For clarity, if no data from a Qualifying Pivotal Study is used in obtaining a European Centralized Approval for a Licensed Product in the Field, no royalties or any other amounts shall be payable pursuant hereto by MHK or its Affiliates to UGNX for any Licensed Product.
Website of the European Central Bank means the website of the European Central Bank currently at http://www.ecb.europa.eu or any successor website officially designated by the European Central Bank.
Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.
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.
Major European Countries means France, Germany, Italy, Spain and the United Kingdom.
Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.
Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.
European Commission means the authority within the European Union that has the legal authority to grant Regulatory Approvals in the European Union based on input received from the EMA or other competent Regulatory Authorities.
Contracting Authority means any contracting authority as defined in Regulation 3 of the Public Contracts Regulations 2006.
Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.
UK Listing Authority means the Financial Services Authority in its capacity as competent authority under the Financial Services and Markets Xxx 0000.
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.
European Community means the territory comprised by the Member States of the European Community as constituted from time to time;
Approved/Approval means the approval in writing.
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.
Major EU Country Major EU Country means France, Germany, Italy, Spain or the United Kingdom.
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.
contracting authorities means the State, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities or one or more such bodies governed by public law;
Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.
CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:
EMEA means the European Medicines Evaluation Agency or any successor agency thereto.
European Union means the member nations of the European Union established by the Treaty of European Union, signed at Maastricht on February 2, 1992, which amended the Treaty of Rome establishing the European Community.
Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
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.
Commercial applicator means a person who, by contract or for hire, engages in the
Government Apprenticeship Programme “ means training which is funded by the Government via the National Apprenticeship Service.