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, irrevocable, non-exclusive, paid-up, royalty-free, 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 Program
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.
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