Item 1.01 Entry into a Material Definitive Agreement.
On September 19, 2018, Opiant Pharmaceuticals, Inc. (the “
Company
”) entered into a contract (“
Contract
”) with the Biomedical Advanced Research and Development Authority (“
BARDA
”), which is part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response, to accelerate the Company’s development of OPTN003, its lead product candidate. OPTN003, nasal nalmefene, is a potent, long-acting opioid antagonist currently in development for the treatment of opioid overdose. The Contract will provide potential funding up to a maximum of approximately $4.6 million and cover activities related to a potential New Drug Application submission for OPTN003 with the Food and Drug Administration. The Contract will provide approximately $611,000 for the project through September 30, 2019, with the balance to be funded over the following two years, subject to satisfactory project progress, availability of funds and certain other conditions.
A copy of the Contract is attached to this Current Report on Form 8-K and is incorporated herein by reference. The description of the Contract provided herein is qualified in its entirety by reference to the terms of the Contract as set forth in Exhibit 10.86.
Item 8.01 Other Events
On September 14, 2018, the Company and Adapt Pharma, Inc. (“
Adapt
”) received notice from Perrigo UK FINCO Limited Partnership (“
Perrigo
”), pursuant to 21 U.S.C. ß 355(j)(2)(B)(ii) (the “
Notice Letter
”), that Perrigo had filed an Abbreviated New Drug Application (“
ANDA
”) with the United States Food and Drug Administration (“
FDA
”) seeking regulatory approval to market a generic version of
NARCAN®
(naloxone hydrochloride) Nasal Spray before the expiration of U.S. Patent Nos. 9,211,253 (the “
‘
253 Patent
” ), 9,468,747 (the “
‘
747 Patent
” ), 9,561,177 (the “
‘
177 Patent
” ), 9,629,965 (the “
‘
965 Patent
” ) and 9,775,838 (the “
‘
838 Patent
” ). The
‘
253,
‘
747,
‘
177,
‘
965 and
‘
838 patents are listed with respect to
NARCAN®
in the FDA's Approved Drug Products with Therapeutic Equivalents Evaluation publication (commonly referred to as the “
Orange Book
”) and expires on March 16, 2035. Perrigo's Notice Letter asserts that its generic product will not infringe the
‘
253,
‘
747,
‘
177,
‘
965 and
‘
838 patents or that the
‘
253,
‘
747,
‘
177,
‘
965 and
‘
838 patents are invalid or unenforceable. Pursuant to an Exclusive License Agreement, entered into on December 14, 2014, as amended, the Company has exclusively licensed the
‘
253,
‘
747,
‘
177,
‘
965 and
‘
838 patents to Adapt. The Company and Adapt are evaluating Perrigo's Notice Letter.
The Company has full confidence in its intellectual property portfolio related to
NARCAN®
. The Company and Adapt may receive additional Notice Letters from other companies seeking to market generic versions of
NARCAN®
in the future and, after evaluation, Adapt may commence patent infringement lawsuits against such companies.