definiens: means the Product in final form, including Produc t that has been Manufactured from the successful process performance qualification ( P PQ ) runs that confirm the process design and demonstrates that the Manufacturing process perform s as expected ; means the Product that has been formulated and is in final form except for fill and finish processing, which includes a final formulati on step, including Product that has been Manufactur ed from the successful process performance qualificati on ( PPQ ) runs that confirm the process design and demonstrates that the Manufacturing process perform s as expected ; has the meaning given in the introductory paragra ph hereto ; has the meaning given in Clause 3.2 ; has the meaning given in Clause 2.4(f ) ; means the United States Federal Food, Drug, and C osmetic Act, as amended and may be amended from time to time, and the rules and regula tions promulgated thereunder ; means the United States Food and Drug Administrat ion, or any successor thereto ; has the meaning given in Clause 3.1 ; means that portion of the Rolling Forecast which begins [ * * * ] ; means any circumstances beyond a Party ’s reasonab le control, including accidents, civil disorders or commotions, riot, war, malicious damage, acts of terrorism, acts of God, Government al Authority - imposed energy or other conservation meas ures, explosions, failure of utilities by the provi der, disease, pandemic, quarantine, or theft ; means an annual rate [ * * * ] for the time of an emp loyee for a full - time equivalent ( ) person year [ * * * ] of work, pro - rated on a daily bas is . Without limiting the above, [ * * * ] ; means any nation or government or governmental or regulatory body thereof, or political subdivision thereof, whether federal, state, local or foreign, or any agency, instrumentality or authority thereof, or any court or arbitrator ( public or private ) or any other enti ty exercising executive, judicial, legislative, regula tory or administrative functions of or pertaining t o regulation or to government ; means the International Financial Reporting Stand ards ; has the meaning given in Clause 15.4 ; has the meaning given in Clause 15.4 ; has the meaning given in Clause 10.5 ; means value added taxes, sales taxes, consumption taxes and other similar Taxes that are required to be disclosed on an Indirect Tax inv oice