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AUTM is the non-profit leader in efforts to educate, promote and inspire professionals to support the development of academic research that changes the world and drives innovation forward. [...] We also appreciate that NIH recognizes its policy needs to “be reasonable and not seek to force licensees into access obligations that obstruct commercial development or damage the viability and sustainability of a product in the market.” We are concerned about potential “gamesmanship.” Given that access plans are to be publicly available, the IRP Policy may provide a roadmap for large companies a. [...] Prior to making the R&D investment required to bring a licensed product successfully to market, licensees and their investors require assurance that their rights under a license to practice the subject inventions are not vulnerable to being taken away late in the game by an unpredictable access plan review process. [...] We applaud the portion of the RFI that states an access plan will be required only at the time of the pivotal clinical trial stage of research and development. [...] However, given the level of investment a licensee has put into R&D by this stage, it is critical that there be clarity about: • what constitutes an acceptable access plan; • the conditions under which waivers for such a plan may be obtained from NIH; • the timeline of access plan review by NIH; and • the consequences of an access plan being rejected by NIH, and recourse available to the licensee.