definiens: means all laws, s tatutes, regulations, rules and guidances applicable to ( a ) activities performed under this A greement in the jurisdiction where they are performed, other than activities described in claus es ( b ) and ( c ) of this paragraph, ( b ) Manufacturing in the jurisdiction of Manufacture, and ( c ) the sup ply, use, marketing or sale of Product in any jurisdiction where such Product is to be supplied, used, marketed or sold, including laws, statutes, regulations, rules and guidances related to Manufac ture of Product that apply by reason of the supply, use, marketing or sale of Product in such jurisdict ion ; provided that, notwithstanding anything to the contrary in this Agreement, with regard to the supp ly, use, marketing or sale of Product, Product Manufactured by [COMPANY] will only be required to co mply with the applicable laws, regulations, guidelines, and directives, including cGMP, of ( i ) the FDA, the EMA, and PMDA, and ( ii ) such other comparable Regulatory Authority ( ies ) in the Territ ory as the Parties agree in writing, such agreement not to be unreasonably withheld, conditioned or del ayed