Common use of Notwithstanding Section IV Clause in Contracts

Notwithstanding Section IV. C.1 directly above, Allergan may engage in other conduct, including but not limited to the following: a. Maintain a corporate website that includes Opioid Products on company’s list of products that contains principally the following content: the FDA-approved package insert, medication guide, and labeling; b. Maintain a product website for any Opioid Product that contains principally the following content: the FDA-approved package insert, medication guide, and labeling, and a statement directing patients or caregivers to speak with a licensed Health Care Provider; c. Provide factual information about Opioid Products sold by Allergan prior to 2021 which may still be circulating in the marketplace outside the possession and control of Allergan (including but not limited to an Opioid Product’s NDC, SKU, or other relevant information such as formulation, package size, dosage, or pricing); d. Provide or collect information or support the provision or collection of information as expressly required by law or any state or federal government agency with jurisdiction in New York (including but not limited to collecting and/or reporting adverse events related to Opioid Products); e. Provide the following by mail, electronic mail, on or through Allergan’s corporate or product websites, or through other electronic or digital methods: FDA-approved package insert, medication guide, and labeling for Opioid Products, or other prescribing information for Opioid Products that are published or approved by a state or federal government agency with jurisdiction in New York; f. Provide scientific and/or medical information to a Health Care Provider consistent with FDA standards, rules, regulations, and/or guidance, including, but not limited to, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (Dec. 2011) as updated or amended by the FDA, and Guidance for Industry, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (Jan. 2009) as updated or amended by the FDA; g. Provide a response to any unsolicited question or request from a patient or caregiver, directing the patient or caregiver to the FDA- approved package insert, medication guide, and labeling for Opioid Products, to speak with a licensed Health Care Provider without describing the safety or effectiveness of any Opioid Product or naming any specific Health Care Provider, or to speak with their health insurance carrier regarding coverage of an Opioid Product; h. Provide Health Care Economic Information, as defined at 21 U.S.C. § 352(a), to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis consistent with FDA standards, rules, regulations, and/or guidance, including, but not limited to, FDA’s Draft Questions and Answers Guidance for Industry and Review Staff, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities (Jan. 2018), as updated or amended by the FDA; i. Conduct or provide financial support or In-Kind Support for bona fide scientific research; and j. Draft, publish, or provide financial support or In-Kind Support for bona fide scientific publications.