definiens: shall have the meaning assigned to s uch term in Section 10.4 . 1.8 shall mean the date of this Agreement, indicated in the first page of this Agreement . 1.9 shall mean the treatment and prevention of diseases, infections or other disorders in humans . 1.10 shall mean, with respect to Product, the first sale for end use or consumption of such Prod uct in a country of the Territory after all required approvals, including marketing and pricing approvals, have been granted by the governing health authority of such country . 1.11 ( FDC ) is a formulation, oral or pare nteral, which includes two or more active pharmaceutical ingredie nts ( APIs ), one of which is a Compound, combined in a single dosage form, which is manufactured a nd commercialized in respective fixed dose forms . Fixed - dose combinations ( FDC ) are to be treated as individual pr oducts and shall not be deemed as Combination Product . [ * ] = 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 ..