definiens: means all laws, statutes, regulations, rules and guidances applicable to ( a ) activities performed under this Agreement in the ju risdiction where they are performed, other than act ivities described in clauses ( b ) and ( c ) of this paragraph, ( b ) Manufacturing in the jurisdiction of Manufacture, a nd ( c ) the supply, use, marketing or sale of Product in an y jurisdiction where such Product is to be supplied, used, marketed or sold, including laws, statutes, regulat ions, rules and guidance related to Manufacture of Product that apply by reason of the supply, use, marketing or sa le of Product in such jurisdiction ; provided, that notwithstanding anything to the contrary in this Agreement, with re gard to the supply, use, marketing or sale of Produ ct, Pro duct Manufactured by Supplier will only be required to c omply with the Applicable Laws, regulations, guidel ines, and directives, including cGMP, of ( i ) the FDA, the EMA, and PMDA, and ( ii ) such other comparable Regulato ry Authority ( ies ) in the Territory a s the Parties agree in writing, such agreement not to be unreasonably withheld, conditioned or delayed