Item 1.01 Entry into a Material Definitive Agreement.
On January 7, 2020, the Company entered into a Co-Promotion Agreement (the
"Agreement") with Eagle Pharmaceuticals, Inc. ("Eagle"), a pharmaceutical
company focused on developing and commercializing innovative and differentiated
injectable products that address the shortcomings, as identified by physicians,
pharmacists and other stakeholders, of existing commercially successful
injectable products. Pursuant to the Agreement, the Company granted Eagle the
non-exclusive right to co-promote SM-88 (racemetyrosine), the Company's novel
oral therapy, to specified medical professionals in the United States for the
treatment of any and all indications for which SM-88 is approved in humans in
the United States.
Pursuant to the Agreement, Eagle will provide sales representatives to cover 25%
of the Company's sales force requirements. The parties will agree on the initial
minimum required number of Eagle sales representatives prior to filing the new
drug application for SM-88. Commencing with the fiscal quarter following the
first commercial sale of SM-88 in the United States, the Company will pay Eagle
a fee equal to fifteen percent of net sales of all SM-88 products sold in the
United States in each fiscal quarter. As part of the Agreement, the Company
granted Eagle the non-exclusive right to use the Company's trademarks and
copyrights in connection with the promotion of SM-88 in the United States. The
Agreement also includes a non-competition provision restricting Eagle and a
mutual non-solicitation provision, each lasting until the first anniversary of
the Agreement's termination date. The Agreement also contains customary
provisions regarding payment, confidentiality and indemnification.
The co-promotion of SM-88 in the United States will be supervised by a joint
sales operations committee composed of representatives from the Company and
Eagle. Under the Agreement, the Company will retain the sole right to the
strategy for development and commercialization of the product and will remain
solely responsible for the costs of seeking regulatory approval of,
manufacturing and distributing SM-88.
The Agreement has a ten year term, expiring on January 7, 2030. Subject to
specified notice periods and limitations, either party may terminate the
Agreement in the event of (i) an uncured material breach by the other party,
(ii) the withdrawal of SM-88 from the market by the Company for certain
specified reasons, or (iii) the filing or institution of bankruptcy,
reorganization, liquidation or receivership proceedings with respect to the
other party. In addition, the Company has a buyout right to terminate the
Agreement and all Eagle's rights thereunder immediately upon a $200 million
payment to Eagle. Eagle may also terminate the Agreement for convenience upon
twelve months' written notice given any time after the second anniversary of the
first commercial sale of SM-88 product in the United States.
The foregoing is a summary description of certain terms of the Agreement, is not
complete and is qualified in its entirety by reference to the text of the
Agreement, which the Company expects to file as an exhibit to the Company's
Annual Report on Form 10-K for the year ending March 31, 2020.
Simultaneously with their entry into the Agreement, the Company and Eagle also
entered into a securities purchase agreement and a registration rights
agreement, as further discussed in Item 3.02 below, the descriptions of which
are incorporated herein to this Item 1.01.
Item 3.02 Unregistered Sales of Equity Securities.
Securities Purchase Agreement
On January 7, 2020, the Company and Eagle entered into a Securities Purchase
Agreement (the "SPA"), pursuant to which the Company issued and sold to Eagle
10,000,000 shares of common stock, par value $0.0001 per share ("Common Stock"),
of the Company (the "Initial Purchase") at a price of $2.00 per share. The SPA
provides that Eagle will, subject to certain conditions, make an additional cash
payment and an additional purchase of preferred stock upon the occurrence of a
Milestone Event, which is defined as the earlier of (i) the successful
completion of a
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pivotal trial in pancreatic cancer, as defined by achieving the primary efficacy
endpoint per the protocol, of (A) Part 2 of the Company's TYME-88-Panc clinical
trial or (B) an arm of the Precision PromiseSM clinical trial with the
Pancreatic Cancer Action Network using SM-88, in either case, with any such
amendments or changes to the protocol resulting from U.S. Food and Drug
Administration ("FDA") guidance or communications and in each case that is
adequate for registration submission and meets the primary endpoint as
prespecified in the protocol provided to the FDA incorporating FDA comments, or
(ii) FDA approval of SM-88 in any cancer indication within the United States
(the "Milestone Event"). Upon the occurrence of a Milestone Event, subject to
certain conditions, Eagle will make a one-time cash payment of $10,000,000 to
the Company and purchase 10,000 shares of Series A Preferred Stock, par value
$0.0001 (the "Preferred Shares"), at a price of $1,000 per share. The Preferred
Shares will be convertible into Common Stock and will have a conversion ratio
equal to the quotient of $1,000 divided by an amount equal to 1.15 times the
average of the volume weighted average price of the Company's Common Stock for
the seven trading days immediately following announcement of the Milestone Event
(the "Conversion Ratio"). Eagle's obligations to effectuate these transactions
will terminate if the Milestone Event does not occur on or prior to the five
year anniversary of the SPA, although Eagle retains the right to waive this
requirement. The rights of the Series A Preferred Stock are further defined and
discussed in Item 3.03 below. The disclosure set forth below in Item 3.03
relating to the Company's Certificate of Designation of Series A Convertible
Preferred Stock is incorporated herein to this Item 3.02.
In the event that the Company consummates a fundamental corporate transaction,
including a sale of all or substantially all of its assets, prior to the
Milestone Closing (as such term is defined in the SPA), Eagle will have no
obligation to purchase the Preferred Shares.
