Safety Testing Clause Samples

Safety Testing. The goal of this task is to demonstrate a safety level of the battery prototypes superior to those of a commercial Li-ion battery with a similar energy level. The safety tests will be conducted in accordance with applicable current test standards for batteries. • Prepare a Safety Test Plan that describes test objectives, procedures, test schedules, conditions, facilities, and equipment used to test. • Procure required number of commercial Li-ion cells with energy similar to 5 Ah prototypes for the tests according to the Safety Test Plan. • Assemble required number of 5 Ah prototypes according to the Safety Test Plan. • Deliver the cells to the safety test facility. • Conduct safety tests according to the Safety Test Plan. • Prepare a Safety Report that describes the results of the safety tests, including a discussion on issues encountered and steps taken to address them. • Safety Test Plan • Safety Report (draft and final)

Safety Testing. Accordingly with Option1 of ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use, the ERN’s Commercially Reasonable Efforts for performing the qualification of degradation product profile of the Product will be: About genotoxicity, i. A test for gene mutation in bacteria. In parallel, one of the following tests: ii. A cytogenetic test for chromosomal damage (the in vitro metaphase chromosome aberration test or in vitro micronucleus test), or an in vitro mouse lymphoma Tk gene mutation assay. Chromosome Aberration: OECD Test No. 473: In vitro Mammalian Chromosome Aberration Test Micronucleus: OECD Test No. 487: In Vitro Mammalian Cell Micronucleus Test MLA: OECD Test No. 476: In vitro Mammalian Cell Gene Mutation Test In case the results would not be clearly negative: iii. An in vivo test for genotoxicity, generally a test for chromosomal damage using rodent hematopoietic cells, either for micronuclei or for chromosomal aberrations in metaphase cells. Chromosome Aberration: OECD Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test Micronucleus: OECD Test No. 474: Mammalian Erythrocyte Micronucleus Test About general toxicity, iv. An Acute Oral Toxicity in rats (Limit dose): OECD Test No. 423. A comparative study of three arm single-dose intravenous toxicity study, with a 14-day observation period, should be performed. Depending on the results of the previous studies (genotoxicity and single-dose study), it could be necessary to perform a repeated dose study. This Amendment No. 1 (this “Amendment”) to the Amended and Restated Pharmaceutical Manufacturing and Exclusive Supply Agreement, dated as of 28 July, 2016 (the “Agreement”), by and between Laboratorios ERN, S.A., a Spanish Company with a principal place of business at 499 ▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ (“ERN”) and Zavante Therapeutics, Inc., a Delaware corporation with a principal place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇, will be effective as of December 1, 2016 (the “Amendment Effective Date”).

Safety Testing. The goal of this task is to demonstrate the high level of safety with Li-ion cells using LiGas Electrolytes. The safety testing will closely follow UL1642 guidelines. Each test will have cell data recorded such as voltage, temperature. In addition, a small module with at least 5 cells will be tested via over charge or thermal ramp to demonstrate no cell-to-cell thermal propagation. To conduct the tests cells will be built based off the learnings from previous tasks. Once the experiments are completed a report of the results and lessons learned will be documented in a Verification Report of Safety Testing. • Conduct safety testing on thermal ramp, crush, over charge, external short circuit, and spark ignition. • Conduct a testing on a small module with at least 5 Li-ion cells using LiGas Electrolytes via over charge or thermal ramp to demonstrate no cell-to-cell thermal propagation. • Create a Verification Report of Safety Testing that includes but is not limited to: o A high-level summary of the process for safety testing. o A summary of results from safety testing. o An overview of lessons learned and how the results will impact the rest of the project. • Verification Report of Safety Testing

Safety Testing. Test equipment in accordance with those annual periodic testing requirements as outlined in the American National Safety Code for Elevators and Escalators, ANSI A 17.1, Which are in effect at the time this agreement is executed. In the event that the state, city or local governing authority in which the equipment is located has adopted different requirements, test equipment in accordance with those annual periodic testing requirements in effect at the time this agreement is executed. The cost of the annual testing is included as part of this quote and service and included in the quarterly bid.

Safety Testing. Contractor will test equipment as outlined in federal, state, and local safety codes toensure inspections will be passed. The testing includes but is not limited to the following: ▪ Perform governor, safety, and load tests ▪ Perform pressure and equipment test ▪ Correct deficiencies and meet compliance requirements ▪ Adhere to new published safety rules/standards Contractor will perform all required safety tests as indicated by the State of Montana Elevator Safety Program. Upon completions ofthe required tests, Contractor will promptly submit the test results to the State of Montana Elevator Program.