definiens: means any law, statute, rule, regula tion, order, judgment or ordinance having the effec t of law of any federal, national, multinational, state, provincial, county, city or other political subdiv ision, including any rules, regulations, regulatory guidelines or ot her requirements of any Governmental Authority, tha t may be in effect from time to time, which, with respect to ea ch Research, Development or Manufacturing activity that will or would reasonably be expected to be submitted to a Regulatory Authority in support of a Regulatory A pproval 16 Application, a Regulatory Approval or Pricing Appro val, shall be deemed to include the applicable regu lations and guidances of the FDA and final guidances of the European Union ( and national implementations there of ) that constitute good laboratory practices, cGMP and good clinical practices ( and, if and as appropriate und er the circumstances, International Conference on Harmoniz ation ( ICH ) guidance or other comparable regulation and guidance of any applicable Regulatory Authority in the Territory )