Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.
Export Laws means all applicable import, export control and sanctions, including but without limitation, the laws of the United States, the EU, and Germany.
FDA means the United States Food and Drug Administration or any successor agency thereto.
foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;
goods and services tax practitioner means any person who has been approved under section 48 to act as such practitioner;
Export Control Laws means all applicable export and re-export control laws and regulations, including (a) the Export Administration Regulations (“EAR”) maintained by the U.S. Department of Commerce, (b) trade and economic sanctions maintained by the U.S. Treasury Department’s Office of Foreign Assets Control, and (c) the International Traffic in Arms Regulations (“ITAR”) maintained by the U.S. Department of State.
Conduct Regulations means the Conduct of Employment Agencies and Employment Businesses Regulations 2003;
MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.
Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.
Cannabis Act means An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, S.C. 2018, c. 16, as amended from time to time.
Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.
Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).
export date means the earlier of the following dates namely —
Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.
Integrated Goods and Services Tax Act means the Integrated Goods and Services Tax Act, 2017;
CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.