Common use of Notice to Health Care Providers and Entities Clause in Contracts

Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by Indivior’s Chief Executive Officer containing the language set forth below: As you may be aware, Xxxxxxxx recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with Indivior’s sales and promotion of Suboxone Film. This letter provides you with additional information about the global settlement, explains Indivior’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges that Indivior engaged in certain unlawful and improper conduct relating to the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to Indivior Corporate Integrity Agreement As part of the global settlement, Indivior also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Indivior’s representatives to Indivior’s Compliance organization or the FDA using the information set out below. Please call Indivior at [insert toll free number] or visit us at [insert web link] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] or visit us at [insert web address] to report any instances in which you believe that an Indivior representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior products to [insert toll free number]. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

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Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by Indivior’s Chief Executive Officer containing the language set forth below: As you may be aware, Xxxxxxxx recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with Indivior’s sales and promotion of Suboxone Film. This letter provides you with additional information about the global settlement, explains Indivior’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges that Indivior engaged in certain unlawful and improper conduct relating to the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior agreed to plead Indivior Corporate Integrity Agreement guilty to criminal charges of making materially false statements relating to health care matters and agreed to pay almost $300 million in criminal fines and forfeiture. In addition, to resolve liability under the Federal False Claims Act, Indivior Corporate Integrity Agreement agreed to enter into a civil settlement agreement and pay $300 million. Further, Xxxxxxxx has agreed to a stipulated injunction with the Federal Trade Commission. More information about this settlement may be found at the following: [Indivior shall include a link to the USAO, OCL, and Indivior websites in the letter.] As part of the global settlement, Indivior also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Indivior’s representatives to Indivior’s Compliance organization or the FDA using the information set out below. Please call Indivior at [insert toll free number] or visit us at [insert web link] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] or visit us at [insert web address] to report any instances in which you believe that an Indivior representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior products to [insert toll free number]. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC)

