
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
|
Tyme Technologies, Inc. |
|
|
|
|
Dated: March 11, 2015 |
By: |
/s/ Steve Hoffman |
|
|
Steve Hoffman, Chief Executive Officer |
Page
|
|||||
ARTICLE I THE MERGER |
2
|
||||
1.1
|
The Merger
|
2
|
|||
1.2
|
The Closing
|
2
|
|||
1.3
|
Actions at the Closing
|
2
|
|||
1.4
|
Additional Actions
|
3
|
|||
1.5
|
Conversion of Company Securities
|
3
|
|||
1.6
|
Dissenting Shares
|
4
|
|||
1.7
|
Fractional Shares
|
5
|
|||
1.8
|
Options and Warrants
|
5
|
|||
1.9
|
Post-Closing Adjustment
|
6
|
|||
1.10
|
Certificate of Incorporation and Bylaws
|
7
|
|||
1.11
|
No Further Rights
|
7
|
|||
1.12
|
Closing of Transfer Books
|
7
|
|||
1.13
|
Exemption from Registration; Rule 144
|
7
|
|||
1.14
|
Adjustments to Parent Stockholders
|
8
|
|||
ARTICLE II REPRESENTATIONS AND WARRANTIES OF THE COMPANY |
9
|
||||
2.1
|
Organization, Qualification and Corporate Power
|
9
|
|||
2.2
|
Capitalization
|
10
|
|||
2.3
|
Authorization of Transaction
|
10
|
|||
2.4
|
Non-contravention
|
11
|
|||
2.5
|
Subsidiaries
|
11
|
|||
2.6
|
Compliance with Laws
|
12
|
|||
2.7
|
Financial Statements
|
13
|
|||
2.8
|
Absence of Certain Changes
|
13
|
|||
2.9
|
Undisclosed Liabilities
|
14
|
|||
2.10
|
Tax Matters
|
14
|
|||
2.11
|
Assets
|
15
|
|||
2.12
|
Owned Real Property
|
15
|
|||
2.13
|
Real Property Leases
|
15
|
|||
2.14
|
Contracts
|
16
|
|||
2.15
|
Accounts Receivable
|
18
|
|||
2.16
|
Powers of Attorney
|
18
|
|||
2.17
|
Insurance
|
18
|
|||
2.18
|
Warranties
|
18
|
|||
2.19
|
Litigation
|
18
|
|||
2.20
|
Employees
|
19
|
|||
2.21
|
Employee Benefits
|
19
|
|||
2.22
|
Environmental Matters
|
21
|
|||
2.23
|
Legal Compliance
|
22
|
|||
2.24
|
Customers
|
22
|
|||
2.25
|
Permits
|
22
|
|||
2.26
|
Certain Business Relationships with Affiliates
|
22
|
|||
2.27
|
Brokers
’
Fees
|
23
|
|||
2.28
|
Books and Records
|
23
|
|||
2.29
|
Intellectual Property
|
23
|
|||
2.30
|
Disclosure
|
24
|
|||
2.31
|
Duty to Make Inquiry
|
24
|
2.32
|
Accountants
|
24
|
|||
2.33
|
FDA and Related Matters
|
24
|
|||
ARTICLE III REPRESENTATIONS AND WARRANTIES OF THE PARENT AND THE ACQUISITION SUBSIDIARY |
25
|
||||
3.1
|
Organization, Qualification and Corporate Power
|
25
|
|||
3.2
|
Capitalization
|
26
|
|||
3.3
|
Authorization of Transaction
|
26
|
|||
3.4
|
Noncontravention
|
27
|
|||
3.5
|
Subsidiaries
|
27
|
|||
3.6
|
Exchange Act Reports
|
28
|
|||
3.7
|
Compliance with Laws
|
28
|
|||
3.8
|
Financial Statements
|
29
|
|||
3.9
|
Absence of Certain Changes
|
29
|
|||
3.10
|
Undisclosed Liabilities
|
29
|
|||
3.11
|
Off-Balance Sheet Arrangements
|
29
|
|||
3.12
|
Tax Matters
|
29
|
|||
3.13
|
Assets
|
30
|
|||
3.14
|
Owned Real Property
|
30
|
|||
3.15
|
Real Property Leases
|
30
|
|||
3.16
|
Contracts
|
31
|
|||
3.17
|
Accounts Receivable
|
32
|
|||
3.18
|
Powers of Attorney
|
32
|
|||
3.19
|
Insurance
|
32
|
|||
3.20
|
Warranties
|
32
|
|||
3.21
|
Litigation
|
33
|
|||
3.22
|
Employees
|
33
|
|||
3.23
|
Employee Benefits
|
33
|
|||
3.24
|
Environmental Matters
|
35
|
|||
3.25
|
Permits
|
35
|
|||
3.26
|
Certain Business Relationships with Affiliates
|
36
|
|||
3.27
|
Tax-Free Reorganization
|
36
|
|||
3.28
|
Split-Off
|
37
|
|||
3.29
|
Brokers
’
Fees
|
37
|
|||
3.30
|
Disclosure
|
37
|
|||
3.31
|
Interested Party Transactions
|
37
|
|||
3.32
|
Duty to Make Inquiry
|
37
|
|||
3.33
|
Accountants
|
37
|
|||
3.34
|
Minute Books
|
38
|
|||
3.35
|
Board Action
|
38
|
|||
ARTICLE IV COVENANTS |
38
|
||||
4.1
|
Closing Efforts
|
38
|
|||
4.2
|
Governmental and Thirty Party Notices and Consents
|
38
|
|||
4.3
|
Super 8-K
|
39
|
|||
4.4
|
Operation of Company Business
|
39
|
|||
4.5
|
Access to Company Information
|
40
|
|||
4.6
|
Operation of Parent Business
|
41
|
|||
4.7
|
Access to Parent Information
|
42
|
|||
4.8
|
Expenses
|
43
|
|||
4.9
|
Indemnification
|
43
|
EXHIBITS
|
||
Exhibit A
|
Form of Split-Off Agreement
|
|
Exhibit B
|
Form of General Release Agreement
|
|
Exhibit C
|
Form of Indemnification Escrow Agreement
|
|
Exhibit D
|
Form of 2015 Equity Incentive Plan
|
|
Exhibit E
|
Signatories to Lock-Up and No-Shorting Agreements
|
Exhibit F
|
Form of Lock-Up and No-Shorting Agreement
|
|
Exhibit G
|
Form of Legal Opinion of Company Counsel
|
|
Exhibit H
|
Form of Legal Opinion of Parent Counsel
|
|
Exhibit I
|
Indemnifying Stockholders
|
|
Exhibit J
|
Form of Subscription Note
|
|
Exhibit K
|
Form of Subscription Note Shares Escrow Agreement
|
|
Exhibit L
|
Form of Registration Rights Agreement
|
|
Exhibit M
|
Form of Adjustment Shares Escrow Agreement
|
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
24 |
25 |
26 |
27 |
28 |
29 |
30 |
31 |
32 |
33 |
34 |
35 |
36 |
37 |
38 |
39 |
40 |
41 |
42 |
43 |
44 |
45 |
46 |
47 |
48 |
49 |
50 |
51 |
52 |
53 |
Defined Term
|
Section
|
|||
Abandonment and Reclamation Obligations
|
6.1(d)
|
|||
Acquisition Subsidiary
|
Introduction
|
|||
ADR Procedure
|
6.3(d)
|
|||
ADR Service
|
6.3(d)
|
|||
Affiliate
|
2.12(a)(vii)
|
|||
Agreed Amount
|
6.3(c)
|
|||
Agreement
|
Introduction
|
|||
Business Day
|
1.2
|
|||
CERCLA
|
2.20
|
|||
Certificate of Merger
|
1.1
|
|||
Claim Notice
|
6.3(b)
|
|||
Claimed Amount
|
6.3(b)
|
|||
Closing
|
1.2
|
|||
Closing Date
|
1.2
|
|||
Code
|
Introduction
|
|||
Company
|
Introduction
|
|||
Company Auditor
|
2.30
|
|||
Company Balance Sheet
|
2.6
|
|||
Company Balance Sheet Date
|
2.6
|
|||
Company Benefit Plans
|
2.19(b)
|
|||
Company Certificate
|
5.2(g)
|
|||
Company Common Stock
|
1.5(a)
|
|||
Company Confidential Information
|
4.5(b)
|
|||
Company Consents
|
2.3
|
|||
Company Disclosure Schedule
|
Article II
|
|||
Company Equity Plan
|
2.2
|
|||
Company Financial Statements
|
2.6
|
|||
Company Interim Balance Sheet
|
2.6
|
|||
Company Interim Balance Sheet Date
|
2.6
|
|||
Company Interim Financial Statements
|
2.6
|
|||
Company Material Adverse Effect
|
2.1
|
|||
Company Options
|
2.2
|
54 |
Defined Term
|
Section
|
|||
Company Stockholder
|
1.3(i)
|
|||
Company Stock Certificate
|
1.5(c)
|
|||
Company Subsidiary
|
2.5(a)
|
|||
Company Warrants
|
2.2
|
|||
Company Year-End Financial Statements
|
2.6
|
|||
Contemplated Transactions
|
8.3
|
|||
Controlling Party
|
6.3(a)
|
|||
Conversion Ratio
|
1.5(a)
|
|||
Damages
|
6.1
|
|||
Damages Threshold
|
6.5(a)
|
|||
Defaulting Party
|
8.6
|
|||
Delaware Act
|
1.1
|
|||
Dispute
|
6.3(c)
|
|||
Dissenting Shares
|
1.6(a)
|
|||
Effective Time
|
1.1
|
|||
Employee Benefit Plan
|
2.19(a)(i)
|
|||
Environmental Law
|
2.20(a)
|
|||
ERISA
|
2.19(a)(ii)
|
|||
ERISA Affiliate
|
2.19(a)(iii)
|
|||
Exchange Act
|
2.6
|
|||
Expected Claim Notice
|
6.4
|
|||
FDA
|
2.31
|
|||
FDCA
|
2.31
|
|||
First PPO
|
Introduction
|
|||
First PPO Amount
|
Introduction
|
|||
First PPO Offering Price
|
Introduction
|
|||
First PPO Shares
|
Introduction
|
|||
GAAP
|
2.6
|
|||
GEM
|
Introduction
|
|||
Governmental Entity
|
2.4
|
|||
Indemnification Escrow Agreement
|
1.3(e)
|
|||
Indemnification Escrow Agent
|
1.3(e)
|
|||
Indemnification Escrow Shares
|
1.5(b)
|
|||
Indemnification Representative
|
6.3(f)
|
|||
Indemnified Executives
|
4.9(b)
|
|||
Indemnifying Stockholders
|
6.1
|
|||
Initial Shares
|
1.5(b)
|
|||
Intellectual Property
|
2.27(a)
|
|||
Intellectual Property Rights
|
2.27(a)
|
|||
Laws
|
2.4
|
|||
Legal Proceeding
|
2.17
|
|||
Merger
|
Introduction
|
|||
Merger Shares
|
1.5(a)
|
|||
Non-Controlling Party
|
6.3(a)
|
|||
Non-Defaulting Party
|
8.6
|
|||
Ordinary Course of Business
|
2.4
|
|||
Organization Date
|
2.9(c)
|
|||
Parent
|
Introduction
|
|||
Parent Certificate
|
5.3(e)
|
55 |
Defined Term
|
Section
|
|||
Parent Common Stock
|
Introduction
|
|||
Parent Confidential Information
|
4.7(b)
|
|||
Parent Disclosure Schedule
|
Article III
|
|||
Parent Equity Plan
|
4.14
|
|||
Parent Financial Statements
|
3.8
|
|||
Parent Material Adverse Effect
|
3.1
|
|||
Parent Option
|
1.8(a)
|
|||
Parent Permits
|
3.24
|
|||
Parent Benefit Plans
|
3.22(a)
|
|||
Parent Liabilities
|
1.9
|
|||
Parent Record Holders
|
1.14(b)
|
|||
Parent Reports
|
3.6
|
|||
Parent Preferred Stock
|
1.5(a)
|
|||
Parent Subsidiary
|
2.5(a)
|
|||
Parent Warrants
|
1.8(c)
|
|||
Party
|
Introduction
|
|||
Permits
|
2.23
|
|||
Qualified Offering
|
1.14(a)
|
|||
Reasonable Best Efforts
|
4.1
|
|||
Registration Rights Agreement
|
1.3(i)
|
|||
Response
|
6.3(c)
|
|||
SEC
|
1.9(a)
|
|||
Securities Act
|
1.12
|
|||
Security Interest
|
2.4
|
|||
Share Contribution
|
1.3(d)
|
|||
Split-Off
|
Introduction
|
|||
Split-Off Agreement
|
Introduction
|
|||
Split-Off Purchaser
|
Introduction
|
|||
Split-Off Subsidiary
|
Introduction
|
|||
Split-Off Shares
|
Introduction
|
|||
Split-Off Transaction
|
Introduction
|
|||
Subscription Agreement
|
1.3(f)
|
|||
Subscription Note
|
1.3(f)
|
|||
Subsidiary
|
2.5(a)
|
|||
Super 8-K
|
4.3
|
|||
Surviving Corporation
|
1.1
|
|||
Tax Returns
|
2.9(a)(ii)
|
|||
Taxes
|
2.9(a)(i)
|
|||
Third Party Intellectual Property Rights
|
2.27(d)
|
|||
Transaction Documentation
|
3.3
|
56 |
57 |
If to the Company or the Company Stockholders:
Tyme Inc.
c/o Moritt Hock & Hamroff LLP
450 Seventh Avenue, 15
th
floor
New York, NY 10123
Attn: Steven Hoffman, CEO
|
Copy to (which copy shall not constitute notice hereunder):
Keith S. Braun, Esq.
Moritt Hock & Hamroff LLP
400 Garden City Plaza
Garden City, NY 11530
|
If to Parent or Acquisition Subsidiary (prior to the Closing):
Tyme Technologies, Inc.
c/o CKR Law LLP
1330 Avenue of the Americas
New York, NY 10019
Attn: Peter E. deSvastich, CEO
Facsimile: [_______________]
|
Copy to (which copy shall not constitute
notice hereunder):
CKR Law LLP
1330 Avenue, of the Americas
New York, NY 10019
Attn: Barrett S. DiPaolo
Facsimile: (212) 400-6930
|
58 |
59 |
PARENT:
|
|||
TYME TECHNOLOGIES, INC.
|
|||
(f/k/a GLOBAL GROUP ENTERPRISES CORP.)
|
|||
By:
|
/s/ Peter de Svastich | ||
Name:
|
Peter de Svastich
|
||
Title:
|
President
|
||
ACQUISITION SUBSIDIARY:
|
|||
TYME ACQUISITION CORP.
|
|||
By:
|
/s/ Peter de Svastich | ||
Name:
|
Peter de Svastich
|
||
Title:
|
President
|
||
COMPANY:
|
|||
TYME INC.
|
|||
By:
|
/s/ Steven Hoffman | ||
Name:
|
Steven Hoffman
|
||
Title:
|
Chief Executive Officer
|
||
Solely with respect to Section 6.3(f):
|
|||
/s/ Steven Hoffman
|
|||
Steven Hoffman, as Indemnification
|
|||
Representative
|
|||
Solely with respect to Sections 1.14, 4.8(b) and 5.1(k):
|
|||
GEM GLOBAL YIELD FUND LLC SCS
|
|||
By:
|
/s/ Christopher Brown | ||
Name:
|
Christopher Brown
|
||
Title:
|
Manager
|
Exhibit 3.4
STATE OF DELAWARE
CERTIFICATE OF MERGER
OF
DOMESTIC CORPORATIONS
_______________________
Pursuant to Title 8, Section 251(c) of the Delaware General Corporation Law, the undersigned corporation executed the following Certificate of Merger:
FIRST: The name of the surviving corporation is Tyme Inc. , a Delaware corporation (the “Surviving Corporation”), and the name of the corporation being merged into the Surviving Corporation is Tyme Acquisition Corp ., a Delaware corporation (“Acquisition Subsidiary”).
SECOND: The Agreement and Plan of Merger and Reorganization, dated as of March 5, 2015 by and among Tyme Technologies, Inc., a Delaware corporation, the Acquisition Subsidiary, the Surviving Corporation, Steven Hoffman, as Indemnification Representative (with respect to Section 6.3(f) thereof only), and GEM Global Yield Fund LLC SCS, a “société en commandite simple” formed under the laws of Luxembourg (with respect to Sections 1.14, 4.8(b) and 5.1(k) thereof only) (the “Agreement of Merger”), has been approved, adopted, executed and acknowledged by each of the constituent corporations.
THIRD : The name of the surviving corporation is Tyme Inc. , a Delaware corporation.
FOURTH : The Certificate of Incorporation of the Surviving Corporation, as in effect immediately prior to the merger, shall be the Certificate of Incorporation of the Surviving Corporation. The Certificate of Incorporation of the Surviving Corporation shall be amended to read, in its entirety, as follows:
|
1. |
Name . The name of the corporation is Tyme Inc. |
|
|
|
|
2. |
Registered Office and Registered Agent . The address of the registered office of the corporation in Delaware is 1811 Silverside Road, Wilmington, DE 19810, County of New Castle. The name of the registered agent at that address is Vcorp Services, LLC. |
|
|
|
|
3. |
Purposes . The purpose of the corporation is to engage in any lawful act or activity for which corporations may be organized under the DGCL. |
|
|
|
|
4. |
Capital Stock . The total number of shares that the corporation is authorized to issue is 100 shares of common stock, par value $0.001 per share. |
|
|
|
|
5. |
Bylaws . The board of directors of the corporation is expressly authorized to adopt, amend or repeal bylaws of the corporation. |
|
|
|
|
6. |
Director Liability . |
|
a) |
Limitation . To the fullest extent permitted by law, a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director. If the DGCL or any other law of the State of Delaware is amended after the date hereof to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the corporation shall be eliminated or limited to the fullest extent permitted by the DGCL as so amended. Any repeal or modification of the foregoing provisions of this Section 6 by the stockholders of the corporation shall not adversely affect any right or protection of a director of the corporation existing at the time of, or increase the liability of any director of the corporation with respect to any acts or omissions of such director occurring prior to, such repeal or modification. |
- 1 -
|
b) |
Indemnification . To the fullest extent permitted by applicable law, the corporation is authorized to provide indemnification of (and advancement of expenses to) directors, officers and agents of the corporation (and any other persons to which DGCL permits the corporation to provide indemnification) through bylaw provisions, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise, in excess of the indemnification and advancement otherwise permitted by Section 145 of the DGCL. |
|
|
|
|
c) |
Modification . Any amendment, repeal or modification of the foregoing provisions of this section 6 shall not adversely affect any right or protection of any director, officer, or other agent of the corporation existing at the time of such amendment, repeal or modification. |
|
7. |
Incorporator . The name and mailing address of the incorporator is as follows: |
Linda Kalayjian
CKR Law LLP
1330 Avenue of the Americas
New York, NY 10019”
FIFTH: The merger is to become effective upon filing of this Certificate of Merger with the Secretary of State of the State of Delaware.
SIXTH: The executed Agreement of Merger is on file at 48 Wall Street, New York, NY 10005, the place of business of the Surviving Corporation.
SEVENTH: A copy of the Agreement of Merger will be furnished by the surviving corporation on request, without cost, to any stockholder of the constituent corporations.
IN WITNESS WHEREOF , said Surviving Corporation has caused this certificate to be signed by an authorized officer, the 5 th day of March, 2015.
TYME INC.
By: /s/ Steven Hoffman
Name: Steven Hoffman
Title: President
- 2 -
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
Company: | |||||
TYME TECHNOLOGIES, INC. | |||||
By:
|
/s/ Peter de Svastich | ||||
Name: Peter de Svastich
|
|||||
Title: President
|
|||||
GLOBAL GROUP ENTERPRISES CORP. | |||||
By: | /s/ Andrew Keck | ||||
Name: Andrew Keck
|
|||||
Title: President
|
|||||
BUYER:
|
|||||
/s/ Andrew Keck | |||||
Andrew Keck |
19 |
Buyer
|
Purchase Price
Security |
Number of Shares
|
Certificate No(s).
|
Andrew Keck
|
Common Stock
|
13,200,000
|
book entry
|
Split-Off Subsidiary
|
Shares
|
Number of Shares
|
Certificate No(s).
|
Global Group Enterprises, Inc.
|
Common Stock
|
100
|
1
|
20 |
Exhibit 10.2
GENERAL RELEASE AGREEMENT
This GENERAL RELEASE AGREEMENT (this “ Agreement ”), dated as of March 5, 2015, is entered into by and among Tyme Technologies, Inc. (f/k/a Global Group Enterprises Corp.), a Delaware corporation (“Seller”), Global Group Enterprises Corp ., a Florida corporation (“Split-Off Subsidiary”), and Andrew Keck (the “ Buyer ”). In consideration of the mutual benefits to be derived from this Agreement, the covenants and agreements set forth herein, and other valuable consideration, the receipt and sufficiency of which are hereby acknowledged by the execution and delivery hereof, the parties hereto hereby agree as follows:
1. Split-Off Agreement . This Agreement is executed and delivered by Split-Off Subsidiary pursuant to the requirements of Section 8.3 of that certain Split-Off Agreement (the “ Split-Off Agreement ”) by and among Seller, Split-Off Subsidiary and Buyer, as a condition to the closing of the purchase and sale transaction contemplated thereby (the “ Transaction ”).
2. Release and Waiver by Split-Off Subsidiary . For and in consideration of the covenants and promises contained herein, in the Split-Off Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Split-Off Subsidiary, on behalf of itself and its assigns, representatives and agents, if any, hereby covenants not to sue and fully, finally and forever completely releases Seller and Tyme Inc., a Delaware corporation (“ PrivateCo ”), along with their respective present, future and former officers, directors, stockholders, members, employees, agents, attorneys and representatives (collectively, the “ Seller Released Parties ”), of and from any and all claims, actions, obligations, liabilities, demands and/or causes of action, of whatever kind or character, whether now known or unknown, which Split-Off Subsidiary has or might claim to have against the Seller Released Parties for any and all injuries, harm, damages (actual and punitive), costs, losses, expenses, attorneys’ fees and/or liability or other detriment, if any, whenever incurred or suffered by Split-Off Subsidiary arising from, relating to, or in any way connected with, any fact, event, transaction, action or omission that occurred or failed to occur at or prior to the closing of the Transaction.
3. Release and Waiver by Buyer . For and in consideration of the covenants and promises contained herein, in the Split-Off Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Buyer on behalf of itself and its assigns, representatives and agents, if any, hereby covenants not to sue and fully, finally and forever completely releases the Seller Released Parties of and from any and all claims, actions, obligations, liabilities, demands and/or causes of action, of whatever kind or character, whether now known or unknown, which such Buyer has or might claim to have against the Seller Released Parties for any and all injuries, harm, damages (actual and punitive), costs, losses, expenses, attorneys’ fees and/or liability or other detriment, if any, whenever incurred or suffered by such Buyer arising from, relating to, or in any way connected with, any fact, event, transaction, action or omission that occurred or failed to occur on or prior to the date of the Closing.
- 1 -
4. Additional Covenants and Agreements .
(a) Each of Split-Off Subsidiary and Buyer, on the one hand, and Seller, on the other hand, waives and releases the other from any claims that this Agreement was procured by fraud or signed under duress or coercion so as to make this Agreement not binding.
(b) Each of the parties hereto acknowledges and agrees that the releases set forth herein do not include any claims the other party hereto may have against such party for such party’s failure to comply with or breach of any provision in this Agreement or the Split-Off Agreement.
(c) Notwithstanding anything contained herein to the contrary, this Agreement shall not release or waive, or in any manner affect or void, any party’s rights and obligations under the following:
(i) the Split-Off Agreement; and
(ii) the Agreement and Plan of Merger and Reorganization among Seller, PrivateCo and Tyme Acquisition Corp., a Delaware corporation, and with Respect to Section 6.3(f) thereof only, Steven Hoffman, as Indemnification Representative, and with respect to Sections 1.14, 4.8(b) and 5.1(k) thereof only, GEM Global Yield Fund LLC SCS, and the other parties thereto (the “ Merger Agreement ”), and the other Transaction Documentation.
5. Modification . This Agreement cannot be modified orally and can only be modified through a written document signed by all parties and PrivateCo.
6. Severability . If any provision contained in this Agreement is determined to be void, illegal or unenforceable, in whole or in part, then the other provisions contained herein shall remain in full force and effect as if the provision that was determined to be void, illegal or unenforceable had not been contained herein.
7. Expenses . The parties hereto agree that each party shall pay its respective costs, including attorneys’ fees, if any, associated with this Agreement.
8. Further Acts and Assurances . Split-Off Subsidiary and Buyer each agrees that it will act in a manner supporting compliance, including compliance by its Affiliates, with all of its obligations under this Agreement and, from time to time, shall, at the request of Seller or PrivateCo, and without further consideration, cause the execution and delivery of such other instruments of release or waiver and take such other action or execute such other documents as such party may reasonably request in order to confirm or effect the releases, waivers and covenants contained herein, and, in the case of any claims, actions, obligations, liabilities, demands and/or causes of action that cannot be effectively released or waived without the consent or approval of other Persons that is unobtainable, to use its best reasonable efforts to ensure that the Seller Released Parties receive the benefits thereof to the maximum extent permissible in accordance with applicable law or other applicable restrictions, and shall perform such other acts which may be reasonably necessary to effectuate the purposes of this Agreement.
- 2 -
9. Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to principles of conflicts or choice of laws thereof.
10. Third-Party Beneficiary . Each of Seller, Buyer and Split-Off Subsidiary acknowledges and agrees that this Agreement is entered into for the express benefit of PrivateCo, and that PrivateCo is relying hereon and on the consummation of the transactions contemplated by this Agreement in entering into and performing its obligations under the Merger Agreement, and that PrivateCo shall be in all respects entitled to the benefit hereof and to enforce this Agreement as a result of any breach hereof.
11. Specific Performance; Remedies . Each of Seller, Buyer and Split-Off Subsidiary acknowledges and agrees that PrivateCo would be damaged irreparably if any provision of this Agreement is not performed in accordance with its specific terms or is otherwise breached. Accordingly, each of Seller, Buyer and Split-Off Subsidiary agrees that PrivateCo will be entitled to seek an injunction or injunctions to prevent breaches of the provisions of this Agreement and to enforce specifically this Agreement and its terms and provisions in any action instituted in any court of the United States or any state thereof having jurisdiction over the parties and the matter, subject to Section 9 , in addition to any other remedy to which they may be entitled, at law or in equity. Except as expressly provided herein, the rights, obligations and remedies created by this Agreement are cumulative and are in addition to any other rights, obligations or remedies otherwise available at law or in equity, and nothing herein will be considered an election of remedies.
12. Entire Agreement . This Agreement constitutes the entire understanding and agreement of Seller, Split-Off Subsidiary and Buyer and supersedes prior understandings and agreements, if any, among or between Seller, Split-Off Subsidiary and Buyer with respect to the subject matter of this Agreement, other than as specifically referenced herein. This Agreement does not, however, operate to supersede or extinguish any confidentiality, non-solicitation, non-disclosure or non-competition obligations owed by Split-Off Subsidiary to Seller under any prior agreement.
13. Definitions . Capitalized terms used herein without definition have the meanings ascribed to them in the Merger Agreement.
[Signature page follows this page.]
- 3 -
IN WITNESS WHEREOF , the undersigned have executed this General Release Agreement as of the day and year first above written.
TYME TECHNOLOGIES, INC.
By: /s/ Peter de Svastich
Name: Peter de Svastich
Title: President
GLOBAL GROUP ENTERPRISES CORP.
By: /s/ Andrew Keck
Name: Andrew Keck
Title: President
BUYER
/s/Andrew Keck
Andrew Keck
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Exhibit 10.3
LOCK-UP AGREEMENT
This LOCK-UP AGREEMENT (this “Agreement”) is made as of March 5, 2015 (the “Effective Date”), by and between the undersigned person or entity (the “Restricted Holder”) and Tyme Technologies, Inc., a Delaware corporation formerly known as Global Group Enterprises Corp. (the “Company”). Capitalized terms used and not otherwise defined herein shall have the meanings given to such terms in the Merger Agreement (as defined herein).
WHEREAS, pursuant to the transactions contemplated under that certain Agreement and Plan of Merger and Reorganization, dated as of March 5, 2015 (the “Merger Agreement”), by and between the Company, Tyme Acquisition Corp., a Delaware corporation (“Merger Sub”), Tyme, Inc., a Delaware corporation (“Tyme”), and, solely with respect to Section 6.3(f), Steven Hoffman, as Indemnification Representative, and, solely with respect to Sections 1.14, 4.8(b) and 5.1(k), GEM Global Yield Fund LLC SCS (“GEM”), and the other parties thereto, Merger Sub will merge with and into Tyme, with the result of such merger being that Tyme will be the surviving entity and become a wholly-owned subsidiary of the Company, with all the shareholders of Tyme exchanging their shares in Tyme for shares of common stock of the Company (the “Common Stock”), all pursuant to the terms of the Merger Agreement (the “Merger”); and
WHEREAS, simultaneously with the closing of the Merger, the Company will complete a private placement offering (the “First PPO”) of shares of its Common Stock for gross proceeds of $6,790,000; and
WHEREAS, it is anticipated that within five (5) months after the earlier of (x) the date on which the Subscription Note (as defined in the Merger Agreement) is fully satisfied or (y) the maturity date of the Subscription Note, GEM will assist the Company in raising additional capital totaling $20,000,000 in an equity financing at a valuation of at least $200,000,000 but not greater than $400,000,000, based upon best efforts (the “Second PPO”); and
WHEREAS, the Restricted Holder will be (a) an officer and/or director of the Company immediately after the closing of the Merger, and/or (b) a beneficial owner of ten percent (10%) or more of the outstanding shares of Common Stock of the Company immediately after the closing of the Merger, and/or (c) a key employee of the Company, as agreed to by the Company and Tyme, immediately after the closing of the Merger; and
WHEREAS, the Merger Agreement provides that, among other things, as a condition to the consummation of the Merger, that Restricted Holder execute this Lock-Up Agreement with respect to all the shares of Common Stock owned by the Restricted Holder, other than (x) shares of Common Stock acquired by Restricted Holder in the First PPO or Second PPO, (y) shares subject to the Registration Rights Agreement, dated as of the Effective Date, among the Company, Restricted Holder and the other parties thereto (the “Registration Rights Agreement”) when such shares are included in the effective registration statement under the Securities Act of 1933, as amended, and (z) 1,000,000 shares of Common Stock which may be sold in a private transaction, provided such private sale is at or above the sale price of $2.00 per share (the shares referred to in clauses (x), (y) and (z) being the “Exempt Shares”), such shares, exclusive of the Exempt Shares, constituting a total of 24,732,798 shares of Common Stock as of the Effective Date (the “Restricted Securities”).
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NOW, THEREFORE, as an inducement to and in consideration of the Company’s agreement to enter into the Merger Agreement and proceed with the Merger, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:
1. Lock Up Period .
(a) During the twelve (12) month period following the Effective Date, as extended for an additional the twelve (12) month period following the closing date of the Second PPO (assuming that such closing occurs within five (5) months of the closing of the First PPO) (the “Restricted Period”), the Restricted Holder will not, directly or indirectly: (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant for the sale of, make any short sale, lend or otherwise dispose of or transfer any Restricted Securities or any securities convertible into or exercisable or exchangeable for Restricted Securities, or (ii) enter into any swap or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, any of the economic consequences of ownership of any Restricted Securities (with the actions described in clause (i) or (ii) above being hereinafter referred to as a “Disposition”); provided , however , that if the Company engages in an underwritten public offering of its equity or convertible securities prior to the end of the Restricted Period, the managing underwriter may waive the balance of the Restricted Period. The foregoing restrictions are expressly agreed to preclude the Restricted Holder from engaging in any hedging or other transaction which is designed to or which reasonably could be expected to lead to or result in a sale or disposition of any of the Restricted Securities of the Restricted Holder during the Restricted Period, even if such securities would be disposed of by someone other than the Restricted Holder.
(b) In addition, during the period of eighteen (18) months immediately following the Closing Date, as extended for an additional eighteen (18) months following the closing date of the Second PPO (assuming that such closing is within five (5) months of the closing of the First PPO), the Restricted Holder will not, directly or indirectly, effect or agree to effect any short sale (as defined in Rule 200 under Regulation SHO of the Securities Exchange Act of 1934 (the “Exchange Act”)), whether or not against the box, establish any “put equivalent position” (as defined in Rule 16a-1(h) under the Exchange Act) with respect to the Common Stock, borrow or pre-borrow any shares of Common Stock, or grant any other right (including, without limitation, any put or call option) with respect to the Common Stock or with respect to any security that includes, is convertible into or exercisable for or derives any significant part of its value from the Common Stock or otherwise seek to hedge the Restricted Holder’s position in the Common Stock.
(c) Notwithstanding anything contained herein to the contrary, the Restricted Holder shall be permitted to engage in any Disposition (i) where the other party to such Disposition is another Restricted Holder and the transferee agrees in writing that the Restricted Securities shall continue to be subject to the restrictions on transfer set forth in this Agreement, (ii) where such Disposition is a bona fide gift or gifts and the donee takes title to such Restricted Securities
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subject to the restrictions on transfer set forth in this Agreement, (iii) where such Disposition is in connection with estate planning purposes, including, without limitation to an inter-vivos trust, and the transferee takes title to such Restricted Securities subject to the restrictions on transfer set forth in this Agreement, or (iv) where such Disposition is to an affiliate of such Restricted Holder (including entities wholly owned by such Restricted Holder or one or more trusts where such Restricted Holder is the grantor of such trust(s)) as long as such affiliate executes a copy of this Agreement.
2. Legends; Stop Transfer Instructions .
(a) In addition to any legends to reflect applicable transfer restrictions under federal or state securities laws, each stock certificate representing Restricted Securities shall be stamped or otherwise imprinted with the following legend:
“THE SECURITIES REPRESENTED HEREBY ARE SUBJECT TO THE TERMS AND CONDITIONS OF A LOCK-UP AGREEMENT, DATED AS OF MARCH 5, 2015, BETWEEN THE HOLDER HEREOF AND TYME TECHNOLOGIES, INC. AND MAY ONLY BE SOLD OR TRANSFERRED IN ACCORDANCE WITH THE TERMS THEREOF.”
(b) The Restricted Holder hereby agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of the Restricted Securities or securities convertible into or exchangeable for Restricted Securities held by the Restricted Holder except in compliance with this Agreement.
3. Miscellaneous .
(a) Specific Performance . The Restricted Holder agrees that in the event of any breach or threatened breach by the Restricted Holder of any covenant, obligation or other provision contained in this Agreement, then the Company shall be entitled (in addition to any other remedy that may be available to the Company) to: (i) a decree or order of specific performance or mandamus to enforce the observance and performance of such covenant, obligation or other provision; and (ii) an injunction restraining such breach or threatened breach. The Restricted Holder further agrees that neither the Company nor any other person or entity shall be required to obtain, furnish or post any bond or similar instrument in connection with or as a condition to obtaining any remedy referred to in this Section 3, and the Restricted Holder irrevocably waives any right that he, she, or it may have to require the obtaining, furnishing or posting of any such bond or similar instrument.
(b) Other Agreements . Nothing in this Agreement shall limit any of the rights or remedies of the Company under the Merger Agreement, or any of the rights or remedies of the Company or any of the obligations of the Restricted Holder under any other agreement between the Restricted Holder and the Company or any certificate or instrument executed by the Restricted Holder in favor of the Company; and nothing in the Merger Agreement or in any other agreement, certificate or instrument shall limit any of the rights or remedies of the Company or any of the obligations of the Restricted Holder under this Agreement.
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(c) Notices . All notices hereunder shall be in writing. Any notice, request, demand, claim or other communication hereunder shall be deemed duly delivered four Business Days after it is sent by registered or certified mail, return receipt requested, postage prepaid, or one Business Day after it is sent for next Business Day delivery via a reputable nationwide overnight courier service (or two Business Days if deposited with such a courier service on a day other than a Business Day), in each case to the intended recipient as set forth below:
If to the Company:
Tyme Technologies, Inc. 48 Wall Street New York, NY 10005 Attn: Steven Hoffman, President |
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Copy to (which copy shall not constitute notice hereunder):
Keith S. Braun, Esq. Moritt Hock & Hamroff LLP 400 Garden City Plaza Garden City, NY 11530 |
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If to the Restricted Holder:
To the address set forth on the signature page hereto. |
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With a copy (which copy shall not constitute notice hereunder):
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Any Party may give any notice, request, demand, claim or other communication hereunder using any other means (including personal delivery, expedited courier, messenger service, telecopy, telex, ordinary mail or electronic mail), but no such notice, request, demand, claim or other communication shall be deemed to have been duly given unless and until it actually is received by the Party for whom it is intended. Any Party may change the address to which notices, requests, demands, claims, and other communications hereunder are to be delivered by giving the other Parties notice in the manner herein set forth.
(d) Severability . Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If the final judgment of a court of competent jurisdiction declares that any term or provision hereof is invalid or unenforceable, the parties hereto agree that the court making such determination shall have the power to limit the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the parties hereto agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term.
(e) Applicable Law; Jurisdiction . THIS AGREEMENT IS MADE UNDER, AND SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED SOLELY THEREIN, WITHOUT GIVING EFFECT TO PRINCIPLES OF
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CONFLICTS OF LAW. In any action between or among any of the parties arising out of this Agreement, (i) each of the parties irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the state and federal courts having jurisdiction over New York County, New York; (ii) if any such action is commenced in a state court, then, subject to applicable law, no party shall object to the removal of such action to any federal court having jurisdiction over New York County, New York; (iii) each of the parties irrevocably waives the right to trial by jury; and (iv) each of the parties irrevocably consents to service of process by first class certified mail, return receipt requested, postage prepared, to the address at which such party is to receive notice in accordance with this Agreement.
