definiens: shall mean any pharmaceutical preparation, compr ising Compound, in final form, including all dosage forms, formulat ions and line extensions thereof, for any and all uses in the Field in the Territory, including without li mitation, any Combination Product ( i ) for sale by prescription, over - the - counter or any other method ; or ( ii ) for administration to human patients in a clinical trial . 1.28 shall mean the specifications for the Product established by [COMPANY] and/or R - Pharm in considerati on of the regulatory requirements in each country of the Territory and each country outside the Territory, as may be amended from time to time . 1.29 shall mean, with respect to each country i n the Territory, approval of the Registration Application for the Product filed in such country, including pricing or reimbursement, where applicable, by the Regulato ry Authority in such country following which the Product may be legal ly marketed and sold in such jurisdiction . 1.30 shall mean any filing(s ) made with t he Regulatory Authority in any country in the Territory for regulatory ap proval of the marketing, manufacture and sale of the Product in such country for human use in t he Field . [ * ] = Certain confidential information contained in this document, ma rked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, a s amended . Prepared by R.R. Donnelley Financial -- EX-10.10 https://www.sec.gov/Archives/edgar/data/1178253/000 1193125141047 ..