(iii) clinical activities (including closing down clinical studies); (iv) remaining lease-related obligations (including rent, common area maintenance, property taxes, insurance, utilities,
janitorial services and other administrative fees); (v) any Contract; and (vi) any existing or anticipated legal proceedings.
Exchange Act means the Securities Exchange Act of 1934, as amended, together with the rules and regulations
promulgated thereunder.
FDA means the U.S. Food and Drug Administration.
FDCA means the Federal Food, Drug, and Cosmetic Act, as amended, and all regulations promulgated thereunder.
GAAP means generally accepted accounting principles in the United States.
Governmental Entity means any supranational, national, federal, state, municipal, provincial, local or other
government, domestic or foreign, or any court, administrative agency or commission or other governmental authority or instrumentality exercising legislative, judicial, regulatory or administrative functions of or pertaining to supranational,
national, federal, state, municipal, provincial or local government, including any department, commission, board, agency, bureau, subdivision, instrumentality or other regulatory, administrative, judicial or arbitral authority, whether domestic or
foreign, and in each case, of competent jurisdiction.
Governmental Official means any official or employee of
any government, or any department, agency, or instrumentality thereof, any political party or official thereof, any candidate for political office, any official or employee of any public international organization, or any person acting in an
official capacity for or on behalf of any such government, department, agency, instrumentality, party, or public international organization.
Hazardous Substance means any pollutant, contaminant, hazardous substance, hazardous material, hazardous waste or
petroleum products, and any other chemical waste, substance or material listed in or regulated or identified in or giving rise to liability or standards of conduct pursuant to any Environmental Law.
Health Laws means any Law applicable to the Company regulating the research, development, manufacturing or
distribution of medicines or pharmaceutical products, provided that Health Laws shall not include Privacy Laws.
HIPAA means the applicable provisions of the Health Information Portability and Accountability Act of 1996, as
amended by the Health Information Technology for Economic and Clinical Health Act of 2009.
HSR Act means the
U.S. Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
Indebtedness means, with respect to the
Company or its subsidiaries, and without duplication (including without duplication of any amounts included in Transaction Expenses) (i) all obligations for borrowed money, or with respect to unearned advances of any kind to the Company or its
subsidiaries, (ii) all obligations evidenced by bonds, debentures, notes or similar instruments, (iii) all obligations under any short-term or long-term contracts, including any installment sale contracts, (iv) all guarantees and
arrangements having the economic effect of a guarantee of the Company or its subsidiaries of any Indebtedness of any other Person, (v) any deferred purchase price obligations for assets, property, securities, business or services, including
seller notes, holdback, or similar payments (whether contingent or otherwise) calculated as the maximum amount payable under or pursuant to such obligation, (vi) all obligations under any interest rate swap, forward contract, currency or other
hedging arrangement, derivative or similar transaction, (vii) any accrued but unpaid federal, state or franchise Taxes, (viii) any unfunded benefit liability with respect to any retirement or deferred compensation plan, program, agreement
or arrangement, (ix) any accrued and unused vacation, paid time off or similar leave, and any accrued and unpaid severance obligations, or bonuses or commissions and any other bonuses or commissions
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