(f) Waiver; Termination . No failure on the part of the Company to exercise any power, right, privilege or remedy under this Agreement, and no delay on the part of the Company in exercising any power, right, privilege or remedy under this Agreement, shall operate as a waiver of such power, right, privilege or remedy; and no single or partial exercise of any such power, right, privilege or remedy shall preclude any other or further exercise thereof or of any other power, right, privilege or remedy. The Company shall not be deemed to have waived any claim arising out of this Agreement, or any power, right, privilege or remedy under this Agreement, unless the waiver of such claim, power, right, privilege or remedy is expressly set forth in a written instrument duly executed and delivered on behalf of the Company; and any such waiver shall not be applicable or have any effect except in the specific instance in which it is given. If the Merger Agreement is terminated, this Agreement shall thereupon terminate.
(g) Captions . The captions contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred to in connection with the construction or interpretation of this Agreement.
(h) Further Assurances . The Restricted Holder hereby represents and warrants that the Restricted Holder has full power and authority to enter into this Agreement and that this Agreement constitutes the legal, valid and binding obligation of the Restricted Holder, enforceable in accordance with its terms. The Restricted Holder shall execute and/or cause to be delivered to the Company such instruments and other documents and shall take such other actions as the Company may reasonably request to effectuate the intent and purposes of this Agreement.
(i) Entire Agreement . This Agreement and the Merger Agreement collectively set forth the entire understanding of the Company and the Restricted Holder relating to the subject matter hereof and supersedes all other prior agreements and understandings between the Company and the Restricted Holder relating to the subject matter hereof.
(j) Non-Exclusivity . The rights and remedies of the Company hereunder are not exclusive of or limited by any other rights or remedies which the Company may have, whether at law, in equity, by contract or otherwise, all of which shall be cumulative (and not alternative).
(k) Amendments . This Agreement may not be amended, modified, altered or supplemented other than by means of a written instrument duly executed and delivered on behalf of the Company and the Restricted Holder.
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(l) Assignment . This Agreement and all obligations of the Restricted Holder hereunder are personal to the Restricted Holder and may not be transferred or delegated by the Restricted Holder at any time. The Company may freely assign any or all of its rights under this Agreement, in whole or in part, to any successor entity without obtaining the consent or approval of the Restricted Holder.
(m) Binding Nature . Subject to Section 3(l) above, this Agreement will inure to the benefit of the Company and its successors and assigns and will be binding upon the Restricted Holder and the Restricted Holder’s representatives, executors, administrators, estate, heirs, successors and assigns.
(n) Survival . Each of the representations, warranties, covenants and obligations contained in this Agreement shall survive the consummation of the Merger.
(o) Counterparts . This Agreement may be executed in separate counterparts, each of which shall be deemed an original and both of which shall constitute one and the same instrument.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the parties hereto have executed and delivered this Agreement as of the date first set forth above.
TYME TECHNOLOGIES, INC.
/s/ Peter de Svastich
By: Peter de Svastich
Its: President
RESTRICTED HOLDER:
STEVEN HOFFMAN
/s/ Steven Hoffman
Address: 15 Knichel Road
Mahwah, New Jersey 07430
Fax: ___________________________________
Address for copy of notice pursuant to Section 3(c):
________________________________________
________________________________________
________________________________________
Fax: ___________________________________
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Exhibit 10.4
LOCK-UP AGREEMENT
This LOCK-UP AGREEMENT (this “Agreement”) is made as of March 5, 2015 (the “Effective Date”), by and between the undersigned person or entity (the “Restricted Holder”) and Tyme Technologies, Inc., a Delaware corporation formerly known as Global Group Enterprises Corp. (the “Company”). Capitalized terms used and not otherwise defined herein shall have the meanings given to such terms in the Merger Agreement (as defined herein).
WHEREAS, pursuant to the transactions contemplated under that certain Agreement and Plan of Merger and Reorganization, dated as of March 5, 2015 (the “Merger Agreement”), by and between the Company, Tyme Acquisition Corp., a Delaware corporation (“Merger Sub”), Tyme, Inc., a Delaware corporation (“Tyme”), and, solely with respect to Section 6.3(f), Steven Hoffman, as Indemnification Representative, and, solely with respect to Sections 1.14, 4.8(b) and 5.1(k), GEM Global Yield Fund LLC SCS (“GEM”), and the other parties thereto, Merger Sub will merge with and into Tyme, with the result of such merger being that Tyme will be the surviving entity and become a wholly-owned subsidiary of the Company, with all the shareholders of Tyme exchanging their shares in Tyme for shares of common stock of the Company (the “Common Stock”), all pursuant to the terms of the Merger Agreement (the “Merger”); and
WHEREAS, simultaneously with the closing of the Merger, the Company will complete a private placement offering (the “First PPO”) of shares of its Common Stock for gross proceeds of $6,790,000; and
WHEREAS, it is anticipated that within five (5) months after the earlier of (x) the date on which the Subscription Note (as defined in the Merger Agreement) is fully satisfied or (y) the maturity date of the Subscription Note, GEM will assist the Company in raising additional capital totaling $20,000,000 in an equity financing at a valuation of at least $200,000,000 but not greater than $400,000,000, based upon best efforts (the “Second PPO”); and
WHEREAS, the Restricted Holder will be (a) an officer and/or director of the Company immediately after the closing of the Merger, and/or (b) a beneficial owner of ten percent (10%) or more of the outstanding shares of Common Stock of the Company immediately after the closing of the Merger, and/or (c) a key employee of the Company, as agreed to by the Company and Tyme, immediately after the closing of the Merger; and
WHEREAS, the Merger Agreement provides that, among other things, as a condition to the consummation of the Merger, that Restricted Holder execute this Lock-Up Agreement with respect to all the shares of Common Stock owned by the Restricted Holder, other than (x) shares of Common Stock acquired by Restricted Holder in the First PPO or Second PPO, (y) shares subject to the Registration Rights Agreement, dated as of the Effective Date, among the Company, Restricted Holder and the other parties thereto (the “Registration Rights Agreement”) when such shares are included in the effective registration statement under the Securities Act of 1933, as amended, and (z) 1,000,000 shares of Common Stock which may be sold in a private transaction, provided such private sale is at or above the sale price of $2.00 per share (the shares referred to in clauses (x), (y) and (z) being the “Exempt Shares”), such shares, exclusive of the Exempt Shares, constituting a total of 24,732,798 shares of Common Stock as of the Effective Date (the “Restricted Securities”).
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NOW, THEREFORE, as an inducement to and in consideration of the Company’s agreement to enter into the Merger Agreement and proceed with the Merger, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:
1. Lock Up Period .
(a) During the twelve (12) month period following the Effective Date, as extended for an additional the twelve (12) month period following the closing date of the Second PPO (assuming that such closing occurs within five (5) months of the closing of the First PPO) (the “Restricted Period”), the Restricted Holder will not, directly or indirectly: (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant for the sale of, make any short sale, lend or otherwise dispose of or transfer any Restricted Securities or any securities convertible into or exercisable or exchangeable for Restricted Securities, or (ii) enter into any swap or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, any of the economic consequences of ownership of any Restricted Securities (with the actions described in clause (i) or (ii) above being hereinafter referred to as a “Disposition”); provided , however , that if the Company engages in an underwritten public offering of its equity or convertible securities prior to the end of the Restricted Period, the managing underwriter may waive the balance of the Restricted Period. The foregoing restrictions are expressly agreed to preclude the Restricted Holder from engaging in any hedging or other transaction which is designed to or which reasonably could be expected to lead to or result in a sale or disposition of any of the Restricted Securities of the Restricted Holder during the Restricted Period, even if such securities would be disposed of by someone other than the Restricted Holder.
(b) In addition, during the period of eighteen (18) months immediately following the Closing Date, as extended for an additional eighteen (18) months following the closing date of the Second PPO (assuming that such closing is within five (5) months of the closing of the First PPO), the Restricted Holder will not, directly or indirectly, effect or agree to effect any short sale (as defined in Rule 200 under Regulation SHO of the Securities Exchange Act of 1934 (the “Exchange Act”)), whether or not against the box, establish any “put equivalent position” (as defined in Rule 16a-1(h) under the Exchange Act) with respect to the Common Stock, borrow or pre-borrow any shares of Common Stock, or grant any other right (including, without limitation, any put or call option) with respect to the Common Stock or with respect to any security that includes, is convertible into or exercisable for or derives any significant part of its value from the Common Stock or otherwise seek to hedge the Restricted Holder’s position in the Common Stock.
(c) Notwithstanding anything contained herein to the contrary, the Restricted Holder shall be permitted to engage in any Disposition (i) where the other party to such Disposition is another Restricted Holder and the transferee agrees in writing that the Restricted Securities shall continue to be subject to the restrictions on transfer set forth in this Agreement, (ii) where such Disposition is a bona fide gift or gifts and the donee takes title to such Restricted Securities
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subject to the restrictions on transfer set forth in this Agreement, (iii) where such Disposition is in connection with estate planning purposes, including, without limitation to an inter-vivos trust, and the transferee takes title to such Restricted Securities subject to the restrictions on transfer set forth in this Agreement, or (iv) where such Disposition is to an affiliate of such Restricted Holder (including entities wholly owned by such Restricted Holder or one or more trusts where such Restricted Holder is the grantor of such trust(s)) as long as such affiliate executes a copy of this Agreement.
2. Legends; Stop Transfer Instructions .
(a) In addition to any legends to reflect applicable transfer restrictions under federal or state securities laws, each stock certificate representing Restricted Securities shall be stamped or otherwise imprinted with the following legend:
“THE SECURITIES REPRESENTED HEREBY ARE SUBJECT TO THE TERMS AND CONDITIONS OF A LOCK-UP AGREEMENT, DATED AS OF MARCH 5, 2015, BETWEEN THE HOLDER HEREOF AND TYME TECHNOLOGIES, INC. AND MAY ONLY BE SOLD OR TRANSFERRED IN ACCORDANCE WITH THE TERMS THEREOF.”
(b) The Restricted Holder hereby agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of the Restricted Securities or securities convertible into or exchangeable for Restricted Securities held by the Restricted Holder except in compliance with this Agreement.
3. Miscellaneous .
(a) Specific Performance . The Restricted Holder agrees that in the event of any breach or threatened breach by the Restricted Holder of any covenant, obligation or other provision contained in this Agreement, then the Company shall be entitled (in addition to any other remedy that may be available to the Company) to: (i) a decree or order of specific performance or mandamus to enforce the observance and performance of such covenant, obligation or other provision; and (ii) an injunction restraining such breach or threatened breach. The Restricted Holder further agrees that neither the Company nor any other person or entity shall be required to obtain, furnish or post any bond or similar instrument in connection with or as a condition to obtaining any remedy referred to in this Section 3, and the Restricted Holder irrevocably waives any right that he, she, or it may have to require the obtaining, furnishing or posting of any such bond or similar instrument.
(b) Other Agreements . Nothing in this Agreement shall limit any of the rights or remedies of the Company under the Merger Agreement, or any of the rights or remedies of the Company or any of the obligations of the Restricted Holder under any other agreement between the Restricted Holder and the Company or any certificate or instrument executed by the Restricted Holder in favor of the Company; and nothing in the Merger Agreement or in any other agreement, certificate or instrument shall limit any of the rights or remedies of the Company or any of the obligations of the Restricted Holder under this Agreement.
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(c) Notices . All notices hereunder shall be in writing. Any notice, request, demand, claim or other communication hereunder shall be deemed duly delivered four Business Days after it is sent by registered or certified mail, return receipt requested, postage prepaid, or one Business Day after it is sent for next Business Day delivery via a reputable nationwide overnight courier service (or two Business Days if deposited with such a courier service on a day other than a Business Day), in each case to the intended recipient as set forth below:
If to the Company:
Tyme Technologies, Inc. 48 Wall Street New York, NY 10005 Attn: Steven Hoffman, President |
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Copy to (which copy shall not constitute notice hereunder):
Keith S. Braun, Esq. Moritt Hock & Hamroff LLP 400 Garden City Plaza Garden City, NY 11530 |
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|
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If to the Restricted Holder:
To the address set forth on the signature page hereto. |
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With a copy (which copy shall not constitute notice hereunder):
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Any Party may give any notice, request, demand, claim or other communication hereunder using any other means (including personal delivery, expedited courier, messenger service, telecopy, telex, ordinary mail or electronic mail), but no such notice, request, demand, claim or other communication shall be deemed to have been duly given unless and until it actually is received by the Party for whom it is intended. Any Party may change the address to which notices, requests, demands, claims, and other communications hereunder are to be delivered by giving the other Parties notice in the manner herein set forth.
(d) Severability . Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If the final judgment of a court of competent jurisdiction declares that any term or provision hereof is invalid or unenforceable, the parties hereto agree that the court making such determination shall have the power to limit the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the parties hereto agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term.
(e) Applicable Law; Jurisdiction . THIS AGREEMENT IS MADE UNDER, AND SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED SOLELY THEREIN, WITHOUT GIVING EFFECT TO PRINCIPLES OF
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CONFLICTS OF LAW. In any action between or among any of the parties arising out of this Agreement, (i) each of the parties irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the state and federal courts having jurisdiction over New York County, New York; (ii) if any such action is commenced in a state court, then, subject to applicable law, no party shall object to the removal of such action to any federal court having jurisdiction over New York County, New York; (iii) each of the parties irrevocably waives the right to trial by jury; and (iv) each of the parties irrevocably consents to service of process by first class certified mail, return receipt requested, postage prepared, to the address at which such party is to receive notice in accordance with this Agreement.
(f) Waiver; Termination . No failure on the part of the Company to exercise any power, right, privilege or remedy under this Agreement, and no delay on the part of the Company in exercising any power, right, privilege or remedy under this Agreement, shall operate as a waiver of such power, right, privilege or remedy; and no single or partial exercise of any such power, right, privilege or remedy shall preclude any other or further exercise thereof or of any other power, right, privilege or remedy. The Company shall not be deemed to have waived any claim arising out of this Agreement, or any power, right, privilege or remedy under this Agreement, unless the waiver of such claim, power, right, privilege or remedy is expressly set forth in a written instrument duly executed and delivered on behalf of the Company; and any such waiver shall not be applicable or have any effect except in the specific instance in which it is given. If the Merger Agreement is terminated, this Agreement shall thereupon terminate.
(g) Captions . The captions contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred to in connection with the construction or interpretation of this Agreement.
(h) Further Assurances . The Restricted Holder hereby represents and warrants that the Restricted Holder has full power and authority to enter into this Agreement and that this Agreement constitutes the legal, valid and binding obligation of the Restricted Holder, enforceable in accordance with its terms. The Restricted Holder shall execute and/or cause to be delivered to the Company such instruments and other documents and shall take such other actions as the Company may reasonably request to effectuate the intent and purposes of this Agreement.
(i) Entire Agreement . This Agreement and the Merger Agreement collectively set forth the entire understanding of the Company and the Restricted Holder relating to the subject matter hereof and supersedes all other prior agreements and understandings between the Company and the Restricted Holder relating to the subject matter hereof.
(j) Non-Exclusivity . The rights and remedies of the Company hereunder are not exclusive of or limited by any other rights or remedies which the Company may have, whether at law, in equity, by contract or otherwise, all of which shall be cumulative (and not alternative).
(k) Amendments . This Agreement may not be amended, modified, altered or supplemented other than by means of a written instrument duly executed and delivered on behalf of the Company and the Restricted Holder.
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(l) Assignment . This Agreement and all obligations of the Restricted Holder hereunder are personal to the Restricted Holder and may not be transferred or delegated by the Restricted Holder at any time. The Company may freely assign any or all of its rights under this Agreement, in whole or in part, to any successor entity without obtaining the consent or approval of the Restricted Holder.
(m) Binding Nature . Subject to Section 3(l) above, this Agreement will inure to the benefit of the Company and its successors and assigns and will be binding upon the Restricted Holder and the Restricted Holder’s representatives, executors, administrators, estate, heirs, successors and assigns.
(n) Survival . Each of the representations, warranties, covenants and obligations contained in this Agreement shall survive the consummation of the Merger.
(o) Counterparts . This Agreement may be executed in separate counterparts, each of which shall be deemed an original and both of which shall constitute one and the same instrument.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the parties hereto have executed and delivered this Agreement as of the date first set forth above.
TYME TECHNOLOGIES, INC.
/s/ Peter de Svastich
By: Peter de Svastich
Its: President
RESTRICTED HOLDER:
MICHAEL DEMURJIAN
/s/ Michael Demurjian
Address: 1400 Winesap Drive
Manasquan, New Jersey 08736
Fax: ___________________________________
Address for copy of notice pursuant to Section 3(c):
________________________________________
________________________________________
________________________________________
Fax: ___________________________________
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|
●
|
The Shares being offered and sold in the Offering and the Shares being subscribed for pursuant to this Agreement have not been registered under the Securities Act of 1933, as amended (the “
Securities Act
”). The Offering is being made on an “all or none” best efforts basis to “accredited investors,” as defined in Regulation D under the Securities Act.
|
|
●
|
The Shares are being offered and sold as a condition precedent to the consummation of and in connection with a reverse triangular merger (the “
Merger
”) between a subsidiary of the Company and Tyme, Inc., a Delaware corporation (“
Tyme
”), and certain other transactions, pursuant to which Tyme will become a wholly owned subsidiary of the Company, and all of the outstanding Tyme stock will be converted into shares of the Company’s Common Stock, and Tyme stock options and warrants will be converted into options and warrants to purchase shares of the Company’s Common Stock.
|
|
●
|
Prior to the Closing (as defined below), the Company will cancel certain outstanding shares of Common Stock (the “
Share Cancellations
”) so as to result in the capitalization described in Section 4.c below.
(For avoidance of doubt, the number of Shares reflected herein and the Per Share Purchase Price are based on having given effect to the Share Cancellations.)
|
|
●
|
On July 11, 2014, Tyme completed a private placement to an accredited investor of a $1,100,000 principal amount 10% secured convertible note of Tyme; on November 24, 2014, an additional $250,000 was advanced to the Company under such note, and such note was amended and restated; on January 15, 2015, an additional $960,000 was advanced to the Company under such note, and such note was further amended and restated; and on March 5, 2015, such note was further amended pursuant to a letter agreement among such investor/holder of such note, Tyme and the Company (the “
Letter Agreement
”) (as so amended and restated and giving effect to the Letter Agreement, the “
Bridge Note
”). Upon closing of the Merger and the Offering, the Bridge Note will convert into shares of Common Stock at a conversion rate of $1.00 of principal per share, or 2,310,000 shares. Upon such conversion, all accrued interest on the Bridge Note will be cancelled in accordance with the terms of the Bridge Note.
|
|
●
|
The undersigned acknowledges receipt of a copy of the Registration Rights Agreement, substantially in the form of
Exhibit A
hereto (the “
Registration Rights Agreement
”).
|
1 |
|
●
|
The closing of the Offering (the “
Closing
,” and the date on which the Closing occurs is hereinafter referred to as the “
Closing Date
”) shall take place at the offices of CKR Law LLP, at 1330 Avenue of the Americas, New York, New York 10019 (or such other place as is agreed to by the Company).
|
|
●
|
The Closing will not occur unless:
|
|
a.
|
funds deposited in escrow plus the principal amount of the Subscription Note (as defined below) equal $6,790,000 and the Subscription Note has been executed and delivered as described in Section 2(b) below and Subscription Documents (as defined below) with respect to such amounts have been delivered to the Company by Subscribers as described in Section 2(a) below; and
|
|
b.
|
the Merger shall have been effected (or is simultaneously effected).
|
|
1.
|
Subscription.
The undersigned Subscriber hereby subscribes to purchase the number of Shares set forth on the Omnibus Signature Page attached hereto, for the aggregate Purchase Price as set forth on such Omnibus Signature Page, subject to the terms and conditions of this Agreement and on the basis of the representations, warranties, covenants and agreements contained herein.
|
|
2.
|
Subscription Procedure.
To complete a subscription for the Shares, the Subscriber must fully comply with the subscription procedure provided in this Section on or before the Closing Date.
|
|
a.
|
Subscription Documents.
On or before the Closing Date, the Subscriber shall review, complete and execute the Omnibus Signature Page to this Agreement, the Investor Profile, Anti-Money Laundering Form and Investor Certification, attached hereto following the Omnibus Signature Page and the Subscription Shares Escrow Agreement (as defined below) (collectively, the “
Subscription Documents
”), and deliver the Subscription Documents to the Company’s attorneys, CKR Law LLP (“
CKR
”), at the address set forth under the caption “
How to subscribe for Shares in the private offering of Tyme Technologies, Inc.
” below. Executed documents may be delivered to CKR by facsimile or electronic mail (e-mail), if the Subscriber delivers the original copies of the documents to CKR as soon as practicable thereafter.
|
|
b.
|
Purchase Price
. Simultaneously with the delivery of the Subscription Documents to CKR as provided herein, and in any event on or prior to the Closing Date, the Subscriber shall (i) deliver the full Subscriber’s Purchase Price as follows: (A) by certified or other bank check or by wire transfer of at least $4,290,000 in immediately available funds, to Delaware Trust Company, in its capacity as escrow agent (the “
Escrow Agent
”), pursuant to the instructions set forth under the caption “
How to subscribe for Shares in the private offering of Tyme Technologies, Inc.
” below (the “
Cash Payment
”), and (B) by execution and delivery to the Company of the limited recourse promissory note in the principal amount of up to $2,500,000 substantially in the form of
Exhibit B
hereto (the “Subscription Note”) (the amount of the Cash Payment and the principal amount of the Subscription Note totaling $6,790,000); and (ii) execute and deliver to the Company the Subscription Note Shares Escrow Agreement substantially in the form of
Exhibit C
hereto (the “Subscription Shares Escrow Agreement”), and deliver to the Escrow Agent (as defined in the Subscription Shares Escrow Agreement) the Deposit Shares (as defined and in the manner specified in the Subscription Shares Escrow Agreement).
|
2 |
|
3.
|
[RESERVED]
|
|
4.
|
Representations and Warranties of the Company
. The Company hereby represents and warrants to the Subscriber the following:
|
|
a.
|
Organization and Qualification
. The Company is and, after the Merger, each of its subsidiaries will be, a corporation or other business entity duly organized and validly existing in good standing under the laws of the jurisdiction of its formation, and the Company and, after the Merger, each of its subsidiaries, has or will have the requisite corporate power to own its properties and to carry on its business as now being conducted. The Company is and, after the Merger, each of its subsidiaries will be duly qualified as a foreign corporation to do business and is in good standing in every jurisdiction in which the nature of the business conducted by it makes such qualification necessary, except to the extent that the failure to be so qualified or be in good standing would not have a material adverse effect on the assets, business, condition (financial or otherwise), results of operations or future prospects of the Company and its Subsidiaries taken as a whole (a “
Material Adverse Effect
”). Each subsidiary of the Company, after giving effect to the Merger, is identified on
Schedule 4a
attached hereto. (For purposes of the representations and warranties contained in this Section 4, the term “
Subsidiary
” as applied to the Company includes Tyme and Tyme’s subsidiaries after giving effect to the Merger.) Immediately prior to the closing of the Merger, under the terms of a split-off agreement and a general release agreement, the Company will transfer all of its pre-Merger operating assets, if any, and liabilities, if any, to a wholly-owned special-purpose subsidiary to be formed (“Split-Off Subsidiary”), and the Company will transfer all of the outstanding shares of capital stock of Split-Off Subsidiary to a pre-Merger stockholder of the Company (the “Split-Off”), in consideration of and in exchange for (i) the surrender and cancellation of an aggregate of 13,000,200 shares of our Common Stock held by such stockholder (which will be cancelled and will resume the status of authorized but unissued shares of our Common Stock) and (ii) certain representations, covenants and indemnities.
|
|
b.
|
Authorization, Enforcement, Compliance with Other Instruments
. (i) The Company has the requisite corporate power and authority to enter into and perform its obligations under this Agreement, the Registration Rights Agreement and each of the other agreements and documents that are exhibits hereto or thereto or are contemplated hereby or thereby or necessary or desirable to effect the transactions contemplated hereby or thereby (the “
Transaction Documents
”) and to issue the Shares in accordance with the terms hereof and thereof, (ii) the execution and delivery by the Company of each of the Transaction Documents and the consummation by the Company of the transactions contemplated hereby and thereby, including, without limitation, the issuance of the Shares,
have been, or will be at the time of execution of such Transaction Document, duly authorized by the Company’s Board of Directors, and no further consent or authorization is, or will be at the time of execution of such Transaction Document, required by the Company, its respective Board of Directors or its stockholders, (iii) each of the Transaction Documents will be duly executed and delivered by the Company, (iv) the Transaction Documents when executed will constitute the valid and binding obligations of the Company enforceable against the Company in accordance with their terms, except as such enforceability may be limited by general principles of equity or applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally, the enforcement of creditors’ rights and remedies.
|
3 |
|
c.
|
Capitalization
. The authorized capital stock of the Company consists of 300,000,000 shares of Common Stock and 10,000,000 shares of preferred stock. All of the outstanding shares of Common Stock and, after the Merger, of the stock of each of the Company’s Subsidiaries have been duly authorized, validly issued and are fully paid and nonassessable. After giving effect to the Share Cancellations, the Split-Off and the Merger: (i) except as set forth on
Schedule 4c(i)
,
no shares of capital stock of the Company or any of its Subsidiaries will be subject to preemptive rights or any other similar rights or any liens or encumbrances suffered or permitted by the Company; (ii) except as set forth in
Schedule 4c(ii)
and in Section 1.14 of the Agreement and Plan of Merger and Reorganization among the Company, Tyme Acquisition Corp., Tyme and the other parties thereto, dated as of March 5, 2015, there will be no outstanding options, warrants, scrip, rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities or rights convertible into, any shares of capital stock of the Company or any of its Subsidiaries, or contracts, commitments, understandings or arrangements by which the Company or any of its subsidiaries is or may become bound to issue additional shares of capital stock of the Company or any of its subsidiaries, (iii) there will be no outstanding debt securities of the Company or any of its subsidiaries, other than indebtedness as set forth in
Schedule 4c(iii)
, (iv) other than pursuant to the Registration Rights Agreement or as set forth in
Schedule 4c(iv)
, there will be no agreements or arrangements under which the Company or any of its Subsidiaries is obligated to register the sale of any of their securities under the Securities Act, (v) there will be no outstanding registration statements, and there will be no outstanding comment letters from the SEC or any other regulatory agency; (vi) except as provided in this Agreement or as set forth in
Schedule 4c(vi)
, there will be no securities or instruments containing anti-dilution or similar provisions, including the right to adjust the exercise, exchange or reset price under such securities, that will be triggered by the issuance of the Shares as described in this Agreement; and (vii) no co-sale right, right of first refusal or other similar right will exist with respect to the Shares or the issuance and sale thereof. After giving effect to the Stock Split, the Share Cancellations, the Split-Off and the Merger and the Closing of the Offering, the pro forma outstanding capitalization of the Company will be as set forth in
Schedule 4c
under “
Pro Forma Capitalization
”. Upon request, the Company will make available to Subscriber true and correct copies of the Company’s Certificate of Incorporation, and as to be in effect after giving effect to the Merger (the “
Certificate of Incorporation
”), and the Company’s By-laws, as to be in effect after giving effect to the Merger
(the “
By-laws
”), and the terms of all securities exercisable for Common Stock and the material rights of the holders thereof in respect thereto other than stock options issued to officers, directors, employees and consultants.
|
|
d.
|
Issuance of Shares
. The Shares are duly authorized and, upon issuance in accordance with the terms hereof, shall be duly issued, fully paid and nonassessable, and are and shall be upon issuance free from all taxes, liens and charges with respect to the issue thereof.
|
|
e.
|
No Conflicts
. The execution, delivery and performance of each of the Transaction Documents by the Company, and the consummation by the Company of the transactions contemplated hereby and thereby will not (i) result in a violation of the Certificate of Incorporation or the By-laws (or equivalent constitutive document) of the Company or any of its Subsidiaries or (ii) violate or conflict with, or result in a breach of any provision of, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which the Company or any Subsidiary is a party, or result in a violation of any law, rule, regulation, order, judgment or decree (including U.S. federal and state securities laws and regulations) applicable to the
|
4 |
|
Company or any Subsidiary or by which any property or asset of the Company or any Subsidiary is bound or affected except for those which could not reasonably be expected to have a Material Adverse Effect. Except those which could not reasonably be expected to have a Material Adverse Effect, neither the Company nor any Subsidiary is in violation of any term of or in default under its constitutive documents. Except those which could not reasonably be expected to have a Material Adverse Effect, neither the Company nor any Subsidiary is in violation of any term of or in default under any material contract, agreement, mortgage, indebtedness, indenture, instrument, judgment, decree or order or any statute, rule or regulation applicable to the Company or any Subsidiary. The business of the Company and its Subsidiaries is not being conducted, and shall not be conducted in violation of any material law, ordinance, or regulation of any governmental entity, except for any violation which could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. Except as specifically contemplated by this Agreement and as required under the Securities Act and any applicable state securities laws, neither the Company nor any of its Subsidiaries is required to obtain any consent, authorization or order of, or make any filing or registration with, any court or governmental agency in order for it to execute, deliver or perform any of its obligations under or contemplated by this Agreement or the other Transaction Documents in accordance with the terms hereof or thereof. Except as set forth on
Schedule 4e
, neither the execution and delivery by the Company of the Transaction Documents, nor the consummation by the Company of the transactions contemplated hereby or thereby, will require any notice, consent or waiver under any contract or instrument to which the Company or any Subsidiary is a party or by which the Company or any Subsidiary is bound or to which any of their assets is subject, except for any notice, consent or waiver the absence of which would not have a Material Adverse Effect and would not adversely affect the consummation of the transactions contemplated hereby or thereby. All consents, authorizations, orders, filings and registrations which the Company or any of its Subsidiaries is required to obtain pursuant to the preceding two sentences have been or will be obtained or effected on or prior to the Closing. The Company is unaware of any facts or circumstance, which might give rise to any of the foregoing.
|
|
f.
|
Absence of Litigation
. There is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body now pending or, to the knowledge of the Company, threatened, against or affecting the Company or any of its Subsidiaries, wherein an unfavorable decision, ruling or finding would (i) adversely affect the validity or enforceability of, or the authority or ability of the Company or any of its Subsidiaries to perform its obligations under, this Agreement or any of the other Transaction Documents, or (ii) have a Material Adverse Effect.
|
|
g.
|
Acknowledgment Regarding Subscriber’s Purchase of the Shares
. The Company acknowledges and agrees that Subscriber is acting solely in the capacity of an arm’s length purchaser with respect to the Transaction Documents and the transactions contemplated hereby and thereby. The Company further acknowledges that Subscriber is not acting as a financial advisor or fiduciary of the Company (or in any similar capacity) with respect to the Transaction Documents and the transactions contemplated hereby and thereby and any advice given by Subscriber or any of his representatives or agents in connection with the Transaction Documents and the transactions contemplated hereby and thereby is merely incidental to Subscriber’s purchase of the Shares. The Company further represents to Subscriber that the Company’s decision to enter into the Transaction Documents has been based solely on the independent evaluation by the Company and its representatives.
|
5 |
|
h.
|
No General Solicitation
. Neither the Company, nor any of its affiliates, nor, to the knowledge of the Company, any person acting on its or their behalf, has engaged in any form of general solicitation or general advertising (within the meaning of Regulation D) in connection with the offer or sale of the Shares.
|
|
i.
|
No Integrated Offering
. Neither the Company, nor any of its affiliates, nor to the knowledge of the Company, any person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would require registration of the Shares under the Securities Act or cause the Offering of the Shares to be integrated with prior offerings by the Company for purposes of the Securities Act.
|
|
j.
|
Employee Relations
. Neither Company nor any Subsidiary is involved in any labor dispute nor, to the knowledge of the Company, is any such dispute threatened. Neither Company nor any Subsidiary is party to any collective bargaining agreement. The Company’s and/or its Subsidiaries’ employees are not members of any union, and the Company believes that its and its Subsidiaries’ relationship with their respective employees is good.
|
|
k.
|
Intellectual Property Rights
. After giving effect to the Merger, except as set forth on
Schedule 4k
, the Company and its Subsidiaries own or possess all patents, trademarks, domain names (whether or not registered) and any patentable improvements or copyrightable derivative works thereof, websites and intellectual property rights relating thereto, service marks, trade names, copyrights, licenses and authorizations, and all rights with respect to the foregoing, which are necessary for the conduct of its business as now conducted without any conflict with the rights of others except for such conflicts that would not result in a Material Adverse Effect. Neither Company nor any Subsidiary has received any notice of infringement of, or conflict with, the asserted rights of others with respect to any intellectual property that it utilizes.
|
|
l.
|
Environmental Laws
.
|
|
(i)
|
The Company and each Subsidiary has complied with all applicable Environmental Laws (as defined below), except for violations of Environmental Laws that, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect. There is no pending or, to the knowledge of the Company, threatened civil or criminal litigation, written notice of violation, formal administrative proceeding, or investigation, inquiry or information request, relating to any Environmental Law involving the Company or any Subsidiary, except for litigation, notices of violations, formal administrative proceedings or investigations, inquiries or information requests that, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Environmental Law” means any national, state, provincial or local law, statute, rule or regulation or the common law relating to the environment or occupational health and safety, including without limitation any statute, regulation, administrative decision or order pertaining to (i) treatment, storage, disposal, generation and transportation of industrial, toxic or hazardous materials or substances or solid or hazardous waste; (ii) air, water and noise pollution; (iii) groundwater and soil contamination; (iv) the release or threatened release into the environment of industrial, toxic or hazardous materials or substances, or solid or hazardous waste, including without limitation emissions, discharges, injections, spills, escapes or dumping of pollutants, contaminants or chemicals; (v) the protection of wild life, marine life and wetlands, including without limitation all endangered and threatened
|
6 |
|
species; (vi) storage tanks, vessels, containers, abandoned or discarded barrels, and other closed receptacles; (vii) health and safety of employees and other persons; and (viii) manufacturing, processing, using, distributing, treating, storing, disposing, transporting or handling of materials regulated under any law as pollutants, contaminants, toxic or hazardous materials or substances or oil or petroleum products or solid or hazardous waste. As used above, the terms “release” and “environment” shall have the meaning set forth in the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended.
|
|
(ii)
|
To the knowledge of the Company there is no material environmental liability with respect to any solid or hazardous waste transporter or treatment, storage or disposal facility that has been used by the Company or any Subsidiary.
|
|
(iii)
|
The Company and its Subsidiaries (i) have received all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses and (ii) are in compliance, in all material respects, with all terms and conditions of any such permit, license or approval.
|
|
m.
|
Permits; FDA Compliance
. The Company and its Subsidiaries have all authorizations, approvals, clearances, licenses, permits, certificates or exemptions (including manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) issued by any regulatory authority or governmental agency (collectively, “
Permits
”) required to conduct their respective businesses as currently conducted except to the extent that the failure to have such Permits would not have a Material Adverse Effect. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “
FDCA
”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “
FDA
”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any such Permit or changing the marketing classification or labeling of the products of the Company or any of its Subsidiaries. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company or any of its Subsidiaries to the FDA or any comparable regulatory authority or governmental agency. The Company or its Subsidiaries have fulfilled and performed in all material respects their obligations under each Permit, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company or any of its Subsidiaries is in compliance in all material respects with all Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company and its Subsidiaries have not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or other governmental agency alleging or asserting noncompliance with any applicable laws or Permits. The Company and its Subsidiaries are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of
|
7 |
|
violation letter or other notice, response or commitment made to or with the FDA or any comparable regulatory authority or governmental agency. The Company and its Subsidiaries have made all notifications, submissions and reports required by the FDCA or similar federal, state and foreign laws, except to the extent that the failure to make such notifications, submission or reports would not have a Material Adverse Effect.
|
|
n.
|
Title
. After giving effect to the Merger, neither the Company nor any of its Subsidiaries owns any real property. After giving effect to the Merger, except as set forth on
Schedule 4n
, each of the Company and its Subsidiaries has good and marketable title to all of its personal property and assets, free and clear of any material restriction, mortgage, deed of trust, pledge, lien, security interest or other charge, claim or encumbrance which would have a Material Adverse Effect
.
After giving effect to the Merger, except as set forth on
Schedule 4n
, with respect to properties and assets it leases, each of the Company and its Subsidiaries is in material compliance with such leases and holds a valid leasehold interest free of any liens, claims or encumbrances which would have a Material Adverse Effect.
|
|
o.
|
No Material Adverse Breaches, etc
. Neither Company nor any Subsidiary is subject to any charter, corporate or other legal restriction, or any judgment, decree, order, rule or regulation which in the judgment of the Company’s officers has had, or is reasonably expected in the future to have, a Material Adverse Effect. Neither Company nor any Subsidiary is in breach of any contract or agreement which breach, in the judgment of the Company’s officers, has had, or is reasonably expected to have a Material Adverse Effect.
|
|
p.
|
Tax Status
. The Company and each Subsidiary has made and filed (taking into account any valid extensions) all federal and state income and all other tax returns, reports and declarations required by any jurisdiction to which it is subject and (unless and only to the extent that the Company or such Subsidiary has set aside on its books provisions reasonably adequate for the payment of all unpaid and unreported taxes) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations, except those being contested in good faith and has set aside on its books provision reasonably adequate for the payment of all taxes for periods subsequent to the periods to which such returns, reports or declarations apply. To the knowledge of the Company, there are no unpaid taxes in any material amount claimed to be due from the Company or any Subsidiary by the taxing authority of any jurisdiction, and the officers of the Company know of no basis for any such claim.
|
|
q.
|
Certain Transactions
. Except as set forth on
Schedule 4q
, and except for arm’s length transactions pursuant to which the Company or any Subsidiary makes payments in the ordinary course of business upon terms no less favorable than it could obtain from third parties, none of the officers, directors, or employees of the Company or any Subsidiary is presently a party to any transaction with the Company or any Subsidiary (other than for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company, any corporation, partnership, trust or other entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee or partner.
|
|
r.
|
Rights of First Refusal
. Except as set forth on
Schedule 4c(i)
or
Schedule 4r
, the Company is not obligated to offer the securities offered hereunder on a right of first refusal basis or
|
8 |
|
otherwise to any third parties including, but not limited to, current or former stockholders of the Company, underwriters, brokers, agents or other third parties.
|
|
s.
|
Reliance
. The Company acknowledges that the Subscriber is relying on the representations and warranties made by the Company hereunder and that such representations and warranties are a material inducement to the Subscriber purchasing the Shares. The Company further acknowledges that without such representations and warranties of the Company made hereunder, the Subscribers would not enter into this Agreement.
|
|
t.
|
Brokers’ Fees
. Except as set forth in Section 3 or
Schedule 4(t)
, the Company does not have any liability or obligation to pay any fees or commissions to any broker, finder or agent with respect to the transactions contemplated by this Agreement.
|
|
u.
|
SEC Reports
. The Company has filed all reports, schedules, forms, statements and other documents required to be filed by the Company under the Securities Exchange Act of 1934, as amended, including pursuant to Section 13(a) or 15(d) thereof, for the two years preceding the date hereof (or such shorter period as the Company was required by law or regulation to file such material).
|
|
5.
|
Representations, Warranties and Agreements of the Subscriber.
