definiens: shall mean all exi sting information in written ------------------------- and electronic form that relates to : ( 1 ) synthetic chemical processes for the production of [ * ] the active pharmaceutical ingre dient in the Product, and intermediates in the preparation of the Product, in cluding the synthetic methods and development reports generated by or for [ * ] but excluding the synthetic methods and development reports generated by or for [ * ] ( 2 ) the in- process analytical controls for production of each of : ( a ) the active pharmaceutical ingredient in the Product ; and ( b ) t he Product ; ( 3 ) the process, formulation and development reports generated for t he preparation of the Product ; ( 4 ) the analytical methods and validation for the quality control release of each of : ( a ) the active pharmaceutical i ngredient in the Product ; and ( b ) the Product ; and ( 5 ) the stability protocols, s tability indicating methods and stability data for each of : ( a ) the active phar maceutical ingredient in the Product ; and ( b ) the Product