SENSOR Kickoff Meeting May 18, 2018 Legal Issues Overview Intellectual Property, Data, and Reporting William Bierbower ARPA-E Chief Counsel 202-287-6585 William.Bierbower@hq.doe.gov
Reporting Requirements ‣ U.S. Manufacturing Plan – Incorporated in the Award ‣ Management Plans – Submit within 6 weeks of award • IP Management Plan: govern management of IP generated during award • sharing of technical data, joint inventions, licensing of technology, dispute resolutions, public availability of data • Data Management Plan: whether and how project-generated digital data may be made available to the public ‣ Intellectual Property Reporting • Subject inventions, elections to retain title, patent filings (timelines vary) • Subject Invention and Utilization Requirements – annual reports throughout project and for 5 years after ‣ Human Subject Testing 1. 48 hours of adverse events or termination of IRB approval 2. Immediately if breach of personal data 3. Annual reporting to DOE Human Subjects Protection Program Manager 1
Human (HST) and Animal (AST) Subject Testing ‣ Prior to initiating HST must provide Contracting Officer with: 1. Federal Wide Assurance (FWA) Number https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/file-a-new-fwa/index.html 2. Certification of review and approval by Institutional Review Board (IRB) ‣ Key: Protection of Personally Identifiable Information (PII) Ex: SSN, place or date of birth, medical or metric information (weight, height), financial information, etc. ‣ Awardees can use DoE IRB at no cost ‣ Prior to initiating AST must provide Contracting Officer with: 1. Documentation showing review by qualified Institutional Animal Care and Use Committee (IACUC) and compliance with IACUC requirements, if any (few requirements anticipated) May 24, 2018 Insert Presentation Name 2
Data ‣ Proprietary – Data that predates the award ‣ Protected – Data arising from/during the award • Not publicly disclosed for 5 years • Automatic at for-profits; must be requested for others ‣ Unlimited Data Rights – negotiated and specified prior to the award ‣ Testing by Category D Teams (Iowa State University and University of Alabama) • Data provided by awardees: 5 years of protection • Category D teams agree to provide other awardees with sufficient rights in testing/validation results to allow commercialization • Category D teams may publish the testing methodologies they develop (not including specific awardee information) 3
Inventions ‣ Awardee receives title to “subject inventions” • Subject inventions: inventions conceived or first actually reduced to practice under the award • All subject inventions must be reported to DoE vis iEdison internet portal ‣ U.S./ARPA-E receives: • Government use license • U.S. manufacturing requirements • March-in rights (never been exercised) 4
U.S. Manufacturing Requirements ‣ Products embodying or produced through the use of subject inventions must be substantially manufactured in the United States by Project Teams and their licensees • U.S. Manufacturing Plan: additional measurable commitments ‣ Minimum for all awards: Applies to products to be used or sold in United States ‣ For large businesses: Applies to products to be used or sold worldwide ‣ Waiver of Requirements: Available for good cause and if will provide alternate benefit to U.S. economy May 24, 2018 Insert Presentation Name 5
IP for ARPA-E Additional Information: Inventions ‣ Who “owns” subject inventions (conceived or first actually reduced to practice under the award)? Awardees/subawardees may retain title to their employees’ inventions. Same for subawardees. • Must report such inventions to DoE via internet portal, iEdison. • Failure to report/elect title to your inventions? US right to take title to the invention! • Note: No government rights in your inventions first actually reduced to practice, solely at private expense prior to issuance of an award. • For more information, please see FAQ 2.20 at https://arpa-e.energy.gov/faq ‣ What’s the quid pro quo for ARPA-E funding? Government use license & march-in rights (no such cases involving an ARPA-E invention) - and US manufacturing requirements. (Government license only arises in performance of a government purpose) ‣ What exactly are the US manufacturing requirements?: Requirements will vary depending upon whether the awardee is a large or small business, University, or other type of awardee. • For all awards: Any grant of an exclusive license for a product embodying or produced through the use of a subject invention must be substantially manufactured in the U.S. • For all for-profit awards: Products embodying or produced through the use of subject inventions must be substantially manufactured in the United States by Project Team members and their licensees. • All awards to large business: manufacture in the US products to be used or sold anywhere that embody subject inventions. • May request modification for good cause and subject to providing an alternate net benefit to the US economy. Hard to get unless you have an existing manufacturing capability or you have a subject invention with a business plan. ‣ Your US Manufacturing Plan: is this added as a contractual requirement in your ARPA-E Cooperative Agreement? Yes. ‣ Will ARPA-E reimburse your costs to obtain US patents for subject inventions? Yes – up $30K allowed for filing US patent applications on disclosed and elected subject inventions. 6
IP for ARPA-E Additional Information: Data ‣ Data rights in your preexisting proprietary data: Government obtains no rights (except as necessary to monitor technical progress/evaluate potential of proposed technologies to reach specific technical and cost metrics) • Do not send proprietary data to ARPA-E. May be disclosed during oral presentations/power point presentations off-site to Government employees (who are subject to Trade Secrets Act) without jeopardizing protections from disclosure. • Distinguish from unlimited data rights list which applies to first produced data, negotiated prior to award. ‣ “Protected Data” rights: data arising from your ARPA-E award: • For-profit entities: are given the automatic right to mark first produced data as “protected data” - means the government cannot publicly disclose such data for 5 years after creation. Parties mutually agree on an unlimited rights list so we can let the public know what their tax dollars were spent on. • University/nonprofit: can request the same protection. Awards must be amended to include this right. 7
IP for ARPA-E Additional Information: Reporting Requirements ‣ Must you periodically report on the utilization (commercialization) of a subject invention, and does this obligation continue after the end of the award/research? Yes, annually for both. – For more information on reporting requirements please see https://arpa-e.energy.gov/?q=site- page/project-management-reporting-requirements ‣ IP and Data Management Plans: • IP Management Plan - required if there is more than one Project team member. Plan addresses: sharing of technical data, dealing with joint inventions, licensing of technology, dispute resolution, possible public availability of data. • Data Management Plan – addresses whether and how project-generated digital data may be made available to public. • Note: More information and sample templates for IP and Data Management plans on ARPA-E web site at https://arpa-e.energy.gov/?q=site-page/project-management-reporting-requirements. ‣ *Working with Iowa State and Alabama – who will be testing the other SENSOR awardees technology • They have been required to keep data you provide them and which they produce that specifically relates to an individual project secret for at least 5 years • They have been required to provide the SENSOR awardee with whom they are working sufficient rights in their generated IP to facilitate the commercialization of the Awardees’ technologies • Iowa State and Alabama have data rights in their testing methodologies 8
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