The Subscriber represents and warrants to, and agrees with, the Company the following:
|
|
a.
|
The Subscriber, its advisers, if any, and its designated representatives, if any, have the knowledge and experience in financial and business matters necessary to evaluate the merits and risks of its prospective investment in the Company, and have carefully reviewed and understand the risks of, and other considerations relating to, the purchase of Shares and the tax consequences of the investment, and have the ability to bear the economic risks of the investment.
|
|
b.
|
The Subscriber is acquiring the Shares being subscribed for pursuant to this Agreement for investment for its own account and not with the view to, or for resale in connection with, any distribution thereof. The Subscriber understands and acknowledges that the Shares have not been registered under the Securities Act or any state securities laws, by reason of a specific exemption from the registration provisions of the Securities Act and applicable state securities laws, which depends upon, among other things, the bona fide nature of the investment intent as expressed herein. The Subscriber further represents that it does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participation to any third person with respect to any of the Shares. The Subscriber understands and acknowledges that the Offering of the Shares will not be registered under the Securities Act nor under the state securities laws on the ground that the sale of the Shares to Subscriber as provided for in this Agreement and the issuance of securities hereunder is exempt from the registration requirements of the Securities Act and any applicable state securities laws.
|
|
c.
|
The Subscriber is an “accredited investor” as defined in Rule 501 of Regulation D as promulgated by the Securities and Exchange Commission under the Securities Act, for the reason(s) specified on the
Accredited Investor Certification
attached hereto as completed by Subscriber, and Subscriber shall submit to the Company such further assurances of such status as may be reasonably requested by the Company. The Subscriber resides in the jurisdiction set forth on the Subscriber’s Omnibus Signature Page affixed hereto.
|
9 |
|
d.
|
The Subscriber (i) if a natural person, represents that he or she is the greater of (A) 21 years of age or (B) the age of legal majority in his or her jurisdiction of residence, and has full power and authority to execute and deliver this Agreement and all other related agreements or certificates and to carry out the provisions hereof and thereof; (ii) if a corporation, partnership, or limited liability company or partnership, or association, joint stock company, trust, unincorporated organization or other entity, represents that such entity was not formed for the specific purpose of acquiring any of the Shares, such entity is duly organized, validly existing and in good standing under the laws of the state or jurisdiction of its organization, the consummation of the transactions contemplated hereby is authorized by, and will not result in a violation of state law or its charter or other organizational documents, such entity has full power and authority to execute and deliver this Agreement and all other related agreements or certificates and to carry out the provisions hereof and thereof and to purchase and hold the Shares being subscribed for pursuant to this Agreement, the execution and delivery of this Agreement has been duly authorized by all necessary action, this Agreement has been duly executed and delivered on behalf of such entity and is a legal, valid and binding obligation of such entity; or (iii) if executing this Agreement in a representative or fiduciary capacity, represents that it has full power and authority to execute and deliver this Agreement in such capacity and on behalf of the subscribing individual, ward, partnership, trust, estate, corporation, or limited liability company or partnership, or other entity for whom the Subscriber is executing this Agreement, and such individual, partnership, ward, trust, estate, corporation, or limited liability company or partnership, or other entity has full right and power to perform pursuant to this Agreement and make an investment in the Company, and represents that this Agreement constitutes a legal, valid and binding obligation of such entity. The execution and delivery of this Agreement will not violate or be in conflict with any order, judgment, injunction, agreement or controlling document to which the Subscriber is a party or by which it is bound.
|
|
e.
|
The Subscriber understands that the Shares are being offered, and any Shares sold to it are being sold, in reliance on specific exemptions from the registration requirements of United States federal and state securities laws and that the Company is relying in part upon the truth and accuracy of, and such Subscriber’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of such Subscriber set forth herein in order to determine the availability of such exemptions and the eligibility of such Subscriber to acquire such securities. The Subscriber further acknowledges and understands that the Company is relying on the representations and warranties made by the Subscriber hereunder and that such representations and warranties are a material inducement to the Company to sell the Shares to the Subscriber. The Subscriber further acknowledges that without such representations and warranties of the Subscriber made hereunder, the Company would not enter into this Agreement with the Subscriber.
|
|
f.
|
The Subscriber understands that no public market now exists, and there never will be a public market for, the Shares, that only a limited public market for the Company’s Common Stock exists and that there can be no assurance that an active public market for the Common Stock will exist or continue to exist.
|
|
g.
|
The Subscriber, its advisers, if any, and its designated representatives, if any, have received, reviewed and understood the information about the Company, Tyme and the Offering and have had an opportunity to discuss the Company’s and Tyme’s business, management and financial affairs with the Company’s management. The Subscriber understands that such discussions were intended to describe the aspects of the Company’s business and prospects and the Offering which the Company believes to be material, but were not necessarily a
|
10 |
|
thorough or exhaustive description, and except as expressly set forth in this Agreement, the Company makes no representation or warranty with respect to the completeness of such information and makes no representation or warranty of any kind with respect to any information provided by any entity other than the Company. Some of such information may include projections as to the future performance of the Company and/or Tyme, which projections may not be realized, may be based on assumptions which may not be correct and may be subject to numerous factors beyond the Company’s control. Additionally, the Subscriber understands and represents that it is purchasing the Shares being subscribed for pursuant to this Agreement notwithstanding the fact that the Company and/or Tyme may disclose in the future certain material information the Subscriber has not received, including (without limitation) financial statements of the Company and/or Tyme for the current or prior fiscal periods, and any subsequent period financial statements that will be filed with the Securities and Exchange Commission, that it is not relying on any such information in connection with its purchase of the Shares being subscribed for pursuant to this Agreement and that it waives any right of action with respect to the nondisclosure to it prior to its purchase of such Shares of any such information. Each Subscriber has sought such accounting, legal and tax advice as it has considered necessary to make an informed investment decision with respect to its acquisition of the Shares being subscribed for pursuant to this Agreement.
|
|
h.
|
The Subscriber acknowledges that the Company is not acting as a financial advisor or fiduciary of the Subscriber (or in any similar capacity) with respect to the Transaction Documents and the transactions contemplated hereby and thereby and no investment advice has been given by the Company or any of its representatives or agents in connection with the Transaction Documents and the transactions contemplated hereby and thereby. The Subscriber further represents to the Company that the Subscriber’s decision to enter into the Transaction Documents has been based solely on the independent evaluation by the Subscriber and its representatives.
|
|
i.
|
As of the Closing, all actions on the part of Subscriber, and its officers, directors and partners, if applicable, necessary for the authorization, execution and delivery of this Agreement and the Registration Rights Agreement and the performance of all obligations of the Subscriber hereunder and thereunder shall have been taken, and this Agreement and the Registration Rights Agreement, assuming due execution by the other parties hereto and thereto, constitute valid and legally binding obligations of the Subscriber, enforceable in accordance with their respective terms, subject to: (i) judicial principles limiting the availability of specific performance, injunctive relief, and other equitable remedies and (ii) bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect generally relating to or affecting creditors’ rights.
|
|
j.
|
Subscriber represents that neither it nor, to its knowledge, any person or entity controlling, controlled by or under common control with it, nor any person having a beneficial interest in it, nor any person on whose behalf the Subscriber is acting: (i) is a person listed in the Annex to Executive Order No. 13224 (2001) issued by the President of the United States (Executive Order Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten to Commit, or Support Terrorism); (ii) is named on the List of Specially Designated Nationals and Blocked Persons maintained by the U.S. Office of Foreign Assets Control; (iii) is a non-U.S. shell bank or is providing banking services indirectly to a non-U.S. shell bank; (iv) is a senior non-U.S. political figure or an immediate family member or close associate of such figure; or (v) is otherwise prohibited from investing in the Company pursuant to applicable U.S. anti-money laundering, anti-terrorist and asset control laws, regulations, rules or orders
|
11 |
|
(categories (i) through (v), each a “
Prohibited Subscriber
”). The Subscriber agrees to provide the Company, promptly upon request, all information that the Company reasonably deems necessary or appropriate to comply with applicable U.S. anti-money laundering, anti-terrorist and asset control laws, regulations, rules and orders. The Subscriber consents to the disclosure to U.S. regulators and law enforcement authorities by the Company and its affiliates and agents of such information about the Subscriber as the Company reasonably deems necessary or appropriate to comply with applicable U.S. antimony laundering, anti-terrorist and asset control laws, regulations, rules and orders. If the Subscriber is a financial institution that is subject to the USA Patriot Act, the Subscriber represents that it has met all of its obligations under the USA Patriot Act. The Subscriber acknowledges that if, following its investment in the Company, the Company reasonably believes that the Subscriber is a Prohibited Subscriber or is otherwise engaged in suspicious activity or refuses to promptly provide information that the Company requests, the Company has the right or may be obligated to prohibit additional investments, segregate the assets constituting the investment in accordance with applicable regulations or immediately require the Subscriber to transfer the Shares. The Subscriber further acknowledges that the Subscriber will have no claim against the Company or any of its affiliates or agents for any form of damages as a result of any of the foregoing actions.
|
|
If the Subscriber is affiliated with a non-U.S. banking institution (a “
Foreign Bank
”), or if the Subscriber receives deposits from, makes payments on behalf of, or handles other financial transactions related to a Foreign Bank, the Subscriber represents and warrants to the Company that: (1) the Foreign Bank has a fixed address, other than solely an electronic address, in a country in which the Foreign Bank is authorized to conduct banking activities; (2) the Foreign Bank maintains operating records related to its banking activities; (3) the Foreign Bank is subject to inspection by the banking authority that licensed the Foreign Bank to conduct banking activities; and (4) the Foreign Bank does not provide banking services to any other Foreign Bank that does not have a physical presence in any country and that is not a regulated affiliate.
|
|
k.
|
The Subscriber or its duly authorized representative realizes that because of the inherently speculative nature of businesses of the kind conducted and contemplated by the Company, the Company’s financial results may be expected to fluctuate from month to month and from period to period and will, generally, involve a high degree of financial and market risk that could result in substantial or, at times, even total losses for investors in securities of the Company.
|
|
l.
|
The Subscriber has adequate means of providing for its current and anticipated financial needs and contingencies, is able to bear the economic risk for an indefinite period of time and has no need for liquidity of the investment in the Shares and could afford complete loss of such investment.
|
|
m.
|
The Subscriber is not subscribing for Shares as a result of or subsequent to any advertisement, article, notice or other communication, published in any newspaper, magazine or similar media or broadcast over television, radio, or the internet, or presented at any seminar or meeting, or any solicitation of a subscription by a person not previously known to the Subscriber in connection with investments in securities generally.
|
|
n.
|
The Subscriber acknowledges that no U.S. federal or state agency or any other government or governmental agency has passed upon the Shares or made any finding or determination as to the fairness, suitability or wisdom of any investments therein.
|
12 |
|
o.
|
The Subscriber agrees to be bound by all of the terms and conditions of the Registration Rights Agreement and to perform all obligations thereby imposed upon it.
|
|
p.
|
All of the information that the Subscriber has heretofore furnished or which is set forth herein is true, correct and complete as of the date of this Agreement, and, if there should be any material change in such information prior to the admission of the undersigned to the Company, the Subscriber will immediately furnish revised or corrected information to the Company.
|
|
q.
|
(For ERISA plans only)
The fiduciary of the ERISA plan (the “
Plan
”) represents that such fiduciary has been informed of and understands the Company’s investment objectives, policies and strategies, and that the decision to invest “plan assets” (as such term is defined in ERISA) in the Company is consistent with the provisions of ERISA that require diversification of plan assets and impose other fiduciary responsibilities. The Subscriber fiduciary or Plan (a) is responsible for the decision to invest in the Company; (b) is independent of the Company or any of its affiliates; (c) is qualified to make such investment decision; and (d) in making such decision, the Purchaser fiduciary or Plan has not relied primarily on any advice or recommendation of the Company or any of its affiliates.
|
|
6.
|
Transfer Restrictions
. The Subscriber acknowledges and agrees as follows:
|
|
a.
|
The Shares have not been registered for sale under the Securities Act, in reliance on the private offering exemption in Section 4(a)(2) thereof; other than as expressly provide in the Registration Rights Agreement, the Company does not currently intend to register the Shares under the Securities Act at any time in the future; and the undersigned will not immediately be entitled to the benefits of Rule 144 with respect to the Shares.
|
|
b.
|
The Subscriber understands that there are substantial restrictions on the transferability of the Shares, accordingly, that the certificates representing the Shares shall bear a restrictive legend in substantially the following form (and a stop-transfer order may be placed against transfer of such certificates or other instruments):
|
13 |
|
c.
|
Subscriber understands that prior to the Merger, the Company is a “shell company” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “
Exchange Act
”), and that upon the filing of a Current Report on Form 8-K reporting the consummation of the Merger and the other transactions described herein and otherwise containing Form 10 information discussed below, the Company will cease to be a shell company. Pursuant to Rule 144(i), the Shares will be deemed securities issued by a current or former shell company and, even where the Shares otherwise meet the holding period and other requirements of Rule 144, nevertheless the Shares cannot be sold in reliance on Rule 144 until
one year
after the Company (a) is no longer a shell company; and (b) has filed current “Form 10 information” (as defined in Rule 144(i)) with the SEC reflecting that it is no longer a shell company, and provided that at the time of a proposed sale pursuant to Rule 144, the Company is subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act and has filed all reports and other materials required to be filed by Section 13 or 15(d) of the Exchange Act, as applicable, during the preceding 12 months (or for such shorter period that the issuer was required to file such reports and materials), other than Form 8-K reports.
As a result, the restrictive legends on certificates for the Shares cannot be removed except in connection with an actual sale meeting the foregoing requirements or pursuant to an effective registration statement
.
|
|
7.
|
Indemnification.
The Subscriber agrees to indemnify and hold harmless the Company, and its officers, directors, employees, agents, control persons and affiliates from and against all losses, liabilities, claims, damages, costs, fees and expenses whatsoever (including, but not limited to, any and all expenses incurred in investigating, preparing or defending against any litigation commenced or threatened) based upon or arising out of the Subscriber’s actual or alleged false acknowledgment, representation or warranty, or misrepresentation or omission to state a material fact, or breach by the Subscriber of any covenant or agreement made by the Subscriber, contained herein or in any other document delivered by the Subscriber in connection with this Agreement.
|
|
8.
|
Revocability; Binding Effect.
The subscription hereunder may be revoked prior to the Closing thereon, provided that written notice of revocation is sent and is received by the Company at least two business days prior to the Closing on such subscription. The Subscriber hereby acknowledges and agrees that this Agreement shall survive the death or disability of the Subscriber and shall be binding upon and inure to the benefit of the parties and their heirs, executors, administrators, successors, legal representatives and permitted assigns. If the Subscriber is more than one person, the obligations of the Subscriber hereunder shall be joint and several and the agreements, representations, warranties and acknowledgments herein shall be deemed to be made by and be binding upon each such person and such person’s heirs, executors, administrators, successors, legal representatives and permitted assigns.
|
|
9.
|
Modification.
This Agreement shall not be modified or waived except by an instrument in writing signed by the party against whom any such modification or waiver is sought to be enforced.
|
14 |
|
10.
|
Immaterial Modifications to the Registration Rights Agreement.
The Company may, at any time prior to the Closing, amend the Registration Rights Agreement if necessary to clarify any provision therein, without first providing notice or obtaining prior consent of the Subscriber.
|
|
11.
|
Notices.
Any notice or other communication required or permitted to be given hereunder shall be in writing and shall be mailed by certified mail, return receipt requested, or delivered against receipt to the party to whom it is to be given (a) if to the Company, at the address set forth above, with a copy to CKR Law LLP, 1330 Avenue of the Americas, New York, NY 10019, Attention: Barrett S. DiPaolo, facsimile +1-212-400-6901, or (b) if to the Subscriber, at the address set forth on the Omnibus Signature Page hereof (or, in either case, to such other address as the party shall have furnished in writing in accordance with the provisions of this Section). Any notice or other communication given by certified mail shall be deemed given at the time of certification thereof, except for a notice changing a party’s address which shall be deemed given at the time of receipt thereof
.
|
|
12.
|
Assignability.
This Agreement and the rights, interests and obligations hereunder are not transferable or assignable by the Subscriber, and the transfer or assignment of the Shares shall be made only in accordance with all applicable laws.
|
|
13.
|
Applicable Law.
This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without reference to the principles thereof relating to the conflict of laws.
|
|
14.
|
Arbitration.
The parties agree to submit all controversies to arbitration in accordance with the provisions set forth below and understand that:
|
|
a.
|
Arbitration shall be final and binding on the parties.
|
|
b.
|
The parties are waiving their right to seek remedies in court, including the right to a jury trial.
|
|
c.
|
Pre-arbitration discovery is generally more limited and different from court proceedings.
|
|
d.
|
The arbitrator’s award is not required to include factual findings or legal reasoning and any party’s right to appeal or to seek modification of rulings by arbitrators is strictly limited.
|
|
e.
|
The panel of arbitrators will typically include a minority of arbitrators who were or are affiliated with the securities industry.
|
|
f.
|
All controversies which may arise between the parties concerning this Agreement shall be determined by arbitration pursuant to the rules then pertaining to the Financial Industry Regulatory Authority in New York, New York. Judgment on any award of any such arbitration may be entered in the Supreme Court of the State of New York or in any other court having jurisdiction of the person or persons against whom such award is rendered. Any notice of such arbitration or for the confirmation of any award in any arbitration shall be sufficient if given in accordance with the provisions of this Agreement. The parties agree that the determination of the arbitrators shall be binding and conclusive upon them. The prevailing party, as determined by such arbitrators, in a legal proceeding shall be entitled to collect any costs, disbursements and reasonable attorney’s fees from the other party. Prior to filing an arbitration, the parties hereby agree that they will attempt to resolve their differences first by submitting the matter for resolution to a mediator, acceptable to all parties, and whose expenses will be borne equally by all parties. The mediation will be held in the County of
|
15 |
|
New York, State of New York, on an expedited basis. If the parties cannot successfully resolve their differences through mediation, the matter will be resolved by arbitration. The arbitration shall take place in the County of New York, State of New York, on an expedited basis.
|
|
15.
|
Blue Sky Qualification.
The purchase of Shares under this Agreement is expressly conditioned upon the exemption from qualification of the offer and sale of the Shares from applicable federal and state securities laws. The Company shall not be required to qualify this transaction under the securities laws of any jurisdiction and, should qualification be necessary, the Company shall be released from any and all obligations to maintain its offer, and may rescind any sale contracted, in the jurisdiction.
|
|
16.
|
Use of Pronouns.
All pronouns and any variations thereof used herein shall be deemed to refer to the masculine, feminine, neuter, singular or plural as the identity of the person or persons referred to may require.
|
|
17.
|
Confidentiality.
The Subscriber acknowledges and agrees that any information or data the Subscriber has acquired from or about the Company or may acquire in the future, not otherwise properly in the public domain, including, without limitation, the Transaction Documents, was received in confidence. The Subscriber agrees not to divulge, communicate or disclose, except as may be required by law or for the performance of this Agreement, or use to the detriment of the Company or for the benefit of any other person, or misuse in any way, any confidential information of the Company, including any scientific, technical, trade or business secrets of the Company and any scientific, technical, trade or business materials that are treated by the Company as confidential or proprietary, including, but not limited to, internal personnel and financial information of the Company or its affiliates, the manner and methods of conducting the business of the Company or its affiliates and confidential information obtained by or given to the Company about or belonging to third parties. The Subscriber understands that the Company may rely on Subscriber’s agreement of confidentiality to comply with the exemptive provisions of Regulation FD under the Securities Act as set forth in Rule 100(a)(b)(2)(ii) of Regulation FD. In addition, the Subscriber acknowledges that it is aware that the United States securities laws generally prohibit any person who is in possession of material nonpublic information about a public company such as the Company from purchasing or selling securities of such company. The provisions of this Section 17 are in addition to and not in lieu of any other confidentiality agreement between the Company and the Subscriber.
|
|
18.
|
Anti-Dilution.
The Shares shall have anti-dilution protection such that if, within twenty-four (24) months after the Closing, the Company shall issue Additional Shares of Common Stock (as defined below) without consideration or for a consideration per share, or with an exercise or conversion price per share, less than $0.50, the Subscriber shall be entitled to receive from the Company (for no additional consideration) additional Shares in an amount such that, when added to the number of Shares purchased by Subscriber under this Agreement, will equal the number of Shares that the Subscriber’s Purchase Price for the Shares set forth on the Subscriber’s signature page hereof would have purchased at the Adjusted Price (as defined below). The “
Adjusted Price
” shall be a price (calculated to the nearest cent) determined by multiplying the Adjusted Price per share in effect immediately prior to such issue (which, for avoidance of doubt, shall be equal $0.50 prior to the first such issue) by a fraction, (A) the numerator of which shall be (1) the number of shares of Common Stock outstanding immediately prior to such issue
plus
(2) the number of shares of Common Stock which the aggregate consideration received or to be received by the Company for the total number of Additional Shares of Common Stock so issued would purchase at such Adjusted Price; and (B) the denominator of which shall be (1) the number of
|
16 |
|
Shares of Common Stock outstanding immediately prior to such issue
plus
(2) the number of such Additional Shares of Common Stock so issued;
provided
that, (i) for the purpose of this Section, all shares of Common Stock issuable upon conversion or exchange of convertible securities outstanding immediately prior to such issue shall be deemed to be outstanding, and (ii) the number of shares of Common Stock deemed issuable upon conversion or exchange of such outstanding convertible securities shall be determined without giving effect to any adjustments to the conversion or exchange price or conversion or exchange rate of such convertible securities resulting from the issuance of Additional Shares of Common Stock that is the subject of this calculation.
|
|
19. | Miscellaneous. |
|
a.
|
This Agreement, together with the Registration Rights Agreement and any confidentiality agreement between the Company or Tyme and the Subscriber, constitute the entire agreement between the Subscriber and the Company with respect to the Offering and supersede all prior oral or written agreements and understandings, if any, relating to the subject matter hereof. The terms and provisions of this Agreement may be waived, or consent for the departure therefrom granted, only by a written document executed by the party entitled to the benefits of such terms or provisions.
|
|
b.
|
The representations and warranties of the Company and the Subscriber made in this Agreement shall survive the execution and delivery hereof and delivery of the Shares for a period of twelve (12) months following the Closing Date.
|
17 |
|
c.
|
Each of the parties hereto shall pay its own fees and expenses (including the fees of any attorneys, accountants, appraisers or others engaged by such party) in connection with this Agreement and the transactions contemplated hereby, whether or not the transactions contemplated hereby are consummated.
|
|
d.
|
This Agreement may be executed in one or more original or facsimile counterparts, each of which shall be deemed an original, but all of which shall together constitute one and the same instrument and which shall be enforceable against the parties actually executing such counterparts. The exchange of copies of this Agreement and of signature pages by facsimile transmission or in .pdf format shall constitute effective execution and delivery of this Agreement as to the parties and may be used in lieu of the original Agreement for all purposes. Signatures of the parties transmitted by facsimile or in pdf format shall be deemed to be their original signatures for all purposes.
|
|
e.
|
Each provision of this Agreement shall be considered separable and, if for any reason any provision or provisions hereof are determined to be invalid or contrary to applicable law, such invalidity or illegality shall not impair the operation of or affect the remaining portions of this Agreement.
|
|
f.
|
Paragraph titles are for descriptive purposes only and shall not control or alter the meaning of this Agreement as set forth in the text.
|
|
g.
|
The Subscriber hereby agrees to furnish the Company such other information as the Company may request prior to the Closing with respect to its subscription hereunder.
|
20.
|
Omnibus Signature Page.
This Agreement is intended to be read and construed in conjunction with the Registration Rights Agreement. Accordingly, pursuant to the terms and conditions of this Agreement and the Registration Rights Agreement, it is hereby agreed that the execution by the Subscriber of this Agreement, in the place set forth on the Omnibus Signature Page below, shall constitute agreement to be bound by the terms and conditions hereof and the terms and conditions of the Registration Rights Agreement, with the same effect as if each of such separate but related agreement were separately signed.
|
21.
|
Public Disclosure.
Neither the Subscriber nor any officer, manager, director, member, partner, stockholder, employee, affiliate, affiliated person or entity of the Subscriber shall make or issue any press releases or otherwise make any public statements or make any disclosures to any third person or entity with respect to the transactions contemplated herein and will not make or issue any press releases or otherwise make any public statements of any nature whatsoever with respect to the Company without the Company’s express prior approval. The Company has the right to withhold such approval in its sole discretion.
|
22.
|
Potential Conflicts.
CKR is counsel to the Company and has represented the Company in the proposed transaction, for which it will receive legal fees in accordance with an executed retainer agreement. CKR and/or its affiliates, principals, representatives or employees may now or hereafter own shares of the Company.
|
18 |
TYME TECHNOLOGIES, INC. | ||||
By: | ||||
Name: | Peter E. de Svastich | |||
Title: | President |
19 |
Exhibit 10.6
LIMITED RECOURSE PROMISSORY NOTE
THIS NOTE IS NOT INTENDED TO BE A NEGOTIABLE INSTRUMENT UNDER THE UNIFORM COMMERCIAL CODE, AND NEITHER THIS NOTE NOR THE COLLATERAL PLEDGED TO SECURE THIS NOTE MAY BE ASSIGNED, PLEDGED, TRANSFERRED OR HYPOTHECATED BY THE LENDER.
THIS NOTE WAS ORIGINALLY ISSUED IN A TRANSACTION EXEMPT FROM REGISTRATION UNDER THE UNITED STATES SECURITIES ACT OF 1933, AND THIS NOTE MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR AN APPLICABLE EXEMPTION THEREFROM.
$2,500,000.00 |
DATED: March 5. 2015 |
FOR VALUE RECEIVED, the undersigned, GEM Global Yield Fund LLC SCS (the “Borrower”) HEREBY PROMISES TO PAY to the order of Tyme Technologies, Inc. (the “Lender”), on June 5, 2015 (the “Maturity Date”) the principal amount of Two Million Five Hundred Thousand dollars ($2,500,000.00). No interest shall accrue or be payable on the principal amount of this Note.
1. |
Reference is made to the Subscription Agreement of even date herewith between the Lender and the Borrower with respect to the purchase by the Borrower of an aggregate of 2,716,000 shares of common stock, par value $0.0001 per share, of the Lender (the “Subscription Agreement”). Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Subscription Agreement. This Note represents the obligation of the Borrower to pay the Purchase Price not paid by Borrower on the Closing Date in accordance with the terms of the Subscription Agreement. |
|
|
2. |
The obligations of the Borrower to the Lender hereunder are secured pursuant to a Subscription Note Shares Escrow Agreement of even date herewith (“Escrow Agreement”) between the Borrower and the Lender. |
|
|
3. |
In the event that |
|
(i) |
the Borrower shall fail to pay any principal under this Note when due and payable hereunder, and such failure shall continue for a period of three (3) Business Days (as defined below) after receipt by Borrower of written notice by the Lender thereof; or |
|
|
|
|
(ii) |
a default shall occur and be continuing under the Escrow Agreement after any time provided therein for curing the same shall have expired, or the Escrow Agreement shall fail to remain in full force and effect, or any action shall be taken to discontinue the Escrow Agreement or to assert the invalidity thereof; or |
|
|
|
|
(iii) |
a receiver, trustee or other similar official shall be appointed over the Borrower or a material part of its assets and such appointment shall remain uncontested for twenty (20) days or shall not be dismissed or discharged within sixty (60) days; or |
|
|
|
|
(iv) |
the Borrower shall become insolvent or generally fails to pay, or admits in writing its inability to pay, its debts as they become due, subject to applicable grace periods, if any; or |
- 1 -
|
(v) |
the Borrower shall make a general assignment for the benefit of creditors; or |
|
|
|
|
(vi) |
the Borrower shall file a petition for relief under any bankruptcy, insolvency or similar law (domestic or foreign); or |
|
|
|
|
(vii) |
an involuntary proceeding shall be commenced or filed against the Borrower under any bankruptcy, insolvency or similar law (domestic or foreign) and such petition shall not be dismissed within sixty (60) days after commencement or filing |
(each event specified in clauses (i) through (vii) above, an “Event of Default”); then, in the case of any of the events specified in clauses (iv), (v), (vi) or (vii), the outstanding principal amount under this Note shall become immediately due and payable without any action on the part of the Lender, and in the case of any of the other events specified above, the Lender may by written notice to the Borrower declare the outstanding principal amount under this Note to be immediately due and payable, whereupon the same shall become immediately due and payable, and, except for the notices specified in this sentence, Borrower waives demand, presentment, protest, notice of protest, dishonor, notice of dishonor or any other notice of any kind. Any notice specified in this paragraph by Lender to Borrower of the occurrence of a failure to pay or other default must be delivered as specified below and must clearly specify that it is a notice of default under this paragraph.
4. |
No delay on the part of Lender in exercise of any right, power or remedy shall operate as a waiver thereof, nor shall any single or partial exercise by Lender of any right, power or remedy preclude other or further exercise thereof, or the exercise of any other right, power or remedy. No waiver of, or consent with respect to, any provision of this Note shall in any event be effective unless the same shall be in writing and signed and delivered by Lender, and then any such waiver or consent shall be effective only in the specific instance and for the specific purpose for which given. |
|
|
5. |
Unless otherwise agreed by the Lender and the Borrower, the principal amount hereof is payable to the Lender at: |
Tyme Technologies, Inc.
48 Wall Street – Suite 1100
New York, New York 10005
in immediately available funds on the Maturity Date, in the lawful currency of the United States of America. Whenever any payment to be made hereunder shall be due on a Saturday, Sunday or public or bank holiday in New York City (any other day being a “Business Day”), such payment shall be made on the next succeeding Business Day.
6. |
The Borrower has the right at any time and from time to time to prepay in whole or in part the principal amount hereof, without premium or penalty. Any amounts so prepaid may not be reborrowed hereunder. |
|
|
7. |
Neither the Lender nor the Borrower shall have the right to assign its rights and obligations under this Note without the prior written consent of the other party. |
|
|
8. |
Notices, confirmations and demands hereunder shall be in writing and will be sufficient if delivered by hand, by first class mail or nationally recognized courier service postage prepaid, or by tested cable, or facsimile transmission, at the following addresses, or to such other address as the recipient shall have designated to the sender by written notice hereunder. |
- 2 -
If to the Borrower:
GEM Global Yield Fund LLC SCS
390 Madison Avenue, 36 th Floor
New York, NY 10019
Attn: Christopher Brown
If to the Lender:
Tyme Technologies, Inc.
48 Wall Street – Suite 1100
New York, New York 10005
Attn.: President
9. |
LIMITED RECOURSE . Notwithstanding anything contained in this Note to the contrary, the Lender agrees that (i) the Borrower shall be liable upon the indebtedness evidenced by this Note to the full extent (but only to the extent) of Borrower’s interest in that certain stock of the Lender owned by Borrower (the “Escrowed Securities”) that the Borrower has deposited with the Escrow Agent (as defined in the Escrow Agreement) pursuant to the Escrow Agreement, (ii) if any default occurs under this Note, or under the Subscription Agreement with respect to the payment of the Purchase Price, any judicial proceedings brought by the Lender against the Borrower shall be limited to the preservation, enforcement and foreclosure, or any thereof, of the liens, rights, benefits and interests of the Lender under the Escrow Agreement, and no attachment, execution or other writ of process shall be sought, issued or levied upon any assets, properties or funds of the Borrower other than the Escrowed Securities, and (iii) in the event of a foreclosure of such liens, rights, benefits or security interests under the Escrow Agreement, whether by judicial proceedings or exercise of power of sale or otherwise, no judgment for any deficiency upon the indebtedness evidenced by this Note shall be sought or obtained by the Lender against the Borrower. |
|
|
10. |
This Note shall be governed by and construed in accordance with the laws of the State of New York applicable to contracts made and to be performed entirely within such State. Any judicial proceeding brought to enforce this Note may only be brought in a federal or New York State court located in the County of New York, State of New York. Each party to this Note waives any objection to jurisdiction of and venue in such courts in any action instituted hereunder and shall not assert any defense based on lack of jurisdiction of or improper venue in any such court or based upon forum non conveniens . |
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11. |
THE BORROWER HEREBY WAIVES ANY RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM ARISING UNDER OR RELATED TO THIS NOTE. |
[Signature page follows.]
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IN WITNESS WHEREOF , with the intent to be legally bound hereby, the Borrower has executed this Note as of the date first written above.
GEM GLOBAL YIELD FUND LLC SCS
By: /s/ Christopher Brown
Name: Christopher Brown
Title: Manager
Acknowledged and agreed:
TYME TECHNOLOGIES, INC.
By: /s/ Peter de Svastich
Name: Peter de Svastich
Title: President
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Exhibit 10.7
SUBSCRIPTION NOTE SHARES ESCROW AGREEMENT
This Subscription Note Shares Escrow Agreement, dated March 5, 2015 (this “ Agreement ”), is by and among Tyme Technologies, Inc., a Delaware corporation (the “ Company ”), GEM Global Yield Fund LLC SCS (“ Depositor ”) and CKR Law LLP, a California limited liability partnership, as escrow agent (in such capacity, “ Escrow Agent ”).
W I T N E S S E T H :
WHEREAS, pursuant to that certain Subscription Agreement, dated of even date herewith (the “ Subscription Agreement ”), Depositor purchased from the Company 2,716,000 shares (the “ Subscription Shares ”) of the common stock, par value $0.0001 per share (the “ Common Stock ”), of the Company for consideration consisting of cash and a Limited Recourse Promissory Note, dated of even date herewith, payable to the Company and in the principal amount of $2,500,000.00 (the “ Note ”), a copy of the forms of the Subscription Agreement and Note being attached as Exhibits A and B hereto, respectively, and delivered the Note to the Company; and
WHEREAS, pursuant to the Subscription Agreement, Depositor is required to deposit with the Escrow Agent 5,000,000 shares of Common Stock (each, an “ Deposit Share ”), the disposition of which is to made in accordance with the terms of this Agreement; and
WHEREAS, the Company would not have entered into the Subscription Agreement, sell to Depositor the Subscription Shares, and accepted the Note in partial payment of the consideration for the sale of the Subscription Shares had Depositor not entered into this Agreement and deposited all of the Deposit Shares and Deposit Stock Certificates (as defined below) with the Escrow Agent to be disposed of in accordance with this Agreement.
NOW, THEREFORE , in consideration of the premises and agreements set forth in this Agreement, and for other good and valuable consideration, the sufficiency and receipt of which each of the parties to this Agreement hereby acknowledges the parties to this Agreement agree as follows:
1. Appointment of Escrow Agent. The Company and Depositor hereby appoint Escrow Agent to serve as, and Escrow Agent hereby agrees to act as, escrow agent upon the terms and conditions set forth in this Agreement. The Company and Depositor acknowledge and agree that CKR Law, LLP (in all capacities other than as Escrow Agent, “ CKR ”) is not providing any legal services to either the Company and Depositor pursuant to this Agreement, but is acting merely in a ministerial capacity as Escrow Agent as requested by the Company and Depositor.
2. Establishment of Escrow .
(a) Escrow of Deposit Shares . Simultaneously with the execution of this Agreement, Depositor shall deposit with the Escrow Agent a stock certificate or certificates registered in the Depositor’s name representing all of the 5,000,000 Deposit Shares, each such certificate accompanied by a stock power duly endorsed in blank with signature(s) guaranteed by a member of one of the “Medallion” guarantee programs (Securities Transfer Agents Medallion Program (STAMP), Stock Exchanges Medallion Program (SEMP), or New York Stock Exchange Medallion Signature Program (MSP)). Each such stock certificate and accompanying stock power deposited with the Escrow Agent pursuant to this section 2(a) are collectively referred to herein as a “ Deposit Stock Certificate .” The Deposit Shares and Deposit Stock Certificates shall be held as a trust fund and shall not be subject to any lien, attachment, trustee process or any other judicial process of any creditor of any party hereto. The Escrow Agent agrees to hold the Deposit Stock Certificate(s) evidencing the Deposit Shares in an escrow account (the “ Escrow Account ”) subject to the terms and conditions of this Agreement.
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(b) Security for Depositor’s Satisfaction of the Note . The Deposit Shares shall be (i) security for the Depositor’s compliance with its payment obligations under the Note and (ii) the exclusive means for the Company to enforce such obligations upon the failure of Depositor to make the required payments under the Note in accordance with the terms of the Note (the “ Surrender Event ”).
(c) Dividends, Etc. Any securities of the Company distributed in respect of or in exchange for any of the Deposit Shares, whether by way of stock dividends, stock splits or otherwise, shall be issued in the name of the Depositor or its nominee specified in writing and shall be delivered to the Escrow Agent, who shall hold such securities in the Escrow Account. Such securities shall be considered Deposit Shares for purposes hereof.
