; or (B) the prompt entry on commercially reasonable terms of an eligible product developer into a previously approved system of elements to assure safe use; and (2) license holders shall negotiate in good faith towards the prompt development of (or entry into) a single shared system of elements to assure safe use under section 505–1(i) on commercially reasonable terms. (e) Procedures for obtaining access to covered products (1) Competitive access to products not subject to REMS impacting product distribution Notwithstanding any other provision of law, a license holder that receives a request from an eligible product developer or its agent for sufficient supplies of a covered product (that is not subject to a REMS impacting product distribution) to conduct testing necessary to support an application under section 505(b)(2) or 505(j) or under section 351(k) of the Public Health Service Act (or otherwise meet the requirements for approval of such an application) shall provide to the eligible product developer or its agent the quantity requested within 30 days of receipt of the request at a nondiscriminatory, commercially reasonable, market-based price for which such covered product has been previously sold by the license holder to third parties in the open market. (2) Competitive access to products subject to REMS impacting product distribution: individual covered product authorization Any eligible product developer may seek an authorization to obtain an individual covered product subject to a REMS impacting product distribution for development and testing purposes by making a written request to the Secretary. Within 120 days of receiving such a request, the Secretary shall, by written notice, issue such authorization for purposes of— (A) development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary