Request for Comments: Division of Cancer Prevention Intellectual Property Option to Collaborators

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>National Institutes of Health</SUBAGY> <SUBJECT>Request for Comments: Division of Cancer Prevention Intellectual Property Option to Collaborators</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> National Institutes of Health, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The National Cancer Institute, an Institute of the National Institutes of Health, Department of Health and Human Services, Division of Cancer Prevention (DCP) is seeking comments on instituting a standard policy on Intellectual Property (IP) developed by certain funding recipients under NCI DCP funding agreements. This standard policy is entitled “The DIVISION OF CANCER PREVENTION INTELLECTUAL PROPERTY OPTION TO COLLABORATORS (IP Option).” The proposed policy, if finalized, shall apply to entities that conduct DCP-funded clinical studies under funding agreements which involve an NCI collaborator that provides its proprietary agent or technology for the DCP-supported studies where this IP Option is included as a term of applicable existing and future funding agreements. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Only written comments which are received by the National Cancer Institute's Technology Transfer Center on or before July 28, 2025 will be considered. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> NCI welcomes public comment on the full text of the DCP IP option, as set forth below. Comments should be addressed to: Sidra Ahsan, Ph.D., Patent Agent, Senior Technology Transfer Manager, NCI Technology Transfer Center, Telephone: (240) 276-6468; Email: <E T="03">sidra.ahsan@nih.gov.</E> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> The NCI's DCP is a division of NCI that supports cancer prevention and early detection research by providing funding and support to clinical and laboratory researchers, community and multidisciplinary teams, and collaborative scientific networks. DCP supports clinical research under funding agreements to funding recipients which conduct the clinical studies. DCP obtains Agents and Technologies from pharmaceutical, biotechnology and nutraceutical companies (hereinafter “Collaborators”) under technology transfer agreements and provides these Agents or Technologies to funding recipients that conduct the clinical research. In exchange for providing their proprietary Agents or Technologies under technology transfer agreements with NCI, Collaborators will often require that the funding recipients conducting the clinical research agree to certain conditions regarding the Agents and Technologies. These conditions include granting options to IP rights arising from the clinical studies using the Collaborator's Agent or Technology. Currently, there is no standard IP option in the DCP funding agreements that covers the Collaborator's Agent or Technology when used in the multitude of studies supported by DCP. These research studies may involve pharmaceutical agents, nutraceuticals, or diagnostic assays for timely prevention and early detection of cancers, and these materials are often obtained by NCI from Collaborators. The lack of clarity regarding IP rights language across the multi-disciplinary clinical programs of DCP that utilize a Collaborator's Agent or Technology has become an impediment in NCI DCP's ability to obtain Collaborators' proprietary Agents or Technologies for use in DCP-supported clinical trials. This has led to uncertainty and delays in initiating important clinical studies for the prevention and early detection of cancer. It is imperative for DCP's programs and networks to institute a uniform IP option that covers the many different types of clinical studies using a Collaborator's Agent or Technology. The “Division of Cancer Prevention Intellectual Property Option to Collaborators” is intended to cover the clinical programs and networks of DCP that utilize Collaborator's Agents or Technologies used in DCP-supported clinical trials and that are obtained from Collaborators under technology transfer agreements with DCP. It is also intended to offer appropriate incentives and assurances for both Collaborators and funding recipients to participate in DCP-funded clinical studies. <HD SOURCE="HD1">II. Division of Cancer Prevention Intellectual Property Option to Collaborators</HD> NCI DCP obtains Agents and Technologies from Collaborators under technology transfer agreements, for use in NCI DCP-funded research conducted at Institutions, under funding agreements. As part of the arrangement with Collaborators to use their Agents or Technologies and to make the collaborative research possible, NCI DCP would agree not to provide Agents or Technologies to Institutions unless the Institutions agree to the Division of Cancer Prevention Intellectual Property Option and Institution Notification described below. This IP Option shall be included as a term of applicable existing and future funding agreements. <E T="03">Definitions:</E> 1. “Affiliate” means any corporation or other business entity controlled by, controlling, or under common control with the Collaborator. For this purpose, “control” means direct or indirect beneficial ownership of at least fifty percent (50%) of the voting stock or at least fifty percent (50%) interest in the income of the corporation or other business entity. 