3. Disposition of the Escrow Funds .
(a) Upon the occurrence of the Surrender Event in the good faith determination of the Board of Directors of the Company, the Company shall provide written notice to the Escrow Agent and Depositor (a “ Surrender Notice ”) that states that there has been an occurrence of the Surrender Event and the nature of such Surrender Event (including the amount of payments not made in accordance with the terms of the Note), and the Escrow Agent shall take the following actions:
(i) In the event that, within ten “ Business Days ” (as defined below) after the giving of the Surrender Notice in accordance with this paragraph 2(a), Depositor has not disputed the basis of the giving of the Surrender Notice ( i.e. , that the Surrender Event has not occurred in that payment(s) under the Note have been made, setting forth in detail the date(s) and amount(s) of such payment(s), accompanied by proof of such payment(s)) by giving written notice thereof to Escrow Agent (a “ Dispute Notice ”), then the Escrow Agent shall deliver the Deposit Stock Certificate(s) representing all of the Deposit Shares then in the Escrow Account to the Company, whereupon the Company shall retain, by utilizing the applicable Deposit Stock Certificate(s), the number of Deposit Shares (the “ Surrendered Shares ”) equal to the quotient of (A) the dollar amount of the principal and/or interest, if any, on the Note that Depositor has failed to pay as of the date of the Surrender Notice divided by (B) $0.50 (the “ Surrender Formula ”). The Company shall utilize the applicable Deposit Stock Certificate(s) to cause all of the Surrendered Shares to be cancelled and no longer be considered issued. In the event that the Surrendered Shares constitute less than all of the Deposit Shares, such remaining Deposit Shares, equal to (x) 5,000,000 minus (y) the number of Surrendered Shares, shall be, contemporaneously with the cancellation of the Surrendered Shares, returned (or, if required, arranged for the return) to Depositor along with all Deposit Stock Certificates, if any, not being utilized in connection with the cancellation of the Surrendered Shares and return of such remaining Deposit Shares. For the avoidance of doubt, all Surrendered Shares shall not be retained by the Company in treasury or otherwise, but shall be cancelled and no longer deemed issued and/or outstanding.
(ii) In the event that, within ten Business Days after the giving of the Surrender Notice in accordance with this paragraph 2(a), Depositor shall have delivered to the Escrow Agent a Dispute Notice (with a copy of the Dispute Notice being given, in the form of a notice, to the Company), the Deposit Stock Certificate(s) evidencing the Deposit Shares shall not be delivered to either the Company or Depositor but retained by the Escrow Agent pending a further agreement executed by both the Company and Depositor as to the disposition of all or any portion of the Deposit Stock Certificate(s) (and the issued and outstanding nature of such Deposit Shares) or receipt of a final non-appealable judgment or final order of a court of competent jurisdiction as to such disposition (and the issued and outstanding nature of such Deposit Shares), in which case the Escrow Agent shall dispose of such Deposit Stock Certificate(s) in accordance with such written agreement, judgment or order.
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(b) If the Company, at any time prior to the occurrence of a Surrender Event, (i) pays a stock dividend in or otherwise makes a distribution or distributions payable in shares of Common Stock on Common Stock, (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues, in the event of a reclassification of shares of Common Stock, any shares of capital stock of the Company, then the number of Deposit Shares shall be, for the purposes of this Agreement, proportionately increased or decreased. Any adjustment made pursuant to this section 2(b) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification. If any event occurs as to which the other provisions of this section 2(b) are not strictly applicable but the lack of any adjustment would not fairly protect the rights of the Company or Depositor in accordance with the basic intent and principles of this Agreement, the Subscription Agreement and the Note, or if strictly applicable would not fairly protect the rights of the Company and/or Depositor in accordance with the basic intent and principles of such provisions, then the Company’s Board of Directors shall, in good faith and subject to applicable law, make an appropriate adjustment to protect the rights of the Company and Depositor.
(c) Upon the satisfaction of the payment obligations of Depositor under the Note, in whole or part, but only if in accordance with the terms of the Note, provided such satisfaction is on or prior to the maturity date of the Note, Depositor shall give notice (each, a “ Payment Notice ”) to Escrow Agent and the Company of such payment, the amount of such payment and the number of Deposit Shares (determined in accordance with the Release Formula set forth in the immediately succeeding sentence) to be released from the Escrow Account and returned to Depositor (the “ Released Shares ”), each such Payment Notice to be accompanied by reasonable evidence of such payment (which evidence may be in the form of a bank-generated wire transfer advice). The number of Released Shares to be set forth in a Payment Notice for release shall be equal to the quotient of (A) the dollar amount of the principal on the Note that Depositor states in such Payment Notice that has been paid as of the date of the Payment Notice and not subject to a previous Payment Notice, divided by (B) $0.50 (the “ Release Formula ”). Upon receipt of a Payment Notice, the Escrow Agent shall take the following actions:
(i) In the event that, within ten Business Days after the giving of the Payment Notice in accordance with this paragraph 2(c), the Company has not disputed the basis of the giving of the Payment Notice ( e.g. , that payment in the amount set forth in the Payment Notice has not occurred, that the number of Released Shares to be released to Depositor is not correct or that the number of Released Shares to be released to Depositor has not been calculated correctly in accordance with the Payment Formula (a “ Payment Dispute Notice ”), then the Escrow Agent shall deliver the Deposit Stock Certificate(s) representing the Released Shares referenced in such Payment Notice to Depositor. In the event that the Released Shares constitute less than all of the Deposit Shares in the Escrow Account, such remaining Deposit Shares shall remain in the Escrow Account and subject to all of the provisions of this Agreement.
(ii) In the event that, within ten Business Days after the giving of the Surrender Notice in accordance with this paragraph 2(c), the Company shall have delivered to the Escrow Agent a Payment Dispute Notice (with a copy of the Payment Dispute Notice being given, in the form of a notice, to the Company), the Deposit Stock Certificate(s) evidencing the Deposit Shares claimed to be Released Shares under such Payment Notice as disputed in the Payment Dispute Notice shall not be delivered to Depositor but retained by the Escrow Agent pending a further agreement executed by both the Company and Depositor as to the disposition of all or any portion of such Deposit Shares and Deposit Stock Certificate(s) evidencing such Deposit Shares or receipt a final non-appealable judgment or final order of a court of competent jurisdiction as to such disposition (and the issued and outstanding nature of such Deposit Shares), in which case the Escrow Agent shall dispose of such Deposit Stock Certificate(s) in accordance with such written agreement, judgment or order.
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(d) At 6:00 p.m. New York time on the twentieth Business Day following the date that is the earlier of (x) the date on which the Note is fully satisfied or (y) the maturity date of the Note (the “ Termination Date ”), the Deposit Stock Certificate(s) evidencing (or appropriately denominated alternative stock certificate(s) evidencing) any Deposit Shares that remain in the Escrow Account and are not the subject of a pending Surrender Notice or Payment Dispute Notice, shall be returned to Depositor.
(e) Notwithstanding anything to the contrary contained in paragraphs 2(a), 2(c) and 2(d), the Escrow Agent shall make such other disposition of the Deposit Stock Certificate(s) evidencing the Deposit Shares as is set forth in a written notice to Escrow Agent executed by both the Company and Depositor.
(f) Notwithstanding anything to the contrary contained in this Agreement, in the event of a dispute between the Company and Depositor as to the return to the Company or release to Depositor of any of the Deposit Shares then represented by Deposit Stock Certificates held in the Escrow account, Escrow Agent shall have the right, but not the duty, to bring an interpleader action in a court of competent jurisdiction to have such court determine the disposition of any Deposit Shares subject to such dispute and the Deposit Stock Certificate(s) evidencing such Deposit Shares (and the issued and outstanding nature of such Deposit Shares) and deposit the applicable Deposit Stock Certificate(s) and all the other properties then held by Escrow Agent in the Escrow Account or otherwise pursuant to this Agreement with such court and shall be reimbursed by Depositor for all of the costs and expenses of Escrow Agent with respect to such interpleader action. The Company and Depositor agree that any such action shall be brought only in a court of the State of New York located in New York County or in the Federal Court for the Southern District of New York (which courts are acknowledged by both the Company and Depositor as courts of competent jurisdiction).
4. Duties of Escrow Agent .
(a) Escrow Agent shall not be liable to any person or entity for any action taken in good faith and believed by Escrow Agent to be authorized or within the rights and powers conferred upon Escrow Agent under this Agreement. Escrow Agent shall also have full and complete authorization and protection for any omission or any action taken, or suffered by Escrow Agent, in good faith. Escrow Agent shall have no duties or obligations other than as expressly stated herein, and shall be protected and not liable for acting upon any notice, certificate or other communication not only with respect to its execution, validity and effectiveness of such notice’s, certificate’s, or other communication’s provisions, but also as to the truth and accuracy of any information therein contained, which notice, certificate or other communication Escrow Agent shall have, in good faith, believed to have been genuine or valid and which Escrow Agent, in good faith, believed to have been signed or presented by a proper person or persons.
(b) Escrow Agent shall not be bound by any notice or demand with respect hereto, or any waiver, modification, amendment, termination or revision of this Agreement unless signed by both the Company and Depositor (unless such notice or demand is a Surrender Notice, Dispute Notice, Payment Notice or Payment Dispute Notice, in which event the signature of only the party giving such notice under the applicable provisions of Article 2 shall be required) and delivered in writing to Escrow Agent and, if the duties of Escrow Agent are affected, unless Escrow Agent shall have given Escrow Agent’s prior written consent thereto. Escrow Agent shall not be liable or responsible for anything done or omitted to be done by Escrow Agent in good faith, it being understood that Escrow Agent’s liability hereunder shall be limited solely to willful misconduct or gross negligence on its part. Escrow Agent may rely conclusively on, and shall be protected from acting or refraining from acting upon, any written notice, instruction or request furnished to Escrow Agent hereunder and reasonably believed by Escrow Agent to be genuine and to have been signed or presented by the proper party or parties. Escrow Agent shall be under no duty to inquire into the authority of any person acting in connection herewith or into the genuineness of any signature.
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(c) Escrow Agent or any successor which is hereafter appointed may, at any time, resign by giving written notice to both the Company and Depositor and shall be discharged of Escrow Agent’s duties under this Agreement upon the appointment of a successor escrow agent. In the event of any such resignation, a successor escrow agent shall be promptly appointed upon the mutual written agreement of the Company and Depositor. Any such successor escrow agent shall deliver to the Company and Depositor a written instrument accepting such appointment hereunder and thereupon the successor escrow agent shall succeed to all the rights and duties of Escrow Agent and shall be entitled to receive the Deposit Stock Certificate(s) and all the other properties then held by Escrow Agent in the Escrow Account or otherwise pursuant to this Agreement. In the event that a successor escrow agent is not appointed by the Company and Depositor within 30 calendar days of such written notice, then Escrow Agent shall have the right, but not the duty, to bring an interpleader action in a court of competent jurisdiction to have a successor agent appointed and deposit the Deposit Stock Certificate(s) and all the other properties then held by Escrow Agent in the Escrow Account or otherwise pursuant to this Agreement with such court and shall be reimbursed by Depositor for all of the costs and expenses of Escrow Agent with respect to such interpleader action. The Company and Depositor agree that any such action shall be brought only in a court of the State of New York located in New York County or in the Federal Court for the Southern District of New York (which courts are acknowledged by both the Company and Depositor as courts of competent jurisdiction).
5. Fees and Indemnification of Escrow Agent .
(a) Depositor agrees to indemnify Escrow Agent and to hold Escrow Agent harmless from and against any loss, cost, liability or expense including reasonable legal fees (including, without limitation, fees generated by Escrow Agent’s internal staff) incurred by Escrow Agent relating to, arising out of, or in connection with the acceptance or administration of Escrow Agent’s duties, or services rendered under this Agreement, including reasonable legal fees, costs and expenses of defending Escrow Agent against claims of liability or incurred in actions of interpleader arising hereunder.
(b) Escrow Agent shall have a lien for the amount of any such expenses or loss on the monies and other property held by Escrow Agent under this Agreement and shall be entitled to reimburse itself from such monies or property for the amount of any such expense or loss.
(c) The Company acknowledges that Escrow Agent, as CKR, has acted, and will continue to act, as counsel to Depositor and did act, prior to the Merger (as defined in the Subscription Agreement), as counsel to the Company. The Company further acknowledges that there may be a potential or actual conflict of interests and agrees that such conflicting interests shall not be a basis for Escrow Agent being disqualified or limited, or not participating, in the exercise of powers or representation with respect to this Agreement, nor shall the Company seek to disqualify CKR from acting as counsel to Depositor in any future matter, whether or not relating to this Agreement, and/or the Note, although both the Company and Depositor acknowledge that disqualification due to its status as a witness may be claimed or, on a court’s own initiative, be made.
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6. Notice . Notices or other communications required or permitted to be given hereunder shall be in writing and shall be deemed duly given if (a) personally delivered, against written receipt therefor, (b) forwarded by pre-paid certified or registered mail, return receipt requested, or (c) forwarded via a nationally recognized overnight courier service ( e.g., Federal Express, USPS Express Mail, UPS, DHL, etc.) to the parties to which such notice or other communication is required by this Agreement to be given, at the address of such parties as follows:
If to the Company, to: |
Steven Hoffman, President |
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Tyme Technologies, Inc. |
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48 Wall Street - Suite 1100 |
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New York, New York 10005 |
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with a copy to (which shall not |
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constitute notice hereunder): |
Keith S. Braun, Esq. |
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Moritt Hock & Hamroff LLP |
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450 Seventh Avenue - 15th Floor |
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New York, New York 10123 |
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If to Depositor: |
Christopher Brown |
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c/o GEM Global Yield Fund LLC SCS |
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590 Madison Avenue - 36th Floor |
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New York, New York 10022 |
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with a copy to (which shall not |
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constitute notice hereunder): |
Barrett DiPaolo, Esq. |
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CKR Law LLP |
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1330 Avenue of the Americas - 35th Floor |
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New York, New York 10019 |
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If to the Escrow Agent: |
Mark Crone, Esq. |
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CKR Law LLP |
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1330 Avenue of the Americas - 35th Floor |
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New York, New York 10019 |
or, in the case of any of the parties to this Agreement, at such other address as such party shall furnish to each of the other parties in accordance with this section 6. Notices and other communications delivered personally shall be deemed given as of the date of actual receipt; mailed notices and other communications shall be deemed given as of the date three Business Days following such mailing; and notices and other communications sent via overnight courier service shall be deemed given as of the date one Business Day after delivery to such courier service.
7. Miscellaneous.
(a) This Agreement and all of the provisions hereof shall be binding upon and inure to the benefit of the parties hereto and their respective administrators, successors and permitted assigns.
(b) This Agreement and the rights and obligations of the parties contained in this Agreement shall be interpreted, construed and enforced in accordance with the laws of the State of New York, without regard to its choice and/or conflict of laws provisions. Any legal action resulting from, arising under, out of or in connection with, directly or indirectly, this Agreement shall be commenced exclusively in the Supreme Court, State of New York, County of New York, or the U.S. District Court for the Southern District of New York. All parties to this Agreement hereby submit themselves to the jurisdiction of any such court, and agree that service of process on them in any such action, suit or proceeding may be affected by the means by which notices are to be given under this Agreement.
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(b) This Agreement sets forth the entire agreement and understanding of the parties hereto in respect of the subject matter contained herein, and supersedes all prior agreements, promises, understandings, letters of intent, covenants, arrangements, communications, representations or warranties, whether oral or written, by any party hereto or by any related or unrelated third party.
(c) This Agreement may not be changed, modified or rescinded orally. Any change, modification or rescission need be in writing, signed by the party against whom enforcement of any change, modification or rescission is sought. Any waiver of any of the provisions of this Agreement, or of any inaccuracy in or non-fulfillment of any of the obligations contemplated by this Agreement or contemplated hereby, shall not be effective unless made in a writing signed by the party against whom the enforcement of any such waiver is sought. A waiver given in any case shall only apply with respect to that particular act or omission, and shall not be effective as to any further acts or omissions, regardless of whether they are of the same or similar nature.
(d) This Agreement may be executed simultaneously in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.
(e) This section and other headings contained in this Agreement are for purposes of reference only, and shall not affect the meaning or interpretation of this Agreement.
(f) Any term or provision of this Agreement which is invalid or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such invalidity or unenforceability without rendering invalid or unenforceable the remaining terms and provisions of this Agreement or affecting the validity or enforceability of any of the terms or provisions of this Agreement in any other jurisdiction.
(g) Each party hereto shall be responsible for their legal and other fees and expenses relating to the negotiation, execution and delivery of this Agreement and related agreements, and the consummation of the transaction contemplated by this Agreement.
(h) For purposes of this Agreement, the capitalized term “Business Day” shall mean any calendar day other than a Saturday, Sunday or other day on which banks in the City of New York are authorized or directed to be closed.
(i) In the event that any portion of the Escrow Account shall be attached, garnished or levied upon by any court order, or the delivery thereof shall be stayed or enjoined by an order of a court, or any order, judgment or decree shall be made or entered by any court order affecting the property deposited under this Agreement, Escrow Agent is hereby expressly authorized, in its sole discretion, to obey and comply with all writs, orders or decrees so entered or issued, which it is advised by legal counsel of its own choosing is binding upon it, whether with or without jurisdiction, and in the event that Escrow Agent obeys or complies with any such writ, order or decree it shall not be liable to any of the parties hereto or to any other person or firm, by reason of such compliance notwithstanding such writ, order or decree be subsequently reversed, modified, annulled, set aside or vacated.
(j) This Escrow Agreement shall terminate on the date on which all of the Deposit Stock Certificates have been released from the Escrow Account by the Escrow Agent in accordance with this Agreement; provided , however , the provisions of Article 5 shall survive such termination.
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(k) So long as no Surrender Event shall have occurred, Depositor may exercise any and all voting and other consensual rights pertaining to any and all of the Deposit Shares evidenced by Deposit Stock Certificates held in the Escrow Account.
(l) Subject to the provisions of paragraph 2(b), any dividends, interests or other distributions made with respect to each Deposit Share then held in the Escrow Account shall attach to and be deemed part of such Deposit Share and shall be returned to the Company or released to Depositor at the same time such Deposit Share is returned to the Company or released to Depositor.
(m) Unless otherwise expressed, all references in this Agreement to sections and paragraphs shall refer to the specified section or paragraph of this Agreement.
[THE REMAINDER OF THIS PAGE HAS INTENTIONALLY BEEN LEFT BLANK.]
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IN WITNESS WHEREOF , the parties hereto have executed this Agreement on the date first indicated above.
Tyme Technologies, Inc. |
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By: |
/s/ Peter de Svastich |
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Name: Peter de Svastich |
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Title: President |
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GEM Global Yield Fund LLC SCS |
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By: |
/s/ Christopher Brown |
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Name: Christopher Brown |
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Title: Manager |
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CKR Law LLP |
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By: |
/s/ Mark E. Crone |
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Name: Mark E. Crone |
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Title: Co-Managing Partner |
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1.1.
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Purpose
. The purposes of this 2015 Equity Incentive Plan are (a) to enable the Company, and the Company’s subsidiaries and affiliates, to attract and retain highly qualified personnel who will contribute to the success of the Company, including the Company’s subsidiaries and certain affiliates, and (b) to provide incentives to participants in this 2015 Equity Incentive Plan that are linked directly to increases in shareholder value which will therefore inure to the benefit of all shareholders of the Company.
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1.2.
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Definitions
. For purposes of this Plan, except as otherwise defined in this Plan, capitalized terms shall have the meanings assigned to them in this Section 1.2.
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1 |
2 |
3 |
4 |
2.1.
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Administration in Accordance with the Code and Exchange Act
. The Plan shall be administered in accordance with the requirements of Section 162(m) of the Code (but only to the extent necessary and desirable to maintain qualification of Awards under the Plan under Section 162(m) of the Code) and, to the extent applicable, Rule 16b-3 under the Exchange Act (“Rule 16b-3”) or the rules of any stock exchange or automated quotation system on which the Common Stock is primarily quoted or listed, by the Board or, at the Board’s sole discretion, by the Committee, which shall be appointed by the Board, and which shall serve at the pleasure of the Board.
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2.2.
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Administrator’s Powers
. Subject to the general purposes, terms and conditions of this Plan, the Administrator will have full power to implement and carry out this Plan. The Administrator will have the authority to:
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5 |
2.3.
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Administrator’s Discretion Final
. Any determination made by the Administrator with respect to any Award will be made in the Administrator’s sole discretion at the time of grant of the Award or, unless in contravention of any express term of the Plan or Award, at any later time, and such determination will be final and binding on the Company and on all persons having an interest in any Award under the Plan.
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2.4.
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Administrator’s Method of Acting; Liability
. The Administrator may act only by a majority of its members then in office, except that the members thereof may authorize any one or more of their members or any officer of the Company to execute and deliver documents or to take any other ministerial action on behalf of the Committee with respect to Awards made or to be made to Eligible Participants. No member of the Administrator and no officer of the Company shall be liable for anything done or omitted to be done by such member or officer, by any other member of the Administrator or by any officer of the Company in connection with the performance of duties under the Plan, except for such member’s or officer’s own willful misconduct or as expressly provided by law.
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3.1.
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Affiliates
. If a Parent, Subsidiary or Affiliate of the Company wishes to participate in the Plan and its participation shall have been approved by the Board, the board of directors or other governing body of the Parent, Subsidiary or Affiliate, as the case may be, shall adopt a resolution in form and substance satisfactory to the Administrator authorizing participation by the Parent, Subsidiary or Affiliate in the Plan. A Parent, Subsidiary or Affiliate participating in the Plan may cease to be a participating company at any time by action of the Board or by action of the board of directors or other governing body of such Parent, Subsidiary or Affiliate, which latter action shall be effective not earlier than the date of delivery to the Secretary of the Company of a certified copy of a resolution of the Parent, Subsidiary or Affiliate’s board of directors or other governing body taking such action. If the participation in the Plan of a Parent, Subsidiary or Affiliate shall terminate, such termination shall not relieve the Parent, Subsidiary or Affiliate of any obligations theretofore incurred by the Parent, Subsidiary or Affiliate, except as may be approved by the Administrator.
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3.2.
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Participants
. Incentive Stock Options may only be granted to employees (including officers and directors who are also employees) of the Company, or any Parent, Subsidiary or Affiliate of the Company. All other Awards may be granted to employees, officers, directors, consultants, independent contractors and advisors of the Company or any Parent, Subsidiary or Affiliate of the Company;
provided
, that such consultants, contractors and advisors render bona fide services to the Company or such Parent, Subsidiary or Affiliate of the Company not in connection with the offer and sale of securities in a capital-raising transaction. An Eligible Participant may be granted more than one Award under the Plan.
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4.1.
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Types of Awards
. Awards under the Plan may include, but need not be limited to, one or more of the following types, either alone or in any combination thereof:
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6 |
4.2.
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Number of Shares Available Under the Plan
. Subject to Section 4.4, the total number of Shares reserved and available for grant and issuance pursuant to the Plan will be 10 million. To the extent that any Award payable in Shares is forfeited, canceled, returned to the Company for failure to satisfy vesting requirements or upon the occurrence of other forfeiture events, or otherwise terminates without payment being made thereunder, the Shares covered by such Award will no longer be charged against the foregoing 10 million Share maximum limitation and may again be made subject to Award(s) under the Plan. Notwithstanding anything to the contrary contained in the Plan, the number of Shares that may be subject to Awards granted on or prior to the first anniversary of the approval of the Plan by the stockholders of the Company shall not exceed 3,333,333.
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4.3.
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Reservation of Shares
. At all times, the Company shall reserve and keep available a sufficient number of Shares as shall be required to satisfy the requirements of all outstanding Options granted under the Plan and all other outstanding but unexercised Awards granted under the Plan.
|
4.4.
|
Adjustment in Number of Shares Available Under the Plan
. In the event that the number of outstanding shares of Common Stock is changed by a stock dividend, recapitalization, stock split, reverse stock split, subdivision, combination, reclassification or similar change in the capital structure of the Company without consideration, then (a) the number of Shares reserved for issuance under the Plan, (b) the number of Shares that may be granted pursuant to the Plan, and (c) the Exercise Prices of and number of Shares subject to outstanding Options and other Awards, will be proportionately adjusted, subject to any required action by the Board or the shareholders of the Company, if any, and compliance with applicable securities laws;
provided
,
however
, that, upon occurrence of such an event, fractions of a Share will not be issued upon exercise of an Award but will, upon such exercise, either be replaced by a cash payment equal to the Fair Market Value of such fraction of a Share on the effective date of such an event or will be rounded down to the nearest whole Share, as determined by the Administrator.
|
7 |
5.1.
|
Grant; Determination of Type of Option
. The Administrator may grant one or more Options to an Eligible Participant and will determine (a) whether each such Option will be an Incentive Stock Option or a Non-Qualified Stock Option, (b) the number of Shares subject to each such Option, (c) the Exercise Price of each such Option, (d) the period during which each such Option may be exercised, and (e) all other terms and conditions of each such Option, subject to the terms and conditions of this Article 5. The Administrator may grant an Option either alone or in conjunction with Stock Appreciation Rights, Performance Grants or other Awards, either at the time of grant or by amendment thereafter.
|
5.2.
|
Form of Option Award Agreement
. Each Option granted under the Plan will be evidenced by an Award Agreement which will expressly identify the Option as an Incentive Stock Option or a Non-Qualified Stock Option, and will be in such form and contain such provisions (which need not be the same for each Participant or Option) as the Administrator may from time to time approve, and which will comply with and be subject to the terms and conditions of the Plan.
|
5.3.
|
Date of Grant
. The date of grant of an Option will be the date on which the Administrator makes the determination to grant such Option, unless otherwise specified by the Administrator.
|
5.4.
|
Exercise Period
. Each Option shall be exercisable within the times or upon the occurrence of one or more events determined by the Administrator and set forth in the Award Agreement governing such Option;
provided
,
however
, that no Option will be exercisable after the expiration of ten years from the date the Option is granted; and
provided
,
further
,
however
, that no Incentive Stock Option granted to a person who directly or by attribution owns more than 10% of the total combined voting power of all classes of stock of the Company or of any Parent, Subsidiary or Affiliate of the Company (each, a “Ten Percent Shareholder”) will be exercisable after the expiration of five years from the date such Incentive Stock Option is granted. The Administrator also may provide for an Option to become exercisable at one time or from time to time, periodically or otherwise, in such number of Shares or percentage of Shares as the Administrator determines. Unless otherwise determined by the Administrator, an Option shall be exercisable as follows:
|
8 |
5.5.
|
Exercise Price
. The Exercise Price of an Option will be determined by the Administrator when the Option is granted and may be not less than 100% of the per share Fair Market Value of the Shares subject to such Option on the date of grant of such Option;
provided
,
however
, the Exercise Price of any Incentive Stock Option granted to a Ten Percent Shareholder will not be less than 110% of the per share Fair Market Value of such Shares on the date of such grant. Payment for the Shares purchased shall be made in accordance with Article 10 of the Plan.
|
5.6.
|
Method of Exercise
. An Option may be exercised only by delivery to the Company of an irrevocable written exercise notice (a) identifying the Option being exercised, (b) stating the number of Shares being purchased, (c) providing any other matters required by the Award Agreement with respect to such Option, and (d) containing such representations and agreements regarding Participant’s investment intent and access to information and other matters, if any, as may be required or desirable by the Company to comply with applicable securities laws. Such exercise notice shall be accompanied by payment in full of the Exercise Price for the number of Shares being purchased in accordance with Article 10 and the executed Award Agreement with respect to such Option.
|
5.7.
|
Termination
. Unless otherwise provided in an Award Agreement, exercise of Options shall be subject to the following:
|
5.8.
|
Limitations on Exercise
. The Administrator may specify a reasonable minimum number of Shares that may be purchased on any exercise of an Option,
provided
, that such minimum number will not prevent Participant from exercising the Option for the full number of Shares for which the Option is then exercisable.
|
9 |
5.9.
|
Limitations on Incentive Stock Options
. The aggregate Fair Market Value (as determined as of the date of grant) of Shares with respect to which an Incentive Stock Option are exercisable for the first time by a Participant during any calendar year (under the Plan or under any other incentive stock option plan of the Company, and any Parent, Subsidiary and Affiliate of the Company) will not exceed $100,000. This $100,000 limitation shall be applied by taking Options into account in the order in which granted. An Incentive Stock Option shall be deemed to be a Non-Qualified Stock Option to the extent that the foregoing $100,000 limitation is exceeded. In the event that the Code or the regulations promulgated thereunder are amended after the effective date of the Plan to provide for a different limit on the Fair Market Value of Shares permitted to be subject to Incentive Stock Options, such different limit will be automatically incorporated herein and will apply to any Options granted after the effective date of such amendment.
|
5.10.
|
Modification, Extension or Renewal
. The Administrator may modify, extend or renew any outstanding Option and authorize the grant of one or more new Options in substitution therefor;
provided
that any such action may not, without the written consent of a Participant, impair any of such Participant’s rights under any Option previously granted. Any outstanding Incentive Stock Option that is modified, extended, renewed or otherwise altered will be treated in accordance with Section 424(h) and other applicable provisions of the Code.
|
5.11.
|
No Disqualification
. Notwithstanding any other provision in the Plan, no term of the Plan relating to an Incentive Stock Option will be interpreted, amended or altered, nor will any discretion or authority granted under the Plan be exercised, so as to disqualify the Plan under Section 422 of the Code or, without the consent of the Participant affected, to disqualify any Incentive Stock Option under Section 422 of the Code.
|
5.12.
|
Prohibition Against Transfer
. No Option may be sold, assigned, transferred, pledged, hypothecated or otherwise disposed of, except by will or the laws of descent and distribution or pursuant to a domestic relations order, and a Participant’s Option shall be exercisable during such Participant’s lifetime only by such Participant or such person receiving such Option pursuant to a domestic relations order.
|
6.2.
|
Prohibition Against Transfer
. No Award of Stock Appreciation Rights may be sold, assigned, transferred, pledged, hypothecated or otherwise disposed of, except by will or the laws of the descent and distribution or pursuant to a domestic relations order, and Stock Appreciation Rights Awarded to a Participant shall be exercisable during such Participant’s lifetime only by such Participant or such person receiving such Option pursuant to a domestic relations order. Unless the Administrator determines otherwise, the Award of Stock
|
10 |
|
Appreciation Rights to a Participant shall not be exercisable for at least six months after the date of grant, unless such Participant is Terminated before the expiration of such six-month period by reason of such Participant’s Disability or death.
|
6.3.
|
Exercise
. The Award of Stock Appreciation Rights shall not be exercisable:
|
6.4.
|
Exercise
.
|
11 |
6.5.
|
Fractional Shares
. No fractional shares may be delivered under this Article 6, but, in lieu thereof, a cash or other adjustment shall be made as determined by the Administrator.
|
7.1.
|
Grant
. An Award of Restricted Stock is an offer by the Company to sell to an Eligible Participant Shares that are subject to restrictions. The Administrator will determine to whom an offer will be made, the number of Shares the person may purchase, the Exercise Price to be paid, the restrictions to which the Shares will be subject, and all other terms and conditions of the Restricted Stock Award, subject to the provisions of this Article 7.
|
7.2.
|
Form of Restricted Stock Award
. All purchases under an Award of Restricted Stock will be evidenced by an Award Agreement that will be in such form (which need not be the same for each Award of Restricted Stock or Participant) as the Administrator will from time to time approve, and will comply with and be subject to the terms and conditions of the Plan. The offer of Restricted Stock will be accepted by the Participant’s execution and delivery of the Award Agreement evidencing the offer to purchase the Restricted Stock and full payment for the Shares to the Company within 30 days from the date such Award Agreement is tendered to such Eligible Participant. If such Eligible Participant does not execute and deliver such Award Agreement along with full payment for the Shares to the Company within such 30 day period, then such offer will terminate, unless otherwise determined by the Administrator.
|
7.3.
|
Purchase Price
. The Exercise Price of Shares sold pursuant to an Award of Restricted Stock will be determined by the Administrator on the date such Award is granted, except in the case of a sale to a Ten Percent Shareholder, in which case the Exercise Price will be 100% of the per share Fair Market Value on the date such Award is granted of the Shares subject to the Award. Payment of the Exercise Price may be made in accordance with Article 10 of the Plan.
|
7.4.
|
Terms of Restricted Stock Awards
. Each Award of Restricted Stock shall be subject to such restrictions as the Administrator may impose. These restrictions may be based upon completion of a specified number of years of service with the Company or upon completion of the performance goals as set out in advance in the
|
12 |
7.5.
|
Termination During Performance Period
. If a Participant is Terminated during a performance period with respect to any Award of Restricted Stock for any reason, then such Participant will be entitled to payment (whether in Shares, cash or otherwise) with respect to the Restricted Stock Award only to the extent earned as of the date of Termination in accordance with the Award Agreement with respect to such Restricted Stock, unless the terms of such Award Agreement provide otherwise or the Administrator determines otherwise.
|
8.1.
|
Award
. The Award of a Performance Grant to a Participant will entitle such Participant to receive a specified amount (the “Performance Grant Actual Value”) as determined by the Administrator;
provided
that the terms and conditions specified in the Plan and in the Award of such Performance Grant are satisfied. Each Award of a Performance Grant shall be subject to the terms and conditions set forth in this Article 8 and such other terms and conditions, including, but not limited to, restrictions upon any cash, Shares, other securities or property of the Company, or other forms of payment, or any combination thereof, issued in respect of the Performance Grant, as the Administrator shall establish, shall be embodied in an Award Agreement in such form and substance as is approved by the Administrator.
|
8.2.
|
Terms
. The Administrator shall determine the value or range of values of a Performance Grant to be awarded to each Participant selected for an Award of a Performance Grant and whether or not such Performance Grant is granted in conjunction with an Award of Options, Stock Appreciation Rights, Restricted Stock or other type of Award, or any combination thereof, under the Plan (which may include, but need not be limited to, deferred Awards) concurrently or subsequently granted to such Participant (the “Associated Award”). As determined by the Administrator, the maximum value of each Performance Grant (the “Maximum Value”) shall be:
|
13 |
8.3.
|
Award Period
. The award period (“Performance Grant Award Period”) in respect of any Performance Grant shall be a period determined by the Administrator. At the time each Performance Grant is made, the Administrator shall establish performance objectives to be attained within the Performance Grant Award Period as the means of determining the Performance Grant Actual Value of such Performance Grant. The performance objectives shall be based on such measure or measures of performance, which may include, but need not be limited to, the performance of the Participant, the Company, one or more Subsidiary, Parent or Affiliate of the Company, or one or more of divisions or units thereof, or any combination of the foregoing, as the Administrator shall determine, and may be applied on an absolute basis or be relative to industry or other indices, or any combination thereof. Each Performance Grant Actual Value of a Performance Grant shall be equal to the Performance Grant Maximum Value of such Performance grant only if the performance objectives are attained in full, but the Administrator shall specify the manner in which the Performance Grant Actual Value shall be determined if the performance objectives are met in part. Such performance measures, the Performance Grant Actual Value or the Performance Grant Maximum Value, or any combination thereof, may be adjusted in any manner by the Administrator at any time and from time to time during or as soon as practicable after the Performance Grant Award Period, if it determines that such performance measures, the Performance Grant Actual Value or the Performance Grant Maximum Value, or any combination thereof, are not appropriate under the circumstances.
|
8.4.
|
Termination
. The rights of a Participant in Performance Grants awarded to such Participant shall be provisional and may be canceled or paid in whole or in part, all as determined by the Administrator, if such Participant’s continuous employment or performance of services for the Company, any Parent, Subsidiary and Affiliate of the Company shall terminate for any reason prior to the end of the Performance Grant Award Period, except solely by reason of a period of Related Employment.
|
8.5.
|
Determination of Performance Grant Actual Values
. The Committee shall determine whether the conditions of Sections 8.2 or 8.3 have been met and, if so, shall ascertain the Performance Grant Actual Value of Performance Grants. If a Performance Grant has no Performance Grant Actual Value, the Award of such Performance Grant shall be deemed to have been canceled and the Associated Award, if any, may be canceled or permitted to continue in effect in accordance with such Associated Award’s terms. If a Performance Grant has a Performance Grant Actual Value and:
|
8.6.
|
Payment
. Payment of any amount in respect of the Performance Grants which the Administrator determines to pay as provided in this Article 8 shall be made by the Company as promptly as practicable after the end of the Performance Grant Award Period or at such other time or times as the Administrator shall determine, and may be made in cash, Shares, other securities or property of the Company, or other forms of payment,
|
14 |
|
or any combination thereof or in such other manner, as determined by the Administrator. Notwithstanding anything in this Article 8 to the contrary, the Administrator may determine and pay out a Performance Grant Actual Value of a Performance Grant at any time during the Performance Grant Award Period.
|
ARTICLE 9. STOCK BONUSES.
|
9.1.
|
Awards of Stock Bonuses
. A Stock Bonus is an Award of Shares (which may consist of Restricted Stock) for services rendered to the Company or any Parent, Subsidiary or Affiliate of the Company. A Stock Bonus may be awarded for services previously rendered to the Company, or any Parent, Subsidiary or Affiliate of the Company, pursuant to an Award Agreement that will be in such form (which need not be the same for each Participant) as the Administrator will from time to time approve, and will comply with and be subject to the terms and conditions of the Plan. A Stock Bonus may be awarded upon satisfaction of such performance goals as are set out in advance in the Participant’s individual Award Agreement that will be in such form (which need not be the same for each Participant) as the Administrator will from time to time approve, and will comply with and be subject to the terms and conditions of the Plan. Stock Bonuses may vary from Participant to Participant and between groups of Participants, and may be based upon the achievement of the Company, any Parent, Subsidiary or Affiliate of the Company and/or individual performance factors or upon such other criteria as the Administrator may determine.
|
9.2.
