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]].

zoning, health, chemical use, safety and sanitation laws, statutes, ordinances and codes as well as common laws, relating to the protection of the environment, human health and/or governing the use, storage, treatment, generation, transportation, processing, handling, production or disposal of Hazardous Materials and the rules, regulations, policies, guidelines, interpretations, decisions,

“Know-How” means any and all proprietary commercial, technical, scientific and other data, information, materials, trade secrets, knowledge, technology, methods, processes, formulae, instructions, techniques, designs, drawings and specifications (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and know-how, including study designs and protocols).

Service Provider’s Quality Assurance Program and associated policies and procedures shall address Service Provider’s Services, including without limitation systems, structures and components in a manner consistent with their classification with respect to their importance to nuclear safety (i.e., safety related, important to safety, non-safety related) or their importance to the capacity, operability and reliability of the Facility as classified in the Vogtle Units 3 and 4 UFSAR.

Except as would not have a Material Adverse Effect:

The Company is not in violation of any applicable statute, law or regulation relating to the environment or occupational health and safety.

Communication of Safety Concerns. Executive understands and acknowledges that nothing in this Agreement prohibits, penalizes, or otherwise discourages him/her from reporting, providing testimony regarding, or otherwise communicating any nuclear safety concern, workplace safety concern, or public safety concern to the U.S. Nuclear Regulatory Commission (NRC) or the U.S. Department of Labor (DOL). Executive further understands and acknowledges that the provisions of this Agreement are not intended to restrict his communication with, or full cooperation in, proceedings or investigations by any agency relating to nuclear regulatory or safety issues. Executive understands that nothing in the Agreement waives his right to file a claim with the DOL pursuant to Section 211 of the Energy Reorganization Act, but Executive expressly waives his/her right to recover any and all damages or other equitable relief, including, but not limited to reinstatement, back pay, front pay, compensatory damages, attorney fees or costs, that may be awarded to the Employee by the DOL as a result of such a claim.

Communication of Safety Concerns. Employee understands and acknowledges that nothing in this Agreement prohibits, penalizes, or otherwise discourages him/her from reporting, providing testimony regarding, or otherwise communicating any nuclear safety concern, workplace safety concern, or public safety concern to the U.S. Nuclear Regulatory Commission (NRC) or the U.S. Department of Labor (DOL). Employee further understands and acknowledges that the provisions of this Agreement are not intended to restrict his communication with, or full cooperation in, proceedings or investigations by any agency relating to nuclear regulatory or safety issues. Employee understands that nothing in the Agreement waives his/her right to file a claim with the DOL pursuant to Section 211 of the Energy Reorganization Act, but the Employee expressly waives his/her right to recover any and all damages or other equitable relief, including, but not limited to reinstatement, back pay, front pay, compensatory damages, attorney fees or costs, that may be awarded to the Employee by the DOL as a result of such a claim.

Compliance with Environmental Laws. (i) The Company and each of its subsidiaries are in compliance with all applicable laws, statutes, ordinances, rules, regulations, orders, judgments, decisions, decrees, standards, and requirements relating to: human health and safety; pollution; management, disposal or release of any chemical substance, product or waste; and protection, cleanup, remediation or corrective action relating to the environment or natural resources (collectively, “Environmental Laws”);

“Environmental Laws” shall mean all federal, state and local environmental, land use, zoning, health, chemical use, safety and sanitation laws, statutes, ordinances and codes relating to the protection of the environment and/or governing the use, storage, treatment, generation, transportation, processing, handling, production or disposal of Hazardous Substances and the rules, regulations, policies, guidelines, interpretations, decisions, orders and directives of federal, state and local governmental agencies and authorities with respect thereto.

F&T International is a purveyor of some of the best foods from around the world. F&T’s list of customers speaks for itself and the quality of its products. Established in 1987, F&T is focused on packing the freshness and taste of safe high-quality harvests from each region produced throughout the world, with standards that are second to none. F&T is continually expanding distribution, with a unique focus on new product development and manufacturing from a global perspective, especially focused on safety and non-chemical produced products, responding to the needs and demands of the increasing food safety-oriented consumers. We’re proud to join the list of these well respected companies and are excited to be a part of this opportunity.