Eagle has agreed to customary "lock-up" and "standstill" restrictions, each
ending at the earlier of the date that is (i) three months after the occurrence
of the Milestone Event or (ii) the three year anniversary of the SPA (the
"Lockup Period"). It has also agreed to execute a customary "lock-up" agreement
in connection with any public offering of shares of Common Stock or securities
exchangeable or convertible into shares of Common Stock that is consummated on
or prior to the third anniversary of the date of the SPA.
The Common Stock issued and sold in connection with the Initial Purchase were,
and any issuance of Preferred Shares at the subsequent closing will be, made in
reliance on an exemption from registration under Section 4(a)(2) of the
Securities Act of 1933, as amended (the "Securities Act"), and Rule 506 of
Regulation D promulgated thereunder, as the sale and issuance in a transaction
by an issuer not involving any public offering.
Registration Rights Agreement
In connection with the SPA, the Company simultaneously entered into a
registration rights agreement (the "Registration Rights Agreement") with Eagle.
In the Registration Rights Agreement, the Company has provided Eagle with demand
registration rights such that the Company has agreed to prepare and file a
registration statement with the Securities and Exchange Commission (the "SEC"),
any time after the expiration of the Lockup Period, within 30 days of either
(i) Eagle's receipt of written notice from the Company that the Company has
determined Eagle is an affiliate of the Company under Rule 144, or (ii) any date
that the Company has not filed all reports required under Section 13 or 15(d) of
the Securities Exchange Act of 1934, as amended, for the preceding 12 months
(the "Trigger Date"), in either case, to the extent such event happens after the
expiration of the Lockup Period. Such registration statement would register the
resale of shares of Common Stock issued to Eagle under the SPA (including any
shares of Common Stock issued upon the conversion of any Preferred Shares issued
to Eagle under the SPA) and any Common Stock issued as a dividend or other
distribution with respect to, or in replacement of, the foregoing securities.
The Company has agreed to use commercially reasonable efforts to cause the
. . .
Item 3.03 Material Modification to Rights of Security Holders.
The rights, preferences and privileges of the Series A Convertible Preferred
Stock (the "Series A Preferred Stock") are set forth in a Certificate of
Designation of Series A Convertible Preferred Stock (the "Certificate of
Designation"), which the Company filed with the Delaware Secretary of State on
January 7, 2020.
Each share of Series A Preferred Stock is convertible, at any time and from time
to time from and after the Issuance Date, at the option of the holder, into a
number of shares of Common Stock equal to the Conversion Ratio.
The holder, however, will be prohibited from converting shares of Series A
Preferred Stock into shares of Common Stock if, as a result of such conversion,
the holder, together with its affiliates, would own more than 9.98% of the total
number of shares of the Company's Common Stock outstanding immediately after
giving effect to the issuance of Common Stock pursuant to such conversion. In
the event of the Company's liquidation, dissolution, or winding up, holders of
Series A Preferred Stock will receive a payment equal to $0.0001 per share of
Series A Preferred Stock, plus an additional amount equal to any dividends
declared but unpaid on such shares, before any proceeds are distributed to the
holders of Common Stock. Shares of Series A Preferred Stock will generally have
no voting rights, except as required by law and except that the affirmative vote
of holders of a majority of the outstanding Series A Preferred Stock will be
required to amend the powers, preferences or rights of the Series A Preferred
Stock or the Certificate of Designation, increase the number of authorized
shares of Series A Preferred Stock or enter into an agreement with respect to
the foregoing. Holders of the Series A Preferred Stock will not be entitled to
receive any dividends, unless and until specifically declared by the Company's
board of directors, and will rank:
• senior to all of the Company's Common Stock;
• senior to any class or series of the Company's capital stock created
specifically ranking by its terms junior to the Series A Preferred Stock;
• on parity with any class or series of capital stock of the Company
created specifically ranking by its terms on parity with the Series A
Preferred Stock; and
• junior to any class or series of the Company's capital stock hereafter
created specifically ranking by its terms senior to the Series A
Preferred Stock;
in each case, as to distributions of assets upon the Company's liquidation,
dissolution or winding up, whether voluntarily or involuntarily.
The foregoing is a summary description of certain terms of the Certificate of
Designation, is not complete and is qualified in its entirety by reference to
the text of the Certificate of Designation, which is attached hereto as Exhibit
3.1 and incorporated herein by reference.
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal
Year.
The disclosure set forth above relating to the Company's Certificate of
Designation is incorporated herein to this Item 5.03.
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Item 8.01 Other Events.
On January 7, 2020, the Company issued a joint press release with Eagle
announcing the transactions described above.
A copy of the full text of the press release referenced above is filed as
Exhibit 99.1 to this Current Report on Form 8-K .
Item 9.01 Financial Statements and Exhibits.
Set forth below is a list of the exhibits to this Current Report on Form 8-K.
Exhibit
Number Description
3.1 Certificate of Designation of Series A Convertible Preferred Stock,
dated January 7, 2020.
4.1 Registration Rights Agreement, dated January 7, 2020, between the
Company and Eagle.
10.1 Securities Purchase Agreement, dated January 7, 2020, between the
Company and Eagle. *
99.1 Joint Press Release, dated January 7, 2020.
* Certain exhibits have been omitted and the Company agrees to furnish
supplementally to the SEC a copy of any omitted exhibits upon request.
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