|
Terms of Stock Bonuses
. The Administrator will determine the number of Shares to be awarded to the Participant. If the Stock Bonus is being earned upon the satisfaction of performance goals set forth in an Award Agreement, then the Administrator will:
|
9.3.
|
Form of Payment
. The earned portion of a Stock Bonus shall be paid currently or on a deferred basis with such interest or dividend equivalent, if any, as the Administrator may determine. Payment may be made in the form of cash or whole Shares or a combination thereof, either in a lump sum payment or in installments, all as the Administrator will determine.
|
10.1.
|
Payment
. Payment for Shares purchased pursuant to this Plan may be made in cash (by check) or, where expressly approved for the Participant by the Administrator and where permitted by law:
|
15 |
10.2.
|
Loan Guarantees
. The Company, in its sole discretion, may assist a Participant in paying for Shares purchased under the Plan by authorizing a guarantee by the Company of a third-party loan to the Participant.
|
11.1.
|
Deferral of Compensation
. The Administrator shall determine whether or not an Award to a Participant shall be made in conjunction with deferral of such Participant’s salary, bonus or other compensation, or any combination thereof, and whether or not such deferred amounts may be:
|
12.1.
|
Deferred Payment of Awards
. The Administrator may specify that the payment of all or any portion of cash, Shares, other securities or property of the Company, or any other form of payment, or any combination thereof, under an Award shall be deferred until a later date. Deferrals shall be for such periods or until the occurrence of such events, and upon such terms, as the Administrator shall determine. Deferred payments of Awards may be made by undertaking to make payment in the future based upon the performance of certain investment equivalents (which may include, but need not be limited to, government securities,
|
16 |
|
Shares, other securities, property or consideration, or any combination thereof), together with such additional amounts of income equivalents (which may be compounded and may include, but need not be limited to, interest, dividends or other rates of return, or any combination thereof) as may accrue thereon until the date or dates of payment, such investment equivalents and such additional amounts of income equivalents to be determined by the Administrator.
|
ARTICLE 13. AMENDMENT OR SUBSTITUTION OF AWARDS UNDER THE PLAN.
|
13.1.
|
Amendment or Substitution of Awards Under the Plan
. The terms of any outstanding Award under the Plan may be amended from time to time by the Administrator in any manner that the Administrator deems appropriate (including, but not limited to, acceleration of the date of exercise of any Award and/or payments thereunder, or reduction of the Exercise Price of an Award);
provided
,
however
, that no such amendment shall adversely affect in a material manner any right of a Participant under such Award without the Participant’s written consent. The Administrator may permit or require holders of Awards to surrender outstanding Awards as a condition precedent to the grant of new Awards under the Plan.
|
ARTICLE 14. DESIGNATION OF BENEFICIARY BY PARTICIPANT.
|
14.1.
|
Designation of Beneficiary by Participant
. A Participant may designate one or more beneficiaries to receive any rights and payments to which such Participant may be entitled in respect of any Award in the event of such Participant’s death. Such designation shall be on a written form acceptable to and filed with the Administrator. The Administrator shall have the right to review and approve beneficiary designations. A Participant may change the Participant’s beneficiary(ies) from time to time in the same manner as the original designation, unless such Participant has made an irrevocable designation. Any designation of beneficiary under the Plan (to the extent it is valid and enforceable under applicable law) shall be controlling over any other disposition, testamentary or otherwise, as determined by the Administrator. If no designated beneficiary survives the Participant and is living on the date on which any right or amount becomes payable to such Participant’s beneficiary(ies), such payment will be made to the legal representatives of the Participant’s estate, and the term “beneficiary” as used in the Plan shall be deemed to include such person or persons. If there is any question as to the legal right of any beneficiary to receive a distribution under the Plan, the Administrator may determine that the amount in question be paid to the legal representatives of the estate of the Participant, in which event the Company, the Administrator, the Board and the Committee and the members thereof will have no further liability to any person or entity with respect to such amount.
|
ARTICLE 15. CHANGE IN CONTROL.
|
15.1.
|
Effect of a Change in Control
. An Award Agreement may provide that, upon a Change in Control, all or any portion of the Award shall automatically become immediately vested and exercisable, that restrictions relating to the Award shall lapse or that the Award shall become immediately payable.
|
15.2.
|
Change of Control
. For this purpose, a Change in Control shall be deemed to occur when and only when any of the following events first occurs:
|
17 |
15.3
|
Tyme Merger
. Notwithstanding anything to the contrary contained in this Plan, for the purposes of determining whether a Change of Control has occurred, the Tyme Merger and all issuances and surrenders or Common Stock, elections of directors and other effects of the Tyme Merger, shall be disregarded.
|
16.1.
|
Plan Amendment or Suspension
. The Plan may be amended or suspended in whole or in part at any time and from time to time by the Board, but no amendment shall be effective unless and until the same is approved by shareholders of the Company where the failure to obtain such approval would adversely affect the compliance of the Plan with Sections 162 and 422 of the Code, Rule 16b-3 and/or with any other applicable law, rule or regulation. No amendment of the Plan shall adversely affect in a material manner any right of any Participant with respect to any Award theretofore granted without such Participant’s written consent.
|
ARTICLE 17. PLAN TERMINATION.
|
17.1.
|
Method of Plan Termination
. The Plan shall terminate upon the earlier of the following dates or events to occur:
|
17.2.
|
Effect of Termination on Outstanding Awards
. No termination of the Plan shall materially alter or impair any of the rights or obligations of any person, without such person’s consent, under any Award theretofore granted under the Plan, except that subsequent to termination of the Plan, the Administrator may make amendments permitted under Article 13.
|
18.1.
|
Stockholder Approval
. The Plan shall be submitted to the stockholders of the Company for their approval either by vote at a meeting of the stockholders of the Company to be duly held on or before March 5, 2015, or by written consent of holders of a majority of the outstanding voting securities of the Company dated on or before March 5, 2015.
|
18.2.
|
Effectiveness of Plan Prior to Stockholder Approval
. The Plan shall not be effective and no Award shall be made hereunder unless and until the Plan has been approved by the stockholders of the Company as provided in Section 18.1. The stockholders shall be deemed to have approved and adopted the Plan only if it is approved in a manner permitted by the laws of the State of Delaware and any applicable federal securities laws.
|
18 |
19.1.
|
Transferability
. Except as may be approved by the Administrator where such approval shall not adversely affect compliance of the Plan with Sections 162 and 422 of the Code and/or Rule 16b-3, a Participant’s rights and interest under the Plan may not be assigned or transferred, hypothecated or encumbered in whole or in part either directly or by operation of law or otherwise (except in the event of a Participant’s death) including, but not by way of limitation, execution, levy, garnishment, attachment, pledge, bankruptcy or in any other manner;
provided
,
however
, except as may be approved by the Administrator, that any Option or similar right (including, but not limited to, a Stock Appreciation Right) offered pursuant to the Plan shall not be transferable other than by will or the laws of descent or pursuant to a domestic relations order and shall be exercisable during the Participant’s lifetime only by such Participant or such person receiving such Option or similar right pursuant to a domestic relations order.
|
20.1.
|
Voting and Dividends
. No Participant will have any of the rights of a shareholder with respect to any Shares subject to or issued pursuant to the Plan until such Shares are issued to the Participant. After Shares are issued to the Participant, the Participant will be a shareholder and have all the rights of a shareholder with respect to such Shares, including the right to vote and receive all dividends or other distributions made or paid with respect to such Shares;
provided
,
however
, that if such Shares are Restricted Stock, then any new, additional or different securities the Participant may become entitled to receive with respect to such Shares by virtue of a stock dividend, stock split or any other change in the corporate or capital structure of the Company will be subject to the same restrictions as the Restricted Stock;
provided
,
however
,
further
, that the Participant will have no right to retain such stock dividends or stock distributions with respect to Restricted Stock that is repurchased at the Participant’s Exercise Price in accordance with an Award Agreement with respect to such Restricted Stock.
|
20.2.
|
Financial Statements
. The Company will provide financial statements to each Participant prior to such Participant’s purchase of Shares under the Plan, and to each Participant annually during the period such Participant has Awards outstanding;
provided
,
however
, that the Company will not be required to provide such financial statements to Participants whose services in connection with the Company assure them access to equivalent information.
|
20.3.
|
Restrictions on Shares
. At the discretion of the Administrator, the Company may reserve to itself and/or its assignee(s) in the Award Agreement a right to repurchase a portion of or all Shares issued pursuant to such Award Agreement and held by a Participant following such Participant’s Termination at any time within 90 days after the later of Participant’s Termination Date or the date Participant purchases Shares under the Plan, for cash and/or cancellation of purchase money indebtedness, at the Participant’s Exercise Price or such other price as the Administrator may determine at the time of the grant of the Award.
|
21.1.
|
Certificates
. All Shares or other securities delivered under this Plan will be subject to such stock transfer orders, legends and other restrictions as the Administrator may deem necessary or advisable, including restrictions under any applicable federal, state or foreign securities law, or any rules, regulations and other requirements promulgated under such laws or any stock exchange or automated quotation system upon which the Shares may be listed or quoted and each stock certificate evidencing such Shares and other certificates shall be appropriately legended.
|
19 |
22.1.
|
Deposit of Shares; Escrow
. To enforce any restrictions on a Participant’s Shares, the Committee may require the Participant to deposit all stock certificates evidencing Shares, together with stock powers or other instruments of transfer approved by the Administrator, appropriately endorsed in blank, with the Company or an agent designated by the Company to hold in escrow until such restrictions have lapsed or terminated, and the Administrator may cause a legend or legends referencing such restrictions to be placed on the certificates. Any Participant who is permitted to execute a promissory note as partial or full consideration for the purchase of Shares under the Plan will be required to pledge and deposit with the Company all or part of the Shares so purchased as collateral to secure the payment of Participant’s obligation to the Company under the promissory note;
provided
,
however
, that the Administrator may require or accept other or additional forms of collateral to secure the payment of such obligation and, in any event, the Company will have full recourse against the Participant under the promissory note notwithstanding any pledge of the Participant’s Shares or other collateral. In connection with any pledge of the Shares, Participant will be required to execute and deliver a written pledge agreement in such form as the Administrator may from time to time approve. The Shares purchased with the promissory note may be released from the pledge on a pro rata basis as the promissory note is paid.
|
23.1.
|
Exchange
. The Administrator may, at any time or from time to time, authorize the Company, with the consent of the respective Participants, to issue new Awards in exchange for the surrender and cancellation of any or all outstanding Awards.
|
23.2.
|
Buyout of Awards
. The Administrator may, at any time or from time to time, authorize the Company to buy from a Participant an Award previously granted with payment in cash, Shares (including Restricted Stock) or other consideration, based on such terms and conditions as the Administrator and the Participant may agree.
|
24.1.
|
Compliance with Applicable Laws
. An Award will not be effective unless such Award is made in compliance with all applicable federal and state securities laws, rules and regulations of any governmental body, and the requirements of any stock exchange or automated quotation system upon which the Shares may then be listed or quoted, as they are in effect on the date of grant of the Award and also on the date of exercise or other issuance. Notwithstanding any other provision in this Plan, the Company will have no obligation to issue or deliver stock certificates for Shares under this Plan prior to:
|
24.2.
|
No Obligation to Register Shares or Awards
. The Company will be under no obligation to register the Shares under the Securities Act or to effect compliance with the registration, qualification or listing requirements of any state securities laws, stock exchange or automated quotation system, and the Company will have no liability for any inability or failure to do so.
|
20 |
25.1.
|
No Right to Employment or Continuation of Relationship
. Nothing in this Plan or any Award granted under the Plan will confer or be deemed to confer on any Participant any right to continue in the employ of, or to continue any other relationship with, the Company or any Parent, Subsidiary or Affiliate of the Company or limit in any way the right of the Company or any Parent, Subsidiary or Affiliate of the Company to terminate Participant’s employment or other relationship at any time, with or without cause.
|
26.1.
|
Non-Exclusivity of the Plan
. Neither the adoption of the Plan by the Board, nor any provision of this Plan will be construed as creating any limitations on the power of the Board or the Committee to adopt such additional compensation arrangements as the Board may deem desirable, including, without limitation, the granting of stock options and bonuses otherwise than under the Plan, and such arrangements may be either generally applicable or applicable only in specific cases.
|
27.1.
|
No Rights Unless Specifically Granted
. No Eligible Participant, employee or other person shall have any claim or right to be granted an Award under the Plan under any contract, agreement or otherwise. Determinations made by the Administrator under the Plan need not be uniform and may be made selectively among Eligible Participants under the Plan, whether or not such Eligible Participants are similarly situated.
|
27.2.
|
No Rights Until Written Evidence Delivered
. No Participant or other person shall have any right with respect to the Plan, the Shares reserved for issuance under the Plan or in any Award, contingent or otherwise, until written evidence of the Award, in the form of an Award Agreement, shall have been delivered to the recipient and all the terms, conditions and provisions of the Plan and the Award applicable to such recipient (and each person claiming under or through such recipient) have been met.
|
27.3.
|
Compliance with Applicable Law
. No Shares, other Company securities or property, other securities or property, or other forms of payment shall be issued hereunder with respect to any Award unless counsel for the Company shall be satisfied that such issuance will be in compliance with applicable federal, state, local and foreign legal, securities exchange and other applicable requirements.
|
27.4.
|
Compliance with Rule 16b-3
. It is the intent of the Company that the Plan comply in all respects with Rule 16b-3 under the Exchange Act, that any ambiguities or inconsistencies in construction of the Plan be interpreted to give effect to such intention and that if any provision of the Plan is found not to be in compliance with Rule 16b-3, such provision shall be deemed null and void to the extent required to permit the Plan to comply with Rule 16b-3.
|
27.5.
|
Right to Withhold Payments
. The Company and any Parent, Subsidiary and Affiliate of the Company shall have the right to deduct from any payment made under the Plan, any federal, state, local or foreign income or other taxes required by law to be withheld with respect to such payment. It shall be a condition to the obligation of the Company to issue Shares, other securities or property of the Company, other securities or property, or other forms of payment, or any combination thereof, upon exercise, settlement or payment of any Award under the Plan, that the Participant (or any beneficiary or person entitled to act) pay to the Company, upon its demand, such amount as may be requested by the Company for the purpose of satisfying any liability to withhold federal, state, local or foreign income or other taxes. If the amount requested is not paid, the Company may refuse to issue Shares, other securities or property of the Company, other securities or property, or other forms of payment, or any combination thereof. Notwithstanding anything in the Plan to the contrary, the Administrator may permit a Participant (or any beneficiary or person entitled to act) to elect to pay a portion or all of the amount requested by the Company for such taxes with respect to such Award, at such time and in such manner as the Administrator shall deem to be appropriate, including, but not limited to, by authorizing the Company to withhold, or agreeing to surrender to the Company on or
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21 |
about the date such tax liability is determinable, Shares, other securities or property of the Company, other securities or property, or other forms of payment, or any combination thereof, owned by such person or a portion of such forms of payment that would otherwise be distributed, or have been distributed, as the case may be, pursuant to such Award to such person, having a fair market value equal to the amount of such taxes. |
27.6.
|
Expenses of Administration
. The expenses of the Plan shall be borne by the Company. However, if an Award is made to an individual employed by or performing services for a Parent, Subsidiary or Affiliate of the Company:
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27.7.
|
Unfunded Plan
. The Plan shall be unfunded. The Company shall not be required to establish any special or separate fund or to make any other segregation of assets to assure the payment of any Award under the Plan, and rights to the payment of Awards shall be no greater than the rights of the Company’s general creditors.
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27.8.
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Acceptance of Award Deemed Consent
. By accepting any Award or other benefit under the Plan, each Participant and each person claiming under or through such Participant shall be conclusively deemed to have indicated such Participant’s (or other person’s) acceptance and ratification of, and consent to, any action taken by the Company, Administrator, Board or Committee or their respective delegates under the Plan.
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27.9.
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Fair Market Value Determined By the Administrator
. Fair market value in relation to other securities or property of the Company, other securities or property or other forms of payment of Awards under the Plan, or any combination thereof, as of any specific time, shall mean such value as determined by the Administrator in accordance with the Plan and applicable law.
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27.10.
|
Use of Terms
. For the purposes of the Plan, in the use of any term, the singular includes the plural and the plural includes the singular wherever appropriate.
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27.11.
|
Filing of Reports
. The appropriate officers of the Company shall cause to be filed any reports, returns or other information regarding Awards hereunder or any Shares issued pursuant hereto as may be required by Section 13 or 15(d) of the Exchange Act (or any successor provision) or any other applicable statute, rule or regulation.
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27.12.
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Validity; Construction; Interpretation
. The validity, construction, interpretation, administration and effect of the Plan, and of its rules and regulations, and rights relating to the Plan and Award Agreements and to Awards granted under the Plan, shall be governed by the substantive laws, but not the choice of law rules, of the State of Delaware.
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The Company:
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TYME TECHNOLOGIES, INC.
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By:
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Name: Peter de Svastich
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Title: President
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Purchasers
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See Omnibus Signature Pages to the Bridge Purchase Agreement and the PPO Subscription Agreement
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18 |
Name:
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Title (if applicable):
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Address:
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19 |
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(a)
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Full Legal Name of Selling Securityholder
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(b)
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Full Legal Name of Registered Holder (holder of record) (if not the same as (a) above) through which Registrable Securities are held:
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(c)
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If you are not a natural person, full Legal Name of Natural Control Person (which means a natural person who directly or indirectly alone or with others has power to vote or dispose of the securities covered by this Questionnaire):
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20 |
Telephone:
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Fax:
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Email:
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Contact Person:
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(a)
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Are you a broker-dealer?
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Yes ☐ | No ☐ |
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(b)
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If “yes” to Section 3(a), did you receive your Registrable Securities as compensation for investment banking services to the Company?
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Yes ☐ | No ☐ |
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Note:
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If “no” to Section 3(b), the Commission’s staff has indicated that you should be identified as an underwriter in the Registration Statement.
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(c)
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Are you an affiliate of a broker-dealer?
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Yes ☐ | No ☐ |
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(d)
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If you are an affiliate of a broker-dealer, do you certify that you purchased the Registrable Securities in the ordinary course of business, and at the time of the purchase of the Registrable Securities to be resold, you had no agreements or understandings, directly or indirectly, with any person to distribute the Registrable Securities?
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Yes ☐ | No ☐ |
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Note:
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If “no” to Section 3(d), the Commission’s staff has indicated that you should be identified as an underwriter in the Registration Statement.
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21 |
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(a)
Please list the type (common stock, warrants, etc.) and amount of all securities of the Company (including any Registrable Securities) beneficially owned
1
by the Selling Securityholder:
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State any exceptions here:
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1
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Beneficially Owned
:
A “beneficial owner” of a security includes any person who, directly or indirectly, through any contract, arrangement, understanding, relationship or otherwise has or shares (i)
voting
power
, including the power to direct the voting of such security,
or
(ii)
investment power
, including the power to dispose of, or direct the disposition of, such security. In addition, a person is deemed to have “beneficial ownership” of a security of which such person has the right to acquire beneficial ownership at any time within 60 days, including, but not limited to, any right to acquire such security: (i) through the exercise of any option, warrant or right, (ii) through the conversion of any security or (iii) pursuant to the power to revoke, or the automatic termination of, a trust, discretionary account or similar arrangement.
It is possible that a security may have more than one “beneficial owner,” such as a trust, with two co-trustees sharing voting power, and the settlor or another third party having investment power, in which case each of the three would be the “beneficial owner” of the securities in the trust. The power to vote or direct the voting, or to invest or dispose of, or direct the investment or disposition of, a security may be indirect and arise from legal, economic, contractual or other rights, and the determination of beneficial ownership depends upon who ultimately possesses or shares the power to direct the voting or the disposition of the security.
The final determination of the existence of beneficial ownership depends upon the facts of each case. You may, if you believe the facts warrant it, disclaim beneficial ownership of securities that might otherwise be considered “beneficially owned” by you.
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2
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Affiliate
:
An “affiliate” is a company or person that directly, or indirectly through one or more intermediaries, controls you, or is controlled by you, or is under common control with you.
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22 |
BENEFICIAL OWNER
(individual)
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BENEFICIAL OWNER
(entity)
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Signature
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Name of Entity
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Print Name
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Signature
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Print Name:
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Signature (if Joint Tenants or Tenants in Common)
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Title:
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24 |
1 |
1.
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Escrow and Indemnification. |
2 |
2.
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Intentionally Omitted. |
3.
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Distribution of Indemnification Escrow Shares. |
3 |
4 |
7.
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Liability and Authority of Indemnification Representative; Successors and Assignees.
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5 |
6 |
7 |
12.
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General. |
8 |
9 |
TYME TECHNOLOGIES, INC.
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By:
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/s/ Peter de Svastich | ||||
Name: | Peter de Svastich | ||||
Title: | President | ||||
STEVEN HOFFMAN , Individually and as Indemnification Representative |
/s/ Steven Hoffman | ||
(signature) |
CKR LAW LLP
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By:
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/s/ Mark E. Crone | ||||
Name: | Mark E. Crone | ||||
Title: | Co-Managing Partner |
GEM GLOBAL YIELD FUND LLC SCS
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By:
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/s/ Christopher Brown | ||||
Name: | Christopher Brown | ||||
Title: | Manager |
10 |
11 |
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3 |
4 |
5 |
6 |
7 |
8 |
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1.
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Step 1, Meeting
: Each Party will each designate one representative with authority to settle the dispute, including, if necessary, by entering into a further license or altering the terms of this License Agreement, and further agree that their representatives will meet face-to-face within sixty (60) days of a request to meet, in a mutually agreeable location in a reasonable effort to resolve the dispute.
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2.
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Step 2, Mediation
: In the event that the dispute is not resolved by the meeting, or, if a Party refuses or fails to meet, either Party may request mediation, and the Parties will mutually agree to a mediator to conduct the mediation. The mediator will determine the schedule and logistics for the mediation.
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3.
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Step 3, Legal Proceedings
: In the event that the dispute is not resolved by mediation, or if a Party refuses or fails to participate in mediation, then the Party having standing to bring an action to resolve the dispute may bring such action in an appropriate court in the State of Delaware. The meeting and mediation shall be conditions precedent to any liability related to or regarding this License Agreement and neither Party shall initiate or file any litigation against the other Party related to this License Agreement or the alleged breach until after meeting and mediation have been carried out. In the event a Party refuses or fails to participate in the meeting and/or mediation, their requirements shall be deemed waived.
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9 |
10 |
For Hoffman:
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Steven Hoffman
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15 Knichel Road
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Mahwah, New Jersey 07430
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For Tyme:
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Tyme, Inc.
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2711 Centerville Road, Suite 400
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Wilmington, Delaware 19808
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11 |
12 |
13 |
Steven Hoffman
|
Tyme, Inc.
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||||
/s/ Steven Hoffman
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By:
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/s/ Michael Demurjian
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Name: Michael Demurjian
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|||||
Title: Vice-President
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|||||
Date: July 10, 2014
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Date: July 10, 2014
|
14 |
Exhibit 10.12
TYME TECHNOLOGIES, INC.
48 Wall Street – Suite 1100
New York, New York 10005
March 5, 2015
Mr. Steven Hoffman
15 Knichel Road
Mahwah, New Jersey 07430
Dear Steven:
This letter (this “ letter agreement ”) sets forth our agreement with respect to your employment with Tyme Technologies, Inc., a Delaware corporation (the “ Company ”).
1. Employment . You will be employed by the Company upon the terms and conditions set forth in this letter agreement for the period effective as of the date of this letter agreement and ending as provided in Section 4 (the “ Employment Period ”).
2. Position and Duties . During the Employment Period, you will serve as President, Chief Executive Officer and Chief Science Officer of the Company and will have the usual and customary duties, responsibilities and authority of a person in such position and such other duties assigned to you by the Board of Directors of the Company (the “ Board ”) which are consistent with your position. You will report directly to the Board. You will devote your full working time, efforts and attention to, and diligently and conscientiously perform the duties of, such position. In addition to performing such duties for the Company, you may be required to perform similar duties for the Company’s existing subsidiaries or affiliates, and/or any subsidiaries and/or affiliates which may be formed or acquired from time to time including, but not limited to, Tyme Inc., a Delaware corporation, and Luminant Biosciences, LLC (collectively, all such subsidiaries and/or affiliates shall be referred to as the “ Affiliates ”).
3. Compensation .
(a) During the Employment Period, your base salary will be $450,000.00 per annum (your “ Base Salary ”). Your Base Salary will be payable in regular installments in accordance with the Company’s general payroll practices and subject to withholding and other payroll taxes. Your Base Salary may be reviewed annually (beginning on or about January 1, 2016) by the Board in its sole discretion; provided , however , that your Base Salary shall not be decreased by the Board.
(b) You will also be entitled, conditioned upon your continued employment with the Company or one of the Affiliates through and including the applicable date of payment, to receive a special bonus (your “ Performance Bonus ”), in such amount(s), for such period(s) and based on such criteria as determined from time to time, and if ever, by the Board in the Board’s sole discretion.
- 1 -
(c) During the Employment Period, you will be entitled to participate in all employee benefit programs, including without limitation health/medical insurance, for which senior executive employees of the Company are generally eligible, subject to applicable plans and policies as may be amended from time to time, in the sole discretion of the Board. During the Employment Period, you will be entitled to four weeks paid vacation during each calendar year, with such vacation time pro-rated for any partial years during the Employment Period; provided , however , that no carry-over of unused vacation time shall be permitted and no compensation shall be paid for any such unused vacation time.
(d) The Company agrees to reimburse you for all reasonable out-of-pocket business expenses incurred by you on behalf of the Company during the Employment Period, provided that you properly account to the Company for all such expenses in accordance with the policies of the Company and the rules, regulations and interpretations of the U.S. Internal Revenue Service relating to reimbursement of business expenses (“ Expenses ”).
(e) During the Employment Period, the Company will maintain Directors and Officers Liability Insurance coverage that includes coverage of you, subject to the terms and conditions of such policy and with limits customary for similarly situated companies.
4. Termination . The Employment Period will end on the fifth anniversary of the date hereof (the “ Expiration Date ”), unless sooner terminated as provided below. Unless the Employment Period has been terminated in accordance with the following sentence of this Article 4, commencing with the one-year anniversary hereof, and on each subsequent annual anniversary thereafter, the Expiration Date shall automatically be extended by one additional year, such that, on any given day during the Employment Period, the remaining Employment Period shall never be less than four years and one day. Notwithstanding the foregoing, the Employment Period will (i) will terminate upon your death, (ii) may be terminated by the Company upon Notice of Termination (as defined in Section 5(e) below) delivered to you as a result of your Disability (as defined in Section 5(g) below), (iii) may be terminated by the Company at any time for Cause (as defined in Section 5(f) below) or without Cause and (iv) may be terminated by you for Good Reason.
5. Severance .
(a) If the Employment Period is terminated by the Company without Cause or by you for Good Reason (as defined in Section 5(h) below), you will be entitled to receive (i) your Base Salary as in effect at the time of such termination to the extent such amount has accrued through the Termination Date (as defined in Section 5(e) below) and remains unpaid, (ii) any fully earned and declared but unpaid Performance Bonus as of the Termination Date, (iii) an amount equal to the sum of Base Salary you would have received from the date of such termination through the then applicable Expiration Date, which shall be payable in the same amounts and at the same intervals as if the Employment Period had not ended and (iv) any unpaid Expenses as of the Termination Date. Upon delivery of the payments and benefits described in this Section 5(a), the Company shall have no further obligation to you under this letter agreement or otherwise with respect to your employment with the Company. The Company’s obligation to make the payments to you described in clause (iv) of this Section 5(a) is conditioned upon your executing and delivering, no later than 14 days following the Termination Date, a release relating to your employment by the Company in favor of the Company, its Affiliates and their respective stockholders, officers, members, managers, directors, employees, subsidiaries and affiliates substantially in the form attached as Exhibit A .
- 2 -
(b) If the Employment Period is terminated by the Company for Cause or by you other than for Good Reason, the Company will pay you (i) your Base Salary as in effect at the time of such termination to the extent such amount has accrued through the Termination Date and remains unpaid, (ii) any fully earned and declared but unpaid Performance Bonus as of the Termination Date, and (iii) any unpaid Expenses as of the Termination Date. Upon delivery of the payment described in this Section 5(b), the Company will have no further obligation to you under this letter agreement or otherwise with respect to your employment with the Company.
(c) If the Employment Period is terminated upon your Disability (as defined in Section 5(g) below) or death, the Company will pay you or your estate or succession, whichever is applicable, (i) your Base Salary as in effect at the time of such termination to the extent such amount has accrued through the Termination Date and remains unpaid, (ii) any fully earned and declared but unpaid Performance Bonus as of the Termination Date, and (iii) any unpaid Expenses as of the Termination Date.
(d) Except as otherwise required by law or as specifically provided herein, all of your rights to salary, severance, fringe benefits, bonuses and any other amounts hereunder (if any) accruing after the termination of the Employment Period will cease upon the earlier of the date of such termination and your last day of active service. In the event the Employment Period is terminated, your sole remedy, and the sole remedy of your successors, assigns, heirs, representatives and estate, will be to receive the payments described in this letter agreement.
(e) Any termination of the Employment Period by the Company (other than termination upon your death) or by you must be communicated by written notice (in either case, a “ Notice of Termination ”) to you. For purposes of this letter agreement, “ Termination Date ” means (i) if the Employment Period is terminated by your death, the date of your death, (ii) if the Employment Period is terminated upon your Disability, by the Company or by you, the date specified in the Notice of Termination (which may not be earlier than the date of such Notice). Notwithstanding anything contained herein to the contrary, any termination of the Employment Period by you must be communicated to the Company no less than 30 days prior to the intended Termination Date.
(f) For purposes of this letter agreement, “ Cause ” means any one of the following: (i) a breach by you of this letter agreement, (ii) your conviction of, guilty plea to, or confession of guilt of, a felony involving the Company, (iii) materially fraudulent, dishonest or illegal conduct by you in the performance of services for or on behalf of the Company or any of its Affiliates, (iv) any conduct by you in material violation of Company policy, (v) any conduct by you that is materially detrimental to the reputation of the Company or any of its Affiliates, (vi) your misappropriation of funds of the Company or any of its Affiliates, (vii) your gross negligence or wilful misconduct or wilful failure to comply with written directions of the Board which directions are within the scope of your duties hereunder, (viii) your engaging in conduct involving an act of moral turpitude, or (ix) a breach of your duty of loyalty to the Company or its Affiliates.
- 3 -
(g) For purposes of this letter agreement “ Disability ” means any accident, sickness, incapacity or other physical or mental disability which prevents you from performing substantially all of the duties you have been assigned by the Company or any of its subsidiaries for either (i) 90 consecutive days or (ii) 120 days during any period of 365 consecutive days, in each case as determined in good faith by a physician selected by the Board. During the time periods specified above, the Company will continue to provide you with the compensation stated in Section 3 above.
(h) For purposes of this letter agreement, “ Good Reason ” means the failure of the Company to make all payments due you under this letter agreement and the continuation thereof for more than five calendar days after notice to the Company of such failure and demand for such outstanding payment(s).
6. Confidential Information .
(a) You will not disclose or use at any time any Confidential Information (as defined below in Section 6(c)), whether or not such information is developed by you, except to the extent that such disclosure or use is required in the performance or exercise by you in good faith of (i) duties assigned to you under this letter agreement or otherwise by the Board, (ii) rights as an employee, officer, director or shareholder of the Company or any of its Affiliates or (iii) rights under any agreement with the Company or any Affiliates.
(b) You will deliver to the Company at the termination of the Employment Period, or at any time the Company may request, all memoranda, notes, plans, designs, records, reports, computer files and software and other documents and data (and copies thereof) that are Confidential Information or Work Product (as defined below) or information relating to the business of the Company or its Affiliates which you may then possess or have under your control.
(c) As used in this letter agreement, the term “ Confidential Information ” means information that is not generally known or available to the public and that is used, developed or obtained by the Company or any Affiliate in connection with its or their businesses, including but not limited to (i) information, observations and data concerning the business or affairs of the Company or its affiliates, (ii) products or services, (iii) fees, costs and pricing structures, (iv) designs, (v) analyses, (vi) drawings, designs, photographs, artwork and reports, (vii) computer software, including operating systems, applications and program listings, (viii) flow charts, manuals and documentation, (ix) data bases, (x) accounting and business methods, (xi) inventions, devices, new developments, methods and processes, whether patentable or unpatentable and whether or not reduced to practice, (xii) other copyrightable works, (xiii) all production methods, processes, technology and trade secrets, (xiv) Company product and product candidate formulae and any trade secrets with respect to such products and product candidates and (xv) all similar and related information in whatever form.
(d) Notwithstanding the provisions of this letter agreement to the contrary, you will have no liability to the Company for disclosure of Confidential Information if the Confidential Information:
- 4 -
(A) is in the public domain or becomes publicly known in the industry in which the Company operates or is disclosed by the Company other than as the result of a breach of this letter agreement or any other agreement by you; or
(B) is required to be disclosed by law, court order, or similar compulsion or in connection with any legal proceeding; provided however , that such disclosure will be limited to the extent so required and, subject to the requirements of law, you will give the Company notice of your intent to so disclose such Confidential Information and will cooperate with the Company in seeking confidentiality protections.
7. Inventions and Patents . You agree that all inventions, innovations, improvements, technical information, trade secrets, systems, software developments, ideas, results, methods, designs, artwork, analyses, drawings, reports, copyrights, service marks, trademarks, trade names, logos and all similar or related information (whether patentable or unpatentable) which relate to the Company’s or any of its Affiliates’ businesses, research and development or existing products (or products under development) or services and which are conceived, developed or made by you (whether or not during usual business hours and whether or not alone or in conjunction with any other person) during your employment with the Company, together with all intellectual property rights therein, including, but not limited to, any patent applications, letters patent, trademark, trade name and service mark applications or registrations, copyrights and reissues thereof that may be granted for or upon any of the foregoing, but only with respect to the treatment of cancer in humans (collectively referred to herein as “ Work Product ”), is the exclusive property of the Company and/or its Affiliates. For the avoidance of doubt and without limiting the foregoing, (x) the Company or any of its Affiliates shall be the sole owner of all right, title and interest in such Work Product, including all intellectual property rights relating to such Work Product, without you retaining any license or other residual right whatsoever, and (y) any rights to any new or an existing Work Product are automatically conveyed, assigned and transferred to the Company pursuant to this agreement. You hereby waive and renounce to all moral rights related, directly or indirectly, to any such existing or new Work Product. You will take reasonable steps to promptly disclose such Work Product to the Board and perform all actions reasonably requested by the Board (whether during or after the Employment Period) to establish and confirm such ownership (including the execution and delivery of assignments, consents, powers of attorney and other instruments) and to provide reasonable assistance to the Company and its Affiliates in connection with the prosecution of any applications for patents, trademarks, trade names, service marks or reissues thereof or in the prosecution or defense of interferences relating to any Work Product.
8. Non-Compete; Non-Solicitation; Non-Disparagement .
(a) You acknowledge that, in the course of your employment with the Company, you will become familiar with the Company’s and its Affiliates’ trade secrets and with other Confidential Information concerning the Company and its Affiliates and that your services will be of special, unique and extraordinary value to the Company and its Affiliates. Therefore, you agree that, during the Restriction Period (as defined in Section 8(b) below), you will not (x) anywhere the Company or any of its Affiliates conducts business or (y) anywhere the Company or any of its Affiliates has spent time and resources in connection with expanding its business, directly or indirectly, either on your own behalf or on behalf of any other person, firm or entity:
- 5 -
(A) own, manage, operate, consult with, provide financing to, or join, control or participate in the ownership, management, operation or control of, or the provision of financing to, any business wherever located (whether in corporate, proprietorship or partnership form or otherwise), if such business is competitive with the business of the Company; or
(B) say anything which is harmful to the reputation of the Company or any of its Affiliates or which could be reasonably expected to lead any person to cease to deal with the Company or any of its Affiliates on substantially equivalent terms to those previously offered or at all.
(b) For purposes of this letter agreement, “ Restriction Period ” means (i) during the Employment Period, and for a period of two years following your receipt of the final payment described in Article 5, as applicable.
(c) Nothing in Section 8(a) will prohibit you from being a passive owner of not more than 2% of the outstanding stock of a publicly-traded corporation, so long as you have no active participation in the business of such corporation.
(d) During the Restriction Period, you will not:
(A) induce or attempt to induce any customer, supplier or other business relation of the Company or any of its affiliates to cease doing business with the Company or any of its Affiliates, or in any way interfere with the relationship between any such customer, supplier or business relation, on the one hand, and the Company or any Affiliates, on the other hand; or
(B) engage, employ, solicit or contact with a view to the engagement or employment of, any employee, officer or manager of, or full-time consultant to, the Company or any Affiliates or any person who has been an employee, officer or manager of, or consultant to, the Company or any Affiliates at any time during the two-year period ending on the date of such determination.
(e) The Company, on behalf of itself and all Affiliates, agrees that during the Restriction Period they and their executive officers (or other persons acting on their behalf) will not say anything which is harmful to your reputation or which could be reasonably expected to lead any person to cease to deal with you or engage you in any consulting or employment position.
9. Enforcement .
(a) Because the employment relationship between you and the Company is unique and because you have access to Confidential Information and Work Product, you agree that money damages would be an inadequate remedy for any breach of Section 6, 7 or 8 of this letter agreement. Therefore, in the event of a breach or threatened breach of Section 6, 7 or 8 of this letter agreement, the Company may, in addition to its other rights and remedies, apply to any court of competent jurisdiction for specific performance and/or injunctive or other relief in order to enforce, or prevent any violations of, such provisions (without posting a bond or other security).
- 6 -
(b) Sections 6, 7, 8 and 9 of this letter agreement will expressly survive termination of this agreement. The existence of any claim or cause of action by you against the Company and/or any of its Affiliates shall not constitute a defense to the enforcement by the Company of the covenants contained in this Articles 6, 7 or 8, but such claim or cause of action shall be litigated separately.
