Table 2 Intellectual property issues that are considered in developing contracts with industry
From: Developing interactions with industry in rare diseases: lessons learned and continuing challenges
1. Ownership of data, rights to data, and data sharing, including strategies for negotiating accessing to Urea Cycle Disorders Consortium (UCDC) data if applicable. |
2. Publishing rights following use of UCDC resources must be negotiated with open publication of research endeavors as a critical expectation. |
3. The UCDC does not seek to profit from collaboration with industry, but costs incurred by the consortium in the course of data sharing should be recouped. Examples of such costs include initial or startup costs for data sets, the cost of ongoing maintenance and continuation, and hourly rates for data retrieval and generation of spreadsheets and reports. |
4. The UCDC and National Institutes of Health (NIH) program partners must review the disposition of any funds received from industry in the context of the cooperative agreement, in which program income may be used only for allowable costs in accordance with the applicable cost principles and the terms and conditions of the award. |
5. Mutual agreements must be clearly defined between the UCDC, NIH, and industrial partners by contract before data sharing can be initiated. |
6. Negotiation by the UCDC central leadership organization on behalf of members can be complicated by difficulties in achieving consensus from member institutions' grant offices regarding contracts for the UCDC. This latter element remains an ongoing challenge. |
