definiens: means a pharmaceutical product sold by a Third Party in theTerritory, which pharmaceutical product ( a ) contains the s ame APls as the applicable PR Productbeing sold in the Territory by [COMPANY] under this Agreement, ( b ) i s bioequivalent to the applicable PRProduct being sold in the Territory by [COMPANY] under this Agreeme nt with respect to phannacokinetic-4 - NSD\9J926.2properties and is AB rated as such by the FDA, ( c ) is the same do sage form, route of administrationand strength of the applicable PR Product being sold in the Te rritory by [COMPANY] under this Agreementand sold for the same indication as the PR Product and ( d ) lawf ully being sold in the Territory by theThird Party under an FDA approved Abbreviated New Drug Appli cation ( ) or anyequivalent approval as may be available at the time ; provide d, however, that shallnot include any aTC Product1.28 means all current good manufacturingpractices that apply to the manufacture of API and clinical o r commercial supply of PR Product forthe Territory, including the United States regulations set forth under Title 21 of the United StatesCode of Federal Regulations, parts 210 and 211, as may be amen ded from time - to - time, as well asall applicable guidance published from time - to - time by the FDA and the International Conference onHarmonisation Guidelines ICHQ7 A Good Manufacturing Pract ice Guidance for API