10. Notices . All notices, requests, demands, claims, and other communications hereunder will be in writing. Any notice, request, demand, claim or other communication hereunder will be deemed duly given (i) upon delivery, if delivered personally to the recipient, against written receipt therefor, or (ii) upon the first business day after the date sent, if sent priority next-day delivery to the intended recipient by reputable express courier service (charges prepaid) and addressed to the intended recipient as set forth below:
If to the Company, to:
Michael Demurjian, Chief Operating Officer
Tyme Technologies, Inc.
48 Wall Street – Suite 1100
New York, New York 10005
and with a copy to:
Moritt Hock & Hamroff LLP
450 Seventh Avenue, 15 th Floor
New York, New York 10123
Attention: Keith S. Braun, Esq.
If to you, to the address shown on the first page.
Any party hereto may send any notice, request, demand, claim or other communication hereunder to the intended recipient at the address set forth above using any other means, but no such notice, request, demand, claim or other communication will be deemed to have been duly given unless and until it actually is received and acknowledged by the intended recipient. Any party hereto may change the address (or add new parties and their addresses) to which notices, requests, demands, claims, and other communications hereunder are to be delivered by giving the other parties hereto notice in the manner set forth in this Section 10.
11. Representations and Warranties . You hereby represent and warrant to the Company that (a) the execution, delivery and performance of this letter agreement by you does not and will not conflict with, breach, violate or cause a default under any agreement, contract or instrument to which you are a party or any judgment, order or decree to which you are subject, (b) you are not a party to or bound by any employment agreement, consulting agreement, non-compete agreement, confidentiality agreement or similar agreement with any other person or entity that is inconsistent with the provisions of this letter agreement, (c) upon the execution and
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delivery of this letter agreement by the Company and you, this letter agreement will be a valid and binding obligation of you and (d) you are in good health and are not suffering from, and have never suffered from, any serious illness, disease or other physical or mental condition that has prevented or materially interfered with, or might reasonably be expected in the future to prevent or materially interfere with, your ability to perform those services described in this letter agreement. The Company hereby represents and warrants to you that (i) the execution, delivery and performance of this letter agreement by the Company does not and will not conflict with, breach, violate or cause a default under any agreement, contract or instrument to which it is a party or any judgment, order or decree to which it is subject and (ii) upon the execution and delivery of this letter agreement by the Company and you, this agreement will be a valid and binding obligation of the Company.
12. General Provisions .
(a) Severability . It is the desire and intent of the parties hereto that the provisions of this letter agreement be enforced to the fullest extent permissible under the laws and public policies applied in each jurisdiction in which enforcement is sought. Accordingly, if any particular provision of this letter agreement will be adjudicated by a court of competent jurisdiction to be invalid, prohibited or unenforceable for any reason, such provision, as to such jurisdiction, will be ineffective, without invalidating the remaining provisions of this agreement or affecting the validity or enforceability of this letter agreement or affecting the validity or enforceability of such provision in any other jurisdiction. Notwithstanding the foregoing, if such provision could be more narrowly drawn so as not to be invalid, prohibited or unenforceable in such jurisdiction, it will, as to such jurisdiction, be so narrowly drawn, without invalidating the remaining provisions of this letter agreement or affecting the validity or enforceability of such provision in any other jurisdiction.
(b) Complete Agreement . This letter agreement and any schedules or exhibits expressly constitute the entire agreement among the parties hereto with respect to the subject matter hereof and supersedes and preempts any prior understandings, agreements or representations by or among the parties, written or oral, which may have related to the subject matter hereof in any way.
(c) Successors and Assigns . Except as otherwise provided herein, this letter agreement will be binding upon and inure to the benefit of you and the Company and our respective successors, permitted assigns, personal representatives, heirs and estates, as the case may be; provided , however , that your rights and obligations under this letter agreement will not be assigned without the prior written consent of the Company.
(d) Governing Law . This letter agreement will be governed by and construed in accordance with the domestic laws of New York, without giving effect to the choice of law provisions thereof. The parties agree that the exclusive venue for all disputes under this agreement shall be the federal and state courts sitting in New York County, New York.
(e) Amendment and Waiver . The provisions of this letter agreement may be amended and waived only with the prior written consent of the Company (with the approval of the Board) and you, and no course of conduct or failure or delay in enforcing the provisions of this letter agreement will affect the validity, binding effect or enforceability of this letter agreement or any provision hereof.
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(f) Headings . The section headings contained in this agreement are inserted for convenience only and will not affect in any way the meaning or interpretation of this agreement.
(g) Counterparts . This letter agreement may be executed in counterparts, each of which will be deemed an original and all of which together will constitute one and the same instrument.
(h) 409A Provision . For purposes of this letter agreement the term “ termination of employment ” and similar terms relating to your termination of employment mean a “ separation from service ” as that term is defined under Section 409A of the Internal Revenue Code of 1986, as amended, and the final regulations issued thereunder (“ Section 409A ”). The Company and you intend that this letter agreement comply in form and operation with the requirements of Section 409A. To the extent permitted by applicable Department of Treasury/Internal Revenue Service guidance, or law or regulation, the Company and you will take reasonable actions to reform this letter agreement or any actions taken pursuant to their operation of this letter agreement in order to comply with Section 409A.
[signature page follows]
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If this letter agreement correctly expresses our mutual understanding, please sign and date a copy of this letter agreement and return it to us.
Very truly yours,
Tyme Technologies, Inc.
By: /s/ Michael Demurjian
Name: Michael Demurjian
Title: Chief Operating Officer
The terms of this letter agreement are accepted and agreed to
on March 5, 2015 by:
/s/ Steven Hoffman
Steven Hoffman
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EXHIBIT A
Form of Release
RELEASE
This Release is delivered by Steven Hoffman on this __ day of _________, 20__.
DEFINITIONS
A. As used herein, unless otherwise specified, the term “Employer” shall mean Tyme Technologies, Inc., and all of its affiliates, successors, predecessors, assigns, parents, subsidiaries, divisions (whether incorporated or unincorporated), and all of its and their past and present owners, directors, officers, trustees, shareholders, managers, employees and agents (in their individual and representative capacities).
B. As used herein, unless otherwise specified, the term “Employee” shall mean Steven Hoffman and all of his heirs, family members, executors, accountants, administrators, attorneys, agents, assigns, successors and representatives.
RECITALS
WHEREAS, Employee’s employment ended on ___________, 20__; and
WHEREAS, it is a condition to the Employee’s receipt of certain post-employment benefits (“Conditional Benefits”) under the Employment Agreement, dated as of ____________, 2014 (the “Employment Agreement”), between Employee and Employer that Employee execute this Release.
NOW THEREFORE, in consideration of the promises, representations and mutual covenants contained in this Release, and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, it is agreed as follows:
1. Consideration . Employee acknowledges that the Conditional Benefits are in excess of any earned wages or benefits due and owing Employee, and would not be paid or provided unless Employee executed this Release. Employee acknowledges and agrees that the Conditional Benefits are adequate and independent consideration for Employee executing this Release and releasing any and all claims against Employer.
2. Release of All Claims . In consideration of the above, and the other promises set forth in this Release, Employee fully and forever waives, releases, acquits and discharges Employer from and for all manner of claims, actions, suits, charges, grievances and/or causes of action, in law or in equity, existing by reason of and/or based upon any fact or set of facts, known or unknown, existing from the beginning of time through the effective date of this Release relating to and/or arising out of the Employment Agreement, Employee’s employment with Employer and/or the cessation of Employee’s employment with Employer (collectively, the “Released Claims”), including, but not limited to, all claims, actions, suits, charges, grievances and/or causes of action for wages,
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compensation, liquidated damages, commissions, bonuses, benefits, sums of money, damages of every type, costs, attorney fees, judgments, executions, wrongful discharge, breach of contract, breach of implied contract, breach of the covenant of good faith and fair dealing, tortious interference with contract or business relationships, assault, battery, invasion of privacy, misappropriation of trade secrets, promissory estoppel, unjust enrichment, loss of consortium, violation of the penal statutes, negligent or intentional infliction of emotional distress, negligence, defamation, retaliation and/or discrimination and/or harassment on account of age, sex, sexual orientation, creed, religion, race, color, national origin, sensory disability, mental disability, physical disability, veteran or military status, marital status, or any other classification recognized under all applicable discrimination laws, or any other claim or cause of action, which has or could have been alleged under the common law, civil rights statutes, Title VII of the Civil Rights Act of 1964 (“Title VII”), the Age Discrimination in Employment Act (“ADEA”), the Family and Medical Leave Act (“FMLA”), the Employee Retirement Income Security Act (“ERISA”), the Rehabilitation Act of 1973, the Older Workers Benefits Protection Act (“OWBPA”), the Americans with Disabilities Act (“ADA”), The Consolidated Omnibus Budget Reconciliation Act (“COBRA”), the Workers Adjustment Retraining Notification Act (“WARN”), the Equal Pay Act (“EPA”), the Uniformed Services Employment and Reemployment Rights Act (“USERRA”), the National Labor Relations Act (“NLRA”), any and all federal, state, local statutes, ordinances, and laws, and every type of relief, (legal, equitable and otherwise) available to Employee. Employee covenants and agrees that he will not pursue or allege any claim, matter or cause of action in violation of, and/or released under, this Release. Nothing in this Release shall be construed as releasing Employer from its obligation to pay those amounts due to Employee under Section 5(a) of the Employment Agreement, subject to the terms and conditions thereof, which obligation is not a Released Claim.
3. Covenant Not to Sue . Employee represents that he has not filed any action, charge, suit, or claim against Employer with any federal, state or local agency or court relating to any Released Claim. Employee further agrees that should any claims, charges, complaints, suits or other actions be filed hereafter on his behalf by any federal, state or local agency or by any other person or entity with respect to a Released Claim, he will immediately withdraw with prejudice, or cause to be withdrawn with prejudice, and/or dismiss with prejudice, or cause to be dismissed with prejudice, any such claims, charges, complaints, suits or other actions filed against Employer. Employee further agrees that, to the fullest extent permitted by law, Employee shall receive no relief of any type (monetary, equitable, or otherwise) with respect to, relating to and/or on account of any such claims, matters or actions. Employee agrees to opt-out of any class action or collective action filed against Employer to the extent related to a Released Claim.
4. Confidentiality . To the fullest extent permitted by law, Employee agrees to keep confidential all facts, opinions, and information which relate in any way to Employee’s employment and/or cessation of employment with Employer, as well as the terms of this Release; provided however , Employee may discuss the terms of this Release with his spouse, legal representative, and/or tax preparer, each of whom must also agree to maintain confidentiality and comply with this Paragraph 4 of the Release.
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5. Return of Employer’s Property . Employee represents that he has returned to Employer any and all property, records, papers, documents and writings, in whatever form, of Employer in Employee’s possession and/or control, and that he has not retained any copies thereof, in whatever form.
6. Cooperation .
(a) To the fullest extent permitted by law, Employee will not cooperate with, or assist in, any claim, charge, lawsuit, or arbitration against Employer with respect to a Released Claim, unless required to do so by a lawfully issued subpoena, by court order or as expressly provided by regulation or statute. In the event Employee is served with a subpoena or is required by court order or otherwise to testify in any type of proceeding involving the Employer and related to a Released Claim, Employee shall immediately advise Employer in writing of same.
(b) Employee agrees to cooperate with Employer in any internal investigation, administrative, regulatory, or judicial proceeding or any dispute with a third party. Employee’s cooperation may include being available to Employer upon reasonable notice for interviews and factual investigations, appearing at Employer’s request to give testimony without requiring service of a subpoena or other legal process, volunteering to Employer pertinent information, and turning over to Employer all relevant documents which are or may come into Employee’s possession. Employee understands that in the event Employer asks for Employee’s cooperation in accordance with this provision, Employer will reimburse him/her for reasonable travel expenses (including lodging and meals) upon submission of receipts acceptable to Employer.
7. ADEA Notice and Acknowledgement . Employee acknowledges that he has carefully read this Release and fully understands its contents. Prior to signing this Release, Employee has been advised in writing hereby and has had an opportunity to consult with his attorney of choice concerning the terms and conditions of this Release with regard to any claim or right Employee may have under the ADEA or otherwise. Employee has been offered at least 21 days to review and consider this Release. Employee may voluntarily and knowingly waive this 21 day period, or any part thereof, if he signs this Release prior to the expiration of 21 days. After signing this Release, Employee shall have seven days from the signing date to revoke this Release. This Release shall not be effective (including for purposes under the Employment Agreement) until after the seven day revocation period has expired. Any revocation must be made in writing and delivered to the Chief Financial Officer and Chief Operating Officer of the Employer. Until all applicable periods set forth in this Section 7 have expired, Employer shall not be required to make any payment to Employee which payment is, under the Employment Agreement, contingent upon the signing and delivery to the Company of this Release. By signing this Release, Employee agrees and understands that he is waiving and releasing any and all rights he may have to pursue claims against Employer, from the beginning of time up to the effective date of this Release, including, without limitation, all ADEA claims.
8. Governing Law . New York law shall govern this Release, without giving effect to any choice of law or conflict of law provision or rule (whether of the State of New York or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of New York.
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10. Successors and Assigns . This Release shall be inure to the benefit of the successors and assigns of Employer.
11. Severability . If any portion of this Release is ruled unenforceable, all remaining portions of this Release shall remain valid.
12. No Reliance; No Waiver . Employee represents that he is not relying on any representation, statement, or promise of Employer or any other party in giving this Release. This Release may not be amended, modified, waived, or terminated except in a writing signed by Employee and an authorized representative of Employer.
13. Headings . The paragraph and section headings in this Release are inserted merely for the convenience of reference only and shall not be used to construe, affect or modify the terms of any paragraph or provision of this Release.
EMPLOYEE WITHOUT ANY DURESS OR COERCION FREELY, KNOWINGLY AND VOLUNTARILY ENTERS INTO, AND GIVES THIS RELEASE. EMPLOYEE UNDERSTANDS AND AGREES WITH ALL OF THE PROVISIONS AND THE TERMS STATED IN THIS RELEASE AND HAS BEEN AFFORDED SUFFICIENT AND REASONABLE TIME TO CONSIDER WHETHER TO ENTER INTO THIS RELEASE. EMPLOYER ADVISES EMPLOYEE TO CONSULT WITH AN ATTORNEY OF EMPLOYEE’S CHOOSING PRIOR TO EXECUTING THIS RELEASE WHICH CONTAINS A RELEASE AND WAIVER.
______________________________
Steven Hoffman
______________________________
Date
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Exhibit 10.13
TYME TECHNOLOGIES, INC.
48 Wall Street – Suite 1100
New York, New York 10005
March 5, 2015
Mr. Michael Demurjian
1400 Winesap Drive
Manasquan, New Jersey 08736
Dear Michael:
This letter (this “ letter agreement ”) sets forth our agreement with respect to your employment with Tyme Technologies, Inc., a Delaware corporation (the “ Company ”).
1. Employment . You will be employed by the Company upon the terms and conditions set forth in this letter agreement for the period effective as of the date of this letter agreement and ending as provided in Section 4 (the “ Employment Period ”).
2. Position and Duties . During the Employment Period, you will serve as Executive Vice President, Chief Operating Officer of the Company and will have the usual and customary duties, responsibilities and authority of a person in such position and such other duties assigned to you by the Board of Directors of the Company (the “ Board ”) and/or Chief Executive Officer of the Company (the “ CEO ”) which are consistent with your position. You will report directly to the CEO. You will devote your full working time, efforts and attention to, and diligently and conscientiously perform the duties of, such position. In addition to performing such duties for the Company, you may be required to perform similar duties for the Company’s existing subsidiaries or affiliates, and/or any subsidiaries and/or affiliates which may be formed or acquired from time to time including, but not limited to, Tyme Inc., a Delaware corporation, and Luminant Biosciences, LLC (collectively, all such subsidiaries and/or affiliates shall be referred to as the “ Affiliates ”).
3. Compensation .
(a) During the Employment Period, your base salary will be $450,000.00 per annum (your “ Base Salary ”). Your Base Salary will be payable in regular installments in accordance with the Company’s general payroll practices and subject to withholding and other payroll taxes. Your Base Salary may be reviewed annually (beginning on or about January 1, 2016) by the Board in its sole discretion; provided , however , that your Base Salary shall not be decreased by the Board.
(b) You will also be entitled, conditioned upon your continued employment with the Company or one of the Affiliates through and including the applicable date of payment, to receive a special bonus (your “ Performance Bonus ”), in such amount(s), for such period(s) and based on such criteria as determined from time to time, and if ever, by the Board in the Board’s sole discretion.
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(c) During the Employment Period, you will be entitled to participate in all employee benefit programs, including without limitation health/medical insurance, for which senior executive employees of the Company are generally eligible, subject to applicable plans and policies as may be amended from time to time, in the sole discretion of the Board. During the Employment Period, you will be entitled to four weeks paid vacation during each calendar year, with such vacation time pro-rated for any partial years during the Employment Period; provided , however , that no carry-over of unused vacation time shall be permitted and no compensation shall be paid for any such unused vacation time.
(d) The Company agrees to reimburse you for all reasonable out-of-pocket business expenses incurred by you on behalf of the Company during the Employment Period, provided that you properly account to the Company for all such expenses in accordance with the policies of the Company and the rules, regulations and interpretations of the U.S. Internal Revenue Service relating to reimbursement of business expenses (“ Expenses ”).
(e) During the Employment Period, the Company will maintain Directors and Officers Liability Insurance coverage that includes coverage of you, subject to the terms and conditions of such policy and with limits customary for similarly situated companies.
4. Termination . The Employment Period will end on the fifth anniversary of the date hereof (the “ Expiration Date ”), unless sooner terminated as provided below. Unless the Employment Period has been terminated in accordance with the following sentence of this Article 4, commencing with the one-year anniversary hereof, and on each subsequent annual anniversary thereafter, the Expiration Date shall automatically be extended by one additional year, such that, on any given day during the Employment Period, the remaining Employment Period shall never be less than four years and one day. Notwithstanding the foregoing, the Employment Period will (i) will terminate upon your death, (ii) may be terminated by the Company upon Notice of Termination (as defined in Section 5(e) below) delivered to you as a result of your Disability (as defined in Section 5(g) below), (iii) may be terminated by the Company at any time for Cause (as defined in Section 5(f) below) or without Cause and (iv) may be terminated by you for Good Reason.
5. Severance .
(a) If the Employment Period is terminated by the Company without Cause or by you for Good Reason (as defined in Section 5(h) below), you will be entitled to receive (i) your Base Salary as in effect at the time of such termination to the extent such amount has accrued through the Termination Date (as defined in Section 5(e) below) and remains unpaid, (ii) any fully earned and declared but unpaid Performance Bonus as of the Termination Date, (iii) an amount equal to the sum of Base Salary you would have received from the date of such termination through the then applicable Expiration Date, which shall be payable in the same amounts and at the same intervals as if the Employment Period had not ended and (iv) any unpaid Expenses as of the Termination Date. Upon delivery of the payments and benefits described in this Section 5(a), the Company shall have no further obligation to you under this letter agreement or otherwise with respect to your employment with the Company. The Company’s obligation to make the payments to you described in clause (iv) of this Section 5(a) is conditioned upon your executing and delivering, no later than 14 days following the Termination Date, a release relating to your employment by the Company in favor of the Company, its Affiliates and their respective stockholders, officers, members, managers, directors, employees, subsidiaries and affiliates substantially in the form attached as Exhibit A .
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(b) If the Employment Period is terminated by the Company for Cause or by you other than for Good Reason, the Company will pay you (i) your Base Salary as in effect at the time of such termination to the extent such amount has accrued through the Termination Date and remains unpaid, (ii) any fully earned and declared but unpaid Performance Bonus as of the Termination Date, and (iii) any unpaid Expenses as of the Termination Date. Upon delivery of the payment described in this Section 5(b), the Company will have no further obligation to you under this letter agreement or otherwise with respect to your employment with the Company.
(c) If the Employment Period is terminated upon your Disability (as defined in Section 5(g) below) or death, the Company will pay you or your estate or succession, whichever is applicable, (i) your Base Salary as in effect at the time of such termination to the extent such amount has accrued through the Termination Date and remains unpaid, (ii) any fully earned and declared but unpaid Performance Bonus as of the Termination Date, and (iii) any unpaid Expenses as of the Termination Date.
(d) Except as otherwise required by law or as specifically provided herein, all of your rights to salary, severance, fringe benefits, bonuses and any other amounts hereunder (if any) accruing after the termination of the Employment Period will cease upon the earlier of the date of such termination and your last day of active service. In the event the Employment Period is terminated, your sole remedy, and the sole remedy of your successors, assigns, heirs, representatives and estate, will be to receive the payments described in this letter agreement.
(e) Any termination of the Employment Period by the Company (other than termination upon your death) or by you must be communicated by written notice (in either case, a “ Notice of Termination ”) to you. For purposes of this letter agreement, “ Termination Date ” means (i) if the Employment Period is terminated by your death, the date of your death, (ii) if the Employment Period is terminated upon your Disability, by the Company or by you, the date specified in the Notice of Termination (which may not be earlier than the date of such Notice). Notwithstanding anything contained herein to the contrary, any termination of the Employment Period by you must be communicated to the Company no less than 30 days prior to the intended Termination Date.
(f) For purposes of this letter agreement, “ Cause ” means any one of the following: (i) a breach by you of this letter agreement, (ii) your conviction of, guilty plea to, or confession of guilt of, a felony involving the Company, (iii) materially fraudulent, dishonest or illegal conduct by you in the performance of services for or on behalf of the Company or any of its Affiliates, (iv) any conduct by you in material violation of Company policy, (v) any conduct by you that is materially detrimental to the reputation of the Company or any of its Affiliates, (vi) your misappropriation of funds of the Company or any of its Affiliates, (vii) your gross negligence or wilful misconduct or wilful failure to comply with written directions of the Board which directions are within the scope of your duties hereunder, (viii) your engaging in conduct involving an act of moral turpitude, or (ix) a breach of your duty of loyalty to the Company or its Affiliates.
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(g) For purposes of this letter agreement “ Disability ” means any accident, sickness, incapacity or other physical or mental disability which prevents you from performing substantially all of the duties you have been assigned by the Company or any of its subsidiaries for either (i) 90 consecutive days or (ii) 120 days during any period of 365 consecutive days, in each case as determined in good faith by a physician selected by the Board. During the time periods specified above, the Company will continue to provide you with the compensation stated in Section 3 above.
(h) For purposes of this letter agreement, “ Good Reason ” means the failure of the Company to make all payments due you under this letter agreement and the continuation thereof for more than five calendar days after notice to the Company of such failure and demand for such outstanding payment(s).
6. Confidential Information .
(a) You will not disclose or use at any time any Confidential Information (as defined below in Section 6(c)), whether or not such information is developed by you, except to the extent that such disclosure or use is required in the performance or exercise by you in good faith of (i) duties assigned to you under this letter agreement or otherwise by the Board, (ii) rights as an employee, officer, director or shareholder of the Company or any of its Affiliates or (iii) rights under any agreement with the Company or any Affiliates.
(b) You will deliver to the Company at the termination of the Employment Period, or at any time the Company may request, all memoranda, notes, plans, designs, records, reports, computer files and software and other documents and data (and copies thereof) that are Confidential Information or Work Product (as defined below) or information relating to the business of the Company or its Affiliates which you may then possess or have under your control.
(c) As used in this letter agreement, the term “ Confidential Information ” means information that is not generally known or available to the public and that is used, developed or obtained by the Company or any Affiliate in connection with its or their businesses, including but not limited to (i) information, observations and data concerning the business or affairs of the Company or its affiliates, (ii) products or services, (iii) fees, costs and pricing structures, (iv) designs, (v) analyses, (vi) drawings, designs, photographs, artwork and reports, (vii) computer software, including operating systems, applications and program listings, (viii) flow charts, manuals and documentation, (ix) data bases, (x) accounting and business methods, (xi) inventions, devices, new developments, methods and processes, whether patentable or unpatentable and whether or not reduced to practice, (xii) other copyrightable works, (xiii) all production methods, processes, technology and trade secrets, (xiv) Company product and product candidate formulae and any trade secrets with respect to such products and product candidates and (xv) all similar and related information in whatever form.
(d) Notwithstanding the provisions of this letter agreement to the contrary, you will have no liability to the Company for disclosure of Confidential Information if the Confidential Information:
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(A) is in the public domain or becomes publicly known in the industry in which the Company operates or is disclosed by the Company other than as the result of a breach of this letter agreement or any other agreement by you; or
(B) is required to be disclosed by law, court order, or similar compulsion or in connection with any legal proceeding; provided however , that such disclosure will be limited to the extent so required and, subject to the requirements of law, you will give the Company notice of your intent to so disclose such Confidential Information and will cooperate with the Company in seeking confidentiality protections.
7. Inventions and Patents . You agree that all inventions, innovations, improvements, technical information, trade secrets, systems, software developments, ideas, results, methods, designs, artwork, analyses, drawings, reports, copyrights, service marks, trademarks, trade names, logos and all similar or related information (whether patentable or unpatentable) which relate to the Company’s or any of its Affiliates’ businesses, research and development or existing products (or products under development) or services and which are conceived, developed or made by you (whether or not during usual business hours and whether or not alone or in conjunction with any other person) during your employment with the Company, together with all intellectual property rights therein, including, but not limited to, any patent applications, letters patent, trademark, trade name and service mark applications or registrations, copyrights and reissues thereof that may be granted for or upon any of the foregoing, but only with respect to the treatment of cancer in humans (collectively referred to herein as “ Work Product ”), is the exclusive property of the Company and/or its Affiliates. For the avoidance of doubt and without limiting the foregoing, (x) the Company or any of its Affiliates shall be the sole owner of all right, title and interest in such Work Product, including all intellectual property rights relating to such Work Product, without you retaining any license or other residual right whatsoever, and (y) any rights to any new or an existing Work Product are automatically conveyed, assigned and transferred to the Company pursuant to this agreement. You hereby waive and renounce to all moral rights related, directly or indirectly, to any such existing or new Work Product. You will take reasonable steps to promptly disclose such Work Product to the Board and perform all actions reasonably requested by the Board (whether during or after the Employment Period) to establish and confirm such ownership (including the execution and delivery of assignments, consents, powers of attorney and other instruments) and to provide reasonable assistance to the Company and its Affiliates in connection with the prosecution of any applications for patents, trademarks, trade names, service marks or reissues thereof or in the prosecution or defense of interferences relating to any Work Product.
8. Non-Compete; Non-Solicitation; Non-Disparagement .
(a) You acknowledge that, in the course of your employment with the Company, you will become familiar with the Company’s and its Affiliates’ trade secrets and with other Confidential Information concerning the Company and its Affiliates and that your services will be of special, unique and extraordinary value to the Company and its Affiliates. Therefore, you agree that, during the Restriction Period (as defined in Section 8(b) below), you will not (x) anywhere the Company or any of its Affiliates conducts business or (y) anywhere the Company or any of its Affiliates has spent time and resources in connection with expanding its business, directly or indirectly, either on your own behalf or on behalf of any other person, firm or entity:
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(A) own, manage, operate, consult with, provide financing to, or join, control or participate in the ownership, management, operation or control of, or the provision of financing to, any business wherever located (whether in corporate, proprietorship or partnership form or otherwise), if such business is competitive with the business of the Company; or
(B) say anything which is harmful to the reputation of the Company or any of its Affiliates or which could be reasonably expected to lead any person to cease to deal with the Company or any of its Affiliates on substantially equivalent terms to those previously offered or at all.
(b) For purposes of this letter agreement, “ Restriction Period ” means (i) during the Employment Period, and for a period of two years following your receipt of the final payment described in Article 5, as applicable.
(c) Nothing in Section 8(a) will prohibit you from being a passive owner of not more than 2% of the outstanding stock of a publicly-traded corporation, so long as you have no active participation in the business of such corporation.
(d) During the Restriction Period, you will not:
(A) induce or attempt to induce any customer, supplier or other business relation of the Company or any of its affiliates to cease doing business with the Company or any of its Affiliates, or in any way interfere with the relationship between any such customer, supplier or business relation, on the one hand, and the Company or any Affiliates, on the other hand; or
(B) engage, employ, solicit or contact with a view to the engagement or employment of, any employee, officer or manager of, or full-time consultant to, the Company or any Affiliates or any person who has been an employee, officer or manager of, or consultant to, the Company or any Affiliates at any time during the two-year period ending on the date of such determination.
(e) The Company, on behalf of itself and all Affiliates, agrees that during the Restriction Period they and their executive officers (or other persons acting on their behalf) will not say anything which is harmful to your reputation or which could be reasonably expected to lead any person to cease to deal with you or engage you in any consulting or employment position.
9. Enforcement .
(a) Because the employment relationship between you and the Company is unique and because you have access to Confidential Information and Work Product, you agree that money damages would be an inadequate remedy for any breach of Section 6, 7 or 8 of this letter agreement. Therefore, in the event of a breach or threatened breach of Section 6, 7 or 8 of this letter agreement, the Company may, in addition to its other rights and remedies, apply to any court of competent jurisdiction for specific performance and/or injunctive or other relief in order to enforce, or prevent any violations of, such provisions (without posting a bond or other security).
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(b) Sections 6, 7, 8 and 9 of this letter agreement will expressly survive termination of this agreement. The existence of any claim or cause of action by you against the Company and/or any of its Affiliates shall not constitute a defense to the enforcement by the Company of the covenants contained in this Articles 6, 7 or 8, but such claim or cause of action shall be litigated separately.
10. Notices . All notices, requests, demands, claims, and other communications hereunder will be in writing. Any notice, request, demand, claim or other communication hereunder will be deemed duly given (i) upon delivery, if delivered personally to the recipient, against written receipt therefor, or (ii) upon the first business day after the date sent, if sent priority next-day delivery to the intended recipient by reputable express courier service (charges prepaid) and addressed to the intended recipient as set forth below:
If to the Company, to:
Steven Hoffman, Chief Executive Officer
Tyme Technologies, Inc.
48 Wall Street – Suite 1100
New York, New York 10005
and with a copy to:
Moritt Hock & Hamroff LLP
450 Seventh Avenue, 15 th Floor
New York, New York 10123
Attention: Keith S. Braun, Esq.
If to you, to the address shown on the first page.
Any party hereto may send any notice, request, demand, claim or other communication hereunder to the intended recipient at the address set forth above using any other means, but no such notice, request, demand, claim or other communication will be deemed to have been duly given unless and until it actually is received and acknowledged by the intended recipient. Any party hereto may change the address (or add new parties and their addresses) to which notices, requests, demands, claims, and other communications hereunder are to be delivered by giving the other parties hereto notice in the manner set forth in this Section 10.
11. Representations and Warranties . You hereby represent and warrant to the Company that (a) the execution, delivery and performance of this letter agreement by you does not and will not conflict with, breach, violate or cause a default under any agreement, contract or instrument to which you are a party or any judgment, order or decree to which you are subject, (b) you are not a party to or bound by any employment agreement, consulting agreement, non-compete agreement, confidentiality agreement or similar agreement with any other person or entity that is inconsistent with the provisions of this letter agreement, (c) upon the execution and
- 7 -
delivery of this letter agreement by the Company and you, this letter agreement will be a valid and binding obligation of you and (d) you are in good health and are not suffering from, and have never suffered from, any serious illness, disease or other physical or mental condition that has prevented or materially interfered with, or might reasonably be expected in the future to prevent or materially interfere with, your ability to perform those services described in this letter agreement. The Company hereby represents and warrants to you that (i) the execution, delivery and performance of this letter agreement by the Company does not and will not conflict with, breach, violate or cause a default under any agreement, contract or instrument to which it is a party or any judgment, order or decree to which it is subject and (ii) upon the execution and delivery of this letter agreement by the Company and you, this agreement will be a valid and binding obligation of the Company.
12. General Provisions .
(a) Severability . It is the desire and intent of the parties hereto that the provisions of this letter agreement be enforced to the fullest extent permissible under the laws and public policies applied in each jurisdiction in which enforcement is sought. Accordingly, if any particular provision of this letter agreement will be adjudicated by a court of competent jurisdiction to be invalid, prohibited or unenforceable for any reason, such provision, as to such jurisdiction, will be ineffective, without invalidating the remaining provisions of this agreement or affecting the validity or enforceability of this letter agreement or affecting the validity or enforceability of such provision in any other jurisdiction. Notwithstanding the foregoing, if such provision could be more narrowly drawn so as not to be invalid, prohibited or unenforceable in such jurisdiction, it will, as to such jurisdiction, be so narrowly drawn, without invalidating the remaining provisions of this letter agreement or affecting the validity or enforceability of such provision in any other jurisdiction.
(b) Complete Agreement . This letter agreement and any schedules or exhibits expressly constitute the entire agreement among the parties hereto with respect to the subject matter hereof and supersedes and preempts any prior understandings, agreements or representations by or among the parties, written or oral, which may have related to the subject matter hereof in any way.
(c) Successors and Assigns . Except as otherwise provided herein, this letter agreement will be binding upon and inure to the benefit of you and the Company and our respective successors, permitted assigns, personal representatives, heirs and estates, as the case may be; provided , however , that your rights and obligations under this letter agreement will not be assigned without the prior written consent of the Company.
(d) Governing Law . This letter agreement will be governed by and construed in accordance with the domestic laws of New York, without giving effect to the choice of law provisions thereof. The parties agree that the exclusive venue for all disputes under this agreement shall be the federal and state courts sitting in New York County, New York.
(e) Amendment and Waiver . The provisions of this letter agreement may be amended and waived only with the prior written consent of the Company (with the approval of the Board) and you, and no course of conduct or failure or delay in enforcing the provisions of this letter agreement will affect the validity, binding effect or enforceability of this letter agreement or any provision hereof.
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(f) Headings . The section headings contained in this agreement are inserted for convenience only and will not affect in any way the meaning or interpretation of this agreement.
(g) Counterparts . This letter agreement may be executed in counterparts, each of which will be deemed an original and all of which together will constitute one and the same instrument.
(h) 409A Provision . For purposes of this letter agreement the term “ termination of employment ” and similar terms relating to your termination of employment mean a “ separation from service ” as that term is defined under Section 409A of the Internal Revenue Code of 1986, as amended, and the final regulations issued thereunder (“ Section 409A ”). The Company and you intend that this letter agreement comply in form and operation with the requirements of Section 409A. To the extent permitted by applicable Department of Treasury/Internal Revenue Service guidance, or law or regulation, the Company and you will take reasonable actions to reform this letter agreement or any actions taken pursuant to their operation of this letter agreement in order to comply with Section 409A.
[signature page follows]
- 9 -
If this letter agreement correctly expresses our mutual understanding, please sign and date a copy of this letter agreement and return it to us.
Very truly yours,
Tyme Technologies, Inc.
By: /s/ Steven Hoffman
Name: Steven Hoffman
Title: Chief Executive Officer
The terms of this letter agreement are accepted and agreed to
on March 5, 2015 by:
/s/ Michael Demurjian
Michael Demurjian
- 10 -
EXHIBIT A
Form of Release
RELEASE
This Release is delivered by Michael Demurjian on this __ day of _________, 20__.
DEFINITIONS
A. As used herein, unless otherwise specified, the term “Employer” shall mean Tyme Technologies, Inc., and all of its affiliates, successors, predecessors, assigns, parents, subsidiaries, divisions (whether incorporated or unincorporated), and all of its and their past and present owners, directors, officers, trustees, shareholders, managers, employees and agents (in their individual and representative capacities).
B. As used herein, unless otherwise specified, the term “Employee” shall mean Michael Demurjian and all of his heirs, family members, executors, accountants, administrators, attorneys, agents, assigns, successors and representatives.
RECITALS
WHEREAS, Employee’s employment ended on ___________, 20__; and
WHEREAS, it is a condition to the Employee’s receipt of certain post-employment benefits (“Conditional Benefits”) under the Employment Agreement, dated as of ____________, 2014 (the “Employment Agreement”), between Employee and Employer that Employee execute this Release.
NOW THEREFORE, in consideration of the promises, representations and mutual covenants contained in this Release, and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, it is agreed as follows:
1. Consideration . Employee acknowledges that the Conditional Benefits are in excess of any earned wages or benefits due and owing Employee, and would not be paid or provided unless Employee executed this Release. Employee acknowledges and agrees that the Conditional Benefits are adequate and independent consideration for Employee executing this Release and releasing any and all claims against Employer.
2. Release of All Claims . In consideration of the above, and the other promises set forth in this Release, Employee fully and forever waives, releases, acquits and discharges Employer from and for all manner of claims, actions, suits, charges, grievances and/or causes of action, in law or in equity, existing by reason of and/or based upon any fact or set of facts, known or unknown, existing from the beginning of time through the effective date of this Release relating to and/or arising out of the Employment Agreement, Employee’s employment with Employer and/or the cessation of Employee’s employment with Employer (collectively, the “Released Claims”), including, but not limited to, all claims, actions, suits, charges, grievances and/or causes of action for wages,
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compensation, liquidated damages, commissions, bonuses, benefits, sums of money, damages of every type, costs, attorney fees, judgments, executions, wrongful discharge, breach of contract, breach of implied contract, breach of the covenant of good faith and fair dealing, tortious interference with contract or business relationships, assault, battery, invasion of privacy, misappropriation of trade secrets, promissory estoppel, unjust enrichment, loss of consortium, violation of the penal statutes, negligent or intentional infliction of emotional distress, negligence, defamation, retaliation and/or discrimination and/or harassment on account of age, sex, sexual orientation, creed, religion, race, color, national origin, sensory disability, mental disability, physical disability, veteran or military status, marital status, or any other classification recognized under all applicable discrimination laws, or any other claim or cause of action, which has or could have been alleged under the common law, civil rights statutes, Title VII of the Civil Rights Act of 1964 (“Title VII”), the Age Discrimination in Employment Act (“ADEA”), the Family and Medical Leave Act (“FMLA”), the Employee Retirement Income Security Act (“ERISA”), the Rehabilitation Act of 1973, the Older Workers Benefits Protection Act (“OWBPA”), the Americans with Disabilities Act (“ADA”), The Consolidated Omnibus Budget Reconciliation Act (“COBRA”), the Workers Adjustment Retraining Notification Act (“WARN”), the Equal Pay Act (“EPA”), the Uniformed Services Employment and Reemployment Rights Act (“USERRA”), the National Labor Relations Act (“NLRA”), any and all federal, state, local statutes, ordinances, and laws, and every type of relief, (legal, equitable and otherwise) available to Employee. Employee covenants and agrees that he will not pursue or allege any claim, matter or cause of action in violation of, and/or released under, this Release. Nothing in this Release shall be construed as releasing Employer from its obligation to pay those amounts due to Employee under Section 5(a) of the Employment Agreement, subject to the terms and conditions thereof, which obligation is not a Released Claim.