2. “Agent” or “Technology” is Collaborator's property and defined in the technology transfer agreement between NCI DCP and Collaborator. 3. “Collaborator” means a biotechnology, pharmaceutical, or nutraceutical company that provides a proprietary Agent or Technology for use in the NCI DCP-supported Study. 4. “Institution” means an NCI DCP funding recipient that utilizes a Collaborator's Agent or Technology under the scope of a funding agreement. 5. “Invention” means any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code, or any novel variety of plant which is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321 <E T="03">et seq.</E> ). 6. “Study” means DCP-supported clinical and associated non-clinical studies conducted by the Institution under the scope of a funding agreement with NCI DCP. 7. “Subject Invention” means an Invention that is conceived or first actually reduced to practice in the performance of the Study conducted by the Institution using Collaborator's Agent or Technology. <E T="03">A. The IP Option described in this Section A applies to Subject Inventions that claim the use and/or composition of the Collaborator's Agent or Technology in patent disclosures (“Section A Subject Inventions”). Collaborator's Agent or Technology will be provided to the Institution by NCI DCP, as applicable:</E> Institution agrees to grant to Collaborator(s): (i) a royalty-free, worldwide, non-exclusive license for commercial purposes with the right to sublicense to Affiliates or collaborators working on behalf of Collaborator for Collaborator's development purposes; and (ii) a time-limited first option to negotiate an exclusive, or co-exclusive, if applicable, world-wide, royalty-bearing license for commercial purposes, including the right to grant sublicenses, subject to any rights of the Government of the United States of America, on terms to be negotiated in good faith by the Collaborator(s) and Institution. If Collaborator accepts the royalty-free, worldwide, non-exclusive commercial license, the Collaborator agrees to pay all out-of-pocket patent prosecution and maintenance costs which will be pro-rated and divided equally among all licensees. If Collaborator obtains an exclusive commercial license, in addition to any other agreed upon licensing arrangements such as royalties and due diligence requirements, the Collaborator agrees to pay all out-of-pocket patent prosecution and maintenance costs. Collaborator will notify Institution, in writing, if it is interested in obtaining a commercial license to any Section A Subject Invention within three (3) months of Collaborator's receipt of a patent application or six (6) months of receipt of an Invention report notification of such a Section A Subject Invention; the timing is based on whichever event comes first. In the event that Collaborator fails to notify Institution, or elects not to obtain an exclusive license, then Collaborator's option expires with respect to that Section A Subject Invention, and Institution will be free to dispose of its interests in accordance with its policies. If Institution and Collaborator fail to reach agreement within ninety (90) days, (or such additional period as Collaborator and Institution may agree) on the terms for an exclusive license for a particular Section A Subject Invention, then for a period of three (3) months thereafter Institution agrees not to offer to license the Section A Subject Invention to any third party on materially better terms than those last offered to Collaborator without first offering such terms to Collaborator, in which case Collaborator will have a period of thirty (30) days in which to accept or reject the offer. If Collaborator elects to negotiate an exclusive commercial license to a Section A Subject Invention, then Institution agrees to file and prosecute patent application(s) diligently and in a timely manner and to give Collaborator an opportunity to comment on the preparation and filing of any such patent application(s). Notwithstanding the above, Institution is under no obligation to file or maintain patent prosecution for any Section A Subject Invention. For all Section A Subject Inventions, regardless of Collaborator's decision to seek a commercial license, Institution agrees to grant Collaborator a paid-up, nonexclusive, royalty-free, world-wide license for research purposes only. Institution retains the right ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 12k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━