definiens: shall have the meaning assigned to that term under 21 CFR 314.108(a ), as such regulation is in effect on the Effective Date, name ly : “ the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, sa lt ( including a salt with hydrogen or coordination bonds ), or other noncovalent derivative ( such as a complex, a chelate or clathrate ) of the molecule, responsible for the physiological or pharmacological action of the drug substance . ” 1.4 . shall mean, with respect to any Person, any other Person which directly or indirectly, by itself or through one or more intermediaries, contr ols, or is controlled by, or is under common contro l with, such Person . The term ( as applied to a Person ) means the possession, direct or indirect, of the p ower to direct or cause the direction of the management and policies of a Person, whether through the ownershi p of voting securities, by contract or otherwise . Contro l will be presumed if one Person owns, either of re cord or beneficially, at least fifty percent ( 50 % ) of the v oting stock of any other Person . Such other Collaboration Agreement — Confidential – Page 2 relationship as in fact results in actual control o ver the management, business, and affairs of a Pers on shall also be deemed to constitute control ; provided, however, that no Person shall be deemed to exercise control over another Person solely because the latter relies on the former for a majority of its business . A Person will be deemed an Affiliate only so long as such ownership or control relationship continues . In the case of N ovartis, shall also expressly be deemed to incl ude the [COMPANY] Institute for Functional Genomics, Inc. and the Friedrich Miescher Institute for BioMedical Res earch and their respective Affiliates