Complex Model Organisms Sharing Plan

Related Extramural SOP: Sharing Model Organisms

The NIH Model Organism Sharing Policy covers all projects that produce or may produce model organisms, regardless of the amount of the budget. Other NIH sharing policies such as the Genomic Data Sharing policy, 2003 Data Sharing Policy, and the Data Management and Sharing Policy pertain to data. To find out which policies apply to a research project, check Which Policies Apply to My Research? 

Below is an actual plan from a principal investigator with [brackets] in place of identifying information. Use it to guide your writing as you comply with the model organism sharing policy. 

You can also find sample model organism sharing plans on NIH’s Model Organism Sharing Policy webpage.

Contact your program officer at Contacting Program Officers and Grants Management Specialists for more information.

Sample Sharing Plan

SPECIAL REQUIREMENTS SECTION OF RFA-[number]

1. Plans to share research resources. All vectors for transgenic production and mouse strains generated over the past several years have been distributed freely to the broader academic community, either before or immediately on publication. Indeed, we have supplied over 250 requesting laboratories with either vectors, mice, or both. Requestees typically receive the desired reagents within two weeks to two months of their request, depending on their chronological position in the queue. The infrastructure for this rapid sharing of newly developed reagents (both vectors and mice) continues to be in place in my lab and supported by the Office of Technology and Licensing, [Applicant Institution] (see attached letter by [name]).

2. Intellectual property rights. Consistent with [Applicant Institution]'s policy on intellectual property rights (see attached letter by [name]), my lab will make available any and all strains of transgenic mice produced under this grant for use at other academic or not-for-profit institutions at no cost except for standard maintenance and transportation expenses. [Applicant Institution] will reserve the right to use these reagents for educational, research, or other nonbusiness purposes. [Applicant Institution] may establish a non-exclusive commercial license granting [Applicant Institution]'s rights to use such animals at specific for-profit entities; in these cases, [Applicant Institution] will maintain the right to grant non-exclusive licenses for use of these materials by academic or not-for-profit institutions.

Transfer of materials to not-for-profit entities will be implemented under terms no more restrictive than the Uniform Biological Materials Transfer Agreement (see example of the [Applicant Institution] simple letter MTA attached in the appendix). Transfer of materials to for-profit entities will be mediated through the [Applicant Institution] Office of Technology and Licensing, and typically involves a simple license agreement with execution or annual fees as deemed appropriate, but in no way prohibitive to the ready distribution of these reagents.

Intellectual property rights as pertains to [certain] reagents. The Non-Profit Institute holds a patent on the use of [product] in mammalian cells. They have made clear that any reagents harboring [product] or [other product] sequences can be freely distributed amongst academic, not-for-profit institutions. Such transfers would be done under a joint [Applicant Institution]/ Non-Profit Institute simple letter MTA (see attached letter from Dr. [Name], Office of Technology and Licensing, [Applicant Institution]). Should reagents be transferred to for-profit institutions, an inter-institutional license ([Applicant Institution] / Non-Profit Institute) will be drafted with execution or annual fees as deemed appropriate, but in no way prohibitive to the ready distribution of these reagents. Those reagents generated in collaboration with Dr. [Name] would require an inter-institutional MTA involving [Applicant Institution] / Non-Profit Institute /Non-Profit Research Center. These simple agreements are already in place.

Intellectual property rights as pertains to [certain] reagents. For-Profit Company holds a patent on the use of [product] in [location]. The memorandum of understanding between For-Profit Company and PHS makes it clear that any and all [products] containing reagents generated under this grant can be readily shared with the broader academic community under a simple MTA, and do not infringe on the uses under restriction (namely: [this], [that] and [a third]) Should our reagents be transferred to for-profit institutions, an inter-institutional license ([Applicant Institution]/ For-Profit Company) will be drafted with execution or annual fees as deemed appropriate. Of course, current For-Profit Company licensing issues as surrounds for-profit institutions would have to be settled between that institution and For-Profit Company.

Intellectual property rights as pertains to the [certain] locus. The Non-Profit Research Center holds a license on use of [certain] sequences. This license stipulates free use for academic, not-for-profit institutions and involves a simple letter MTA. Those reagents generated in collaboration with Dr. [Name] that incorporate [certain] sequences will require an inter-institutional MTA involving [Applicant Institution] Medical School and Non-Profit Research Center. These simple agreements are currently in place. Should reagents be transferred to for-profit institutions, an inter-institutional license ([Applicant Institution] Medical School/Non-Profit Research Center) will be drafted with execution or annual fees as deemed appropriate, but in no way prohibitive to the ready distribution of these reagents.

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