Notice to Health Care Providers and Entities. Within 30 90 days after the Effective Date, Indivior AstraZeneca shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance send, by OIG)first class mail, postage prepaid and return receipt requested, a copy of a letter signed by Indivior’s Chief Executive Officer notice containing the language set forth belowbelow to all HCPs and HCIs that AstraZeneca currently details. This notice shall be dated and shall be signed by AstraZeneca’s President. The body of the letter shall state the following: As you may be aware, Xxxxxxxx AstraZeneca recently entered into a civil, criminal, civil and administrative settlement with the United States and individual states in connection with Indivior’s sales and the promotion of Suboxone Filmone of its products. This letter provides you with additional information about the global settlement, explains IndiviorAstraZeneca’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges alleged that Indivior engaged in AstraZeneca unlawfully promoted the drug Seroquel for certain unlawful and improper conduct relating to uses not approved by the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to Indivior Food & Drug Corporate Integrity Agreement AstraZeneca Administration (FDA). To resolve these matters, although AstraZeneca did not admit any wrongful conduct, AstraZeneca agreed to pay more than $520 million to the Federal Government and State Medicaid programs. More information about this settlement may be found at the following: [AstraZeneca shall include a link to the USAO, and AstraZeneca websites in the letter.] As part of the global federal settlement, Indivior AstraZeneca also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior AstraZeneca agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Indivior’s AstraZeneca's representatives to IndiviorAstraZeneca’s U.S. Compliance organization Department or the FDA using the information set out belowFDA. Please call Indivior or email AstraZeneca at 1-800-TBD or [AstraZeneca shall insert toll free number] website or visit us at [insert web linke-mail address in the letter] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] above or visit us at [insert web address] to report any instances in which you believe that an Indivior a AstraZeneca representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative such instances to the FDA’s Office Division of Prescription Drug Promotion Marketing, Advertising, and Communications at 000-000- 000-0000. You should direct medical questions or concerns about Indivior the products to [insert toll free numbername and telephone number for contact line]. The U.S. Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, AstraZeneca shall provide to the OIG a summary of the calls and messages received.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by Indivior’s Chief Executive Officer containing the language set forth below: As you may be aware, Xxxxxxxx Indivior recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with Indivior’s sales and promotion of Suboxone Film. This letter provides you with additional information about the global settlement, explains Indivior’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges that Indivior engaged in certain unlawful and improper conduct relating to the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to Indivior Corporate Integrity Agreement As part of the global settlement, Indivior also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Indivior’s representatives to Indivior’s Compliance organization or the FDA using the information set out below. Please call Indivior at [insert toll free number] or visit us at [insert web link] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] or visit us at [insert web address] to report any instances in which you believe that an Indivior representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior products to [insert toll free number]. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Notice to Health Care Providers and Entities. Within 30 90 days after the Effective Date, Indivior Amgen shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance send, by OIG)first class mail, postage prepaid with delivery confirmation, a copy of a letter signed by Indivior’s Chief Executive Officer notice containing the language set forth belowbelow to all HCPs and HCIs that Amgen currently details. This notice shall be dated and shall be signed by Xxxxx’s Chief Executive Officer. The body of the letter shall state the following: Corporate Integrity Agreement Amgen Inc. As you may be aware, Xxxxxxxx Amgen recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with IndiviorAmgen’s sales and promotion of Suboxone Filmseveral of its products. This letter provides you with additional information about the global settlement, explains IndiviorXxxxx’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges alleged that Indivior Amgen unlawfully promoted Aranesp® (darbepoetin alfa), Enbrel® (etanercept), and Neulasta® (pegfilgrastim) for uses not approved by the Food & Drug Administration (FDA) and that Amgen engaged in certain unlawful and other improper conduct relating to these and other Amgen drugs, including EPOGEN® (epoetin alfa), NEUPOGEN® (filgrastim), and Sensipar® (cinacalcet), which constituted violations of the False Claims Act. To resolve these matters, Amgen pled guilty to one-count misdemeanor criminal violation of the Federal Food, Drug & Cosmetic Act (FDCA) relating to the promotion of Suboxone Film. To address criminal liabilityAranesp, a subsidiary of Indivior and agreed to plead guilty pay a combined criminal fine and forfeiture amount of $150 million. In addition, Amgen and the Federal and State Governments entered into civil settlements to criminal charges of making materially false statements relating resolve False Claims Act allegations, pursuant to Indivior Corporate Integrity Agreement which Amgen agreed to pay approximately $612.1 million to the Federal Government and State Medicaid programs. More information about this settlement may be found at the following: [Amgen shall include a link to the USAO, OCL, and Amgen websites in the letter.] As part of the global settlement, Indivior Amgen also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.htmlxxxxx://xxx.xxx.xxx/compliance/corporate- integrity-agreements/cia-documents.asp. Under this agreement, Indivior Amgen agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorXxxxx’s representatives to IndiviorAmgen’s Compliance organization or the FDA using the information set out below. Please call Indivior Amgen at [insert toll free number] XXXX or visit us at [insert name of web link] if you Corporate Integrity Agreement Amgen Inc. have questions about the settlement referenced above. Please call Indivior Amgen at [insert toll free number] XXXX or visit us at [insert name of web addresslink] to report any instances in which you believe that an Indivior Amgen representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Amgen Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior Amgen products to [insert toll free number]XXXX. The Compliance Officer CCO (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, Amgen shall provide to the OIG a summary of the calls and messages received.