Intellectual Property Option to Collaborator Revised 9/12/03

Institution agrees to promptly notify the NCI and "Collaborator" in writing of any inventions, discoveries or innovations made by the Institution's principal investigator or any other employees or agents of Institution, whether patentable or not, which are conceived or first actually reduced to practice in the performance of this study using Collaborator's Study Drug or Agent (hereinafter "Institution Inventions"). 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 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 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 USC 201(e) , arising out of any unauthorized use of the Collaborator's Study Drug and/or any modifications to the Study Drug, shall be the property of the Collaborator (hereinafter "Collaborator Inventions"). Institution will promptly notify the Collaborator in writing of any such Collaborator Inventions and, at Collaborator's request and expense, Institution will 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 Study Drug under the authority of a separate Material Transfer Agreement (MTA), or other such agreement with the Collaborator. Inventions arising thereunder shall be subject to the terms of the MTA or other such agreement, and not to this clause. Combination Intellectual Property Option to Collaborator For clinical studies involving combinations of investigational agents provided by more than one Collaborator, Institution agrees to grant a non-exclusive, fully paid and royalty-free license to Institution Inventions incorporating such combination of investigational agents for all purposes, including commercial purposes, to each Collaborator providing an investigational agent for that study. It is not a requirement by NCI that this license be given; however, the agents can not be provided for the study in the absence of such agreement. This option shall only be applicable so long as Collaborators agree to pay patent prosecution and maintenance costs for a given Institution Invention. Protection of Proprietary Data "Clinical Data and Results and Raw Data will be provided exclusively to the NCI, the Collaborator(s), and the FDA, as appropriate and unless additional disclosure is required by law or court order. Additionally, all Clinical Data and Results and Raw Data will be collected, used and disclosed consistent with all applicable federal statutes and regulations for the protection of human subjects, including, if applicable, the Standards for Privacy of Individually Identifiable Health Information set forth in 45 C.F.R. Part 46. This provision shall not affect the investigators right to publish or present as described in the NCI/DCTD Standard Protocol Language." This statement ensures that data generated using an investigational agent proprietary to Collaborator(s) will be kept confidential and shared only with the NCI, the FDA, and the Collaborator. Furthermore, as described in the above-referenced NCI/DCTD Standard Protocol Language, 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 USC(e): "(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."

Home   |   Contact   |   Privacy Notice   |   Accessibility