; or (ii) as otherwise determined by the Secretary. (2) Eligible product developer The term eligible product developer means a person that seeks to develop a product for approval pursuant to an application under section 505(b)(2) or 505(j) or for licensing pursuant to an application under section 351(k) of the Public Health Service Act. (3) License holder The term license holder means the holder of an application approved under section 505(b) or section 505(j) of this Act or under section 351 of the Public Health Service Act for a covered product (including the holder’s agents, wholesalers, distributors, assigns, corporate affiliates, and contractors). (4) REMS The term REMS means a risk evaluation and mitigation strategy under section 505–1. (5) REMS product The term REMS product means a covered product that— (A) is subject to a risk evaluation and mitigation strategy under section 505–1