“FD&C Act” means the Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations of the FDA promulgated thereunder.

“FDA” means the U.S. Food and Drug Administration.

“Good Clinical Practices” shall mean the then current Good Clinical Practices as such term is defined from time to time by the United States Food and Drug Administration (“FDA”) or other relevant governmental authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.

Lonza or its personnel have not been and are not debarred under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b)) (the “Act”).

“ANDA” means an “abbreviated new drug application,” as defined in 21 U.S.C. Section 355(j) of the FD&C Act and applicable FDA rules and regulations.

The Farm Bill established that hemp containing less the .03% THC was no longer a [Schedule 1] drug under the CSA. Previously, the U.S. Food and Drug Administration (“FDA”) did not approve hemp or CBD derived from hemp as a safe and effective drug for any indication. The FDA considered hemp and hemp-derived CBD as illegal [Schedule 1] drugs. Further, the FDA has concluded that products containing hemp or CBD derived from hemp are excluded from the dietary supplement definition under [sections 201(ff)(3)] (B)(i) and (ii) of the U.S. Food, Drug & Cosmetic Act, respectively. However, as a result of the passage of the Farm Bill, at some indeterminate future time, the FDA may choose to change its position concerning products containing hemp, or CBD derived from hemp, and may choose to enact regulations that are applicable to such products, including, but not limited to: the growth, cultivation, harvesting and processing of hemp; regulations covering the physical facilities where hemp is grown; and possible testing to determine efficacy and safety of hemp derived CBD. In this hypothetical event, products containing CBD may be subject to regulation. In the hypothetical event that some or all of these regulations are imposed, we do not know what the impact would be on the hemp industry in general, and what costs, requirements and possible prohibitions may be enforced. If we are unable to comply with the conditions and possible costs of possible regulations and/or registration as may be prescribed by the FDA, we may be unable to continue to operate our business.

“Product Safety Laws” means the Dietary Supplements Health and Education Act; the Dietary Supplement and Nonprescription Drug Consumer Protection Act; the Federal Food, Drug, and Cosmetic Act; the Food Safety Modernization Act; the Federal Trade Commission Act; the Consumer Product Safety Act; the Poison Prevention Packaging Act; the Federal Hazardous Substances Act; the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65); and all comparable federal, state, local and foreign Laws or requirements of any Governmental Authority where the Loan Parties conduct their business or where the Company Products are sold.

i. ​ paid in four equal installments (each equal to ​) on the first day of each of the first four (4) calendar months following the submission of the first Investigational New Drug Application (“IND”) to the Food and Drug Administration (“FDA”) or an equivalent application to a regulatory agency anywhere in the world, for a Product.

“Health Care Laws” shall mean any and all applicable current and future laws, rules, regulations, codes, ordinances, orders, decrees, judgments, injunctions or binding agreements issued, promulgated or entered into by the Food and Drug Administration, the Health Care Financing Administration, the Department of Health and Human Services (“HHS”), the Office of Inspector General of HHS, the Drug Enforcement Administration or any other Governmental Authority, including any state and/or local professional licensing laws, certificate of need laws and state reimbursement laws, applicable in any way to the conduct of the business of Borrower or any Subsidiary thereof.

Avail is a manufacturer of e-liquid products and provides regulatory analysis, strategy, and other consulting services in connection with regulation by the U.S. Food and Drug Administration (“FDA”) of certain e-liquid products and vapor devices (collectively, “Products”).