Indivior Pharmaceuticals, Inc.

ANDA means an abbreviated new drug application filed with the FDA.

Aquestive means Aquestive Therapeutics, a third-party CMO that manufactures and supplies SUBOXONE Film exclusively for us.

BARDA meansthe U.S. Biomedical Advanced Research and Development Authority.

BMAT means buprenorphine-medically assisted treatment, the process to treat OUD patients treated with Buprenorphine (as opposed to methadone or other medicines).

CHMP means the Committee for Medicinal Products for Human Use, which is the relevant scientific committee in most cases with which one files marketing authorization applications under the EMA.

CIA refers to the Corporate Integrity Agreement which Indivior Inc. entered into in July 2020 with HHS-OIG. The five-year CIA requires, among other things, that Indivior Inc. implement measures designed to ensure compliance with the statutes, regulations, and written directives of U.S. Medicare, U.S. Medicaid, and all other U.S. federal healthcare programs, as well as with the statutes, regulations, and written directives of the U.S. Food and Drug Administration.

CMO means a contract manufacturing organization.

CMS means the Centers for Medicare and Medicaid Services.

CRO means a contract research organization, a third-party that performs clinical research on our behalf.

Curia means Curia Burlington, Inc. or its affiliate Curia New Mexico, LLC, as the context requires, a third-party CMO who manufactures SUBLOCADE exclusively for us.

DEA means the United States Drug Enforcement Administration.

Demerger means the acquisition of the specialty pharmaceutical business unit of RB by Indivior PLC, which became effective on December 23, 2014.

Demerger Agreement refers to that certain agreement entered into on November 17, 2014 between Indivior PLC and RB, Reckitt Benckiser Healthcare ( U.K.) Limited, RB Pharmaceuticals Limited and RBP Global Holdings Limited to affect the Demerger and to govern the relationship between RB and Indivior PLC following the Demerger.

DOJ means the U.S. Department of Justice.

EMA means the European Medicines Agency.

EU means the European Union.

Exchange Act means the U.S. Securities Exchange Act of 1934, as amended.

FCP means our Fine Chemical Plant at which we manufacture the active pharmaceutical ingredient buprenorphine.

FDA means the U.S. Food and Drug Administration.

FFDCA means the Federal Food, Drug, and Cosmetic Act under which the FDA derives its authority to regulate pharmaceuticals.

FTC means the U.S. Federal Trade Commission.

FTC Order means that certain Stipulated Order for Permanent Injunction and Equitable Monetary Relief in the United States District Court for the Western District of Virginia, Abingdon, between the FTC and Indivior Inc. entered November 20, 2020. As part of the resolution with the FTC and as detailed in the text of the FTC Order, for a ten-year period Indivior Inc. is required to make specified disclosures to the FTC and is prohibited from certain conduct.

Group means Indivior Pharmaceuticals, Inc. and, as the context requires, its consolidated subsidiaries.

HCl means buprenorphine hydrochloride, the active pharmaceutical ingredient used in the formulation of SUBLOCADE long-acting injection, SUBOXONE Film, SUBUTEX Tablet, and SUBOXONE Tablet.

HCP means healthcare provider, and may refer to a physician, physician’s assistant, or nurse, under appropriate circumstances.

HHS-OIG means the Health and Human Services Office of the Inspector General.

HMRC means His Majesty's Revenue and Customs, the taxing authority in the U.K.

ICFR means internal control over financial reporting

ICH means International Conference on Harmonization, which publishes guidelines by which clinical trials of medicinal products in the EU must be conducted.

IND means an investigational new drug application filed with the FDA.

Indivior Inc. is an indirect wholly owned United States subsidiary of the Company and directly or through its subsidiaries the entity that commercializes our products and runs the Company’s operations in the U.S.

IPR&D means in-process research and development.

LAI means long-acting injectable.

MAT means medication-assisted treatment.

MHRA means the U.K. Medicines and Healthcare products Regulatory Agency.

MOUD means medication for opioid use disorder, which is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders. Medications used in MOUD are approved by the FDA and MOUD programs are clinically driven and tailored to meet each patient’s needs.

Nasdaq means the Global Select Market of The Nasdaq Stock Market LLC.

NDA means a new drug application submitted to the FDA for review, which generally must include data from at least two well-controlled clinical trials demonstrating safety and effectiveness, as well as characterization of the drug product and a description of the manufacturing process, controls and facilities.

Note Purchase Agreement means the Company's 2024 debt agreement. See Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 12. Debt.

NPV means net present value.

OHS means an Organized Health System, which is a network of physician organizations (such as a hospital system) that provides or manages the provision of a coordinated continuum of healthcare services to a defined population.

Opiant means Opiant Pharmaceuticals Inc., a specialty pharmaceutical company developing medicines for addictions and drug overdose. We completed our acquisition of Opiant on March 2, 2023.

Opioid MDL means the multi-district litigation in which the Company was named as a defendant in more than 400 civil lawsuits alleging that manufacturers, distributors, and retailers of opioids engaged in a longstanding practice to market opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market share, or alleging individual personal injury claims.

OPVEE, means OPVEE® (nalmefene) nasal spray, whichis an opioid receptor antagonist approved by the FDA to reverse opioid overdose. OPVEE is indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. OPVEE (nalmefene) nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. OPVEE (nalmefene) nasal spray is not a substitute for emergency medical care.

OUD means opioid use disorder.

Raleigh Manufacturing Facility means theapproximately 80,000 square foot facility in Raleigh NC which we purchased in November 2023 to provide additional manufacturing capacity.

RB means Reckitt, f/k/a Reckitt Benckiser Group PLC.

RB Group means RB and its subsidiaries.

REMS means a risk evaluation and mitigation strategy. The FDA has the authority to require the manufacturer to provide a REMS that is intended to ensure that the benefits of a drug product (or class of drug products) outweigh the risks of harm.

Resolution Agreement refers to an agreement by and among Indivior PLC, Indivior Inc., the United States Attorney’s Office for the Western District of Virginia, and the United States Department of Justice’s Consumer Protection Branch made as of July 24, 2020 by which the Company settled with DOJ, the FTC, and U.S. state attorneys general the criminal and civil liability in connection with a multi-count indictment brought in April 2019 by a grand jury in the Western District of Virginia, a civil lawsuit joined by the DOJ in 2018, and an FTC investigation.

Rest of World means all countries globally where Indivior sells or operates, excluding the United States and, where the U.K. is disclosed separately, the U.K.

SEC means the United States Securities and Exchange Commission.

Securities Act means the U.S. Securities Act of 1933, as amended.

SOFR means the Secured Overnight Financing Rate benchmark interest rate published by the Federal Reserve Bank of New York.

SUD means substance use disorder.

U.S. GAAP means accounting principles generally accepted in the United States of America.