Each Party shall carry out its obligations under this Agreement in material compliance with all applicable Laws, including, without limitation, (a) the Food, Drug and Cosmetic Act and any applicable implementing regulations, and relevant foreign equivalents thereof; (b) GMPs; (c) all other applicable FDA guidelines and relevant guidelines of other applicable Regulatory Authorities; (d) all other applicable laws and regulations, including, without limitation, all applicable federal, national, multinational, state, provincial and local environmental, health and safety laws and regulations in effect at the time and place of manufacture of a Product; and (e) all applicable export and import control laws and regulations.