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<br />C-10 <br /> <br /> <br />a. Any litigation or civil or criminal law enforcement subpoenas or Civil <br />Investigative Demands relating to Janssen’s Opioid Product(s); and <br />b. Warning or untitled letters issued by the FDA regarding Janssen’s Opioid <br />Product(s) and all correspondence between Janssen and the FDA related to <br />such letters. <br />5. The Agreement applies to conduct that results in the Promotion of Opioids or Opioid <br />Products, or the Treatment of Pain inside the United States. <br />6. Janssen will enter into the Agreement solely for the purpose of settlement, and <br />nothing contained therein may be taken as or construed to be an admission or <br />concession of any violation of law, rule, or regulation, or of any other matter of fact <br />or law, or of any liability or wrongdoing, all of which Janssen expressly denies. No <br />part of the Agreement, including its statements and commitments, shall constitute <br />evidence of any liability, fault, or wrongdoing by Janssen. The Agreement is not <br />intended for use by any third party for any purpose, including submission to any <br />court for any purpose. <br />7. Nothing in the Agreement shall be construed to limit or impair Janssen’s ability to: <br />a. Communicate its positions and respond to media inquiries concerning <br />litigation, investigations, reports or other documents or proceedings relating <br />to Janssen or its Opioid Products. <br />b. Maintain a website explaining its litigation positions and responding to <br />allegations concerning its Opioid Products, including the website, <br />www.factsaboutourprescriptionopioids.com. <br />I. Compliance with All State Laws and Regulations Relating to the Sale, Promotion, and <br />Distribution of Any Opioid Product <br />1. Janssen shall comply with all applicable state laws and regulations that relate to the <br />sale, promotion, distribution, and disposal of Opioids or Opioid Products, including <br />conduct permitted by subsection B.2, provided that nothing in this paragraph requires <br />Janssen to violate federal law or regulations, including but not limited to: <br />a. Washington’s Uniform Controlled Substances Act, including all guidance <br />issued by the applicable state regulator(s); <br />b. Washington’s Consumer Protection Act; and <br />c. Washington State laws, regulations, and guidelines related to opioid <br />prescribing, distribution, and disposal. <br />J. Clinical Data Transparency