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					      Contracting with Industry:
  Bridging the Gap between Industry
             and Universities

Presented by:
Lillian Smith
Director, Industry Sponsored Research

UCLA Office of Intellectual Property & Industry
Sponsored Research (OIP-ISR)
Publication Rights

Data Rights

 Issues relating to the Statement of Work
Publication Rights
 Publication: Academic Interests
 Fulfills the University’s mission to disseminate results for the
  public benefit.
 Important component for student matriculation and job prospects;
  central to faculty promotion/tenure and reputation
 Essential requirement to keep Universities within the
  “fundamental research exemption” when working in export-
  controlled environment
 Research results must be publically accessible in an adequate
  and timely manner in order to satisfy the requirements of
  501(c)(3) as a tax-exempt entity participating in sponsored
 Maintaining unfettered ability to publish is critical to maintaining
  public confidence and lack of bias in University research
  Publication: Industry Interests
 Control over what is published
    Keep results away from competitors
    Want approval rights to ensure that results that are potentially
      harmful to the company are not disseminated
    Want editorial rights so that publication is written in a manner
      that can benefit the company
 Protect its own trade secrets from being inadvertently disclosed in
 Prevent intellectual property from being prematurely disclosed
 Keep results confidential
      The Suggested Compromise
 A good clause that takes both positions into account should
  address the following:
    Affirms that University has the right to use any
      information/results that it developed in the research.
    Provides the sponsor the right of prior “review” (not approval,
      not editorial rights)
         May allow delays to protect patentable information identified in writing
          by Company
         May allow delays to remove any Company proprietary information that
          is identified in writing by Company.
     Limits review period, including any agreed upon delays –
      preferably no more than 90 days total. (Don’t forget to consult
      with your PI.)
   Common Issues and Possible Work Arounds
 Issue: There are multiple sites conducting the research. Company
  doesn’t allow publication until all sites are done and a joint publication is
 Work Around: Set limits. It’s okay to wait for a reasonable period of time
  until the other sites are done but specify that University can publish
  independently if research is not concluded by a certain date.

 Issue: Company is concerned that University will publish results that it
  does not consider to be scientifically accurate.
 Work Around:
     Communicate that research will be conducted in accordance with the approved scope
      of work and any other acceptable standards that are imposed in the contract.
     Remind Company that they are sponsoring research at University because of its
      reputation for good science.
     If that doesn’t work, offer to include a disclaimer in the publication that the publication
      was not approved by the Sponsor.
  Common Issues and Possible Work Arounds
Issue: Company is hung-up on having “approval” rights.

    Work Around #1: No approval rights, but specify, instead, that the
     Company may provide comment on the publication and that such
     comments will be considered by University. If stronger language is
     needed, specify that University and Company shall discuss
     Company’s comments or, alternatively, specify that University shall
     give “good faith” consideration to Company’s comments.

    DO NOT promise that Company’s comments will be incorporated into
     the publication.
  Common Issues and Possible Work Arounds
Issue: Company is hung-up on having “approval” rights.
    Work Around #2: Specifically define “Approval” in an a manner that
     works for University.
   Example: “University shall provide Sponsor a copy of any proposed written
     publication or presentation at least thirty (30) days prior to submission for
     publication (“Pre-Publication Review Period”). Upon written notification by
     Sponsor, the Publication Review Period may be extended an additional thirty
     (30) days to remove Sponsor proprietary information or protect patentable
     inventions described therein. University may publish the results of its
     research with prior approval from Sponsor. For the purposes of this clause,
     “approval” shall be deemed as granted once the Pre-Publication Review
     Period, including any extensions thereof, has expired.”
  Publication Points to Be Aware Of
 BE CAREFUL: Make sure that you and the Company are on the
  same page with respect to what “publication” means. Sometimes
  companies believe that publication of results pertains to any form
  of dissemination and therefore expect a review period before any
  of the results are shared outside the University – even before
  your researcher picks up the phone to talk to a colleague at
  another University. Make sure the sponsor understands that the
  review period applies only when there is a submission for
  publication to a journal and/or conference.

ALERT!!: “Subject to Section [Publication clause], University shall
  have the right to use all data and information generated in the
  Publication Points to Be Aware Of
 BE CAREFUL!: Make sure “Confidential Information” is not
  defined in a way that would prevent University from publishing its
  results. This means framing the definition of “Confidential
  Information” so that it excludes know how, data, or any
  information provided/generated by the University in the study.
Rights in Data
Rights in Data: Academic Interests
 Maintaining ownership of data and information is
  critical for Universities:
     Assures unrestricted, open publication
     Assures researchers are free to disseminate data for teaching
      and other educational purposes
     Assures researchers are free to use the data in future
      research projects and to solicit research funding from other
     Assures other researchers, including those at other
      institutions, can use the data
     Assures ability to use data to secure IP rights
Rights in Data: Industry Interests
 Want to control what gets disseminated

 Want to own data so that it can verify results and
 control its use

 Want to own data so that they can submit in support
 of regulatory filings

 If copyrightable, wants to have sole ownership for
 commercialization purposes.
                  Rights in Data
KEEP IN MIND: Remember to distinguish between
 intangible rights (copyright), tangible rights
 (deliverables), and rights to work product (drafts, raw
 data, etc.)

