definiens: shall mean such laws and regulations relating to the Manufacture ofIntennediate Compound and API and release of Placebo and Clinical Product in theUnited States, including but not limited 10,the current Good Manufacturing Practices asspecified in International Committee on Harmonization Q7A as applicable for the phaseof Clinical Development Program activities for which the Placebo, IntermediateCompound, API and Clinical Product are intended to be used, as are in effect on theEffective Date or as may subsequently be modified or supplemented . In the eventMERCK provides written notice to ISIS that MERCK intends to conduct ClinicalDevelopment Program activities outside of the United States, thc tern1 shallalso include such laws and regulations relating to the Manufacture of IntennediateCompound and API, and release of Placebo and Clinical Product, as are in effect on theEffeclive Date or as may subsequently be modified or supplemented in the countryspecified in such notice