United States securities and exchange commission logo
March 20, 2023
Ryan Preblick
Chief Financial Officer
Indivior PLC
234 Bath Road, Slough, Berks, SL1 4EE
United Kingdom
Re: Indivior PLC
Amendment No. 3 to
Draft Registration Statement on Form 20-F
Submitted March 10,
2023
CIK No. 0001625297
Dear Ryan Preblick:
We have reviewed your amended draft registration statement and
have the following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendment No. 3 to Draft Registration Statement on Form 20-F, submitted
March 10, 2023
Risk Factors
Risks Related to our Group and its Business
Compliance with the terms and conditions of our Corporate Integrity
Agreement..., page 14
1. We note your revised
disclosure on page 15 that the Group's Board of Directors has
reviewed the
effectiveness of the Group's "Compliance Measures." Please clarify whether
"Compliance Measures"
is a defined term and, if so, please revise your disclosure to
define this term in the
first instance. Additionally, we note that you have removed the
following sentence from
the registration statement, "The FTC Order contains notice and
reporting requirements
over a 10 year period related to certain activities, including product
switching conduct and
filing of a Citizen Petition." Please tell us why this disclosure has
Ryan Preblick
Indivior PLC
March 20, 2023
Page 2
been removed.
Risks Related to Intellectual Property
We may incur substantial costs as a result of litigation or other proceedings
relating to patents
and other intellectual property rights..., page 34
2. We note the removal here of your disclosure regarding the U.S. District
Court for the
District of Delaware's ruling in June 2016 that certain claims in your
Patent 8,475,832
were invalid and that you intend to file a notice of appeal in regard to
aspects of that
decision. With a view toward disclosure, please tell us whether the
notice of appeal was
filed and the status of that proceeding. To the extent material, please
include risk factor
disclosure regarding any adverse impact that this ruling may have on
your business.
Business Overview
Research and Development
Long term pipeline
OPNT004 - Drinabant Injection for Acute Cannabinoid Overdose ("ACO"), page 82
3. We note your disclosure that an exclusive global licensing agreement was
signed with
Sanofi for the development and commercialization of drinabant for the
treatment of ACO.
Please revise your disclosure to quantify any milestone payments and
up-front payments
paid to date, and potential milestone and royalty obligations.
Additionally, please file the
agreement with Sanofi as an exhibit to your registration statement or
tell us why you
believe such filing is not required.
You may contact Eric Atallah at 202-551-3663 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Joshua Gorsky at 202-551-7836 or Suzanne Hayes at 202-551-3675 with any
other
questions.
Sincerely,
FirstName LastNameRyan Preblick
Division of
Corporation Finance
Comapany NameIndivior PLC
Office of Life
Sciences
March 20, 2023 Page 2
cc: Michael Levitt, Esq.
FirstName LastName