International Foreign Investment Approvals means the filings, approvals, clearances, indications or certificates of no action or similar items with or by any International Foreign Investment Authority.
international application means an application filed under this Treaty;
Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.
Foreign Investment means any investment made by a person resident outside India on a repatriable basis in capital instruments of an Indian company or to the capital of an LLP;
MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.
International Student means a student holding a student visa for the purpose of obtaining an education in Australia and includes a student on a study abroad or international exchange program;
Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).
Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.
International Financial Reporting Standards means the accounting standards and interpretations adopted by the International Accounting Standards Board.
International Financial Institution means any bank in the top 1,000 (together with their affiliated companies) as measured by "Tier 1" capital or any broker/dealer in the top 100 as measured by capital.
international organization shall have the meanings set forth in Section 7701 of the Code or successor provisions.
Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.
international flight means all flights other than Domestic Flights.
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
foreign national means the following:
FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.
Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.
international voyage means a voyage from a country to which the present Convention applies to a port outside such country, or conversely.
Applicable Insurance Regulatory Authority means the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.
Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).
Investment Canada Act means the Investment Canada Act (Canada).
Organ procurement organization means a person designated by the Secretary of the United States Department of Health and Human Services as an organ procurement organization.
Commercial sex act means any sex act on account of which anything of value is given to or received by any person.
Required Governmental Approvals With respect to each Facility, all licenses, permits, accreditations, authorizations and certifications from any Governmental Authority which are material to or required for (i) the operation of such Facility and any Capital Addition thereto for its Primary Intended Use in accordance with all applicable, material Legal Requirements, including, without limitation, material state facility licenses, certificates of need, permits, provider agreements and accreditations or certifications from Medicare and/or Medicaid, and (ii) for any other use conducted on the Leased Property of such Facility and any Capital Additions thereto as may be permitted from time to time hereunder in accordance with all applicable, material Legal Requirements.
IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.