Item 1.01. Entry into a Material Definitive Agreement.
Commercialization and License Agreement
On January 3, 2022, Regnum Corp. ("Regnum"), CytoDyn Inc. ("CytoDyn"), and
SevenScore Pharmaceuticals, LLC ("SevenScore") entered into an Assignment and
Assumption Agreement ("Assignment") of the Commercialization and License
Agreement (the "License Agreement") and a Supply Agreement (the "Supply
Agreement") executed between Vyera Pharmaceuticals, LLC, a Delaware limited
liability company ("Vyera") and CytoDyn on December 17, 2019. Through the
Assignment, Regnum has the exclusive right to commercialize pharmaceutical
preparations containing leronlimab (PRO 140) (the "Product") for treatment of
HIV in humans (the "Field") in the United States (the "Territory"). In exchange
for these agreements SevenScore will receive 4,094,023 shares of Regnum
Pursuant to the terms of the License Agreement, and subject to the conditions
set forth therein, Regnum will bear the cost of, and be responsible for, among
other things, commercializing the Product in the Territory and will use
commercially reasonable efforts to commercialize the Product in the Field in the
Territory. Under the terms of the License Agreement, CytoDyn is permitted to
license the Product outside of the Territory for uses in the Field or outside
the Field or inside the Territory for uses outside of the Field.
Regnum is obligated to pay CytoDyn potential milestone payments upon certain
regulatory and sales-based milestones. In addition, during the term of the
agreement, Regnum is obligated to pay CytoDyn a royalty equal to 50% of the
Regnum's gross profit margin from Product sales (defined in the License
Agreement as "Net Sales") in the Territory. The royalty is subject to reduction
during the Royalty Term after patent expiry and expiry of regulatory
exclusivity. Following expiration of the Royalty Term, Regnum will continue to
maintain non-exclusive rights to commercialize the Product.
The License Agreement will expire upon the expiration of the Royalty Term. The
"Royalty Term" means the period beginning on the date of the first commercial
sale of the Product and ends on the latest of (i) the expiration of the last
valid claim of the patents covering the Product, (ii) ten years after the first
commercial sale of the Product, (iii) the expiration of regulatory exclusivity
for the Product and (iv) the Biosimilar Entry Date (as defined in the License
Agreement). The License Agreement may be terminated by either party for material
breach, upon a party's insolvency or bankruptcy, or for a safety concern or
clinical failure.
Regnum has the right to terminate the License Agreement (i) on or after the
second anniversary of the effective date of the License Agreement upon written
notice to CytoDyn in the event the approval ("Regulatory Approval") by the U.S.
Food and Drug Administration of the Biologics License Application for the
Product for the manufacture and sale of the Product in the Territory for the
Initial Indication (as defined in the License Agreement) has not been received
by such second anniversary, (ii) if Regnum fails to achieve certain aggregate
Net Sales (as defined in the License Agreement) of the Product during the period
beginning on the date of first commercial sale and ending on the date that is
two years from the date of the first commercial sale, and (iii) at Regnum's
convenience following the second anniversary of the first commercial sale of the
Product with 180 days' written notice.
The License Agreement also contains customary representations, warranties, and
covenants by both parties, as well as customary provisions relating to
indemnification, confidentiality, and other matters.
Supply Agreement
Pursuant to the Supply Agreement, CytoDyn has agreed to supply to Regnum the
Product for commercialization under the License Agreement. The Supply
Agreement contains customary representations, warranties, and covenants,
including representations and warranties relating to compliance of the Product
with specifications and applicable governmental rules and covenants with respect
to the rejection of delivered Product and non-conforming Product, product
recalls and regulatory communications.
The Supply Agreement will expire at the expiration of the Royalty Term, provided
that Regnum shall have the right, in its sole discretion, to extend the term of
the Supply Agreement for so long as Regnum agrees to continue to pay CytoDyn an
agreed-upon royalty payment.
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Item 7.01. Regulation FD Disclosure.
Copies of the License Agreement and the Supply Agreement will be filed as
exhibits in an amendment to this Current Report on Form 8-K or in a subsequent
periodic report to be filed under the Securities Exchange Act of 1934.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit Description
10.1 Assignment and Assumption Agreement
10.2 Contribution Agreement
104 Cover Page Interactive Data File (formatted as Inline XBRL)
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