definiens: means, with respect to a particular Collaboration Product, any pharmaceutical or biological product that ( i ) isdistributed by a Person other than [COMPANY] or its Affiliates under a Drug Approval Application approved by a Regulatory Authority in reliance, inwhole or in part, on the prior approval ( or on safety or efficacy data submitted in support of the prior approval ) of such Collaboration Product, including any product authorized for sale ( a ) in the U.S. pursuant to Section 505(b)(2 ) or Section 505(j ) of the Act ( 21 U.S.C. 355(b)(2 ) and 21U.S.C. 355(j ), respectively ), ( b ) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83 / EC asamended ( including an application under Article 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content on anysuch provision ) or ( c ) in any other country or jurisdiction pursuant to all equivalents of such provisions or ( ii ) is otherwise substitutable underApplicable Law for such Collaboration Product when dispensed without the intervention of a physician or other health care provider withprescribing authority