Safety Agreement Clause Samples

Safety Agreement. The Parties shall execute a Safety Agreement in the form attached in Schedule 5 at the same time as the execution of this Agreement.

Safety Agreement. Promptly following [*] the safety departments of Amgen and Licensee shall develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events with respect to the Licensed Product sufficient to permit each Party, its Affiliates, permitted licensees (including permitted sublicensees) to comply with Law, including, to the extent applicable, those obligations contained in applicable Governmental Authority regulations (including those of the FDA, EMEA and MHLW). The safety data exchange procedures shall be documented in writing, and promptly updated if required by changes in Law or by agreement of the Parties.

Safety Agreement. Promptly after the Effective Date and before the date that Licensee commences any clinical trials of the Licensed Product in the Territory, the Parties shall enter into a separate written safety agreement containing (i) appropriate provisions addressing safety issues relating to the Licensed Products, (ii) a description of the types of side effects and reactions that must be reported pursuant to Section 7.6(a) and any other complaints or information requests that must be reported, and (iii) such cooperative working procedures as are reasonably necessary to ensure that satisfactory systems and processes are in place to ensure the effective exchange of safety and other medical information relating to the Licensed Product (the “Safety Agreement”).

Safety Agreement. Promptly after the Effective Date, but in any event no later than the date of initiation of a Clinical Trial by Astellas in the Territory, the Parties shall enter into a safety agreement governing the Parties’ respective obligations with respect to allocation of responsibilities for reporting to the other Party and appropriate Regulatory Authorities adverse events, complaints, and other safety-related matters. Astellas shall be responsible for creation and maintenance of the global safety database for Products following the date agreed by the JSC.

Safety Agreement. Prior to the commencement of the first Clinical Trial of the Licensed Product conducted by or on behalf of Partner or its Affiliates, the Parties will enter into a written agreement setting forth worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Product (the “Safety Agreement”). The Safety Agreement will describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting, and exchange of information between the Parties concerning any adverse event experienced by a subject, and the seriousness thereof, whether or not determined to be attributable to the Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) and will be sufficient to permit each Party and its Affiliates, licensees, or Sublicensees (as applicable) to comply with its legal obligations with respect thereto, including each Party’s obligations as the owner or holder of Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals for the Licensed Product in the Territory, as applicable. The Safety Agreement will also detail each Party’s responsibilities with respect to recalls and withdrawals of the Licensed Product inside and outside of the Territory. If required by changes in Applicable Law, the Parties will make appropriate updates to the Safety Agreement. Each Party will comply with its respective obligations under the Safety Agreement and cause its Affiliates, licensees, and Sublicensees to comply with such obligations. Each time the JSC approves a new planned Clinical Trials for the Licensed Product, the Parties will update the Safety Agreement to the extent necessary to comply with any applicable requirements set forth under Applicable Law or of any Regulatory Authorities related to adverse event reporting, drug safety, patient safety, pharmacovigilance, and risk management. Notwithstanding any provision to the contrary in this Agreement or the Safety Agreement, each Party and its Affiliates, licensees, and Sublicensees will have the right to disclose information related to the safety of the Licensed Product to the extent that such disclosure is required for such Party to comply with its obligations under Applicable Law or the safety requirements of the applicable Regulatory Authorities. The Parties will cooperate with each other to address any safety-related inquiries or requests for...

Safety Agreement. Within [***] months of the Effective Date of this Agreement, the JSC will develop a mutually acceptable safety agreement (to be agreed upon and executed by both Parties) setting forth the Parties’ respective obligations in detail regarding pharmacovigilance and the exchange of drug safety data.

Safety Agreement. EXHIBIT 12.8

Safety Agreement. Prior to the Transition Event, the Parties shall enter into a separate safety agreement that defines the safety report, safety database, product recall, post marketing survey, and so on in compliance with the requirement of relevant laws and regulations in Japan and the United States.

Safety Agreement. Promptly following the Effective Date, Amgen and Novartis shall amend the Safety Agreement to include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events with respect to the Product sufficient to permit each Party, its Affiliates, permitted sublicensees and licensees to comply with Law, including, to the extent applicable, those obligations contained in FDA regulations. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed amendment to the Safety Agreement which shall be entered into within ninety (90) days after the Effective Date (or any other longer period as may be agreed between the Parties).