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.

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).

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.

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.

Provision of Chemical Structures. For each CDC for which Ag Partner requests in writing from Legacy chemical structure information concerning such CDC in accordance with the Existing Ag Agreement, Legacy shall have the right, to the extent it is obligated to provide such information to Ag Partner under the Existing Ag Agreement, to request in writing from Primary such information and the right to reveal such information to Ag Partner, and promptly following such a request, Primary shall provide to Legacy, and Legacy shall be permitted to reveal (to the extent permitted by the Existing Ag Agreement), such chemical structure information concerning such CDC.

“Safety Program” means the comprehensive safety program that governs all of Service Provider’s activities at the Site in connection with its performance of the Services.

Program Documents. The Program Documents duly executed and delivered by the parties thereto.

Exchange Program. The Administrator may not institute an Exchange Program.

Program Awards. Program Awards will consist of restricted stock units (“RSUs”) awarded under Section 9 of the Plan. An Eligible Director shall be automatically granted a Program Award in the form of RSUs as follows: # in the case of an Eligible Director who is first elected to the Board between annual meetings of stockholders of the Company, on the date of such first election; and # in case of each Eligible Director (including an Eligible Director described in clause (i)) who is elected (including reelected) at an annual meeting of stockholders of the Company, immediately following each such annual meeting.

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]].