3. Covenant Not to Sue . Employee represents that he has not filed any action, charge, suit, or claim against Employer with any federal, state or local agency or court relating to any Released Claim. Employee further agrees that should any claims, charges, complaints, suits or other actions be filed hereafter on his behalf by any federal, state or local agency or by any other person or entity with respect to a Released Claim, he will immediately withdraw with prejudice, or cause to be withdrawn with prejudice, and/or dismiss with prejudice, or cause to be dismissed with prejudice, any such claims, charges, complaints, suits or other actions filed against Employer. Employee further agrees that, to the fullest extent permitted by law, Employee shall receive no relief of any type (monetary, equitable, or otherwise) with respect to, relating to and/or on account of any such claims, matters or actions. Employee agrees to opt-out of any class action or collective action filed against Employer to the extent related to a Released Claim.
4. Confidentiality . To the fullest extent permitted by law, Employee agrees to keep confidential all facts, opinions, and information which relate in any way to Employee’s employment and/or cessation of employment with Employer, as well as the terms of this Release; provided however , Employee may discuss the terms of this Release with his spouse, legal representative, and/or tax preparer, each of whom must also agree to maintain confidentiality and comply with this Paragraph 4 of the Release.
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5. Return of Employer’s Property . Employee represents that he has returned to Employer any and all property, records, papers, documents and writings, in whatever form, of Employer in Employee’s possession and/or control, and that he has not retained any copies thereof, in whatever form.
6. Cooperation .
(a) To the fullest extent permitted by law, Employee will not cooperate with, or assist in, any claim, charge, lawsuit, or arbitration against Employer with respect to a Released Claim, unless required to do so by a lawfully issued subpoena, by court order or as expressly provided by regulation or statute. In the event Employee is served with a subpoena or is required by court order or otherwise to testify in any type of proceeding involving the Employer and related to a Released Claim, Employee shall immediately advise Employer in writing of same.
(b) Employee agrees to cooperate with Employer in any internal investigation, administrative, regulatory, or judicial proceeding or any dispute with a third party. Employee’s cooperation may include being available to Employer upon reasonable notice for interviews and factual investigations, appearing at Employer’s request to give testimony without requiring service of a subpoena or other legal process, volunteering to Employer pertinent information, and turning over to Employer all relevant documents which are or may come into Employee’s possession. Employee understands that in the event Employer asks for Employee’s cooperation in accordance with this provision, Employer will reimburse him/her for reasonable travel expenses (including lodging and meals) upon submission of receipts acceptable to Employer.
7. ADEA Notice and Acknowledgement . Employee acknowledges that he has carefully read this Release and fully understands its contents. Prior to signing this Release, Employee has been advised in writing hereby and has had an opportunity to consult with his attorney of choice concerning the terms and conditions of this Release with regard to any claim or right Employee may have under the ADEA or otherwise. Employee has been offered at least 21 days to review and consider this Release. Employee may voluntarily and knowingly waive this 21 day period, or any part thereof, if he signs this Release prior to the expiration of 21 days. After signing this Release, Employee shall have seven days from the signing date to revoke this Release. This Release shall not be effective (including for purposes under the Employment Agreement) until after the seven day revocation period has expired. Any revocation must be made in writing and delivered to the Chief Executive Officer and Chief Financial Officer of the Employer. Until all applicable periods set forth in this Section 7 have expired, Employer shall not be required to make any payment to Employee which payment is, under the Employment Agreement, contingent upon the signing and delivery to the Company of this Release. By signing this Release, Employee agrees and understands that he is waiving and releasing any and all rights he may have to pursue claims against Employer, from the beginning of time up to the effective date of this Release, including, without limitation, all ADEA claims.
8. Governing Law . New York law shall govern this Release, without giving effect to any choice of law or conflict of law provision or rule (whether of the State of New York or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of New York.
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10. Successors and Assigns . This Release shall be inure to the benefit of the successors and assigns of Employer.
11. Severability . If any portion of this Release is ruled unenforceable, all remaining portions of this Release shall remain valid.
12. No Reliance; No Waiver . Employee represents that he is not relying on any representation, statement, or promise of Employer or any other party in giving this Release. This Release may not be amended, modified, waived, or terminated except in a writing signed by Employee and an authorized representative of Employer.
13. Headings . The paragraph and section headings in this Release are inserted merely for the convenience of reference only and shall not be used to construe, affect or modify the terms of any paragraph or provision of this Release.
EMPLOYEE WITHOUT ANY DURESS OR COERCION FREELY, KNOWINGLY AND VOLUNTARILY ENTERS INTO, AND GIVES THIS RELEASE. EMPLOYEE UNDERSTANDS AND AGREES WITH ALL OF THE PROVISIONS AND THE TERMS STATED IN THIS RELEASE AND HAS BEEN AFFORDED SUFFICIENT AND REASONABLE TIME TO CONSIDER WHETHER TO ENTER INTO THIS RELEASE. EMPLOYER ADVISES EMPLOYEE TO CONSULT WITH AN ATTORNEY OF EMPLOYEE’S CHOOSING PRIOR TO EXECUTING THIS RELEASE WHICH CONTAINS A RELEASE AND WAIVER.
______________________________
Michael Demurjian
______________________________
Date
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1.
|
Services. |
|
1.1
|
Generally
.
Consultant agrees to provide Tyme with the Services set forth in
Exhibit A
(the “
Services
”). Consultant agrees that Consultant will, from time to time during the term of this Agreement or any extension thereof, keep Tyme advised as to Consultant’s progress in performing the Services under this Agreement. Consultant also agrees that Consultant will, as reasonably requested by Tyme, prepare written reports with respect to such progress as described in Exhibit A.
|
|
1.2
|
Authority.
Consultant shall be entitled to represent to third parties, including potential investors or subject matter experts that he serves as a consultant to Tyme and, if so instructed in writing by an appropriate officer of Tyme, is authorized to enter into discussions with such third parties on Tyme’s behalf to the extent so specifically authorized. However, Consultant shall not have the authority to make any commitments or enter into any agreements whatsoever on behalf of Tyme or bind Tyme in any way.
|
|
1.3
|
Access to Consultant.
Consultant agrees that all Services, unless otherwise approved by Tyme, shall be performed by Raghuram Selvaraju (“
Selvaraju
”).
|
1 |
|
1.4
|
Warranty
.
Consultant warrants to Tyme that: (i) the Services will be performed in a professional and workmanlike manner and that none of such Services or any obligation of Consultant under this Agreement is inconsistent with any obligation Consultant has or may have to others; (ii) Consultant shall comply with all applicable laws and regulations in the course of performing the Services; and (iii) if Consultant’s work requires a license, Consultant has obtained that license and the license is in full force and effect. Consultant certifies that Consultant has no outstanding agreement or obligation that is in conflict with any of the provisions of this Agreement or that would preclude Consultant from complying with the provisions of this Agreement. Consultant will not enter into any such conflicting agreement during the term of this Agreement.
|
|
1.5
|
Effective Date
. Notwithstanding anything to the contrary contained in this Agreement or the date of this Agreement, this Agreement, and the provision of services hereunder and obligation to compensate Consultant hereunder, shall commence as of the date (the “
Effective Date
”) on which the merger (the “
Merger
”) of Tyme Acquisition Corp., a Delaware corporation and wholly-owned subsidiary of Tyme, with and into Tyme Inc., a Delaware corporation (“
TI
”), is made effective by the filing with the Delaware Secretary of State of a certificate of merger with respect to the Merger;
provided
that the Board of Directors of Tyme shall have approved this Agreement and the issuance of the shares of Common Stock constituting the Stock Retainer (as such capitalized terms are defined below) prior to the filing of such certificate of merger.
|
2.
|
Compensation . |
|
2.1
|
Fees
.
In consideration of the Consultant’s performance of the Services, Tyme agrees to pay Consultant a monthly retainer of eight thousand three hundred thirty-three and 34/100 dollars ($8,333.34), payable in advance via wire transfer or direct deposit commencing on the first business day following the Effective Date and thereafter on the same calendar day of each calendar month for the remainder of the Term (unless such day shall not be a Business Day; in which event, payment shall be made on the next succeeding Business Day) (the “
Cash Retainer
”). In addition, Tyme shall provide to Consultant a one-time issuance of 250,000 shares of the common stock, par value $0.0001 per share (the “Common Stock”), of Tyme (the “
Stock Retainer
”). Consultant acknowledges and agrees that none of such shares of Common Stock shall be issued pursuant to an effective registration statement and, as such, the shares shall be deemed “restricted securities” within the meaning of such term under Rule 144 promulgated under the Securities Act of 1933, as amended (the “
Securities Act
”). Notwithstanding anything to the contrary contained herewith, Tyme agrees to include all of the shares constituting the Stock Retainer in the registration statement Tyme will be required to file with the Securities and Exchange Commission pursuant to the subscription
|
2 |
|
agreement(s) Tyme will enter into in connection with the private placement Tyme is conducting and which shall close simultaneously with the consummation of the Merger (but subject to the same limitations and claw backs as the shares being sold in such private placement). The Cash Retainer and Stock Retainer are designed to cover Consultant’s time spent assessing materials related to specific life sciences projects, interacting with various industry professionals and in contact with Tyme stockholders and potential investors, as and when appropriate, and in providing the Services. Tyme shall be entitled to reclaim from Consultant an amount equal to the profit realized by Consultant with respect to the shares of Common Stock issued to Consultant as the Stock Retainer which Consultant sells or otherwise transfers within twelve (12) months of the Effective Date (such profit being equal to (A) the positive difference between the price per share of the shares actually sold and $3.00
multiplied
by (B) the number of shares sold by Consultant during such twelve (12) month period). In furtherance of the foregoing, for so long as the shares of Common Stock constituting the Stock Retainer are not registered for resale under an effective Securities Act registration statement, Tyme shall be entitled to place a legend on each stock certificate evidencing the shares of Common Stock constituting the Stock Retainer to the effect that the shares evidenced thereby have not been registered under the Securities Act and may not be transferred absent registration under the Securities Act or an applicable exemption from the registration requirements of the Securities Act (
i.e.,
a standard “restricted securities” legend). Consultant represents and warrants that Consultant is an “Accredited Investor” as such term is defined in Rule 501(a) promulgated under the Securities Act. Consultant will be responsible for all necessary tax payments, withholding, and the like with respect to all amounts (cash and Common Stock) paid by Tyme to Consultant under this Agreement. Consultant agrees to indemnify and hold harmless Tyme from any and all claims made by any entity on account of an alleged failure by Consultant to satisfy any tax, withholding, or similar obligation arising in connection with the Services. Consultant shall invoice Tyme for reasonable costs incurred (materials, lodging and/or transportation expenses) in performing any actual Services as described in Exhibit A. All proposed costs shall be subject to review of all relevant documentation and prior approval by Tyme in order to be reimbursable by Tyme. Payment will be due within thirty (30) days of the receipt of an invoice containing such reimbursable costs. If Tyme disputes any invoice amount, it shall pay the undisputed amount and notify the Consultant in writing within twenty (20) days of receipt of such invoice of the dispute. The parties to this Agreement shall cooperate to resolve the dispute and, upon resolution, Tyme shall pay such amounts with no interest or penalty, if paid within ten (10) days of resolution or the issuance of an arbiter’s award. The Federal short-term interest rate under Section 1274(d) of the Internal Revenue Code of 1986, as amended (the “Code”), in effect on the date of resolution or arbiter’s award shall apply to any and all
|
3 |
|
amounts not paid after such ten-day grace period.
|
|
2.2
|
Limitation of Liability
.
Tyme’s sole monetary obligation under this Agreement shall be to pay the Consultant for the Services as set forth in Paragraph 2.1 herein. In no event shall Tyme be liable to the Consultant and/or any other third party for any other payment and/or damage whatsoever incurred in connection with and/or arising out of this Agreement or otherwise, including, but not limited to, loss of profits, incidental, indirect, consequential, punitive or exemplary damages of any kind, even if Tyme has been advised of the possibility of such damages.
|
|
2.3
|
Up-Front Cash Retainer Payment
.
Notwithstanding the fact that the Effective Date may not have occurred as of the date of this Agreement, upon the execution of this Agreement by both Consultant and Tyme, TI shall, on behalf of Tyme, make a payment to Consultant of the sum of ten thousand ($10,000), which amount shall be credited against the first (in full) and second (in remaining part) payments of the Cash Retainer payable to Consultant under paragraph 2.1 above.
|
3.
|
Term
and Termination.
|
|
3.1
|
Term
.
The term of this Agreement shall commence on the Effective Date and continue for one year thereafter (the “
Term
”), unless earlier terminated pursuant to this Article 3.
|
|
3.2
|
Termination
.
Either party may terminate this Agreement for any reason upon thirty (30) days prior written notice to the other party;
provided
,
however
, that the obligation of Tyme to pay the Cash Retainer shall terminate immediately upon the death or permanent and total disability (as such term is defined in Section 22(e)(3) of the Code) of Selvaraju.
|
|
3.3
|
Effect of Termination
.
Upon termination or expiration of this Agreement, all rights of the parties under this Agreement shall immediately cease (except with respect to those provisions of the Agreement which, by their nature, survive termination), including any right to receive additional Cash Retainer for periods following the effective date of such termination or expiration and Consultant shall within ten (10) days deliver and return to Tyme any Developments or Confidential Information in his possession or control and certify same in writing to Tyme. Upon the termination of this Agreement, or upon Tyme’s earlier request, Consultant will deliver to Tyme all of Tyme’s property, including, but not limited to all electronically stored information and passwords to access such property, or Confidential Information that Consultant may have in Consultant’s possession or control.
|
4 |
4.
|
Proprietary Rights.
|
|
4.1
|
Definitions
.
|
|
(i)
|
“
Business
” means the business of Tyme, involving TI and any other subsidiary, direct or indirect, of Tyme, as conducted by Tyme, TI or any other TI subsidiary, direct or indirect, during the term of this Agreement or as planned to be conducted by Tyme pursuant to a product or business plan developed during the term of this Agreement.
|
|
(ii)
|
“
Technology
” refers to the know-how, data and information
associated with any Tyme and/or TI corporate client focusing on the life sciences domain
.
|
|
(iii)
|
“
Confidential Information
” means any information provided by Tyme and/or TI to Consultant in connection with this Agreement and/or Consultant’s work with Tyme, whether orally or in writing, except to the extent such information (i) is available in the public domain; (ii) is independently developed by Consultant without access to or use of any Confidential Information; or (iii) is lawfully obtained by Consultant from a third party without violation of a confidentiality obligation to Tyme. “Confidential Information” includes, without limitation, any Developments.
|
|
(iv)
|
“
Developments
” means any work product, including designs, business plans, correspondence (printed or electronic), inventions, improvements, software, works of authorship, information, know-how, or other materials made, conceived, reduced to practice or developed in whole or in part by Consultant during the term of this Agreement in connection with the Services or that relate to the Confidential Information or the Business.
|
|
(v)
|
“
Intellectual Property Right(s)
” means all forms of intellectual property rights including, without limitation, patents, trademarks, copyrights, mask rights, trade secrets and proprietary know-how related to or covering Property.
|
|
4.2
|
Ownership of Intellectual Property
.
Consultant and Tyme intend for this to be a contract for Services to by rendered by the Consultant hereunder (the “
Work
”) to be a work made for hire. Tyme shall own all right, title and interest in and to the Developments, and shall be deemed to be the author of the Developments for copyright purposes. Any and all Intellectual Property Rights therein resulting directly from the work done by Consultant under the scope of this Agreement shall be owned by Tyme and may be registered exclusively in the name of Tyme in the U.S. Copyright Office, the U.S. Patent and Trademark Office, and other similar registries in other
|
5 |
|
countries.
|
|
4.3
|
Confidential Information
.
Consultant agrees not to disclose any Confidential Information to any third party, except to parties designated by Tyme as being party to a confidentiality agreement with Tyme (provided Consultant complies with all procedures required under any such confidentiality agreement) or as may be expressly authorized in writing by Tyme, and to use the same degree of care to protect the confidentiality of the Confidential Information and to prevent its unauthorized use or dissemination as Consultant uses to protect Consultant’s own confidential information of a similar nature. Consultant further agrees to use the Confidential Information only for purposes directly related to the performance of this Agreement. Upon request by Tyme, or termination or expiration of this Agreement, Consultant shall within ten (10) days, at Tyme’s sole option, either return to Tyme or destroy (including deletion from his computer storage systems) all Confidential Information. Consultant acknowledges that it will receive significant value and advantage as a result of the access to such Confidential Information, both old and new, which, if used improperly, would cause irreparable harm to Tyme and negatively impact the good will of Tyme.
|
|
4.4
|
Non–Competition
.
In consideration of Tyme’s retention of Consultant under this Agreement, disclosure to Consultant of the Confidential Information, and other valuable consideration, Consultant agrees that during the Term of this Agreement, and for a period of twelve (12) months thereafter, it shall not, directly or indirectly, do any of the following:
|
|
(i)
|
Start or establish an oncology-focused drug discovery/development company; nor
|
|
(ii)
|
Develop a technology or product that incorporates the essence of any of Tyme’s intellectual property.
|
|
4.5
|
Equitable Relief.
Consultant acknowledges that Tyme is entitled to obtain
|
6 |
|
an injunction or other equitable relief, without bond, from a court of competent jurisdiction against Consultant’s breach of the terms of any provision of this Article 4, in addition to any other legal or equitable remedies which may be available to Tyme.
|
|
4.6
|
Survival.
Consultant’s obligations under Article 4 shall survive the termination or expiration of this Agreement for any reason.
|
5.
|
Indemnification.
|
6.
|
Miscellaneous.
|
|
6.1
|
Independent Contractor
.
Consultant enters into this Agreement as an independent contractor. Nothing in this Agreement shall be construed as creating the relationship of joint ventures, partners, employer and employee, franchiser and franchisee, master and servant, or principal and agent. Consultant shall be solely responsible for all taxes, withholdings and other similar statutory obligations, including without limitation, Workers’ Compensation Insurance.
|
|
6.2
|
Parties in Interest, Assignment.
This Agreement shall be binding upon and inure to the benefit of the parties to this Agreement and their respective successors and assigns. Except as expressly provided in this Agreement, nothing contained in this Agreement is intended to confer upon any third party any rights, benefits or remedies of any kind or character whatsoever under or by reason of this Agreement. Consultant may not assign this Agreement or its obligations hereunder without obtaining the prior written consent of Tyme. However, Tyme, upon prior
|
7 |
|
written notice to Consultant, may assign this Agreement or any part of its rights or obligations hereunder to any of its affiliates, provided that the party receiving such assignment agrees to be bound by the terms and conditions of this Agreement.
|
|
6.3
|
Governing Law
.
This Agreement shall be governed in all respects by the laws of the United States of America and by the laws of the State of New York. Each of the parties irrevocably consents to the exclusive personal jurisdiction of the federal and state courts located in New York, New York, as applicable, for any matter arising out of or relating to this Agreement, except that in actions seeking to enforce any order or any judgment of such federal or state courts located in New York, such personal jurisdiction shall be nonexclusive.
|
|
6.4
|
Headings
.
All section headings are provided for convenience only, and shall not be used for purposes of construction of this Agreement.
|
|
6.5
|
Notices
.
Except where provided otherwise, notices hereunder shall be in writing and shall be deemed to have been fully given and received (i) when delivered in writing personally, against receipt therefor; (ii) five (5) business days after having been sent by registered or certified mail, return receipt requested, postage prepaid; or (iii) one (1) business day after deposit on a business day for next business day delivery with a commercial overnight carrier guaranteeing overnight delivery, with written verification of such receipt. All communications will be sent to the party’s address as set forth herein, or at such address as the parties may later specify in writing for such purposes.
|
|
6.6
|
Entire Agreement
.
This Agreement, including all exhibits or appendices, constitutes the entire agreement between the parties with respect to the subject matter hereof, and supersedes and replaces all prior and contemporaneous understandings or agreements, written or oral, regarding such subject matter. No amendment or modification of this Agreement will be binding unless in writing and signed by a duly authorized representative of both parties.
|
|
6.7
|
Counterparts.
This Agreement may be executed in one or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same agreement.
|
|
6.8
|
Dispute Resolution
.
The Parties agree to attempt to resolve any dispute under this Agreement amicably through negotiations. Nothing in this clause shall preclude any Party from commencing arbitration if said negotiations do not result in a signed written settlement agreement within sixty (60) days after written notice that these amicable resolution negotiations have commenced. Any dispute under this Agreement that cannot be resolved amicably shall be referred to and exclusively resolved by arbitration in accordance with the American Arbitration Association.
|
8 |
|
The arbitration shall be conducted in New York, New York, by a sole arbitrator. The arbitrator shall be appointed by mutual consent of the parties hereto. In the event that the parties fail to agree upon the arbitrator within fourteen (14) days of either party’s written notice with respect to the referral of a dispute to arbitration, the arbitrator shall be appointed by the American Arbitration Association. The arbitrator’s decisions shall be based upon the provisions of this Agreement. The arbitrator shall have no power or authority to make or issue orders of any kind except as permitted by this Agreement, and in no event shall the arbitrator have the authority to make any award that provides for punitive or exemplary damages. The decision of the arbitrator shall be final and binding on the parties, shall not be subject to appeal, and shall be enforceable in any competent court having jurisdiction. The arbitrator will have the authority to award reasonable attorney’s fees and costs to the prevailing party.
|
|
6.9
|
Severability
.
It is the desire and intent of the parties hereto that the provisions of this Agreement be enforced to the fullest extent permissible under the laws and public policies applied in each jurisdiction in which enforcement is sought. Accordingly, if any particular provision of this Agreement will be adjudicated by a court of competent jurisdiction to be invalid, prohibited or unenforceable for any reason, such provision, as to such jurisdiction, will be ineffective, without invalidating the remaining provisions of this Agreement or affecting the validity or enforceability of this Agreement or affecting the validity or enforceability of such provision in any other jurisdiction. Notwithstanding the foregoing, if such provision could be more narrowly drawn so as not to be invalid, prohibited or unenforceable in such jurisdiction, it will, as to such jurisdiction, be so narrowly drawn, without invalidating the remaining provisions of this Agreement or affecting the validity or enforceability of such provision in any other jurisdiction.
|
|
6.10
|
No Waiver
.
Failure to exercise, or any delay in exercising, any right or remedy provided under this agreement or by law shall not constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict any further exercise of that or any other right or remedy. No single or partial exercise of any right or remedy provided under this agreement or by law shall preclude or restrict the further exercise of that or any other right or remedy.
|
|
6.11
|
Business Day.
When used in this Agreement, the term “Business Day” shall mean any calendar day other than a Saturday, Sunday or other day on which commercial banks in New York City are required or authorized to be closed.
|
9 |
By:
|
/s/ Peter de Svastich
|
Name:
|
Peter de Svastich
|
Title:
|
President
|
By:
|
/s/ Raghuram Selvaraju
|
Name:
|
Raghuram Selvaraju
|
☐ | Assessment of likelihood of success, practicality of timelines, and costs for: | |||
o | Specific drug candidates | |||
o | Medical devices | |||
o | Diagnostics | |||
☐ | Market research: | |||
o | Market size (epidemiology and patient stratification) | |||
o | Current therapeutic / device-based / diagnostic options | |||
o | Current and future competitive landscape | |||
o | Reimbursement and pricing considerations | |||
o | Intellectual property protection | |||
☐ | Investor Relations: | |||
o | Field calls and respond to inquiries regarding Tyme and TI from stockholders and potential investors | |||
o Provide consultation services regarding press releases, stockholder and investor meetings and public dissemination of Tyme-approved information concerning Tyme and TI, as and to the extent requested by the chief executive and/or chief operating officers of Tyme | ||||
☐ | General corporate objectives: | |||
o | Public relations and outreach | |||
o | Key opinion leader outreach | |||
o | Overall marketability |
11 |
1 |
2 |
3 |
4 |
5 |
If to the Company: | ||||
Tyme Technologies, Inc.
|
||||
48 Wall Street - Suite 1100
|
||||
New York, NY 10005
|
||||
Attn: Steven Hoffman, President | ||||
Facsimile:
|
||||
with a copy to (which shall not constitute notice hereunder): | ||||
Keith S. Braun, Esq.
|
||||
Moritt Hock & Hamroff LLP | ||||
450 Seventh Avenue - 15 th Floor | ||||
New York, NY 10123 | ||||
Facsimile: 646-688-6096 | ||||
If to the Depositor: | ||||
c/o GEM Global Yield Fund LLC SCS | ||||
590 Madison Ave., 36th Fl. | ||||
New York, NY 10022 | ||||
Facsimile: 212-265-4035 | ||||
with a copy to (which shall not constitute notice hereunder): |
6 |
CKR Law LLP | |||
1330 Avenue of the Americas, 35 th Floor | |||
New York, NY 10019 | |||
Attn: Mark Crone | |||
Facsimile: 212-400-6901 | |||
If to the Escrow Agent: | |||
CKR Law LLP | |||
1330 Avenue of the Americas, 35 th Floor | |||
New York, NY 10019 | |||
Attn: Mark Crone | |||
Facsimile: 212-400-6901 |
7 |
8 |
9 |
COMPANY: | |||||
TYME TECHNOLOGIES, INC. | |||||
By: | /s/ Steven Hoffman | ||||
Name: | Steven Hoffman | ||||
Title: | President |
DEPOSITOR: | ||||
GEM GLOBAL YIELD FUND LLC SCS | ||||
By: | /s/ Christopher Brown | |||
Name: | Christopher Brown | |||
Title: | Manager |
ESCROW AGENT: | |||||
CKR LAW LLP | |||||
By: | /s/ Mark E. Crone | ||||
Name: | Mark E. Crone | ||||
Title: | Co-Managing Partner |
10 |
Depositor
|
Number of
Deposit Shares |
Issuer
|
Class
|
Certificate
No(s).
|
||||
GEM Global Yield Fund LLC
|
3,500,000
|
Tyme Technologies, Inc.
|
Common
|
11 |
Exhibit 10.16
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”). THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED ONLY (A) TO THE COMPANY, (B) IN COMPLIANCE WITH RULE 144 UNDER THE SECURITIES ACT, IF AVAILABLE, AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS, (C) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT, OR (D) IN A TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE SECURITIES ACT AND/OR ANY APPLICABLE STATE SECURITIES LAWS, AND THE HOLDER HAS, PRIOR TO SUCH SALE, FURNISHED TO THE COMPANY AN OPINION OF COUNSEL THAT SUCH REGISTRATION IS NOT REQUIRED OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE COMPANY. HEDGING TRANSACTIONS INVOLVING THESE SECURITIES MAY NOT BE CONDUCTED UNLESS IN COMPLIANCE WITH THE SECURITIES ACT.
Tyme Inc.
10% SECURED CONVERTIBLE PROMISSORY NOTE
DUE OCTOBER 11, 2015
Original Issue Date: July 11, 2014 |
US$1,100,000 |
This Secured Convertible Promissory Note, one of a series of duly authorized and issued secured convertible promissory notes of Tyme Inc. , a Delaware corporation (the “ Company ”), designated as its 10% Secured Convertible Promissory Notes and in the aggregate principal amount of $1,100,000 (the “ Notes ”), is issued to Christopher Brown (together with his permitted successors and assigns, the “ Holder ”) in accordance with exemptions from registration under the Securities Act of 1933, as amended (the “ Securities Act ”), pursuant to that certain Securities Purchase Agreement relating to the Notes (the “ Purchase Agreement ”), by and among the Company, the Holder and other purchasers of Notes (collectively with the Holder, the “ Holders ”). Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Purchase Agreement.
Article I.
Section 1.01 Principal and Interest . (a) FOR VALUE RECEIVED, the Company hereby promises to pay to the order of the Holder, in lawful money of the United States of America and in immediately available funds the principal sum of One Million One Hundred Thousand Dollars ($1,100,000) on October 11, 2015 (the “ Maturity Date ”).
(b) The Company further promises to pay interest in cash on the unpaid principal amount of this Note at a rate per annum equal to ten percent (10%), commencing to accrue on the date hereof and payable on the Maturity Date or earlier prepayment. Interest will be computed on the basis of a 360-day year of twelve 30-day months for the actual number of days elapsed; provided , however , interest is not payable in the event of the conversion of this Note in accordance with Section 1.02 below.
(c) The Company may prepay all or any portion of the principal amount of this Note at any time and from time to time without penalty or premium.
- 1 -
Section 1.02 Mandatory Conversion . (a) Upon the closings of the Merger and the PPO for at least the Minimum PPO amount (which shall include, for purposes of determining such amount, the aggregate outstanding principal amount of the Notes), all of the outstanding principal amount of this Note shall automatically, without the necessity of any action by the Holder or the Company, be converted into PPO Securities of Pubco (such PPO Securities issued upon conversion of the Notes, the “ Conversion Securities ”), at the Conversion Price. All accrued but unpaid interest on this Note shall be forgiven in full upon such conversion of the principal amount of this Note into Conversion Securities.
(b) No fraction of shares or scrip representing fractions of shares will be issued on conversion. Upon any conversion of the entire outstanding principal of and interest on this Note, the number of shares or other securities issuable shall be rounded to the next higher whole number.
(c) The date upon which the conversion shall be effective (the “ Conversion Date ”) shall be deemed to be the date on which the Merger and Minimum PPO closes. The number of Conversion Securities issuable upon conversion of this Note shall be equal to the quotient obtained by dividing (x) the outstanding principal amount of this Note by (y) the Conversion Price then in effect. The calculation by the Company of the number of Conversion Securities to be received by the Holder upon conversion hereof, and of the applicable Conversion Price, shall be conclusive absent manifest error.
Section 1.03 [Intentionally Omitted]
Section 1.04 Absolute Obligation/Ranking . Except as expressly provided herein, no provision of this Note shall alter or impair the obligation of the Company, which is absolute and unconditional, to pay the principal of, and liquidated damages (if any) on, this Note at the time, place, and rate, and in the coin or currency, herein prescribed. This Note is a direct debt obligation of the Company. This Note ranks pari passu with all other Notes now or hereinafter issued pursuant to the Purchase Agreement.
Section 1.05 Paying Agent and Registrar . Initially, the Company will act as paying agent and registrar. The Company may change any paying agent, registrar, or Company-registrar by giving the Holder not less than ten (10) business days’ written notice of its election to do so, specifying the name, address, telephone number and facsimile number of the paying agent or registrar. The Company may act in any such capacity.
Section 1.06 Different Denominations . This Note is exchangeable for an equal aggregate principal amount of Notes of different authorized denominations, as reasonably requested by the Holder surrendering the same. No service charge will be made for such registration of transfer or exchange. Notwithstanding anything to the contrary contained herein, in the event of a mandatory conversion of the outstanding principal amount of this Note in accordance with Section 1.02 above, the aggregate outstanding principal amount of all Notes owned of record by Holder shall be used in the calculation of the number of Conversion Securities to be issued to Holder in connection with such conversion regardless of the denominations of the individual Notes owned by Holder.
Section 1.07 Investment Representations . This Note has been issued subject to certain investment representations of the original Holder set forth in the Purchase Agreement and may be transferred or exchanged only in compliance with the Purchase Agreement and applicable federal and state securities laws and regulations.
Section 1.08 Reliance on Note Register . Prior to due presentment to the Company for transfer or conversion of this Note, the Company and any agent of the Company may treat the person in whose name this Note is duly registered on the Note Register as the owner hereof for the purpose of receiving payment as herein provided and for all other purposes, whether or not this Note is overdue, and neither the Company nor any such agent shall be affected by notice to the contrary.
- 2 -
Section 1.09 Security; Other Rights . The obligations of the Company to the Holder under this Note are secured pursuant to the Security Agreement and the Pledge Agreement and are guaranteed under the Guaranty. In addition to the rights and remedies given it by this Note, the Purchase Agreement, the Security Agreement, the Pledge Agreement and the Guaranty, the Holder shall have all those rights and remedies allowed by applicable laws. The rights and remedies of the Holder are cumulative and recourse to one or more right or remedy shall not constitute a waiver of the others.
Article II.
Section 2.01 Events of Default . Each of the following events shall constitute a default under this Note (each an “ Event of Default ”):
(a) failure by the Company to pay any principal amount or interest due hereunder within five (5) days of the date such payment is due;
(b) failure by Pubco to issue, or cause it’s transfer agent to issue, to the Holder the number of shares of PPO Securities (if any) issuable to the Holder as a result of the conversion of this Note within ten (10) days after the Conversion Date;
(c) any event of default by the Company or any subsidiary under the Security Agreement, the Pledge Agreement or the Guaranty shall have occurred and be continuing beyond all grace and/or cure periods, or the Security Agreement, the Pledge Agreement or the Guaranty shall fail to remain in full force and effect prior to payment in full of all amounts payable under this Note, or any action shall be taken by the Company to discontinue the Security Agreement the Pledge Agreement or the Guaranty or to assert the invalidity thereof prior to payment in full of all amounts payable under this Note;
(d) the Company shall: (1) make a general assignment for the benefit of its creditors; (2) apply for or consent to the appointment of a receiver, trustee, assignee, custodian, sequestrator, liquidator or similar official for itself or any of its assets and properties; (3) commence a voluntary case for relief as a debtor under the United States Bankruptcy Code; (4) file with or otherwise submit to any governmental authority any petition, answer or other document seeking: (A) reorganization, (B) an arrangement with creditors or (C) to take advantage of any other present or future applicable law respecting bankruptcy, reorganization, insolvency, readjustment of debts, relief of debtors, dissolution or liquidation; (5) file or otherwise submit any answer or other document admitting or failing to contest the material allegations of a petition or other document filed or otherwise submitted against it in any proceeding under any such applicable law; or (6) be adjudicated a bankrupt or insolvent by a court of competent jurisdiction;
(e) any case, proceeding or other action shall be commenced against the Company for the purpose of effecting, or an order, judgment or decree shall be entered by any court of competent jurisdiction approving (in whole or in part) anything specified in Section 2.01(d) hereof, or any receiver, trustee, assignee, custodian, sequestrator, liquidator or other official shall be appointed with respect to the Company, or shall be appointed to take or shall otherwise acquire possession or control of all or a substantial part of the assets and properties of the Company, and any of the foregoing shall continue unstayed and in effect for any period of sixty (60) days;
(f) default shall occur with respect to any indebtedness for borrowed money of the Company (including, without limitation, any other Note(s)) or under any agreement under which such indebtedness may be issued by the Company and such default shall continue for more than the period of grace, if any, therein specified, if the aggregate amount of such indebtedness for which such default shall have occurred exceeds $50,000;
- 3 -
(g) default shall occur with respect to any contractual obligation of the Company under or pursuant to any contract, lease, or other agreement to which the Company is a party and such default shall continue for more than the period of grace, if any, therein specified, if the aggregate amount of the Company’s contractual liability arising out of such default exceeds or is reasonably estimated to exceed $50,000;
(h) final judgment for the payment of money in excess of $50,000 shall be rendered against the Company and the same shall remain undischarged for a period of twenty (20) days during which execution shall not be effectively stayed;
(i) any material breach by the Company of any of its representations or warranties under the Purchase Agreement; or
(j) any default, whether in whole or in part, shall occur in the due observance or performance of any obligations or other covenants, terms or provisions to be performed under this Note or the Purchase Agreement which is not cured by the Company within five (5) days after receipt of written notice thereof.
Section 2.02 If any Event of Default specified in Section 2.01(d) or Section 2.01(e) occurs, then the full principal amount of this Note, together with any other amounts owing in respect thereof, to the date of the Event of Default, shall become immediately due and payable without any action on the part of the Holder, and if any other Event of Default occurs, the full principal amount of this Note, together with any other amounts owing in respect thereof, to the date of acceleration shall become, at the Majority Holders’ election, immediately due and payable in cash. Commencing five (5) days after the occurrence of any Event of Default, interest on this Note shall begin to accrue at the rate of interest specified in Section 1.01(b) PLUS five percent (5%) per annum , or such lower maximum amount of interest permitted to be charged under applicable law. All Notes for which the full amount hereunder shall have been paid in accordance herewith shall promptly be surrendered to or as directed by the Company. The Holder need not provide, and the Company hereby waives, any presentment, demand, protest or other notice of any kind, and the Holder may immediately and without expiration of any grace period enforce any and all of its rights and remedies hereunder and all other remedies available to it under applicable law. Such declaration may be rescinded and annulled by the Majority Holders at any time prior to payment hereunder, and the Holder shall have all rights as a Note holder until such time, if any, as the full payment under this Section shall have been received by it. No such rescission or annulment shall affect any subsequent Event of Default or impair any right consequent thereon. “ Majority Holders ” means at any time a Holder or Holders then holding in excess of 50% of the then aggregate unpaid principal amount of the Notes.
Article III.
Section 3.01 Negative Covenants . So long as this Note shall remain in effect and until any outstanding principal and interest and all fees and all other expenses or amounts payable under this Note and the Purchase Agreement have been paid in full, unless the Majority Holders shall otherwise consent in writing, the Company shall not:
- 4 -
(a) Senior or Pari Passu Indebtedness . Incur, create, assume, guaranty or permit to exist any indebtedness that ranks senior in priority to, or pari passu with, the obligations under this Note, except for (i) indebtedness existing on the date hereof and set forth in Schedule A attached hereto and only to the extent that such indebtedness ranks senior in priority to or pari passu with the obligations under this Note and the Purchase Agreement on the Original Issue Date, (ii) indebtedness secured by a lien described in paragraph (ix) in the definition of “Permitted Liens” in the Security Agreement in an aggregate amount outstanding not to exceed $50,000; and (iii) indebtedness created as a result of a subsequent financing if the gross proceeds to the Company of such financing are equal to or greater than the aggregate principal amount of the Notes and the Notes are repaid in full upon the closing of such financing.
