; or (B) license holders impede the prompt negotiation and development of a single, shared system of elements to assure safe use and supporting agreements under section 505–1(i)(1)(B) of such Act ( 21 U.S.C. 355–1(i)(1)(B) ), on commercially reasonable terms. (4) Requiring license holders to comply with requirements for competitive access to their products, and for the negotiation and development of single, shared systems of elements to assure safe use under section 505–1(i)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(i)(1)(B) ), and subjecting license holders to liability for failing to do so, will not impose obligations on the courts that they cannot adequately and reasonably adjudicate. 3. Competitive access to covered products for development purposes (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 505–1 of such Act ( 21 U.S.C. 355–1 ) the following new section: 505–2. Competitive access to covered products for development purposes (a) Definitions In this section: (1) Covered product The term covered product — (A) means— (i) any drug approved under section 505 or biological product licensed under section 351 of the Public Health Service Act; (ii) any combination thereof; or (iii) when reasonably necessary to demonstrate sameness, biosimilarity, or interchangeability for purposes of this section, section 505, or section 351 of the Public Health Service Act (as applicable), any product, including any device, that is marketed or intended for use with such drug or biological product; and (B) excludes any drug or biological product which the Secretary has determined to be currently in shortage and that appears on the drug shortage list in effect under section 506E, unless the shortage will not be promptly resolved— (i) as demonstrated by the fact that the drug or biological product has been in shortage for more than 6 months