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<br />C-11 <br /> <br /> <br />1. Janssen agrees to continue sharing clinical trial data under the Yale University Open <br />Data Access (YODA) Project to allow researchers qualified under the program to <br />access the company’s propriety data under the terms of the project. <br />2. In the event Yale University discontinues or withdraws from the YODA Project <br />agreement with Janssen, Janssen shall make its clinical research data regarding <br />Opioids and Opioid Products, and any additional clinical research data that Janssen <br />sponsors and controls regarding Opioids and Opioid Products, available to an <br />independent entity that is the functional equivalent of the YODA Project under <br />functionally equivalent terms. <br />K. Enforcement <br />1. For the purposes of resolving disputes with respect to compliance with this Exhibit, <br />should the State of Washington have a reasonable basis to believe that Janssen has <br />engaged in a practice that violates a provision of this Exhibit subsequent to the <br />Effective Date, the State of Washington shall notify Janssen in writing of the specific <br />objection, identify with particularity the provision of the Agreement that the practice <br />appears to violate, and give Janssen thirty (30) days to respond in writing to the <br />notification; provided, however, that the State of Washington may take any action if <br />the State believes that, because of the specific practice, a threat to health or safety of <br />the public requires immediate action. <br />2. Upon receipt of written notice, Janssen shall provide a good faith written response to <br />the State’s notification, containing either a statement explaining why Janssen <br />believes it is in compliance with the provisions of this Exhibit of the Agreement, or a <br />detailed explanation of how the alleged violation occurred and a statement <br />explaining how Janssen intends to remedy the alleged breach. Nothing in this section <br />shall be interpreted to limit the State of Washington’s civil investigative demand <br />(“CID”) or investigative subpoena authority, to the extent such authority exists under <br />applicable law, and Janssen reserves all of its rights in responding to a CID or <br />investigative subpoena issued pursuant to such authority. <br />3. The State of Washington may agree, in writing, to provide Janssen with additional <br />time beyond thirty (30) days to respond to a notice provided under subsection L.1, <br />above, without Court approval. <br />4. Upon giving Janssen thirty (30) days to respond to the notification described above, <br />the State shall also be permitted reasonable access to inspect and copy relevant, non- <br />privileged, non-work product records and documents in possession, custody, or <br />control of Janssen that relate to Janssen’s compliance with each provision of the <br />Agreement pursuant to the State of Washington’s CID or investigative subpoena <br />authority. <br />5. The State of Washington may assert any claim that Janssen has violated the <br />Agreement in a separate civil action to enforce compliance with the Agreement, or <br />may seek any other relief afforded by law for violations of the Agreement, but only