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

Contracting with Industry:Bridging the Gap between Industry

and Universities

Presented by: Lillian SmithDirector, Industry Sponsored Research

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 research.

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

publication

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 published.

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 research.

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 entities

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 information.

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 deliverable.

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 published.

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.

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 Work.

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

THANK YOU!