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Notice to Health Care Providers and Entities. Within 30 90 days after the Effective Date, Indivior Novartis shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance send, by OIG)first class mail, postage prepaid and return receipt requested, a copy of a letter signed by Indivior’s Chief Executive Officer notice containing the language set forth belowbelow to all U.S.-based HCPs and HCIs that Novartis currently details. This notice shall be dated and shall be signed by Novartis’ President. The body of the letter shall state the following: As you may be aware, Xxxxxxxx Novartis Pharmaceuticals Corporation (NPC) recently entered into a global civil, criminal, and administrative settlement with the United States and individual states in connection with Indivior’s sales the promotion and promotion use of Suboxone Filmseveral of its products. This letter provides you with additional information about the global settlement, explains IndiviorNPC’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges alleged that Indivior engaged NPC unlawfully promoted the drugs Trileptal, Diovan, Zelnorm, Sandostatin, Exforge, and Tekturna. With respect to Trileptal, the Government alleged that NPC promoted the drug for uses not approved by the Food & Drug Administration (FDA). Novartis pled guilty to a misdemeanor criminal violation of the Federal Food, Drug & Cosmetic Act (FDCA) in certain unlawful connection with Trileptal and improper conduct relating agreed to pay a fine of $185 million. With respect to Trileptal, Diovan, Zelnorm, Sandostatin, Exforge, and Tekturna, the Government alleged that Novartis violated the False Claims Act. Novartis entered into a civil settlement to resolve those allegations pursuant to which Novartis agreed to pay $237.5 million to the promotion of Suboxone FilmFederal Government and State Medicaid programs. To address criminal liabilityMore information about this settlement may be found at the following: [Novartis shall include a link to the USAO, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to Indivior Corporate Integrity Agreement OCL, and Novartis websites in the letter.] As part of the global federal settlement, Indivior NPC also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior NPC agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices Novartis Pharmaceuticals Corporation Corporate Integrity Agreement by IndiviorNPC’s representatives to IndiviorNPC’s Ethics & Compliance organization Department or the FDA using Food & Drug Administration (FDA). In addition, as part of our agreement with the information set out belowgovernment, we will disclose certain payments or transfers of value to U.S.-based Healthcare Professionals. This data will be posted in a prominent position on our website in an easily accessible and searchable list for public viewing. Please call Indivior NPC at [insert toll free number] 1-800-xxx-xxx or visit us at [insert name of web link] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] above or visit us at [insert web address] to report any instances in which you believe that an Indivior a Novartis representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative such instances to the FDA’s Office Division of Prescription Drug Promotion Marketing, Advertising, and Communications at 000301-000-0000796- 1200. You should direct medical questions or concerns about Indivior the products to [insert toll free number]1-800-526-7736. The Chief Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, Novartis shall provide to the OIG a summary of the calls and messages received.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Notice to Health Care Providers and Entities. ‌‌‌ Within 30 days after the Effective Date, Indivior ACell shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by IndiviorXXxxx’s Chief Executive Officer containing the language set forth below: below:‌‌‌ As you may be aware, Xxxxxxxx XXxxx recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with IndiviorACell’s promotion and sales and promotion of Suboxone Filmseveral of its products. This letter provides you with additional information about the global settlement, explains IndiviorXXxxx’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges that Indivior engaged in certain unlawful and improper conduct relating to the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior XXxxx has agreed to plead guilty to criminal charges of making materially false statements a misdemeanor under the Federal Food, Drug and Cosmetic Act relating to Indivior Corporate Integrity Agreement its failure to properly implement a recall in 2012. In addition, ACell entered into a separate civil settlement relating to allegations that XXxxx engaged in improper sales and marketing practices. To resolve those allegations, XXxxx agreed to pay approximately $15 million to federal and state health care programs. More information about this settlement may be found at the following: [The notice shall include a link to the USAO, OCL, and ACell websites in the letter.] As part of the global settlement, Indivior XXxxx also entered into a five-year corporate integrity agreement with the Office of Inspector General of the the‌‌ U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under xxxx://xxx.xxx.xxx/fraud/cia/index.html.Under this agreement, Indivior ACell agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorACell’s representatives to IndiviorACell’s Compliance organization or the FDA using the information set out below. Please call Indivior ACell’s Ethics and Integrity Helpline at [insert toll free number] 0-000-000-0000 or visit us at [insert web link] xxx.xxxxxxxxxx-xxxxxxxx.xxx/xxxxx if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] above or visit us at [insert web address] to report any instances in which you believe ACell, Inc. Corporate Integrity Agreement that an Indivior ACell representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior ACell Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior ACell products to [insert toll free number]0-000-000-0000 or visit us at www.lighthouse- xxxxxxxx.xxx/xxxxx.‌‌‌‌ The notice shall remain posted for a period of at least 180 days. The Compliance Officer CCO (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, ACell shall provide to OIG a summary of the calls and messages received.

