U.S. Department of Health and Human Services

Intellectual Property & Patents

Institution agrees to promptly notify the NIDDK and the commercial Collaborator, if appropriate, in writing of any inventions, discoveries or innovations made by the Institution's investigator or any other employees or agents of Institution, whether patentable or not, which are conceived and/or first actually reduced to practice in the performance of this study using the commercial Collaborator's Agent (hereinafter "Institution Inventions"). Institution agrees to notify NIDDK and Collaborator in writing upon the filing of any patent applications related to the research with the Agent.

Institution agrees to grant to Collaborator: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Institution Inventions for research purposes only; and (ii) a time-limited first option to negotiate an exclusive, or co-exclusive, if applicable, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to all Institution Inventions on terms to be negotiated in good faith by Collaborator and Institution. Collaborator shall notify Institution, in writing, of its interest in obtaining an exclusive license to any Institution Invention within six (6) months of Collaborator's receipt of written notice of such Institution Invention(s). In the event that Collaborator fails to so notify Institution, or elects not to obtain an exclusive license, then Collaborator's option shall expire with respect to that Institution Invention, and Institution will be free to dispose of its interests in such Institution Invention in accordance with Institution's policies. If Institution and Collaborator fail to reach agreement within ninety (90) days, (or such additional period as Collaborator and Institution may agree) on the terms for an exclusive or co-exclusive license for a particular Institution Invention, then for a period of six (6) months thereafter Institution shall not offer to license the Institution Invention to any third party on materially better terms than those last offered to Collaborator without first offering such terms to Collaborator, in which case Collaborator shall have a period of thirty (30) days in which to accept or reject the offer.

Institution agrees that notwithstanding anything herein to the contrary, any inventions, discoveries or innovations, whether patentable or not, which are not Subject Inventions as defined in 35 U.S.C. § 201(e),* arising out of any unauthorized use of the Collaborator's Agent and/or any modifications to the Agent, shall be the property of the Collaborator (hereinafter "Collaborator Inventions"). Institution will promptly notify the NIDDK and Collaborator in writing of any such Collaborator Inventions and, at Collaborator's request and expense, Institution will request permission from the NIH*, if necessary, to cause to be assigned to Collaborator all right, title and interest in and to any such Collaborator Inventions and provide Collaborator with reasonable assistance to obtain patents (including causing the execution of any invention assignment or other documents). Institution may also be conducting other more basic research using the Agent under the authority of a separate Material Transfer Agreement (MTA), or other such agreement with the NIDDK or Collaborator. Inventions arising thereunder shall be subject to the terms of the separate MTA, and not to this clause. 

Protection of Proprietary Data

"Clinical Data and Results and Raw Data will be provided exclusively to the NIDDK, the Collaborator, and the FDA, as appropriate. This provision shall not affect the investigators right to publish or present as described in the standard protocol language." 

This statement ensures that data generated using an investigational agent proprietary to a Collaborator will be kept confidential and shared only with the NIDDK, the FDA, and the Collaborator. Furthermore, this addresses the needs of the Collaborator to have access to the patient records and raw data; it has no effect on the investigator's right to publish.

* 35 U.S.C. § 201 (e): The term "subject invention" means any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement: Provided, That in the case of a variety of plant, the date of determination (as defined in section 41(d) (FOOTNOTE 1) of the Plant Variety Protection Act (7 U.S.C. § 2401(d))) must also occur during the period of contract performance.