definiens: OR means the Technical Manufacturing, Release and relev ant Regulatory files and information, for each Product which contai n documents relating to such Products, including, without limitation : ( a ) a detailed description for each P roduct, including its physical and chemical characteris tics and stability ; ( b ) product manufacturing and packagi ng instructions ; ( c ) product shipping and storage requ irements ; ( d ) protocols for validating the proc esses and equipment to manufacture the Products ; ( e ) quality control and quality assur ance procedures and analytical test methods for sampl ing, testing, documenting and releasing : API, Components, in - pr ocess control and finished Product ; ( f ) procedures and analytical test me thods for testing the stability of the Product ; ( g ) procedures and analytical test me thods for cleaning of the Product ; -4- ( h ) all environmental, health and saf ety information relating to the Product including material sa fety data sheets, incident reports, risk analyses, health co ncerns, preventative measures and procedures for waste disposal ; and ( i ) any other technical information n ecessary to carry out the contracted operations correctly i n accordance with the Marketing Authorization and any o ther legal requirements, all as updated, amended and revised from t ime to time by SciClone in accordance with the terms of this Agreemen t ; means [ * * * * ] means the Intellectua l Property of any third party ; and means the twelve - month period comme ncing, in the case of the first Year of this Agreement, on the date of execution of this Agreement, and thereafter commencing upon completion of the immediately preceding Year