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NOT-DA-06-001: Amendments and Corrections to RFA-DA-06-009 Development and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants Amendments and Corrections to RFA-DA-06-009 "Development and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants”

Notice Number: NOT-DA-06-001

Key Dates
Release Date: October 14, 2005

Issued by
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)

On September 16, 2005 , the National Institutes of Health (NIH) issued a Request for Applications entitled, RFA-DA-06-009 “ Development and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants. ” This Notice is to inform the scientific community that the NIH is amending RFA-DA-06-009, “ Development and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants ” as follows:

The paragraph in “ Section I. Funding Opportunity Description, 1. Research Objectives”, entitled “Intellectual Property”, located in the paragraph prior to the “Budget” section should be deleted and replaced as indicated in the following:

Delete:

“Intellectual Property. If, in the course of constructing the desired mouse knockouts, the applicant proposes to use technology covered by third party patent claims, then the applicant must provide evidence that s/he will be able to freely practice the technology. The applicant must also demonstrate that s/he will be free to distribute the knockout ES cells, embryos and mice to the repositories and, ultimately, end-users without any restriction on the repositories' ability to transfer the materials to end-users or end-users' ability to use the materials for research purposes.  This plan must include users in both the public and private sectors, although it is recognized that there may be different approaches to the issue of use in the two sectors. A uniform MTA such as the SLA (http://ott.od.nih.gov/NewPages/SimplLtrAgr.pdf) or the UBMTA (http://ott.od.nih.gov/NewPages/ubmta.pdf) will be used for all repositories which receive resources made by this effort to ensure that the resources made by this initiative are available in a manner consistent with the goals of this RFA and with no additional reach through rights to inventions[/discoveries] made by the end users.  (See additional information section for issues regarding the intellectual property plan that must be addressed). Applicants with insufficient plans to deal with the intellectual property will not be funded. Applicants are free to patent their discoveries so long as the ES cells, embryos and mice are made available for research purposes in a manner consistent with the goals of this RFA.”

Replace with:

“Intellectual Property. The purpose of the Knockout Mouse Project (KOMP) is to generate a comprehensive resource of research tools for distribution to the scientific community. A goal of this KOMP is to ensure that the ES cells, embryos, mice, and other resources (“Materials”) generated under this award are made freely available and accessible for research purposes to the entire research community across the public and private sectors, although it is recognized that different approaches for the two sectors may be appropriate, consistent with the precepts of the NIH Research Tools Policy. Accordingly, applicants are expected to include a plan addressing how they will exercise their intellectual property rights, while making such research resources available to the broader scientific community for research purposes consistent with the goals of the KOMP, as well as enable an end user of the ES cells and embryos (and eventually mice) to use the resources for research purposes. Furthermore, transfers of research resources must be made consistent with the NIH Research Tools Policy (http://www.ott.nih.gov/policy/rt_guide_final.html) and other NIH sharing policies. A uniform MTA such as the SLA (http://ott.od.nih.gov/NewPages/SimplLtrAgr.pdf) or the UBMTA (http://ott.od.nih.gov/NewPages/ubmta.pdf) may be used for all repositories which receive resources made by this effort, to ensure that the mice are available for use under reasonable conditions to all end users with no additional reach-through rights. Awardees will be free to patent any inventions they develop under this award consistent with the Bayh-Dole Act and NIH policies, so long as the ES cells, embryos, and mice are made available for research purposes in a manner consistent with the goals of the KOMP as described in this RFA. Applications with insufficient plans for sharing and using the resources will not be funded. Such a plan will be will be made a condition of the awards made as a result of this RFA.

In addressing these considerations and developing this plan, investigators are advised to confer with their organization's offices responsible for matters involving technology transfer and sponsored programs, as well as any other relevant offices of their organization . ”

The paragraphs at the end of “ Section IV. Application and Submission Information ”, immediately prior to “Section V. Application Review Information”, entitled “Intellectual Property.” Should be deleted and replaced as indicated in the following:

Delete:

“Intellectual Property. If, in the course of constructing the proposed mouse knockouts, the applicant intends to use technology covered by third party patent claims, then the applicant must provide evidence that s/he will be able practice such technology. Furthermore, the applicant must also propose a plan that would enable an end user of the ES cells and embryos (and eventually mice) to use the resources in light of any such applicable patents.  This plan must include end users in both the public and private sectors, although it is recognized that there may be different approaches to the issue of use in the two sectors. A uniform MTA such as the SLA (http://ott.od.nih.gov/NewPages/SimplLtrAgr.pdf) or the UBMTA (http://ott.od.nih.gov/NewPages/ubmta.pdf) will be used for all repositories which receive resources made by KOMP to ensure that the resources generated by the program will be available in a manner consistent with its goals as described in this RFA and with no additional reach-through rights to inventions/discoveries made by the end users.  (See additional information section for issues that must be addressed regarding the intellectual property plan).  Applications with unacceptable plans to address intellectual property issues will not be funded.  Awardees will be free to patent any inventions, but funding of an award will be dependent upon an acceptable plan to ensure that the ES cells, embryos, mice and other resources generated under this award will be available for research purposes in a manner consistent with the goals of KOMP as described in this RFA.  Such a plan will be will be made a condition of the awards made as a result of this RFA.”

Replace with:

“Intellectual Property. The purpose of the Knockout Mouse Project (KOMP) is to generate a comprehensive resource of research tools for distribution to the scientific community. A goal of this KOMP is to ensure that the ES cells, embryos, mice, and other resources (“Materials”) generated under this award are made freely available and accessible for research purposes to the entire research community across the public and private sectors, although it is recognized that different approaches for the two sectors may be appropriate, consistent with the precepts of the NIH Research Tools Policy. Accordingly, applicants are expected to include a plan addressing how they will exercise their intellectual property rights, while making such research resources available to the broader scientific community for research purposes consistent with the goals of the KOMP, as well as enable an end user of the ES cells and embryos (and eventually mice) to use the resources for research purposes. Furthermore, transfers of research resources must be made consistent with the NIH Research Tools Policy (http://www.ott.nih.gov/policy/rt_guide_final.html) and other NIH sharing policies. A uniform MTA such as the SLA (http://ott.od.nih.gov/NewPages/SimplLtrAgr.pdf) or the UBMTA (http://ott.od.nih.gov/NewPages/ubmta.pdf) may be used for all repositories which receive resources made by this effort, to ensure that the mice are available for use under reasonable conditions to all end users with no additional reach-through rights. Awardees will be free to patent any inventions they develop under this award consistent with the Bayh-Dole Act and NIH policies, so long as the ES cells, embryos, and mice are made available for research purposes in a manner consistent with the goals of the KOMP as described in this RFA. Applications with insufficient plans for sharing and using the resources will not be funded. Such a plan will be will be made a condition of the awards made as a result of this RFA.

In addressing these considerations and developing this plan, investigators are advised to confer with their organization's offices responsible for matters involving technology transfer and sponsored programs, as well as any other relevant offices of their organization.”

Inquiries

Direct questions about scientific/research issues to:

Jonathan Pollock, Ph.D.
Division of Basic Neuroscience and Behavioral Research
Genetics and Molecular Neurobiology Research Branch
National Institute of Drug Abuse/NIH/DHHS
6001 Executive Blvd. , Rm. 4282, MSC 9555
Bethesda , MD 20892-9555
Telephone: (301) 435-1309
Email: jpollock@mail.nih.gov


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