definiens: means all filings, records, and other documents ( whether in hardcopy or electronic form)Controlled by ALZA ( directly or through its Affiliates ) pertaining to the manufacture of Dapoxetine or any ExistingProduct, including the portions of any such documents bearing Know - How relating to the manufacture of Dapoxetine orany Existing Product, the chemistry, manufacturing and controls portion of all Regulatory Submissions and ExistingProduct Registrations for Dapoxetine or any Existing Product, all drug master files for Dapoxetine or any ExistingProduct, together with all amendments and supplements, in support thereof, records used to obtain and maintain ExistingProduct Registrations or Regulatory Submissions, and records needed to support clinical development of Dapoxetine orany Existing Product.1.7 means an entity to which ALZA ( directly or through its Affiliates thereof ) delegates authority under aDelegation of Authority to distribute Existing Product in a country under the Existing Product Registration in suchcountry