(b) Liens . Create, incur, assume or permit to exist any lien on any property or assets (including stock or other securities of the Company) now owned or hereafter acquired by it or on any income or revenues or rights in respect of any thereof, except Permitted Liens (as defined in the Security Agreement).
(c) Dividends and Distributions . Declare or pay, directly or indirectly, any dividend or make any other distribution (by reduction of capital or otherwise), whether in cash, property, securities or a combination thereof, with respect to any shares of its capital stock or directly or indirectly redeem, purchase, retire or otherwise acquire for value any shares of any class of its capital stock or set aside any amount for any such purpose; provided, however, that the Company may complete the Merger.
(d) Limitation on Certain Payments and Prepayments .
(i) Pay in cash any amount in respect of any indebtedness or preferred stock that may at the obligor’s option be paid in kind or in other securities; or
(ii) Optionally prepay, repurchase or redeem or otherwise defease or segregate funds with respect to any indebtedness of the Company, other than for senior indebtedness existing on the date hereof and set forth in Schedule A attached hereto, indebtedness under this Note or the Purchase Agreement.
Article IV.
Section 4.01 Notices . Notices regarding this Note shall be sent to the parties at the following addresses, unless a party notifies the other parties, in writing, of a change of address:
|
If to the Company: |
At the address set forth in the Purchase Agreement |
|
|
|
|
If to the Holder: |
At the address set forth in the Purchase Agreement |
- 5 -
Section 4.02 Governing Law . All questions concerning the construction, validity, enforcement and interpretation of this Note shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by any of the Transaction Documents (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, employees or agents) shall be commenced in the state and federal courts sitting in the City of New York, Borough of Manhattan (the “ New York Courts ”). Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the New York Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, or such New York Courts are improper or inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Note and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. Each party hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Note or the transactions contemplated hereby. If either party shall commence an action or proceeding to enforce any provisions of this Note, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its reasonable attorney’s fees and other costs and expenses incurred with the investigation, preparation and prosecution or defense of such action or proceeding.
Section 4.03 Severability . The invalidity of any of the provisions of this Note shall not invalidate or otherwise affect any of the other provisions of this Note, which shall remain in full force and effect.
Section 4.04 Entire Agreement and Amendments . This Note, together with the Purchase Agreement and the Transaction Documents, represents the entire agreement between the parties hereto with respect to the subject matter hereof and there are no representations, warranties or commitments, except as set forth herein. This Note may be amended only by an instrument in writing executed by the parties hereto.
Section 4.05 Transfer . This Note shall not be transferred or assigned by the Holder except in accordance with the provisions of this Note and the Purchase Agreement.
[Remainder of Page Intentionally Left Blank]
- 6 -
IN WITNESS WHEREOF , with the intent to be legally bound hereby, the Company as executed this Note as of the date first written above.
TYME INC.
By: /s/ Michael Demurjian
Name: Michael Demurjian
Title: Vice President
- 7 -
SCHEDULE A
SENIOR AND PARI PASSU INDEBTEDNESS
All amounts due and owing under that certain Convertible Promissory Note of the Company, dated August 2, 2013, in the principal amount of $997,000 and payable to US VC Partners, L.P. (“USVCP”). It is noted that, besides funding in full such Note, USVCP made additional advances to the Company or approximately $129,000. Accordingly, the total principal amount due USVCP from the Company is $1,126,000. USVCP has filed a UCC Financing Statement with the Delaware Department of State.
- 8 -
Exhibit 10.17
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”). THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED ONLY (A) TO THE COMPANY, (B) IN COMPLIANCE WITH RULE 144 UNDER THE SECURITIES ACT, IF AVAILABLE, AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS, (C) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT, OR (D) IN A TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE SECURITIES ACT AND/OR ANY APPLICABLE STATE SECURITIES LAWS, AND THE HOLDER HAS, PRIOR TO SUCH SALE, FURNISHED TO THE COMPANY AN OPINION OF COUNSEL THAT SUCH REGISTRATION IS NOT REQUIRED OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE COMPANY. HEDGING TRANSACTIONS INVOLVING THESE SECURITIES MAY NOT BE CONDUCTED UNLESS IN COMPLIANCE WITH THE SECURITIES ACT.
Tyme Inc.
AMENDED & RESTATED 10% SECURED CONVERTIBLE PROMISSORY NOTE
DUE OCTOBER 11, 2015
Original Issue Date: July 11, 2014 |
US$1,350,000 |
This Secured Convertible Promissory Note, amends and restates in its entirety and supersedes the 10% Secured Convertible Promissory Note dated July 11, 2014, in the original principal amount of US$1,100,000 of Tyme Inc. , a Delaware corporation (the “ Company ”), issued to Christopher Brown (together with his permitted successors and assigns, the “ Holder ”), and is one of a series of duly authorized and issued secured convertible promissory notes of designated as the Company’s 10% Secured Convertible Promissory Notes (the “ Notes ”), and is issued in accordance with exemptions from registration under the Securities Act of 1933, as amended (the “ Securities Act ”), pursuant to that certain Securities Purchase Agreement relating to the Notes, as amended (the “ Purchase Agreement ”), by and among the Company, the Holder and other purchasers of Notes (collectively with the Holder, the “ Holders ”). Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Purchase Agreement.
Article I.
Section 1.01 Principal and Interest . (a) FOR VALUE RECEIVED, the Company hereby promises to pay to the order of the Holder, in lawful money of the United States of America and in immediately available funds the principal sum of One Million Three Hundred Fifty Thousand Dollars ($1,350,000) on October 11, 2015 (the “ Maturity Date ”).
(b) The Company further promises to pay interest in cash on the unpaid principal amount of this Note at a rate per annum equal to ten percent (10%) as follows: interest on the principal amount of One Million One Hundred Thousand Dollars ($1,100,000) commenced to accrue on July 11, 2014, and interest on the sum of Two Hundred Fifty Thousand Dollars ($250,000) commenced to accrue on November 24, 2014. All interest accrued or accruing hereunder is payable on the Maturity Date or earlier prepayment. Interest will be computed on the basis of a 360-day year of twelve 30-day months for the actual number of days elapsed; provided , however , interest is not payable in the event of the conversion of this Note in accordance with Section 1.02 below.
- 1 -
(c) The Company may prepay all or any portion of the principal amount of this Note at any time and from time to time without penalty or premium.
Section 1.02 Mandatory Conversion . (a) Upon the closings of the Merger and the PPO for at least the Minimum PPO amount (which shall include, for purposes of determining such amount, the aggregate outstanding principal amount of the Notes) or lesser amount as agreed to by the Company, all of the outstanding principal amount of this Note shall automatically, without the necessity of any action by the Holder or the Company, be converted into PPO Securities of Pubco (such PPO Securities issued upon conversion of the Notes, the “ Conversion Securities ”), at the Conversion Price. All accrued but unpaid interest on this Note shall be forgiven in full upon such conversion of the principal amount of this Note into Conversion Securities.
(b) No fraction of shares or scrip representing fractions of shares will be issued on conversion. Upon any conversion of the entire outstanding principal of and interest on this Note, the number of shares or other securities issuable shall be rounded to the next higher whole number.
(c) The date upon which the conversion shall be effective (the “ Conversion Date ”) shall be deemed to be the date on which the Merger and Minimum PPO closes. The number of Conversion Securities issuable upon conversion of this Note shall be equal to the quotient obtained by dividing (x) the outstanding principal amount of this Note by (y) the Conversion Price then in effect. The calculation by the Company of the number of Conversion Securities to be received by the Holder upon conversion hereof, and of the applicable Conversion Price, shall be conclusive absent manifest error.
Section 1.03 [Intentionally Omitted]
Section 1.04 Absolute Obligation/Ranking . Except as expressly provided herein, no provision of this Note shall alter or impair the obligation of the Company, which is absolute and unconditional, to pay the principal of, and liquidated damages (if any) on, this Note at the time, place, and rate, and in the coin or currency, herein prescribed. This Note is a direct debt obligation of the Company. This Note ranks pari passu with all other Notes now or hereinafter issued pursuant to the Purchase Agreement.
Section 1.05 Paying Agent and Registrar . Initially, the Company will act as paying agent and registrar. The Company may change any paying agent, registrar, or Company-registrar by giving the Holder not less than ten (10) business days’ written notice of its election to do so, specifying the name, address, telephone number and facsimile number of the paying agent or registrar. The Company may act in any such capacity.
Section 1.06 Different Denominations . This Note is exchangeable for an equal aggregate principal amount of Notes of different authorized denominations, as reasonably requested by the Holder surrendering the same. No service charge will be made for such registration of transfer or exchange. Notwithstanding anything to the contrary contained herein, in the event of a mandatory conversion of the outstanding principal amount of this Note in accordance with Section 1.02 above, the aggregate outstanding principal amount of all Notes owned of record by Holder shall be used in the calculation of the number of [Conversion Securities] to be issued to Holder in connection with such conversion regardless of the denominations of the individual Notes owned by Holder.
- 2 -
Section 1.07 Investment Representations . This Note has been issued subject to certain investment representations of the original Holder set forth in the Purchase Agreement and may be transferred or exchanged only in compliance with the Purchase Agreement and applicable federal and state securities laws and regulations.
Section 1.08 Reliance on Note Register . Prior to due presentment to the Company for transfer or conversion of this Note, the Company and any agent of the Company may treat the person in whose name this Note is duly registered on the Note Register as the owner hereof for the purpose of receiving payment as herein provided and for all other purposes, whether or not this Note is overdue, and neither the Company nor any such agent shall be affected by notice to the contrary.
Section 1.09 Security; Other Rights . The obligations of the Company to the Holder under this Note are secured pursuant to the Security Agreement and the Pledge Agreement , each as amended pursuant to the Omnibus Amendment, dated as of November 24, 2014 (the “ Omnibus Amendment ”), among the Company, Subscriber and various other parties, and are guaranteed under the Guaranty, as amended by the Omnibus Amendment. In addition to the rights and remedies given it by this Note, the Purchase Agreement, the Security Agreement, the Pledge Agreement and the Guaranty, each as amended by the Omnibus Amendment, the Holder shall have all those rights and remedies allowed by applicable laws. The rights and remedies of the Holder are cumulative and recourse to one or more right or remedy shall not constitute a waiver of the others.
Article II.
Section 2.01 Events of Default . Each of the following events shall constitute a default under this Note (each an “ Event of Default ”):
(a) failure by the Company to pay any principal amount or interest due hereunder within five (5) days of the date such payment is due;
(b) failure by Pubco to issue, or cause it’s transfer agent to issue, to the Holder the number of shares of PPO Securities (if any) issuable to the Holder as a result of the conversion of this Note within ten (10) days after the Conversion Date;
(c) (c) any event of default by the Company or any subsidiary under the Security Agreement, the Pledge Agreement or the Guaranty, each as amended by the Omnibus Amendment, shall have occurred and be continuing beyond all grace and/or cure periods, or the Security Agreement, the Pledge Agreement or the Guaranty, each as amended by the Omnibus Amendment, shall fail to remain in full force and effect prior to payment in full of all amounts payable under this Note, or any action shall be taken by the Company to discontinue the Security Agreement the Pledge Agreement or the Guaranty, each as amended by the Omnibus Amendment, or to assert the invalidity thereof prior to payment in full of all amounts payable under this Note;
(d) the Company shall: (1) make a general assignment for the benefit of its creditors; (2) apply for or consent to the appointment of a receiver, trustee, assignee, custodian, sequestrator, liquidator or similar official for itself or any of its assets and properties; (3) commence a voluntary case for relief as a debtor under the United States Bankruptcy Code; (4) file with or otherwise submit to any governmental authority any petition, answer or other document seeking: (A) reorganization, (B) an arrangement with creditors or (C) to take advantage of any other present or future applicable law respecting bankruptcy, reorganization, insolvency, readjustment of debts, relief of debtors, dissolution or liquidation; (5) file or otherwise submit any answer or other document admitting or failing to contest the material allegations of a petition or other document filed or otherwise submitted against it in any proceeding under any such applicable law; or (6) be adjudicated a bankrupt or insolvent by a court of competent jurisdiction;
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(e) any case, proceeding or other action shall be commenced against the Company for the purpose of effecting, or an order, judgment or decree shall be entered by any court of competent jurisdiction approving (in whole or in part) anything specified in Section 2.01(d) hereof, or any receiver, trustee, assignee, custodian, sequestrator, liquidator or other official shall be appointed with respect to the Company, or shall be appointed to take or shall otherwise acquire possession or control of all or a substantial part of the assets and properties of the Company, and any of the foregoing shall continue unstayed and in effect for any period of sixty (60) days;
(f) default shall occur with respect to any indebtedness for borrowed money of the Company (including, without limitation, any other Note(s)) or under any agreement under which such indebtedness may be issued by the Company and such default shall continue for more than the period of grace, if any, therein specified, if the aggregate amount of such indebtedness for which such default shall have occurred exceeds $50,000;
(g) default shall occur with respect to any contractual obligation of the Company under or pursuant to any contract, lease, or other agreement to which the Company is a party and such default shall continue for more than the period of grace, if any, therein specified, if the aggregate amount of the Company’s contractual liability arising out of such default exceeds or is reasonably estimated to exceed $50,000;
(h) final judgment for the payment of money in excess of $50,000 shall be rendered against the Company and the same shall remain undischarged for a period of twenty (20) days during which execution shall not be effectively stayed;
(i) any material breach by the Company of any of its representations or warranties under the Purchase Agreement; or
(j) any default, whether in whole or in part, shall occur in the due observance or performance of any obligations or other covenants, terms or provisions to be performed under this Note or the Purchase Agreement which is not cured by the Company within five (5) days after receipt of written notice thereof.
Section 2.02 If any Event of Default specified in Section 2.01(d) or Section 2.01(e) occurs, then the full principal amount of this Note, together with any other amounts owing in respect thereof, to the date of the Event of Default, shall become immediately due and payable without any action on the part of the Holder, and if any other Event of Default occurs, the full principal amount of this Note, together with any other amounts owing in respect thereof, to the date of acceleration shall become, at the Majority Holders’ election, immediately due and payable in cash. Commencing five (5) days after the occurrence of any Event of Default, interest on this Note shall begin to accrue at the rate of interest specified in Section 1.01(b) PLUS five percent (5%) per annum , or such lower maximum amount of interest permitted to be charged under applicable law. All Notes for which the full amount hereunder shall have been paid in accordance herewith shall promptly be surrendered to or as directed by the Company. The Holder need not provide, and the Company hereby waives, any presentment, demand, protest or other notice of any kind, and the Holder may immediately and without expiration of any grace period enforce any and all of its rights and remedies hereunder and all other remedies available to it under applicable law. Such declaration may be rescinded and annulled by the Majority Holders at any time prior to payment hereunder, and the Holder shall have all rights as a Note holder until such time, if any, as the full payment under this Section shall have been received by it. No such rescission or annulment shall affect any subsequent Event of Default or impair any right consequent thereon. “ Majority Holders ” means at any time a Holder or Holders then holding in excess of 50% of the then aggregate unpaid principal amount of the Notes.
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Article III.
Section 3.01 Negative Covenants . So long as this Note shall remain in effect and until any outstanding principal and interest and all fees and all other expenses or amounts payable under this Note and the Purchase Agreement have been paid in full, unless the Majority Holders shall otherwise consent in writing, the Company shall not:
(a) Senior or Pari Passu Indebtedness . Incur, create, assume, guaranty or permit to exist any indebtedness that ranks senior in priority to, or pari passu with, the obligations under this Note, except for (i) indebtedness existing on the date hereof and set forth in Schedule A attached hereto and only to the extent that such indebtedness ranks senior in priority to or pari passu with the obligations under this Note and the Purchase Agreement on the Original Issue Date, (ii) indebtedness secured by a lien described in paragraph (ix) in the definition of “Permitted Liens” in the Security Agreement, as amended by the Omnibus Amendment, in an aggregate amount outstanding not to exceed $50,000; and (iii) indebtedness created as a result of a subsequent financing if the gross proceeds to the Company of such financing are equal to or greater than the aggregate principal amount of the Notes and the Notes are repaid in full upon the closing of such financing.
(b) Liens . Create, incur, assume or permit to exist any lien on any property or assets (including stock or other securities of the Company) now owned or hereafter acquired by it or on any income or revenues or rights in respect of any thereof, except Permitted Liens (as defined in the Security Agreement, as amended by the Omnibus Amendment).
(c) Dividends and Distributions . Declare or pay, directly or indirectly, any dividend or make any other distribution (by reduction of capital or otherwise), whether in cash, property, securities or a combination thereof, with respect to any shares of its capital stock or directly or indirectly redeem, purchase, retire or otherwise acquire for value any shares of any class of its capital stock or set aside any amount for any such purpose; provided, however, that the Company may complete the Merger.
(d) Limitation on Certain Payments and Prepayments .
(i) Pay in cash any amount in respect of any indebtedness or preferred stock that may at the obligor’s option be paid in kind or in other securities; or
(ii) Optionally prepay, repurchase or redeem or otherwise defease or segregate funds with respect to any indebtedness of the Company, other than for senior indebtedness existing on the date hereof and set forth in Schedule A attached hereto, indebtedness under this Note or the Purchase Agreement.
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Article IV.
Section 4.01 Notices . Notices regarding this Note shall be sent to the parties at the following addresses, unless a party notifies the other parties, in writing, of a change of address:
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If to the Company: |
At the address set forth in the Purchase Agreement |
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If to the Holder: |
At the address set forth in the Purchase Agreement |
Section 4.02 Governing Law . All questions concerning the construction, validity, enforcement and interpretation of this Note shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by any of the Transaction Documents (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, employees or agents) shall be commenced in the state and federal courts sitting in the City of New York, Borough of Manhattan (the “ New York Courts ”). Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the New York Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, or such New York Courts are improper or inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Note and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. Each party hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Note or the transactions contemplated hereby. If either party shall commence an action or proceeding to enforce any provisions of this Note, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its reasonable attorney’s fees and other costs and expenses incurred with the investigation, preparation and prosecution or defense of such action or proceeding.
Section 4.03 Severability . The invalidity of any of the provisions of this Note shall not invalidate or otherwise affect any of the other provisions of this Note, which shall remain in full force and effect.
Section 4.04 Entire Agreement and Amendments . This Note, together with the Purchase Agreement and the Transaction Documents, each as amended by the Omnibus Amendment, represents the entire agreement between the parties hereto with respect to the subject matter hereof and there are no representations, warranties or commitments, except as set forth herein. This Note may be amended only by an instrument in writing executed by the parties hereto.
Section 4.05 Transfer . This Note shall not be transferred or assigned by the Holder except in accordance with the provisions of this Note and the Purchase Agreement, as amended by the Omnibus Amendment.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF , with the intent to be legally bound hereby, the Company as executed this Note as of the date first written above.
TYME INC.
By: /s/ Michael Demurjian
Name: Michael Demurjian
Title: Vice President
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SCHEDULE A
SENIOR AND PARI PASSU INDEBTEDNESS
None.
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Exhibit 10.18
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”). THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED ONLY (A) TO THE COMPANY, (B) IN COMPLIANCE WITH RULE 144 UNDER THE SECURITIES ACT, IF AVAILABLE, AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS, (C) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT, OR (D) IN A TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE SECURITIES ACT AND/OR ANY APPLICABLE STATE SECURITIES LAWS, AND THE HOLDER HAS, PRIOR TO SUCH SALE, FURNISHED TO THE COMPANY AN OPINION OF COUNSEL THAT SUCH REGISTRATION IS NOT REQUIRED OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE COMPANY. HEDGING TRANSACTIONS INVOLVING THESE SECURITIES MAY NOT BE CONDUCTED UNLESS IN COMPLIANCE WITH THE SECURITIES ACT.
Tyme Inc.
SECOND AMENDED AND RESTATED
10% SECURED CONVERTIBLE PROMISSORY NOTE
DUE OCTOBER 11, 2015
Original Issue Date: July 11, 2014 |
US$2,310,000 |
This Second Amended and Restated 10% Secured Convertible Promissory Note (this “ Note ”) amends and restates in its entirety and supersedes the Amended & Restated 10% Secured Convertible Promissory Note, dated July 11, 2014, in the principal amount of US$1,350,000, of Tyme Inc. , a Delaware corporation (the “ Company ”), which amended and restated in its entirety and superseded the 10% Secured Convertible Promissory Note, dated July 11, 2014, in the original principal amount of US$1,100,000, of the Company (the “ Original Note ”), each issued to Christopher Brown (together with his permitted successors and assigns, the “ Holder ”). The Original Note was issued pursuant to that certain Securities Purchase Agreement, dated as of July 11, 2014 (the “ Purchase Agreement ”), between the Company and Holder. Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Purchase Agreement.
Article I.
Section 1.01 Principal and Interest . (a) FOR VALUE RECEIVED, the Company hereby promises to pay to the order of the Holder, in lawful money of the United States of America and in immediately available funds the principal sum of Two Million Three Hundred Ten Thousand Dollars ($2,310,000) on October 11, 2015 (the “ Maturity Date ”).
(b) The Company further promises to pay interest in cash on the unpaid principal amount of this Note at a rate per annum equal to ten percent (10%) as follows: (i) interest on the principal amount of One Million One Hundred Thousand Dollars ($1,100,000) commenced to accrue on July 11, 2014, (ii) interest on the principal amount of Two Hundred Fifty Thousand Dollars ($250,000) commenced to accrue on November 24, 2014, and (iii) interest on the principal amount of Nine Hundred Sixty Thousand Dollars ($960,000) commenced to accrue on January 15, 2015. All interest accrued or accruing hereunder is payable on the Maturity Date or earlier prepayment. Interest will be computed on the basis of a 360-day year of twelve 30-day months for the actual number of days elapsed ; provided , however , interest is not payable in the event of the conversion of this Note in accordance with Section 1.02 below.
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(c) The Company may prepay all or any portion of the principal amount of this Note at any time and from time to time without penalty or premium.
Section 1.02 Mandatory Conversion . (a) Upon the closings of the Merger and the PPO for at least $9,100,000 (which shall include, for purposes of determining such amount, the aggregate outstanding principal amount of this Note) or lesser amount as agreed to by the Company, all of the outstanding principal amount of this Note shall automatically, without the necessity of any action by the Holder or the Company, be converted into PPO Securities of Pubco (such PPO Securities issued upon conversion of the Notes, the “ Conversion Securities ”), at the Conversion Price. All accrued but unpaid interest on this Note shall be forgiven in full upon such conversion of the principal amount of this Note into the Conversion Securities.
(b) No fraction of shares or scrip representing fractions of shares will be issued on conversion. Upon any conversion of the entire outstanding principal of and interest on this Note, the number of shares or other securities issuable shall be rounded to the next higher whole number.
(c) The date upon which the conversion shall be effective (the “ Conversion Date ”) shall be deemed to be the date on which the Merger and Minimum PPO closes. The number of Conversion Securities issuable upon conversion of this Note shall be equal to the quotient obtained by dividing (x) the outstanding principal amount of this Note by (y) the Conversion Price then in effect. The calculation by the Company of the number of Conversion Securities to be received by the Holder upon conversion hereof, and of the applicable Conversion Price, shall be conclusive absent manifest error.
Section 1.03 [Intentionally Omitted]
Section 1.04 Absolute Obligation/Ranking . Except as expressly provided herein, no provision of this Note shall alter or impair the obligation of the Company, which is absolute and unconditional, to pay the principal of, and liquidated damages (if any) on, this Note at the time, place, and rate, and in the coin or currency, herein prescribed. This Note is a direct debt obligation of the Company. This Note ranks pari passu with all other Notes now or hereinafter issued pursuant to the Purchase Agreement.
Section 1.05 Paying Agent and Registrar . Initially, the Company will act as paying agent and registrar. The Company may change any paying agent, registrar, or Company-registrar by giving the Holder not less than ten (10) business days’ written notice of its election to do so, specifying the name, address, telephone number and facsimile number of the paying agent or registrar. The Company may act in any such capacity.
Section 1.06 Different Denominations . This Note is exchangeable for an equal aggregate outstanding principal amount of notes of different authorized denominations but otherwise substantially identical to this Note (the “ Exchanged Notes ”), as reasonably requested by the Holder surrendering the same. No service charge will be made for such registration of transfer or exchange. Notwithstanding anything to the contrary contained herein, in the event of a mandatory conversion of the outstanding principal amount of this Note in accordance with Section 1.02 above, the aggregate outstanding principal amount of all Exchanged Notes owned of record by Holder shall be used in the calculation of the number of Conversion Securities to be issued to Holder in connection with such conversion regardless of the denominations of the individual Exchanged Notes owned of record by Holder.
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Section 1.07 Investment Representations . This Note has been issued subject to certain investment representations of the original Holder set forth in the Purchase Agreement and may be transferred or exchanged only in compliance with the Purchase Agreement and applicable federal and state securities laws and regulations.
Section 1.08 Reliance on Note Register . Prior to due presentment to the Company for transfer or conversion of this Note, the Company and any agent of the Company may treat the person in whose name this Note is duly registered on the Note Register as the owner hereof for the purpose of receiving payment as herein provided and for all other purposes, whether or not this Note is overdue, and neither the Company nor any such agent shall be affected by notice to the contrary.
Section 1.09 Security; Other Rights . The obligations of the Company to the Holder under this Note are secured pursuant to the Security Agreement and the Pledge Agreement, each as amended pursuant to the Second Omnibus Amendment, dated as of January 9, 2015 (the “ Omnibus Amendment ”), among the Company, Subscriber and various other parties, and are guaranteed under the Guaranty, as amended by the Omnibus Amendment. In addition to the rights and remedies given it by this Note, the Purchase Agreement, the Security Agreement, the Pledge Agreement and the Guaranty, each as amended by the Omnibus Amendment, the Holder shall have all those rights and remedies allowed by applicable laws. The rights and remedies of the Holder are cumulative and recourse to one or more right or remedy shall not constitute a waiver of the others.
Article II.
Section 2.01 Events of Default . Each of the following events shall constitute a default under this Note (each an “ Event of Default ”):
(a) failure by the Company to pay any principal amount or interest due hereunder within five (5) days of the date such payment is due;
(b) failure by Pubco to issue, or cause it’s transfer agent to issue, to the Holder the number of shares of PPO Securities (if any) issuable to the Holder as a result of the conversion of this Note within ten (10) days after the Conversion Date;
(c) (c) any event of default by the Company or any subsidiary under the Security Agreement, the Pledge Agreement or the Guaranty, each as amended by the Omnibus Amendment, shall have occurred and be continuing beyond all grace and/or cure periods, or the Security Agreement, the Pledge Agreement or the Guaranty, each as amended by the Omnibus Amendment, shall fail to remain in full force and effect prior to payment in full of all amounts payable under this Note, or any action shall be taken by the Company to discontinue the Security Agreement the Pledge Agreement or the Guaranty, each as amended by the Omnibus Amendment, or to assert the invalidity thereof prior to payment in full of all amounts payable under this Note;
(d) the Company shall: (1) make a general assignment for the benefit of its creditors; (2) apply for or consent to the appointment of a receiver, trustee, assignee, custodian, sequestrator, liquidator or similar official for itself or any of its assets and properties; (3) commence a voluntary case for relief as a debtor under the United States Bankruptcy Code; (4) file with or otherwise submit to any governmental authority any petition, answer or other document seeking: (A) reorganization, (B) an arrangement with creditors or (C) to take advantage of any other present or future applicable law respecting bankruptcy, reorganization, insolvency, readjustment of debts, relief of debtors, dissolution or liquidation; (5) file or otherwise submit any answer or other document admitting or failing to contest the material allegations of a petition or other document filed or otherwise submitted against it in any proceeding under any such applicable law; or (6) be adjudicated a bankrupt or insolvent by a court of competent jurisdiction;
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(e) any case, proceeding or other action shall be commenced against the Company for the purpose of effecting, or an order, judgment or decree shall be entered by any court of competent jurisdiction approving (in whole or in part) anything specified in Section 2.01(d) hereof, or any receiver, trustee, assignee, custodian, sequestrator, liquidator or other official shall be appointed with respect to the Company, or shall be appointed to take or shall otherwise acquire possession or control of all or a substantial part of the assets and properties of the Company, and any of the foregoing shall continue unstayed and in effect for any period of sixty (60) days;
(f) default shall occur with respect to any indebtedness for borrowed money of the Company (including, without limitation, any other Note(s)) or under any agreement under which such indebtedness may be issued by the Company and such default shall continue for more than the period of grace, if any, therein specified, if the aggregate amount of such indebtedness for which such default shall have occurred exceeds $50,000;
(g) default shall occur with respect to any contractual obligation of the Company under or pursuant to any contract, lease, or other agreement to which the Company is a party and such default shall continue for more than the period of grace, if any, therein specified, if the aggregate amount of the Company’s contractual liability arising out of such default exceeds or is reasonably estimated to exceed $50,000;
(h) final judgment for the payment of money in excess of $50,000 shall be rendered against the Company and the same shall remain undischarged for a period of twenty (20) days during which execution shall not be effectively stayed;
(i) any material breach by the Company of any of its representations or warranties under the Purchase Agreement; or
(j) any default, whether in whole or in part, shall occur in the due observance or performance of any obligations or other covenants, terms or provisions to be performed under this Note or the Purchase Agreement which is not cured by the Company within five (5) days after receipt of written notice thereof.
Section 2.02 If any Event of Default specified in Section 2.01(d) or Section 2.01(e) occurs, then the full principal amount of this Note, together with any other amounts owing in respect thereof, to the date of the Event of Default, shall become immediately due and payable without any action on the part of the Holder, and if any other Event of Default occurs, the full principal amount of this Note, together with any other amounts owing in respect thereof, to the date of acceleration shall become, at the Majority Holders’ election, immediately due and payable in cash. Commencing five (5) days after the occurrence of any Event of Default, interest on this Note shall begin to accrue at the rate of interest specified in Section 1.01(b) PLUS five percent (5%) per annum , or such lower maximum amount of interest permitted to be charged under applicable law. All Notes for which the full amount hereunder shall have been paid in accordance herewith shall promptly be surrendered to or as directed by the Company. The Holder need not provide, and the Company hereby waives, any presentment, demand, protest or other notice of any kind, and the Holder may immediately and without expiration of any grace period enforce any and all of its rights and remedies hereunder and all other remedies available to it under applicable law. Such declaration may be rescinded and annulled by the Majority Holders at any time prior to payment hereunder, and the Holder shall have all rights as a Note holder until such time, if any, as the full payment under this Section shall have been received by it. No such rescission or annulment shall affect any subsequent Event of Default or impair any right consequent thereon. “ Majority Holders ” means at any time a Holder or Holders then holding in excess of 50% of the then aggregate unpaid principal amount of the Notes.
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Article III.
Section 3.01 Negative Covenants . So long as this Note shall remain in effect and until any outstanding principal and interest and all fees and all other expenses or amounts payable under this Note and the Purchase Agreement have been paid in full, unless the Majority Holders shall otherwise consent in writing, the Company shall not:
(a) Senior or Pari Passu Indebtedness . Incur, create, assume, guaranty or permit to exist any indebtedness that ranks senior in priority to, or pari passu with, the obligations under this Note, except for (i) indebtedness existing on the date hereof and set forth in Schedule A attached hereto and only to the extent that such indebtedness ranks senior in priority to or pari passu with the obligations under this Note and the Purchase Agreement on the Original Issue Date, (ii) indebtedness secured by a lien described in paragraph (ix) in the definition of “Permitted Liens” in the Security Agreement, as amended by the Omnibus Amendment, in an aggregate amount outstanding not to exceed $50,000; and (iii) indebtedness created as a result of a subsequent financing if the gross proceeds to the Company of such financing are equal to or greater than the aggregate principal amount of the Notes and the Notes are repaid in full upon the closing of such financing.
(b) Liens . Create, incur, assume or permit to exist any lien on any property or assets (including stock or other securities of the Company) now owned or hereafter acquired by it or on any income or revenues or rights in respect of any thereof, except Permitted Liens (as defined in the Security Agreement, as amended by the Omnibus Amendment).
(c) Dividends and Distributions . Declare or pay, directly or indirectly, any dividend or make any other distribution (by reduction of capital or otherwise), whether in cash, property, securities or a combination thereof, with respect to any shares of its capital stock or directly or indirectly redeem, purchase, retire or otherwise acquire for value any shares of any class of its capital stock or set aside any amount for any such purpose; provided, however, that the Company may complete the Merger.
(d) Limitation on Certain Payments and Prepayments .
(i) Pay in cash any amount in respect of any indebtedness or preferred stock that may at the obligor’s option be paid in kind or in other securities; or
(ii) Optionally prepay, repurchase or redeem or otherwise defease or segregate funds with respect to any indebtedness of the Company, other than for senior indebtedness existing on the date hereof and set forth in Schedule A attached hereto, indebtedness under this Note or the Purchase Agreement.
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Article IV.
Section 4.01 Notices . Notices regarding this Note shall be sent to the parties at the following addresses, unless a party notifies the other parties, in writing, of a change of address:
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If to the Company: |
At the address set forth in the Purchase Agreement |
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If to the Holder: |
At the address set forth in the Purchase Agreement |
Section 4.02 Governing Law . All questions concerning the construction, validity, enforcement and interpretation of this Note shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by any of the Transaction Documents (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, employees or agents) shall be commenced in the state and federal courts sitting in the City of New York, Borough of Manhattan (the “ New York Courts ”). Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the New York Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, or such New York Courts are improper or inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Note and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. Each party hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Note or the transactions contemplated hereby. If either party shall commence an action or proceeding to enforce any provisions of this Note, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its reasonable attorney’s fees and other costs and expenses incurred with the investigation, preparation and prosecution or defense of such action or proceeding.
Section 4.03 Severability . The invalidity of any of the provisions of this Note shall not invalidate or otherwise affect any of the other provisions of this Note, which shall remain in full force and effect.
Section 4.04 Entire Agreement and Amendments . This Note, together with the Purchase Agreement and the Transaction Documents, each as amended by the Omnibus Amendment, represents the entire agreement between the parties hereto with respect to the subject matter hereof and there are no representations, warranties or commitments, except as set forth herein. This Note may be amended only by an instrument in writing executed by the parties hereto.
Section 4.05 Transfer . This Note shall not be transferred or assigned by the Holder except in accordance with the provisions of this Note and the Purchase Agreement, as amended by the Omnibus Amendment.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF , with the intent to be legally bound hereby, the Company as executed this Note as of the date first written above.
TYME INC.
By: /s/ Michael Demurjian
Name: Michael Demurjian
Title: Vice President
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SCHEDULE A
SENIOR AND PARI PASSU INDEBTEDNESS
None.
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Exhibit 10.19
TYME INC.
48 Wall Street - Suite 1100
New York, NY 10005
March 5, 2015
Mr. Christopher Brown
c/o GEM
590 Madison Ave.
36th Floor
New York, NY 10022
Re: Second Amended and Restated 10% Secured Convertible Promissory Note
Dear Chris:
We refer to the Second Amended and Restated 10% Secured Convertible Promissory Note with Original Issue Date of July 11, 2014, in the principal amount of US$2,310,000 (the “Note”), of Tyme Inc. (the “Company”) payable to you. This letter agreement amends the Note as follows:
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(a) |
The term “Pubco” as used in the Note is hereby amended to mean “Tyme Technologies, Inc. (f/k/a Global Group Enterprises Corp.), a Delaware corporation.” |
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(b) |
The term “PPO Securities” as used in the Note is hereby amended to mean “shares of common stock, par value $0.0001 per share, of Pubco (“Pubco Common Stock”). |
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(c) |
The term “Conversion Price” as used in the Note is hereby amended, effective as of the closing of the PPO, to mean a fixed price of $1.00 per share of Pubco Common Stock. |
We and you acknowledge and agree that closings of the Merger and of the PPO for at least $9,100,000 (which includes, for purposes of determining such amount, the aggregate outstanding principal amount of this Note) have each occurred as provided in Section 1.02(a) of the Note. Accordingly, all of the outstanding principal amount of the Note has automatically, without the necessity of any action by you, the Company and/or PubCo, been converted into 2,310,000 shares of Pubco Common Stock on the date hereof, and all accrued but unpaid interest on the Note shall be forgiven in full upon such conversion.
If you agree with the foregoing, please signify your acceptance by signing a copy of this letter in the place indicated below, and return the same to us.
Very truly yours,
TYME INC.
By: /s/ Steven Hoffman
Name: Steven Hoffman
Title: President
Acknowledged and agreed:
/s/ Christopher Brown
Christopher Brown
TYME TECHNOLOGIES, INC.
By: /s/ Steven Hoffman
Name: Steven Hoffman
Title: President
Exhibit 16
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2451 N. McMullen Booth Road Suite.308 Clearwater, FL 33759
Toll fee: 855.334.0934
Fax: 800.581.1908 |
Office of the Chief Accountant
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
March 10, 2015
Dear Sir/Madam:
We have read the statements included in the Form 8-K dated March 11, 2015, of Tyme Technologies, Inc. to be filed with the Securities and Exchange Commission and are in agreement with the statements contained in Item 4.01 insofar as they relate to our audit for November 30, 2014 and 2013 and any subsequent interim period through the date of change in auditor decision by the Board of Directors.
Very truly yours,
/s/ DKM Certified Public Accountants
DKM Certified Public Accountants
Clearwater, Florida
Exhibit 21
SUBSIDIARIES OF TYME TECHNOLOGIES, INC.
Tyme Inc., a Delaware corporation
Luminant Biosciences, LLC, a Delaware limited liability company