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<br />C-2 <br /> <br /> <br />pharmaceutical ingredients (APIs) used in the manufacture or study of Opioids or <br />Opioid Products, but only when such materials, immediate precursors, and/or APIs <br />are sold or marketed exclusively to DEA-licensed manufacturers or DEA-licensed <br />researchers. <br />9. “OUD” means opioid use disorder defined in the Diagnostic and Statistical Manual <br />of Mental Disorders, Fifth Edition (DSM–5), as updated or amended. <br />10. “Product(s) for the Treatment of Opioid-Induced Side Effects ” means any over-the- <br />counter or prescription remedy used to treat those side effects identified on the FDA <br />label for any Opioid Product, except that, for purposes of the Agreement, Product(s) <br />for the Treatment of Opioid-Induced Side Effects shall not include products that treat <br />OUD or respiratory depression. <br />11. “Promote,” “Promoting,” “Promotion,” and “Promotional” means dissemination of <br />information or other practices intended or reasonably anticipated to increase sales, <br />prescriptions, or that attempts to influence prescribing practices in the United States. <br />These terms shall not include the provision of scientific information or data in <br />response to unsolicited requests from Health Care Providers or payors as allowed in <br />subsection C.2.e-h. <br />12. “Third Party(ies)” means any person or entity other than Janssen or a government <br />entity. <br />13. “Treatment of Pain” means the provision of therapeutic modalities to alleviate or <br />reduce pain. <br />14. “Unbranded Information” means any information that does not identify a specific <br />branded or generic product. <br />B. Ban on Selling and Manufacturing Opioids <br />1. Janssen shall not manufacture or sell any Opioids or Opioid Products for distribution <br />in the State of Washington. Janssen represents that prior to the Effective Date, it de- <br />listed all of its Opioid Products and no longer ships any of them to or within the <br />United States. <br />C. Ban on Promotion <br />1. Janssen shall not engage in Promotion of Opioids or Opioid Products including but <br />not limited to, by: <br /> <br />a. Employing or contracting with sales representatives or other persons to <br />Promote Opioids or Opioid Products to Health Care Providers or patients, or <br />to persons involved in determining the Opioid Products included in <br />formularies;