definiens: means, ( i ) with resp ect to each Product, the New Drug Application or Abbreviated New Drug Application ( including those u nder development ), as applicable, set forth on Schedule 1.1(hhhhh ) for such Product, all transitio n items to support path back to market for Faciliti es and Products pending US Food and Drug Administration ap proval, all supplements thereto and the official regulatory files, approvals, registrations and auth orizations - 12 - granted by Food and Drug Administration or any othe r Governmental and Regulatory Authority, correspondence, recertification work plans, certifi cations and data in Sellers ’ possession or control as of the Closing relating thereto, including, but not li mited to the labeling of the Products and the NDC l abeler code therefor, and ( ii ) all Business Permits and al l applications relating to development, manufacturi ng, marketing, sales and distribution of Products, incl uding ( A ) license for controlled substance products, including application for narcotics license, and ( B ) Drug Enforcement Administration ( DEA ) licenses an d quotas