Global Safety Database. Within […​…] after [[Organization A:Organization]] proceeds with the In-Licensing, [[Organization A:Organization]] shall set up, hold, and maintain (at [[Organization A:Organization]]’s sole cost and expense, but subject to the last sentence of this subsection) the global safety database for Licensed Compounds or Licensed Products. ​ shall provide [[Organization A:Organization]] with all Information necessary or desirable for [[Organization A:Organization]] to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences, from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, Clinical Studies, and commercial experiences with a Licensed Compound or Licensed Product, in each case in the form reasonably requested by [[Organization A:Organization]].

Safety Database. The Parties shall in good faith negotiate and execute a mutually acceptable pharmacovigilance agreement addressing drug safety and adverse event reporting and compliance (the “Pharmacovigilance Agreement”) within ninety (90) days following the Effective Date. Before the execution of such Pharmacovigilance Agreement, the terms of this [Section 3.2.3] apply. Allergan shall establish, hold and maintain (at Allergan’s cost and expense) a safety database for Licensed Products. UroGen shall provide Allergan with all information necessary for Allergan to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. [sections 312.32 or 314.80]0] or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with an RTGel Product or Licensed Product. Allergan shall provide UroGen a copy of all Information maintained by Allergan in the Allergan safety database for Licensed Products or otherwise, to the extent such Information is related to RTGel Products or otherwise as necessary for UroGen to comply with Applicable Law or a request by a Regulatory Authority.

ACADIA shall maintain a global safety database for the Products. Neuren reporting and right to information with respect to any Product shall be addressed in the PVA.

Safety Agreements. Promptly after the Effective Date, but in any event no later than the date of Initiation of the first Clinical Trial of a Development Candidate in the Territory, the Parties will enter into one or more safety agreement(s) requiring # Unum to be responsible for the global safety database that are specific to the ACTR T-cells within the Development Candidates and Products, # SGI to be responsible for the global safety database that are specific to the SGI Antibodies within the Development Candidates and Products, and # either Unum or SGI to be responsible for the global safety database for Development Candidates and Products, such Party to be determined by the JSC by reference to any requirements under Applicable Law (if any), whether the expected safety needs of the applicable Development Candidate and Product are more likely attributable to the applicable ACTR T-cells or the SGI Antibody, prior experiences in interacting with Regulatory Authorities regarding those applicable ACTR T-cells and SGI Antibody, and other relevant factors. The safety agreement(s) will govern the responsibilities of the Parties and include # safety data exchange procedures governing the coordination of collection, investigation, reporting and exchange of information concerning any adverse experiences, and any product quality and product complaints associated with adverse experiences, related to such Development Candidates and Products sufficient to enable each Party to comply with its legal and regulatory obligations, and # obligations on the Party responsible for such global safety database for Development Candidates and Products to make such database readily available to the other Party in such format and in a timely manner as the other Party may reasonably request and any in event in a manner sufficient for such other Party to comply with any other product safety requirements, including those required by Applicable Law. In addition, as appropriate, such safety agreement(s) will include the safety data exchange procedures governing the exchange of information affecting the class (e.g., serious adverse events, emerging safety issues).

Safety. Service Provider will be solely responsible for conforming to safety practices dictated by the nature and condition of the Services while at the Site, including compliance with OSHA of 1970. Service Provider and its Representatives must be trained in accordance with applicable OSHA Standards. Within a reasonable time following a specific request by Owners, Service Provider shall provide Owners copies of training records for its Representatives concerning a particular safety and health standard and/or particular substantive or technical training requirement of the job.

Global Addendum. Notwithstanding any provisions in this document to the contrary, the RSUs will also be subject to the special terms and conditions set forth on [Appendix A] for Grantees who reside outside of the United States. Moreover, if a Grantee is not a resident of any of the countries listed on [Appendix A] as of the Grant Date, but relocates to one of the listed countries at any point thereafter, the special terms and conditions for such country will apply to the Grantee, to the extent the Company determines that the application of such terms and conditions is necessary or advisable in order to comply with local law or facilitate the administration of the Plan. [Appendix A] constitutes part of this Grant Agreement.

SGI will have the right to terminate this Agreement upon ninety (90) days prior written notice to Unum with an explanation contained therein if, in the reasonable opinion of SGI’s senior management, the Research, Development or Commercialization of all Development Candidates and associated Products must be terminated for Safety Reasons attributable to ACTR T-cells. If SGI terminates this Agreement pursuant to this Section 16.5(a), then any obligation of SGI to continue to supply SGI Antibodies or of Unum to supply ACTR T-cells, or for either Party to otherwise facilitate the continued Development and Commercialization of Development Candidates and associated Products, under Section 16.6(a) will be of no force or effect. For clarity, Unum may challenge any such termination as an Arbitral Matter under Article 17; provided that the applicable Clinical Trial will be suspended pending the resolution of such challenge.

service date as shown on the Company’s global human resources database) with the Company or any Affiliate or # at least 65 years of age.

The term “Retirement Eligible” means # at least 55 years of age with at least 10 years of service (measured from your service date as shown on TI’s global human resources database) as a TI employee or # at least 65 years of age.

“Regulatory Documentation” means, with respect to a Product Candidate or Licensed Product, all INDs, NDAs, and other regulatory applications submitted to any Regulatory Authority, copies of Regulatory Approvals, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.FJL §314.420 and any non-United States equivalents), and any other reports, records, regulatory correspondence, meeting minutes, telephone logs, and other materials relating to Regulatory Approval of Product Candidates or Licensed Products (including any underlying safety and effectiveness data whether or not submitted to any Regulatory Authority), or required to manufacture, distribute or sell the Licensed Product including any information that relates to pharmacology, toxicology, chemistry, manufacturing and controls data, batch records, safety and efficacy, and any safety database required to be maintained for Regulatory Authorities.