Item 1.01 Entry into a Material Definitive Agreement.
Co-Promotion Agreement
On January 7, 2020, Eagle Pharmaceuticals, Inc., or the Company, entered into a
Co-Promotion Agreement with Tyme Technologies Inc., or Tyme, an emerging
biotechnology company developing cancer metabolism-based therapies, including
SM-88 (racemetyrosine) novel oral therapy, or SM-88. Pursuant to the
Co-Promotion Agreement, Tyme granted the Company the non-exclusive right to
co-promote SM-88 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 Co-Promotion Agreement, the Company will provide sales
representatives to cover 25% of Tyme's sales force requirements. The parties
will agree on the initial minimum required number of Company 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, Tyme will pay the Company a fee equal to 15% of net sales of all
SM-88 products sold in the United States in each fiscal quarter. As part of the
Co-Promotion Agreement, Tyme granted the Company the non-exclusive right to use
Tyme's trademarks and copyrights in connection with the promotion of SM-88 in
the United States. The Co-Promotion Agreement also includes a non-competition
provision restricting the Company and a mutual non-solicitation provision, each
lasting until the first anniversary of the Co-Promotion Agreement's termination
date. The Co-Promotion 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
Tyme. Under the Co-Promotion Agreement, Tyme will retain the sole right to
develop and commercialize the product and will remain solely responsible for the
costs of seeking regulatory approval of, manufacturing, selling and distributing
SM-88.
The Co-Promotion Agreement has a ten year term, expiring on January 7, 2030.
Subject to specified notice periods and limitations, either party may terminate
the Co-Promotion Agreement in the event of (i) an uncured material breach by the
other party, (ii) the withdrawal of SM-88 from the market by Tyme 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, Tyme has a buyout right to terminate the Co-Promotion
Agreement and all of the Company's rights thereunder immediately upon a $200
million payment to the Company. The Company may also terminate the Co-Promotion
Agreement for convenience upon 12 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 Co-Promotion
Agreement, is not complete and is qualified in its entirety by reference to the
text of the Co-Promotion Agreement, which the Company expects to file as an
exhibit to the Company's Quarterly Report on Form 10-Q for the quarter ending
March 31, 2020.
Simultaneously with their entry into the Co-Promotion Agreement, the Company and
Tyme also entered into a Securities Purchase Agreement, as further discussed
below.
Securities Purchase Agreement
On January 7, 2020, the Company and Tyme entered into a Securities Purchase
Agreement, or SPA, pursuant to which Tyme issued and sold to the Company
10,000,000 shares of common stock, par value $0.0001 per share, or Common Stock,
of Tyme at a price of $2.00 per share, or the Initial Purchase. The SPA provides
that the Company 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 pivotal trial in pancreatic cancer, as defined by achieving the
primary efficacy endpoint per the protocol, of (A) Part 2 of Tyme'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, or FDA, guidance or communications and in each case that is
adequate for registration submission and meets the primary endpoint as
pre-specified in the protocol provided to FDA incorporating FDA comments, or
(ii) FDA approval of SM-88 in any cancer indication within the United States.
Upon the occurrence of a Milestone Event, subject to certain conditions, the
Company will make a one-time cash payment of $10,000,000 to Tyme and purchase
10,000 shares of Series A Preferred Stock, par value $0.0001, or 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 Tyme's Common Stock for the seven trading days
immediately following announcement of the Milestone Event. The Company'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 the Company retains the right to waive this requirement.
In the event that Tyme 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), the Company will have no
obligation to effect the Milestone Share Purchase (as such term is defined in
the SPA).
The Company 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 Company 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.
In addition, pursuant to the terms of the SPA, the Company and Tyme entered into
a Registration Rights Agreement providing the Company with certain demand and
piggyback registration rights with respect to any shares of Common Stock issued
to the Company under the SPA, any shares of Common Stock issued to the Company
upon the conversion of any Preferred Shares issued to the Company 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 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, and Rule 506 of Regulation D promulgated
thereunder, as the sale and issuance in a transaction by an issuer not involving
any public offering.
The foregoing is a summary description of certain terms of the SPA, is not
complete and is qualified in its entirety by reference to the text of the SPA
which is attached hereto as Exhibit 10.1 and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
10.1 Securities Purchase Agreement, dated January 7, 2020, between the
Company and Tyme.
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