Environmental Laws means all Laws relating to (a) protection of human health and/or the environment, including those relating to pollution, waste, emissions, discharges, or releases of Hazardous Substances or any other solid, liquid, gas, odour, heat, sound, vibration, or radiation, (b) protection and conservation of natural resources, including climate, air, surface water, groundwater, wetlands, land surface, subsurface strata, wildlife, aquatic, terrestrial, avian or microbial species and vegetation, (c) the manufacture, generation, handling, transport, transfer, labelling, packaging, sale, distribution, import, export, use, processing, treatment, recycling, storage, destruction, or disposal of, or exposure to, Hazardous Substances, and/or (d) any other criminal, civil, equitable, or common law principle concerning any act or omission relating to the environment or Hazardous Substances.
ERISA means the Employee Retirement Income Security Act of 1974.
ERISA Affiliate means any Person that is, or has at any relevant time been, under common control, a member of the same controlled group or treated as a “single employer” with the Corporation or any of its Subsidiaries within the meaning of Sections 414(b), (c), (m) or (o) of the Code.
Exchange Act means the Securities Exchange Act of 1934.
Existing Credit Agreement means that certain Loan and Security Agreement, dated as of April 4, 2022 (as amended by that certain Consent and First Amendment to Loan and Security Agreement, dated as of August 23, 2022, that certain Second Amendment to Loan and Security Agreement, dated as of September 21, 2022, and that certain Third Amendment to Loan and Security Agreement, dated as of March 30, 2023), by and among, inter alia, the Corporation, and Fusion Pharmaceuticals US Inc., a Delaware corporation, as borrowers, and Oxford Finance LLC, a Delaware limited liability company, as collateral agent, and the lenders party thereto from time to time.
Fairness Opinion means the oral opinion (to be subsequently confirmed in writing) of Centerview Partners LLC, the financial advisor to the Corporation, addressed to the Board of Directors that, as of the date of such opinion and based upon and subject to the various assumptions made, procedures followed, matters considered and qualifications and limitations set forth in such opinion, the Consideration to be paid to the holders of Shares (other than Shares (a) held by the Parent or any of its affiliates immediately prior to the Effective Time and (b) held by a Dissenting Shareholder that is ultimately entitled to be paid fair value by the Purchaser for their Shares) is fair, from a financial point of view, to such holders.
FDA means the United States Food and Drug Administration, or any successor entity.
Final Order means the final order of the Court approving the Arrangement pursuant to Section 192(4) of the CBCA, as such order may be varied by the Court (with the written consent of both the Corporation and the Parent, each acting reasonably) at any time prior to the Effective Date.
GAAP means United States generally accepted accounting principles.
Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Parts 50, 54, 56 and 312, as applicable, and any substantially similar rules arising under applicable Law in other jurisdictions.
Good Laboratory Practices means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58, and any substantially similar rules arising under applicable Law in other jurisdictions.
Good Manufacturing Practices means the FDA’s standards for the manufacture, processing, packing, or holding of a drug contained in 21 C.F.R. Parts 210 and 211, and any substantially similar rules arising under applicable Law in other jurisdictions.
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