Principles and Policies: Intellectual Property

 In this section:

Intellectual Property

Data and Materials Furnished by FDA

FDA's Rights

All data and materials, and any and all intellectual property rights therein, furnished by the FDA for use in Mini-Sentinel and/or Sentinel shall be owned by the FDA (“FDA Data and Materials”). The term “intellectual property rights” as used in this section shall mean any rights in inventions, concepts, ideas, designs, processes, software, works of authorship, know-how, patents, patent applications, trade secrets, copyrights and copyright registrations.

License

The FDA hereby grants to all Collaborators a license to use the FDA Data and Materials for all purposes required in their respective roles for the duration of their participation in Mini-Sentinel and/or Sentinel.

Limitations on License

Collaborators in Mini-Sentinel and/or Sentinel are not permitted to retain, reproduce, or use for private or commercial purposes, the FDA Data and Materials.

Data and Materials Furnished by Collaborators

Collaborator's Rights

All data and materials, and any and all intellectual property rights therein, furnished by each Collaborator for use in Mini-Sentinel and/or Sentinel shall be owned by that respective Collaborator (“Collaborator Data and Materials”). As stated above in FDA's Rights, the term “intellectual property rights” as used in this section shall mean any rights in inventions, concepts, ideas, designs, processes, software, works of authorship, know-how, patents, patent applications, trade secrets, copyrights and copyright registrations. This includes Collaborators’ raw data held in Mini-Sentinel or SCDM format and in their portion of the Mini-Sentinel and/or Sentinel Distributed Database.

License

Each Collaborator hereby grants to the FDA, and others acting on its behalf, a license to use their Collaborator Data and Materials for all purposes required in their respective roles for the duration of their participation in Mini-Sentinel and/or Sentinel.

Limitations on License

Parties to Mini-Sentinel and/or Sentinel are not permitted to retain, reproduce, or use for private or commercial purposes, Collaborator Data and Materials that did not originate with their own institution without the express permission of the original owner.

Data and Materials First Produced in the Performance of the Mini-Sentinel and/or Sentinel Contracts [1]

Collaborators Rights

Except as otherwise specifically provided in subcontracts, Collaborators may assert copyright in any Data and Materials first produced by their institution in the performance of this contract. The prior, express written permission of the Contracting Officer is required to assert copyright in all other data first produced in the performance of this contract. When asserting copyright, the Collaborator shall affix the applicable copyright notice of 17 U.S.C. 401 or 402, and an acknowledgment of FDA sponsorship (including contract number), to the data when such data are delivered to the FDA, as well as when the data are published or deposited for registration as a published work in the U.S. Copyright Office. 

FDA's Rights

For data other than computer software, Collaborators grant to the FDA, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the FDA. For computer software, the Contractor grants to the FDA and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public), by or on behalf of the FDA.

Publications by Collaborators

Sentinel Collaborators (1) are encouraged to present and to publish results of their work in keeping with the stipulations described in Communications, and (2) are permitted, without prior approval of the FDA, to assert copyright in technical or scientific articles based on or containing Sentinel Data first produced in the performance of this contract and published in academic, technical, or professional journals, symposia proceedings, and similar works. Per Communications section, the FDA may post these results at the Agency’s discretion.

 

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[1] The Sentinel Intellectual Property Policy is governed by Federal Acquisition Regulation (FAR) (52.227-14, Alt IV, Rights in Data – General, section (c)(1)).