Step therapy protocol means a protocol or program that establishes the specific
Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.
FDA means the United States Food and Drug Administration and any successor agency thereto.
Development Plan has the meaning set forth in Section 3.2.
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.
MFDA means the Mutual Fund Dealers Association of Canada;
Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.
Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.