“cGMP” means the current Good Manufacturing Practices and General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21 CFR (Chapters 210, 211, 600 and 610), the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC and ICH Guidance [[Unknown Identifier]] (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients that are applicable to the Services. WuXi ATU’s operational quality standards are defined in internal GMP policy documents.

For purposes of the preceding paragraphs, the Company has elected to determine the compensation of an officer or One Percent Owner in accordance with [section 1.415(c)-2(d)(4)])] of the Treasury Regulations (i.e., W-2 wages plus amounts that would be includible in wages except for an election under section 125(a) of the Code (regarding cafeteria plan elections) under section 132(f) of the Code (regarding qualified transportation fringe benefits) or section 402(e)(3) of the Code (regarding [section 401(k)] plan deferrals)) without regard to the special timing rules and special rules set forth, respectively, in [sections 1.415(c)-2(e) and 2(g)])])] of the Treasury Regulations.

adheres to 121 INFLIGHT's standards for flight security, food safety and food quality;

Historically, the DEA has made persistent efforts to regulate hemp products. In 2001, DEA issued an Interpretive Rule attempting to ban all hemp seed and hempseed oil food products that contained even minuscule, insignificant amounts of residual THC. The Hemp Industries Association immediately filed suit to stop the enforcement of this rule, which resulted in what became known as the “Hemp Food Rules Challenge.” Ultimately, the subsequent ruling made by the Ninth Circuit issued serendipitously on February 6, 2004, found that the DEA had not followed necessary scheduling procedures to add non-psychoactive hemp to the list of [Schedule I] controlled substances; and additionally, that Congress clearly did not intend that hemp be prohibited by the Controlled Substance Act when it adopted language from the 1937 Marijuana Tax Act to define the drug ‘marijuana.’

identify its partners, members or other Affiliates, as applicable, as a division or part of it;

Tenant shall be required to use the food service operator designated by The Alexandria Landlord at The Alexandria (the “Designated Food and Beverage Operator”) for any food and/or beverage service or catered events held by Tenant in the Shared Conference Facilities. As of the date of this Lease, the Designated Food and Beverage Operator is The Farmer and the Seahorse. The Alexandria Landlord has the right, in its sole and absolute discretion, to change the Designated Food and Beverage Operator at any time. Tenant may not use any vendors other than the Designated Food and Beverage Operator nor may Tenant supply its own food and/or beverages in connection with any food and/or beverage service or catered events held by Tenant in the Shared Conference Facilities.

"Related Entity" means any entity which is aggregated with the Corporation pursuant to Section 414(b) or 414(c) of the Code or would be so aggregated if the language "at least 50 percent" were used instead of "at least 80 percent" each place it appears in [Section 1563(a)(1), (2) and (3)])])] of the Code and Treasury Regulations Section 1.414(c)-2.

Neither Althea nor, to Althea’s actual knowledge, any employee, agent or subcontractor of Althea involved in the Development of Licensed Products, has been debarred under [Subsection (a) or (b)])] of Section 306 of the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) and Althea has not knowingly permitted any Person on any of the FDA clinical investigator enforcement lists (including the # Disqualified/Totally Restricted List, # Restricted List and # Adequate Assurances List) to participate in the Development and Commercialization of Licensed Products.

a certificate (in form and substance reasonably satisfactory to Buyer) duly executed on or as of no more than thirty (30) days prior to the Closing Date, pursuant to U.S. Treasury Regulations Section 1.1445-2(c)(3), stating that [[Organization A:Organization]] Biodiagnostics, Inc. is not and has not been a U.S. real property holding corporation (as defined in Section 897(c)(2) of the Code) during the applicable period specified in Section 897(c) of the Code; and

Rules and Regulations. Without limiting the applicable provisions of this Lease, Tenant’s use of the roof of the Building for the installation, operation, maintenance and use of the Equipment shall be subject to the terms and conditions contained in the Rooftop Work Rules and Regulations attached hereto as Exhibit F.