Interagency Collaboration: Barriers / Solutions J. Susan Sprake Los Alamos National Laboratory Business Development Executive 22 April 2014 Slide 1
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Interagency Collaboration: Barriers / Solutions Two examples of attempts to establish a CRADA with another Federal laboratory Case Study #1 Case Study #2 Discuss issues or barriers Resolution Suggestions
Case study #1 CRADA Brief Background Corporation X wanted LANL to enhance an existing LANL simulation/model with data provided from X and then utilizing LANL s unique expertise further specialize the model. Initially, Corp. X requested a Non Federal-WFO Agreement. Corporation X identified itself as a non-federal entity on the standard LANL questionnaire. Corporation X indicated that the interaction would be very collaborative and new intellectual property would be created. NF-WFO at DOE/LANL is not designed for a highly collaborative relationship a CRADA would be must better suited for collaboration
Case study #1 CRADA Corporation X requested licensing rights to new developments under the agreement Corporation X indicated it was interested in sub-licensing to others CRADA is well designed to address new IP and Licensing rights CRADA à ownership follows inventorship and to some degree authorship (option and license rights; royalty sharing with LANL inventors/authors) License Option Agreement à the vehicle to grant rights in patents, copyrights, etc. Commercial Noncommercial
Case study #1 CRADA Corporation X and LANL created the SOW, negotiated licensing option terms and submitted a preliminary draft for round one approvals. CRADA was rejected by DOE reviewers because Corporation X was deemed a federal corporation. Corporation X provided a legal determination which declared it was not a federal entity and also, that it had not been funded by federal funds for over 40 years and could act in its commercial capacity. CRADA was rejected the second time by DOE reviewers because Corporation X is considered a federal corporation.
CRADA Policy (a) General authority Each Federal agency may permit the director of any of its Government-operated Federal laboratories, and, to the extent provided in an agency-approved joint work statement or, if permitted by the agency, in an agencyapproved annual strategic plan, the director of any of its Government-owned, contractor-operated laboratories (1) to enter into cooperative research and development agreements on behalf of such agency (subject to subsection (c) of this section) with other Federal agencies; units of State or local government; industrial organizations (including corporations, partnerships, and limited partnerships, and industrial development organizations); public and private foundations; nonprofit organizations (including universities); or other persons (including licensees of inventions owned by the Federal agency); and (d) Definitions As used in this section (1) the term cooperative research and development agreement means any agreement between one or more Federal laboratories and one or more non-federal parties under which the Government, through its laboratories, provides personnel, services, facilities, equipment, intellectual property, or other resources with or without reimbursement
Case study #1 CRADA DOE/ LANL decision was the CRADA was not the appropriate mechanism unless a non-fed third party was included. A federal work-for-others (WFO) would be more appropriate. Unfortunately, no listing of Corporation X was readily found in any of LANL federal financial codes nor was there a pre-negotiated federal overarching agreement for Corporation X. WFO was not going to be an available route in a timely fashion. Corporation X insisted no fed money was involved or identified. Could not do work with Corporation X at that time too much time had been lost and they needed to move on.
Interagency Collaboration: Barriers / Solutions Resolution (next action items) A third party (non-federal) be brought in as a party to the CRADA agreement. Further efforts be made to recognize the commercial side of Corporation X A special agreement be negotiated to do work with Corporation X Suggestions
Case study #2 CRADA Interagency Cooperative Research and Development Agreement (CRADA) 3 Party Agreement Two federal labs One Government Owned Government-Operated federal lab (GOGO) One Government Owned Contractor-Operated federal lab (GOCO) One non-federal, foreign entity (participant) Army requested the CRADA with LANL and the foreign participant.
Purpose: Case study #2 CRADA LANL has an expertise in certain genomic bio-assay protocols A third party (non-federal & foreign) desires collaboration, assistance, and some training in developing their protocols Army very interested in getting the protocols right LANL is invested through its mission to assist Very active LANL scientist involved in establishing the protocols
Case study #2 CRADA ISSUES & CHALLENGES CRADA agreement terms and conditions are slightly different DOE / Laboratory standard CRADAs contain more clauses (T&C) Army agreed to use DOE/LANL standard CRADA template Intellectual Property No intellectual property expected to be created Agreement among the Parties was to publish results of the work Was a CRADA the appropriate mechanism? In-kind funding by all Parties.
Case study #2 CRADA ISSUES & CHALLENGES Both organizations require final approval for release of final report. Which one is really the final and does it matter? Issue of control of CRADA results. Export Control processing at DOE/LANL Subject matter of CRADAs with Foreign Participants must be processed for Export Control determination ( EAR99) Except when everything is going to be published. Army and LANL (PI) position was that all would be published LANL processed it through Export Control review anyway Publications of protocol results deemed controlled because of review requirements
Case study #2 CRADA ISSUES & CHALLENGES Classification Because so much time had elapsed a new classification review was initiated Normal classification review - no problems Office Counter Intelligence at DOE/LANL Standard requirement then but now a new / modified requirement Lengthy process A year later and a half later still no CRADA signing in sight.
Interagency Collaboration: Barriers / Solutions Resolution CRADA with another federal entity may not always work in the DOE system. Lengthy processes to bring terms and conditions into alignment. Who is the final reviewer for release of information? Perceived that a CRADA was note necessary to do the work. (everyone was funded) Suggestions
Questions & Comments J. Susan Sprake Los Alamos National Laboratory (505) 665-3613 sprake@lanl.gov Slide 18 Operated by Los Alamos National Security, LLC for DOE/NNSA