Appears in 1 contract

Samples: Integrity Agreement

Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior Insys shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by IndiviorInsys’s Chief Executive Officer containing the language set forth below: below:‌‌‌ As you may be aware, Xxxxxxxx Insys recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with IndiviorInsys’s sales and promotion of Suboxone FilmSubsys. This letter provides you with additional information about the global settlement, explains IndiviorInsys’s commitments going forward, and provides you with access to information about those commitments. In general terms, the The Government alleges that Indivior Insys engaged in certain several types of unlawful and improper conduct relating to the promotion of Suboxone FilmSubsys. To address criminal liability, Insys agreed to enter a Deferred Prosecution Agreement and pay $30 million in criminal fines and forfeiture. A subsidiary of Indivior Insys agreed to plead guilty to criminal charges charges. In addition, to resolve liability under the Federal False Claims Act (including the alleged payment of making materially false statements relating kickbacks), Insys agreed to Indivior Corporate Integrity Agreement enter a civil settlement and pay $195 million. More information about the criminal and civil resolutions may be found at the following: [Insys shall include a link to the USAO, OCL, and Insys websites in the letter.] As part of the global settlement, Indivior Insys also entered into a five-year corporate integrity agreement and conditional exclusion release with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity That agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.htmlxxxx://xxx.xxx.xxx/fraud/CIA/index.html. Under this the agreement, Indivior Insys agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorInsys’s representatives to IndiviorInsys’s Compliance organization or the FDA using the information set out below. Please call Indivior Insys at [insert toll free number] or visit us at [insert web link] if you have questions about the settlement referenced above. Please call Indivior Insys at [insert toll free number] or visit us at [insert web address] to report any instances in which you believe that an Indivior Insys representative inappropriately promoted a product or engaged in other questionable conduct. conduct.‌‌ Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Insys Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior Insys products to [insert toll free number]. The notice shall remain posted for a period of at least 180 days. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement and Conditional

Notice to Health Care Providers and Entities. Within 30 90 days after the Effective Date, Indivior Allergan shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance send, by OIG)first class mail, postage prepaid and return receipt requested, a copy of a letter signed by Indivior’s Chief Executive Officer notice containing the language set forth belowbelow to all HCPs and HCIs that Allergan currently details. This notice shall be dated and shall be signed by Allergan’s President. The body of the letter shall state the following: As you may be aware, Xxxxxxxx Allergan recently entered into a global civil, criminal, criminal and administrative settlement with the United States and individual states in connection with Indivior’s sales the promotion and promotion use of Suboxone Filmone of its products. This letter provides you with additional information about the global settlement, explains IndiviorAllergan’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges alleged that Indivior engaged in Allergan unlawfully promoted the drug Botox for certain unlawful uses not approved by the Food & Drug Administration (FDA). To resolve these matters, Allergan pled guilty to a misdemeanor criminal violation of the Federal Food, Drug & Cosmetic Act (FDCA), settled certain civil claims, and improper conduct relating agreed to pay $600 million to the promotion of Suboxone FilmFederal Government and State Medicaid programs. To address criminal liabilityMore information about this settlement may be found at the following: [Allergan shall include a link to the USAO, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to Indivior Corporate Integrity Agreement and Allergan websites in the letter.] As part of the global federal settlement, Indivior Allergan also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior Allergan agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorAllergan’s representatives to IndiviorAllergan’s Corporate Compliance organization Department or the FDA using the information set out belowFDA. Please call Indivior or email Allergan at 1-800-TBD or [Allergan shall insert toll free number] or visit us at [insert web linkwebsite address in the letter] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] above or visit us at [insert web address] to report any instances in which you believe that an Indivior a Allergan representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative such instances to the FDA’s Office Division of Prescription Drug Promotion Marketing, Advertising, and Communications at 000-000-0000. You should direct medical questions or concerns about Indivior the products to [insert toll free numbername and telephone number for contact line]. The Chief Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The disclosure log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, Allergan shall provide to the OIG a summary of the calls and messages received.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Allergan Inc)

Notice to Health Care Providers and Entities. Within 30 90 days after the Effective Date, Indivior Lilly shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance send, by OIG)first class mail, postage prepaid and return receipt requested, a copy of a letter signed by Indivior’s Chief Executive Officer notice containing the language set forth belowbelow to all HCPs and HCIs that Lilly currently details. This notice shall be dated and shall be signed by Lilly’s Chief Executive Officer. The body of the letter shall state the following: As you may be aware, Xxxxxxxx Xxx Xxxxx and Company (Lilly) recently entered into a global civil, criminal, and administrative settlement with the United States and individual states in connection with Indivior’s sales and of its promotion of Suboxone Filmits drug Zyprexa. This letter provides you with additional information about the global settlement, explains IndiviorLilly’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges alleged that Indivior engaged in Lilly unlawfully promoted the drug Zyprexa for certain unlawful uses not approved by the Food & Drug Administration (FDA). To resolve these matters, Lilly pled guilty to a misdemeanor criminal violation of the Federal Food Drug and improper conduct relating Cosmetic Act and agreed to pay more than $1 billion to the promotion of Suboxone FilmFederal Government and state Medicaid programs. To address criminal liabilityMore information about this settlement may be found at the following: [Lilly shall include a link to the USAO, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to Indivior Corporate Integrity Agreement OCL, and Xxx Xxxxx websites in the letter.] As part of the global federal settlement, Indivior Lilly also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior Lilly agreed to undertake certain obligations designed to promote compliance with Federal health care healthcare program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorLilly’s representatives to IndiviorLilly’s Compliance organization Department or the FDA using the information set out belowFDA. Please call Indivior or email Lilly at 1-800-TBD or [Lilly shall insert toll free number] or visit us at [insert web linkwebsite address in the letter.] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] above or visit us at [insert web address] to report any instances in which you believe that an Indivior a Lilly representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative such instances to the FDA’s Office Division of Prescription Drug Promotion Marketing, Advertising, and Communications at 000-000-0000. You should direct medical questions or concerns about Indivior the products to [insert toll free number]The Lilly Answer Center at 1-800-Lilly-Rx. Corporate Integrity Agreement Xxx Xxxxx Company We appreciate your time and attention. We are dedicated to ensuring that we bring you the scientific and medical information you need to make well-informed decisions about whether Lilly products are right for your patients. The Chief Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The disclosure log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, Lilly shall provide to the OIG a summary of the calls and messages received.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Lilly Eli & Co)

Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior Insys shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by IndiviorXxxxx’s Chief Executive Officer containing the language set forth below: below:‌‌‌ As you may be aware, Xxxxxxxx Xxxxx recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with IndiviorInsys’s sales and promotion of Suboxone FilmSubsys. This letter provides you with additional information about the global settlement, explains IndiviorXxxxx’s commitments going forward, and provides you with access to information about those commitments. In general terms, the The Government alleges that Indivior Xxxxx engaged in certain several types of unlawful and improper conduct relating to the promotion of Suboxone FilmSubsys. To address criminal liability, Xxxxx agreed to enter a Deferred Prosecution Agreement and pay $30 million in criminal fines and forfeiture. A subsidiary of Indivior Xxxxx agreed to plead guilty to criminal charges charges. In addition, to resolve liability under the Federal False Claims Act (including the alleged payment of making materially false statements relating kickbacks), Insys agreed to Indivior Corporate Integrity Agreement enter a civil settlement and pay $195 million. More information about the criminal and civil resolutions may be found at the following: [Insys shall include a link to the USAO, OCL, and Insys websites in the letter.] As part of the global settlement, Indivior Xxxxx also entered into a five-year corporate integrity agreement and conditional exclusion release with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity That agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.htmlxxxx://xxx.xxx.xxx/fraud/CIA/index.html. Under this the agreement, Indivior Insys agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorXxxxx’s representatives to IndiviorInsys’s Compliance organization or the FDA using the information set out below. Please call Indivior Insys at [insert toll free number] or visit us at [insert web link] if you have questions about the settlement referenced above. Please call Indivior Insys at [insert toll free number] or visit us at [insert web address] to report any instances in which you believe that an Indivior Insys representative inappropriately promoted a product or engaged in other questionable conduct. conduct.‌‌ Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Insys Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior Insys products to [insert toll free number]. The notice shall remain posted for a period of at least 180 days. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement and Conditional

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Notice to Health Care Providers and Entities. Within 30 90 days after the Effective Date, Indivior Par shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance send, by OIG)first class mail, postage prepaid with delivery confirmation, a copy of a letter signed by Indivior’s Chief Executive Officer notice containing the language set forth belowbelow to all HCPs and HCIs that Par currently details. This notice shall be dated and shall be signed by the CEO of Par Pharmaceutical Companies, Inc. The body of the letter shall state the following: As you may be aware, Xxxxxxxx Par recently entered into a global civil, criminal, and administrative settlement with the United States and individual states States in connection with Indivior’s sales the promotion and promotion use of Suboxone Filmone of its products. This letter provides you with additional information about the global settlement, explains IndiviorPar’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges alleged that Indivior Par introduced misbranded quantities of Megace® ES into interstate commerce and that Par engaged in certain unlawful and other improper conduct relating to the promotion of Suboxone FilmMegace® ES. To address resolve these matters, Par pled guilty to one misdemeanor criminal liabilityviolation of the Federal Food, a subsidiary of Indivior Drug, and Cosmetic Act and agreed to plead guilty pay a criminal fine of $18 million and to criminal charges of making materially false statements relating criminally forfeit an additional $4.5 million. In addition, the Government alleged that Par violated the False Claims Act, and Par entered into a civil settlement to Indivior resolve these allegations pursuant to which Par Par Corporate Integrity Agreement agreed to pay $22.5 million to the Federal Government and State Medicaid programs. More information about this settlement may be found at the following: [Par shall include a link to the USAO, DOJ Consumer Protection Branch, and Par websites in the letter.] As part of the global federal settlement, Indivior Par also entered into a five-year corporate integrity agreement (CIA) with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement CIA is available at xxxx://xxx.xxx.xxx/fraud/cia/index.htmlxxxxx://xxx.xxx.xxx/compliance/corporate-integrity-agreements/cia- documents.asp. Under this agreement, Indivior Par agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We Par also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorPar’s representatives to IndiviorPar’s Compliance organization Department or the FDA using the information set out belowFDA. Please call Indivior Par at [insert toll free number] XXXX or visit us at [insert name of web link] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] above or visit us at [insert web address] to report any instances in which you believe that an Indivior a Par representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative a Par representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior the products to [insert toll free number]XXXXX. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the noticenotices. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice notices shall be made available to OIG upon request.. As part of the Implementation Report and each Annual Report, Par shall provide to the OIG a summary of the calls and messages received. Par Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement

Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior Aegerion shall post in a prominent place on the main page of the health care professional section of its company website that is likely to be accessed by HCPs (or other placement agreed to in advance by the OIG), a copy of a letter signed by IndiviorAegerion’s Chief Executive Officer Board Chair containing the language set forth below: As you may be aware, Xxxxxxxx Aegerion Pharmaceuticals, Inc. (Aegerion) recently entered into a global civil, criminal, and administrative settlement with the United States and individual states in connection with IndiviorAegerion’s promotion and sales and promotion of Suboxone Filmits product Juxtapid. This letter provides you with additional information about the global settlement, explains IndiviorAegerion’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges that Indivior Aegerion engaged in certain several types of unlawful and improper conduct relating conduct. More specifically, the Government alleges that Aegerion unlawfully distributed Juxtapid for intended uses not approved by FDA and failed to comply with a Risk Evaluation and Mitigation Strategy required by the promotion of Suboxone FilmFDA for Juxtapid. The Government also alleges that certain Aegerion employees made false and misleading statements about Juxtapid, that the company violated certain patient privacy requirements, and that Aegerion made payments to an independent charity for patient co-payment assistance that violated the Anti-kickback Statute. To address criminal liabilitythese issues, a subsidiary of Indivior Aegerion pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act and agreed to plead guilty pay approximately $7 million in criminal fines and forfeiture. Aegerion also entered into a five-year Deferred Prosecution Agreement to criminal charges resolve claims that it violated the Health Insurance Portability and Accountability Act of making materially false statements relating 1996 (HIPAA). Separately, Aegerion agreed to Indivior Corporate Integrity Agreement enter into a civil Consent Decree of Permanent Injunction to be monitored by the U.S. Food and Drug Administration (FDA). In addition, the federal government and several individual states alleged that Aegerion’s conduct violated the federal False Claims Act and equivalent state statutes. To resolve those allegations, Aegerion entered into a separate civil False Claims Act settlement whereby Aegerion agreed to reimburse federal and state health care programs approximately $29 million. Finally, the Securities and Exchange Commission alleged that Aegerion’s conduct violated federal security statutes. To resolve those allegations, Aegerion entered into a separate civil securities settlement whereby Aegerion agreed to pay approximately $4 million. Copies of and more information about these settlements may be found at the following website: xxxxx://xxx.xxxxxxx.xxx/civil/current-and-recent-cases#_Pharm2 As part of the global settlement, Indivior Aegerion also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior Aegerion agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorAegerion’s representatives to IndiviorAegerion’s Compliance organization or the FDA using the information set out below. Please call Indivior Aegerion at [insert toll free number] 0-000-000-0000 or visit us at [insert web link] xxxx://xxxxxxxx.xxx/about-novelion/aegerion-pharmaceuticals/aegerion-government-settlement if you have questions about the settlement referenced above. Please call Indivior Aegerion at [insert toll free number] 0-000-000-0000 or visit us at [insert web address] xxxxx://xxxxxxxxxxxxxxxxxx.xxxxxxxxxx.xxx to report any instances in which you believe that an Indivior Aegerion representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Aegerion Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior Aegerion products to [insert toll free number]0-000-000-0000 or xxxx://xxx.xxxxxxxx.xxx/physician-resources/global-medical-information. . The notice shall remain posted for a period of at least 180 days. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, Aegerion shall provide to OIG a summary of the calls and messages received.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)

Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior Xxxxxx shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by IndiviorXxxxxx’s Chief Executive Officer containing the language set forth below: As you may be aware, Xxxxxxxx Avanir Pharmaceuticals, Inc. (Avanir) recently entered into a criminal, civil, criminal, and administrative settlement with the United States and individual states in connection with IndiviorAvanir’s sales marketing and promotion of Suboxone FilmNuedexta. This letter provides you with additional information about the global settlement, explains IndiviorXxxxxx’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges government alleged that Indivior engaged in certain unlawful Xxxxxx violated the Federal Avanir Pharmaceuticals, Inc. Corporate Integrity Agreement Anti-Kickback Statute and improper conduct relating caused the submission of false claims for Nuedexta to the promotion of Suboxone FilmFederal health care programs. To address criminal liability, Xxxxxx entered into a subsidiary Deferred Prosecution Agreement with the United States relating to violations of Indivior the federal Anti-Kickback Statute and agreed to plead guilty pay more than $12.8 million in criminal fines and forfeiture. In addition Xxxxxx entered into settlement agreements with the Federal government and certain states to criminal charges resolve allegations that it engaged in improper marketing and promotion of making materially false statements relating Nuedexta. To resolve those allegations, Xxxxxx agreed to Indivior Corporate Integrity Agreement pay $103 million to federal and state health care programs. More information about this settlement may be found at the following: [Avanir shall include a link to the USAO, OCL, and Avanir websites in the letter.]‌ As part of the global settlement, Indivior Xxxxxx also entered into a five-year corporate integrity agreement with the Office of Inspector General of the the‌ U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior Avanir agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorXxxxxx’s representatives to IndiviorAvanir’s Compliance organization or the FDA using the information set out below. Please call Indivior Avanir at [insert toll free number] or visit us at [insert web link] if you have questions about the settlement referenced above. Please call Indivior Avanir at [insert toll free number] or visit us at [insert web address] to report any instances in which you believe that an Indivior a Avanir representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior a Avanir Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior Avanir products to [insert toll free number]. The notice shall remain posted for a period of at least 180 days. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message message‌‌ Avanir Pharmaceuticals, Inc. Corporate Integrity Agreement received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request.. As part of the Implementation Report and each Annual Report, Avanir shall provide to OIG a summary of the calls and messages received.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Notice to Health Care Providers and Entities. ‌‌‌ Within 30 days after the Effective Date, Indivior ACell shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by IndiviorACell’s Chief Executive Officer containing the language set forth below: below:‌‌‌ As you may be aware, Xxxxxxxx ACell recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with IndiviorACell’s promotion and sales and promotion of Suboxone Filmseveral of its products. This letter provides you with additional information about the global settlement, explains IndiviorACell’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges that Indivior engaged in certain unlawful and improper conduct relating to the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior ACell has agreed to plead guilty to criminal charges of making materially false statements a misdemeanor under the Federal Food, Drug and Cosmetic Act relating to Indivior Corporate Integrity Agreement its failure to properly implement a recall in 2012. In addition, ACell entered into a separate civil settlement relating to allegations that ACell engaged in improper sales and marketing practices. To resolve those allegations, ACell agreed to pay approximately $15 million to federal and state health care programs. More information about this settlement may be found at the following: [The notice shall include a link to the USAO, OCL, and ACell websites in the letter.] As part of the global settlement, Indivior ACell also entered into a five-year corporate integrity agreement with the Office of Inspector General of the the‌‌ U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under xxxx://xxx.xxx.xxx/fraud/cia/index.html.Under this agreement, Indivior ACell agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorACell’s representatives to IndiviorACell’s Compliance organization or the FDA using the information set out below. Please call Indivior ACell’s Ethics and Integrity Helpline at [insert toll free number] 0-000-000-0000 or visit us at [insert web link] xxx.xxxxxxxxxx-xxxxxxxx.xxx/xxxxx if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] above or visit us at [insert web address] to report any instances in which you believe ACell, Inc. Corporate Integrity Agreement that an Indivior ACell representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior ACell Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior ACell products to [insert toll free number]0-000-000-0000 or visit us at www.lighthouse- xxxxxxxx.xxx/xxxxx.‌‌‌‌ The notice shall remain posted for a period of at least 180 days. The Compliance Officer CCO (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, ACell shall provide to OIG a summary of the calls and messages received.

