alternative accounting method used in the ordinary course of business. 1.2 "Act" means the U.S. Federal Food, Drug, and Cosmetic Act, as amended. 1.3 "Action" means any demand, action, claim, dispute, suit, countersuit, arbitration, inquiry, subpoena, proceeding or investigation of any nature (whether criminal, civil, legislative, administrative, regulatory, prosecutorial or otherwise) by or before any federal, state, local, foreign or international Governmental Authority or any arbitration or mediation tribunal. Source: UPJOHN INC, 10-12G, 1/21/2020 1.4 "Additional Quantities" shall have the meaning set forth in Section 2.4(c). 1.5 "Affected Products" shall have the meaning set forth in Section 10.4(a). 1.6 "Affiliate(s)" means, when used with respect to a specified Person, a Person that controls, is controlled by, or is under common control with such specified Person. As used herein, "control" (including, with correlative meanings, "controlled by" and "under common control with"), when used with respect to any specified Person shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities or other interests, by contract, agreement, obligation, indenture, instrument, lease, promise, arrangement, release, warranty, commitment, undertaking or otherwise. It is expressly agreed that, from and after the Effective Date, solely for purposes of this Agreement (a) each member of the Spinco Group shall be deemed to not be an Affiliate of any member of the Pluto Group and (b) each member of the Pluto Group shall be deemed to not be an Affiliate of any member of the Spinco Group. 1.7 "Agreement" shall have the meaning set forth in the Preamble. 1.8 "API" means active pharmaceutical ingredient. 1.9 "Batch Size" shall have the meaning set forth in Section 2.4(e)(ii). 1.10 "Binding Forecast Period" shall have the meaning set forth in Section