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Contract Accord 4: Other Research Results

Accord Revision Date: September 2019
Page Updated: January 2020
©2020 University-Industry Demonstration Partnership (UIDP). Please refer to the copyright and disclosure statement for UIDP Contract Accords usage and rights.

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OVERVIEW AND BACKGROUND

Sponsored research produces results in a variety of forms. Potentially patentable results are addressed in UIDP Contract Accord 6: Foreground Intellectual Property. Copyrightable results are addressed in UIDP Contract Accord 8: Copyright. Software is discussed in UIDP Contract Accord 16: Software. Transfer of materials in agreements that are not Sponsored Research Agreements (SRAs) is addressed in UIDP Contract Accord 10: Material Transfer Agreements, and data issues and exchange are covered in UIDP Contract Accord 14: Data. For purposes of this Contract Accord, other research results (ORR) include tangible other research results (TORR) and intangible other research results (IORR) of a sponsored research project that are not patentable or copyrightable.

ORR are often the unintended results of open exchange of information among researchers. They may have been originally developed and used by researchers over the course of various research projects and are being modified or adapted for a particular research project. ORR may have application in multiple research projects and have potential to impact broad research programs. Intellectual property (IP) rights in ORR may therefore be difficult to pin down and protect.

ORR means IORR and TORR that are generated, developed, or produced in the performance of a sponsored project. Examples of IORR include findings, conclusions, and information communicated to the Company. IORR also includes methodologies, techniques, and know-how. (For a description of know-how, see sidebar below.) Examples of TORR include raw data or factual information recorded in any medium, unpatentable samples and prototypes, unpatentable chemical intermediates and unpatentable biological materials.1

INDUSTRY PERSPECTIVE

Research sponsors (Companies) will seek appropriate access to use the ORR for varied purposes (i.e., for commercial purposes, such as regulatory filings and practice of rights granted in related Foreground Intellectual Property (FIP) and Background Intellectual Property (BIP)). Company ownership of ORR developed by the University is not required. The types of ORR may vary across industry sectors. Companies need to have ORR access and use provisions in the SRA that are adapted to their particular industry sector where necessary. Companies are wary of being burdened by access and use restrictions, especially since the open nature of the University makes it likely that the ORR will not be protected and may be available to competitors. A non-exclusive, royalty-free (NERF) right to use ORR resulting from the sponsored research is generally sufficient to provide such access. In addition, Companies will expect access to the ORR necessary to practice rights in FIP and BIP that are granted in the research agreement. Companies also expect access to the ORR necessary to understand the results of the sponsored research.

In rare cases, ORR may result from a sponsored project and be solely and directly related to proprietary information or materials supplied by the Company. In those cases, Companies would expect to treat such ORR within the context of other FIP provisions under the SRA.

UNIVERSITY PERSPECTIVE

The results of University research, including ORR from industry-sponsored projects, are often used in follow-on research and teaching efforts at Universities. These activities facilitate further research, advance undergraduate and graduate education, drive promotion and tenure for faculty, and supply the information necessary to fulfill the University’s social responsibilities to advance the public good. The University needs to maintain the flexibility to leverage and reuse ORR in order to fully perform its research and teaching activities without restriction. This need requires that ORR not be considered as confidential information of the Company.

ORR should be carefully defined in the SRA to avoid ambiguous terms, such as “unpatented inventions” or “discoveries.” The University usually has no legal mechanism to restrict access to or enforce limitations on such abstractions.

While know-how could be considered an IORR, it is hard to define and fraught with difficulty. Rather, know-how can be thought of as uniquely tied to an individual researcher and not the IP of the University. Universities generally allow the faculty to use their know-how in private consulting under separate agreements that do not involve the University. For these reasons, the University does not generally grant exclusive rights to know-how to Companies. (See sidebar on this page.)

SIDEBAR: Defining “know-how”

For the purposes of this publication, know-how is not being used as a precise legal term. The following two references give a sense of what we are talking about in the context of IORR:

Know-how means any form of technical information or assistance relating to the manufacture or placing into operation of the said products. It also means any practical knowledge, techniques, and skill that are required to achieve some practical end. It is considered an intangible property in which rights may be bought and sold. Know-how also means the technical skill which large groups of men acquire through extensively financed experimentation and cooperation. [Know-How Law and Legal Definition. (n.d.). Retrieved from https://definitions.uslegal.com/k/know-how-intellectual-property-rights/]

Know-how is generally defined as factual knowledge not capable of precise, separate description. However, when used in an accumulated form, after being acquired as the result of trial and error, gives to the one acquiring it an ability to produce something which [they] otherwise would not have known how to produce with the same accuracy or precision found necessary for commercial success. [Hooker Chemical Corp. v. Velsicol Chemical Corp., 235 F. Supp. 412 (W.D. Tenn. 1964)]

Successful projects generally result in publication of at least summaries of IORR, making it broadly available for use by the Company and others. IORR that are not published are generally made available to the Company in the form of reports or datasets. IORR may not be separable from knowledge acquired by students during the course of their participation in a sponsored research project, thus making it difficult for a University to precisely identify and protect or license them as IP.

If TORR are described in a Statement of Work (see UIDP Contract Accord 1: Statement of Work) as an expected outcome of the research, ownership and access should be specifically addressed in the contract. There is an increasing interest in improving the validity and reproducibility of published research results by making data described in a publication available to other researchers. Universities would therefore require the right to distribute such ORR to researchers external to the University for this purpose.

Universities should provide Companies with the right to use ORR for any purpose but may do so with a disclaimer of any warranties against patent infringement or suitability for any particular purpose. Universities may also require that the Company not publish the IORR prior to the University investigator’s publication or before the lapse of a specific period of time.

PRINCIPLES

1. The Company should generally have a NERF right to use ORR for any purpose subject to a University’s disclaimers of warranties and right to publish.

2. The University retains the right to publish results of its research, including ORR.

3. The Company may have limited access to TORR that can be consumed by use without the potential for renewing the supply (e.g., biological specimens and samples, prototypes, and samples of difficult-to-synthesize small molecules). Such products may be exhausted, thereby restricting access for validation of the science and other research uses. Access to such research results requires special consideration in the SRA.

4. Limitations on the Company’s right to use ORR based on regulatory or privacy constraints should be described in the SRA (e.g., Institutional Review Board (IRB) approval and oversight for use of human subjects, privacy and consistency with subject consents, and special precautions for hazardous materials).

5. Delay of publication provisions should be limited in duration but sufficient to avoid premature public disclosure of preliminary findings related to FIP. (See UIDP Contract Accord 3: Publication.)

6. The University should consult with the principal investigator(s) regarding the Company’s access to and use of ORR.

7. The University retains the right to control use of the ORR for any purpose by third parties, including distribution in accordance with federal agency requirements.

8. Faculty are free to use their know-how in private consulting under separate agreements not involving the University, unless otherwise restricted by University policies.

9. The University should retain physical custody and ownership of original research records, including raw data from sponsored research.

10. The University’s access to the Company’s data, know-how, etc. to do the research should be addressed in the SRA.

11. A grant of exclusive rights to ORR is rare and should be negotiated separately, recognizing the particular circumstances warranting the unique treatment.

OUTLIERS

ORR resulting from Specialized Service and Testing Agreements are not included in this Contract Accord. (See UIDP Contact Accord 13: Specialized Services and Testing Agreements.)

FOOTNOTES

[1] NIH Research Tools Policy (Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources) (12/1999)

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