definiens: with a correlative meaning for means all activities related to themanufacturing of a pharmaceutical product, or any ingredient thereof, including manufacturing Product in finished formfor Development, manufacturing finished Product for Commercialization, packaging, in - process and finished producttesting, release of product or any component or ingredient thereof, quality assurance activities related tomanufacturing and release of product, all stability studies including those for registration, the development andvalidation of testing methods used for, but not limited to, release test, stability test and every testing method forcommercial use, preparation of the documents of any related reports in form described in International Conference of Harmonization of Technical Requirements of Registration ofPharmaceuticals for Human Use ( ICH ), and documents necessary for clinical and market authorization developmentincluding but not limited to development history reports for drug substance and drug product, comparability studiesand reports, in the Licensed Territory and regulatory activities related to any of the foregoing