Hatch-Waxman Act means the U.S. Drug Price Competition and Patent Term Restoration Act of 1984, as set forth at 21 U.S.C. §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV).
414(s) Compensation included all items includible in compensation under Regulation §1.415(c)-2(b) (Regulation §1.415-2(d)(2) under the Regulations in effect for Limitation Years beginning prior to July 1, 2007), then 415 Compensation for Limitation Years prior to
§1.401(m)-2(c)(4), then any adjustments to the "NHCE's" ACP for the prior year will be made in accordance with such Regulations, if
Earnout Cash Milestone. Upon the earlier to occur of # FDA approval of the Company COVID-19 Drug and the listing of the Company COVID-19 Drug in the FDA’s “Orange Book” and # FDA approval of the Company Antidepressant Drug Regimen and the listing of the Company Antidepressant Drug Regimen in the FDA’s “Orange Book”, in each case prior to December 31, 2022 (the occurrence of either of clauses (1) or (2), the “Earnout Cash Milestone”), BRPA shall deliver, in accordance with Section 1.8(c) and subject to the terms and conditions set forth herein, to each holder of Company Common Stock outstanding immediately prior to the Effective Time (including the holders of shares of Company Common Stock resulting from the Preferred Stock Conversion), an amount of cash equal to such holder’s Earnout Pro Rata Portion multiplied by one hundred million dollars ($100,000,000) (the aggregate amount of such cash being referred to as the “Earnout Cash”, and together with the Earnout Shares, the “Earnout Consideration”).
2.10Disability means that Executive becomes "disabled" within the meaning of [Section 409A(a)(2)(C)] of the Code or any successor provision and the applicable regulations thereunder.
FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which # imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, # enjoins production at any facility of the Company or any of its Subsidiaries, # enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or # otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company.
“Related Company” means ALLETE, Inc. and all persons with whom the ALLETE, Inc. would be considered a single employer under Code section 414(b) (employees of controlled group of corporations), and all persons with whom such person would be considered a single employer under Code section 414(c) (employees of partnerships, proprietorships, etc., under common control); provided that in applying Code sections 1563(a)(1), (2), and (3) for purposes of determining a controlled group of corporations under Code section 414(b), the language “at least 50 percent” is used instead of “at least 80 percent” each place it appears in Code sections 1563(a)(1), (2), and (3), and in applying Treasury Regulations [section 1.414(c)-2]2] for purposes of determining trades or businesses (whether or not incorporated) that are under common control for purposes of Code section 414(c), “at least 50 percent” is used instead of “at least 80 percent” each place it appears in Treasury Regulations [section 1.414(c)-2]2].
given notice of any dismissals or redundancies to the relevant public authority or started consultations under Part IV of TULR(C)A or the Transfer Regulations;
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.
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