Appears in 1 contract

Samples: Integrity Agreement

Notice to Health Care Providers and Entities. Within 30 90 days after the Effective Date, Indivior Par shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance send, by OIG)first class mail, postage prepaid with delivery confirmation, a copy of a letter signed by Indivior’s Chief Executive Officer notice containing the language set forth belowbelow to all HCPs and HCIs that Par currently details. This notice shall be dated and shall be signed by the CEO of Par Pharmaceutical Companies, Inc. The body of the letter shall state the following: As you may be aware, Xxxxxxxx Par recently entered into a global civil, criminal, and administrative settlement with the United States and individual states States in connection with Indivior’s sales the promotion and promotion use of Suboxone Filmone of its products. This letter provides you with additional information about the global settlement, explains IndiviorXxx’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges alleged that Indivior Par introduced misbranded quantities of Megace® ES into interstate commerce and that Par engaged in certain unlawful and other improper conduct relating to the promotion of Suboxone FilmMegace® ES. To address resolve these matters, Xxx pled guilty to one misdemeanor criminal liabilityviolation of the Federal Food, a subsidiary of Indivior Drug, and Cosmetic Act and agreed to plead guilty pay a criminal fine of $18 million and to criminal charges of making materially false statements relating criminally forfeit an additional $4.5 million. In addition, the Government alleged that Par violated the False Claims Act, and Par entered into a civil settlement to Indivior resolve these allegations pursuant to which Par Par Corporate Integrity Agreement agreed to pay $22.5 million to the Federal Government and State Medicaid programs. More information about this settlement may be found at the following: [Par shall include a link to the USAO, DOJ Consumer Protection Branch, and Par websites in the letter.] As part of the global federal settlement, Indivior Par also entered into a five-year corporate integrity agreement (CIA) with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement CIA is available at xxxx://xxx.xxx.xxx/fraud/cia/index.htmlxxxxx://xxx.xxx.xxx/compliance/corporate-integrity-agreements/cia- documents.asp. Under this agreement, Indivior Par agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We Par also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by IndiviorPar’s representatives to IndiviorPar’s Compliance organization Department or the FDA using the information set out belowFDA. Please call Indivior Par at [insert toll free number] XXXX or visit us at [insert name of web link] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] above or visit us at [insert web address] to report any instances in which you believe that an Indivior a Par representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative a Par representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior the products to [insert toll free number]XXXXX. The Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the noticenotices. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice notices shall be made available to OIG upon request.. As part of the Implementation Report and each Annual Report, Par shall provide to the OIG a summary of the calls and messages received. Par Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement

Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior NPC shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by IndiviorNPC’s Chief Executive Officer President containing the language set forth below: As you may be aware, Xxxxxxxx Novartis Pharmaceuticals Corporation recently entered into a civil, criminal, civil and administrative settlement with the United States and individual states the State of New York in connection with Indivior’s sales and Novartis’ promotion of Suboxone Filmseveral of its cardiovascular and other products. This letter provides you with additional information about the global settlement, explains Indivior’s Novartis’ commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges government alleged that Indivior engaged in certain unlawful Novartis Pharmaceuticals Corporation violated the Federal Anti-kickback statute and improper conduct relating caused the submission of false claims to the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to Indivior Federal health care programs through its speaker programs and other interactions with health care practitioners Novartis Corporate Integrity Agreement during which the company promoted certain of its cardiovascular and other drugs. To resolve its liability for remuneration Novartis agreed to enter a civil settlement agreement and pay $678 million. More information about this settlement may be found at the following: [Novartis shall include a link to the USAO, OCL, and its own websites in the letter.] As part of the global settlement, Indivior Novartis also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior Novartis agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Indivior’s Novartis’ representatives to Indivior’s Novartis’ Compliance organization or the FDA using the information set out below. Please call Indivior Novartis at [insert toll free number] or visit us at [insert web link] if you have questions about the settlement referenced above. Please call Indivior Novartis at [insert toll free number] or visit us at [insert web address] to report any instances in which you believe that an Indivior a Novartis representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior a Novartis Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior Novartis products to [insert toll free number]. The notice shall remain posted for a period of at least 180 days. The Chief Compliance Officer (or a designee) shall maintain a log of all calls and messages received in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The log of all calls and messages received in response to the notice shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, Novartis shall provide to OIG a summary of the calls and messages received.

Appears in 1 contract

Samples: Corporate Integrity Agreement

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