It is permissible for a project to receive additional funding from another source. However, this information must be provided on the full application form. The maximum amount of additional funding allowed is 100% of the value of the award, i.e. matching funding. For example, if the Bayer award is for $25,000, the recipient could receive $25,000 from another source. In the event of a change in the status of a pending application, all applicants are required to notify the Administrator.
Applicants may request institutional overhead payments. In some instances, the Grants Review and Awards Committee may determine if or to what extent institutional overhead payments will be made in conjunction with a particular proposal. It is important to note that any institutional overhead payments will be paid out of the amount funded, not in addition to it. The maximum payment will be 20% of the value of the award.
These last two bullets do not apply to the Clinical Training Award.
All awardees are required to submit a statement from their institution stating that the grant has been received. In the event that unexpended funds remain at the end of the funding period, these funds must be returned to the Bayer Hemophilia Awards Program. A final financial report is due 60 days after the end of the funding period reconciling the proposed budget with the actual expenditure.
One-year projects will receive full funding at the beginning of the grant period after all required documents have been received. For two-year grants, funds will be disbursed annually at the beginning of the grant period after all required documents have been received.
Applicants may only receive one Clinical Training Award and one Early Career Award from the program.
Applicants who have received funding for a Special Projects Award must wait one year from the expiration of current funding before re-applying to this category.
More than one application from the same institution, i.e. university, hospital, haemophilia treatment center, is permitted. However, multiple applications from researchers at such an institute collaborating on one project are not permitted.
If there are any significant changes in an award recipient's circumstances, the award recipient must contact the Program Administrator to describe these changes and explain how they might affect the use of awarded funds. Awards are made to the award recipient and the institution with which he/she is affiliated. Thus, the Program must be notified of any changes in institutional affiliation.
The transfer of a grant to another institution or investigator will be at the sole discretion of the Program.
Progress reports for one-year awards must be submitted to the Program Administrator at 6 months, and reports for two-year awards must be submitted at 6, 12 and 18 months. For the two-year Awards, the 12-month progress report must be received within 30 days of the end of the first year in order for the Awardee to receive funding for the second year. Final reports are due 60 days after the end of the funding period. Pro-forma progress and final reports will be e-mailed to awardees at least one month before these deadlines.
The Program reserves the right to terminate support of a funded project at any time for any reason at its sole discretion.
For-profit organizations are not allowed to apply to the Bayer Hemophilia Awards Program, e.g. pharmaceutical companies, homecare companies, health maintenance organizations, etc. The exceptions are research laboratories and academic institutions that may exist as part of a hospital that is run for profit. If in doubt about eligibility, please contact the Program Administrator.
As a condition of funding, Bayer may ask for a right of first refusal to obtain an exclusive worldwide license to any technology invented or improved under the grant. This intellectual property includes, but is not limited to, patented inventions, technical data, materials and know-how. It does not include any technology invented prior to the award period or after the end of the award period, or to technology invented by the investigators during the period of funding but not supported in any way by this award.
Bayer recognizes that its conditions may prove prohibitive for certain institutions with conflicting intellectual property policies in place, and consequently it is open to alternate arrangements if necessary. Such arrangements, however, should be aligned with the Program's objective of treating, to the greatest extent possible, all award recipients in a substantially identical manner.
Researchers funded by the Bayer Hemophilia Awards Program may produce inventions that should be patented. The investigator and/or the institution will own the patent according to arrangements they have made with each other.
Because it is important to Bayer as well as to investigators that inventions are patented properly, we encourage investigators to protect their inventions. Researchers may not be familiar with the patent process, while Bayer often has a clear idea of the kinds of inventions that should be protected. Bayer can offer advice, in a manner that will not compromise ownership, to ensure that adequate patent protection is obtained. However, Bayer can neither prepare the patent application for the investigator nor fund the patent application process. In our view, any patent remains the property of the investigator and/or the host institution, and it is the responsibility of one or both to patent inventions of merit.
The award recipient is responsible for ensuring that intellectual property is protected by assuring confidentiality until appropriate patent applications can be filed and by notifying the Program Administrator of potential inventions in time to permit proper evaluation and action.
Patent applications cannot be filed overnight, and advance planning is needed prior to any publications. Bayer will have a minimum of 30 days and a maximum of 60 days to evaluate an invention for patentability before the applicant is free to publish the information. In this case, 'publication' includes any oral presentation and electronic information transfer in addition to the publication of manuscripts and abstracts. If Bayer decides that the invention should be patented, the investigator may not publish anything until the relevant patent applications have been filed. This is in the best interests of the investigator, the host institution, and Bayer.
Bayer may wish to acquire a license to intellectual property developed under its sponsorship and will negotiate with the appropriate party to seek an appropriate arrangement.
There may be important scientific interactions between Bayer and the applicants as the research progresses. Jointly developed intellectual property will be protected with joint patent applications in which the corporate inventors are co-applicants. Bayer will share the ownership of such jointly developed intellectual property with the sponsored investigators.
If the award recipient's institution chooses not to file any patent application arising from work performed under a grant from the Program, Bayer may seek the option to file such a patent application on the invention. It will be the responsibility of the award recipient to assist in the preparation of such patent applications and to preserve their confidentiality. In this case, Bayer will pay the cost of patent preparation and filing and the patents will be assigned to Bayer.
If the investigators are receiving funding from other agencies or companies that precludes signing this agreement, it is the responsibility of the award recipient to inform the Program Administrator as soon as possible.
For applications to the Early Career and Special Project categories, applicants will be required to describe how their proposed research will translate into clinical benefits for patients with hemophilia and to those health care professionals providing care. The applications which offer the most compelling translational opportunities will be given greater weight during the review process.
Applicants requesting an award to carry out research with recombinant molecules and/or animal or human subjects must obtain approval from the appropriate institutional or government authorities, e.g. an Institutional Review Board. If an applicant's institute does not require special permission for using recombinant molecules, then this must be communicated to the Program Administrator. Bayer can provide assistance with this process if requested by the investigator.
The Program Administrator must receive copies of appropriate permissions before any award funds will be disbursed.
The applicant's institution has responsibility for ensuring that the rights of any human subjects are upheld and that animals are cared for in a humane manner.
The Program encourages award recipients to publish work carried out under an award; this includes abstract submissions to congresses. Award recipients must acknowledge the receipt of funding from the Bayer Hemophilia Awards Program in publications and abstracts describing research conducted with awards made by the Program.
When clinical trials are required for clinical investigation, the project must meet certain Bayer international standards for clinical studies and conform to all local safety reporting regulations.
Patient safety is the primary concern in any clinical study, so the company will not release funds for the clinical trial until both the company and the investigators agree on the safety and suitability of the trial. In addition, relevant patient safety data must be supplied to the appropriate Bayer safety officer.