  For example, when one purchases a book (tangible deliverable),
  it is not a draft manuscript (work product). The owner of the book
  owns a published copy of the book that the owner is able to use,
  but that does not affect the copyrights (intangible right) of the
  author or publisher.
          The Suggested Compromise
 Data Rights clauses should address the following:

    Affirms that University owns data and has unrestricted right to use,
     disseminate, publish, and copyright all data and information
     generated by University that does not contain Company’s confidential

    Limit definition of “Data” to information, data, and results generated by
     University and delivered to Sponsor.

    Provides the Company with the right to use all data and information
     that is delivered to the Company.
  Common Issues and Possible Work Arounds
Issue: Company insists on ownership because it paid for
 these results.

    Work Around #1: Point out various subsidies of the research that
     Company did not pay for such as equipment used, under-recovery of
     overhead, inability of University to charge more than cost.

    Work Around #2: Offer to better define what information the
     Company will have the right to use. If Company wants reports to
     include certain underlying information or information on how to
     achieve the results (“know-how”) ,or that the reports be formatted in a
     specific way, work with your Investigator to determine what the
     Company wants and what University can provide.
  Common Issues and Possible Work Arounds
Issue: Company insists on ownership because the results
 are needed to support its regulatory filings

    Workaround: If not overly burdensome, allow Company to have
     scheduled access to review and copy (at Company’s expense) the
     underlying data and results needed for regulatory purposes.
  Common Issues and Possible Work Arounds
If Company Insists on Ownership of Data
    Confirm that your University policies will allow this. If so, narrowly define
     what the Company can own – for example, just the final report or the final
        Don’t allow the company to have ownership rights to all results, including work
         product. First, this can be intrusive as this could include lab notebooks, all
         scribbled notes that have no meaning except to the note taker, and information
         that may not be owned by the University. Second, it should be restricted to only
         those results that are actually delivered to Company.

        Companies don’t always know what it is that they want, but when you talk it
         through, you can usually define it. For example, “120/80” can be a result of the
         research, but it is meaningless until it is given context in a report (which is what
         the Company really wants.)

        Make sure to clarify that ownership of this data does not assign any copyright or
         patent right to the Company.
Data Rights: Points to Be Aware Of
 BE CAREFUL!: Don’t let Companies limit University’s rights to
  only use data that is published. Investigators should not be
  forced to publish if they do not feel that the results are ready to be

 BE CAREFUL!: Think carefully before offering Joint Ownership
  of Copyrights in the data. Under copyright law, joint copyright
  owners must share with each other the profits of licensing. (This
  is different from patents where this obligation does not exist).
Issues Relating to the
  Statement of Work
             Statement of Work
 Defines the work that the PI is responsible to perform in exchange
  for Company funds
 Discloses whether work is permissible under University policies –
  ITAR controlled, or classified research, etc.
 Discloses whether other approvals (IRB, ARC, ESCRO, etc.) are
  required before research contract can be executed
 Explains what deliverables are expected under the Agreement
 Provides objective justification for relaxing or strengthening
  University’s adherence to policy
 Defines Company’s expectations of what work will be done
Statement of Work: Academic Interests
    Summarizes the work the PI intends to conduct under the
     agreement including project goals and tasks

    Clarifies what deliverables will be provided to the Company

    Provides the basis for the budget

    Provides University with flexibility as to the manner of which the
     research will be conducted.
Statement of Work: Industry Interests
   Requires strict adherence to Scope of Work; no ability to make
    changes without prior approval.

   Wants guaranteed results.

   Prefers to condition payment on achievement of certain results.
          The Suggested Compromise
 A well written Statement of Work should address the following:

     Describes the project in sufficient detail such that the specific aims
      and goals of the project are defined.

     Specifies what deliverables the University is obligated to provide.

     Allows for flexibility as to manner in which the research aims and
      goals will be achieved by University.

     BE CAREFUL! The Statement of Work should not contain other
      contractual terms. As Contract Officers, you must review the
      Statement of Work carefully to ensure that no contractual terms were
      inadvertently included.
          The Suggested Compromise
 The contract should also address the following:

     That the Statement of Work will be performed on a “reasonable
     efforts” basis and that University will employ reasonable efforts to
     perform the research in accordance with the planned objectives.

     Minor deviations from the scope of work may occur to achieve the
     project goals.

    Example: “Sponsor acknowledges and agrees that University cannot
      guarantee the results of any of its research activities and that minor
      deviations from the Statement of Work may occur to further the
      scientific goals of the Statement of Work.”
  Common Issues and Possible Work Arounds
Company wants strict adherence to the Statement of Work
 and assurance that all milestones will be achieved.
    Work Around #1: Remind Company that research is unpredictable
     and, as such, specific results or completion of milestones cannot be
     guaranteed. University will employ reasonable efforts to reach the
     intended goals and aims of the research as described in the scope of

    Work Around #2: With your Investigator’s consent, add progress
     reports or scheduled meetings so that Company can be kept apprised
     of the how the research is being conducted and advanced.

    Work Around #3: Include a statement that any material changes to
     the Statement of Work will be discussed with Company in advance.
Statement of Work: Points to Be Aware Of
    BE CAREFUL!: Don’t tie payments to certain milestones
     unless the milestones can actually be achieved.

    BE CAREFUL!: If material changes are made to the
     Statement of Work, amend the research contract to include
     these changes so that there is no dispute in the future as to
     what the University is obligated to perform under the contract.

     Make sure any additions to the Statement of Work coincide
     with the budget and that additional payment is sought if there
     are increased costs to perform the revised Statement of
      THANK YOU!

UCLA Office of Intellectual Property &
Industry Sponsored Research (OIP-ISR)