The Manufacturing Agreement, unless earlier terminated, will
continue until December 31, 2030, and will be automatically
extended for successive two-year periods unless either the
Company or Catalent provides the other party with at least
18-months’ prior written
notice of non-renewal.
Either party may terminate the Manufacturing Agreement by written
notice under certain circumstances, including material breach by
the other party (subject to specified cure periods) or the
insolvency of the other party. The Company may also terminate the
Manufacturing Agreement upon certain specified regulatory events
and for convenience upon 180 days’ prior written notice, subject to
payment of a specified termination fee.
The Company will agree to purchase from Catalent at least
$16 million of Product in 2021 (pro-rated for a partial year) and
$18 million of Product from 2022 through 2030 (and an
additional amount in the last year in the case of such a
proration), subject to reduction in certain cases. The Company will
be obligated to provide Catalent with a rolling 24-month forecast of production
requirements, a portion of which will be considered a binding, firm
order by the Company. Catalent will be required to reserve
sufficient capacity for the manufacture of a specified amount of
Product per year, with such capacity reservation to be reviewed on
an annual basis.
In addition, the Company will grant to Catalent a non-exclusive, paid-up, royalty-free, non-transferrable, non-assignable, non-sublicensable license to certain of
its intellectual property in order to enable the manufacture of the
Product. Catalent will grant to the Company a worldwide, perpetual,
assignable and sublicensable license to certain of its intellectual
property as reasonably necessary to allow the Company to
commercialize the Product.
The Manufacturing Agreement will contain customary representations,
warranties and covenants, including with respect to the ownership
of any intellectual property created pursuant to the Manufacturing
Agreement, as well as provisions relating to ordering, payment and
shipping terms, regulatory matters, reporting obligations,
indemnity, confidentiality and other matters.
The foregoing description of the Manufacturing Agreement does not
purport to be complete and is qualified in its entirety by
reference to such document, which will be filed as an exhibit to a
future periodic or current report of the Company.
At The Market Offering
On January 13, 2021, the Company entered into an At The Market
Offering Agreement (the “ATM Agreement”) with H.C.
Wainwright & Co., LLC (the “Agent”) pursuant to which the
Company may offer and sell from time to time to or through the
Agent shares of the Company’s common stock, $0.001 par value per
share (“Common Stock”).
The offer and sale of shares of Common Stock through the Agent will
be made pursuant to the Registration Statement on Form S-3 (File No. 333-248738), which was
declared effective by the Securities and Exchange Commission (the
“SEC”) on September 17, 2020, and a related prospectus
supplement filed with the SEC on the date hereof pursuant to which
the Company is offering shares of its Common Stock having an
aggregate offering price of up to $15,250,000.
Under the ATM Agreement, the Company may offer and sell shares of
Common Stock through the Agent by any method deemed to be an “at
the market offering” as defined in Rule 415 of the Securities Act
of 1933, as amended, including sales made directly on or through
The Nasdaq Global Select Market, sales made to or through a market
maker other than on an exchange or otherwise, directly to the Agent
as principal, in negotiated transactions at market prices
prevailing at the time of sale or at prices related to such
prevailing market prices, and/or in any other method permitted by
law. If the Company elects to utilize the ATM Agreement, the Agent
would be obligated to use commercially reasonable efforts
consistent with its normal trading and sales practices and
applicable law and regulations to sell such shares in accordance
with the Company’s instructions (including as to price, time or
size limit or other parameters or conditions the Company may
impose). The Company will pay the Agent a commission of 3.0% of the
gross sales price of any shares of Common Stock sold under the ATM
Agreement. The Company has also provided the Agent with customary
indemnification rights and has agreed to reimburse the Agent for
certain specified expenses up to $50,000 plus up to $2,500 per
quarter while the ATM Agreement remains in effect.