Control Act (22 U.S.C. §1778), the International Emergency Economic Powers Act (50 U.S.C. §§1701–1706), Section 999 of the Internal Revenue Code, the U.S. customs laws at Title 19 of the U.S. Code, the Export Control Reform Act of 2018 (50 U.S.C. §§4801-4861), the International Traffic in Arms Regulations (22 C.F.R. Parts 120–130), the Export Administration Regulations (15 C.F.R. Parts 730-774), the U.S. customs regulations at 19 C.F.R. Chapter I, and the Foreign Trade Regulations (15 C.F.R. Part 30); and (b) all applicable trade, export control, import, and antiboycott laws and regulations imposed, administered or enforced by any other country, except to the extent inconsistent with U.S. law.
1.21“FDA” means the United States Food and Drug Administration, or any successor thereto.
1.22“FDA Meeting” means an end of phase 2 meeting to be held between Buyer and the FDA to discuss the development of the Compound.
1.23“FDCA” means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the rules and regulations promulgated thereunder.
1.24“Fraud” means a claim for Delaware common law fraud brought in respect of a representation or warranty made in this Agreement. For the avoidance of doubt, “Fraud” does not include any claim for equitable fraud, promissory fraud, unfair dealings fraud, or any torts (including a claim for fraud) based on negligence.
1.25“Fuji License Agreement” means that certain License Agreement, dated as of November 25, 2020, by and between Fuji Yakuhin Co. Ltd. (“Fuji”) and Seller, as amended by that certain First Amendment to License Agreement, dated as of August 16, 2022, as further amended by that certain Second Amendment to License Agreement, dated as of November 2, 2022, including any subsequent amendments, restatements or modifications thereof and any further agreements entered into by Fuji and Buyer or its Affiliates relating to the Compound and/or any data provided by Fuji used to obtain regulatory approval of dotinurad.
1.26“Future Notes” means those certain convertible promissory notes expected to be issued by Buyer following the Closing in the aggregate principal amount of up to $5,499,994 on the same terms as the Outstanding Notes.
1.27“Governmental Authority” means any multi-national, federal, state, local, municipal, or provincial government; any governmental or quasi-governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal); any tribunal, court of competent jurisdiction, administrative agency or commission or other governmental authority or body exercising or entitled to exercise, any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power of any nature (in each case whether federal, state, local, foreign, international or multinational); any Regulatory Authority; or any arbitrator with authority to bind a party at Law.
1.28“Healthcare Laws” means all healthcare Laws applicable to the ownership, testing, development, sale, marketing, manufacture, packaging, processing, use, distribution, storage, import, export, or disposal of the Compound, including but not limited to, the FDCA, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. §§ 286, 287, 1035, 1347, 1349 and the healthcare fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA and similar state and foreign data privacy and security laws such as the European Union General Data Protection Regulation, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), any other healthcare Law governing a government healthcare program, and any and all other comparable state, local, federal or foreign healthcare Laws and the regulations promulgated pursuant to such Laws, each as amended from time to time.