Notice Number: NOT-HG-06-001

Key Dates
Release Date: October 6, 2005

Issued by
National Institute of Human Genome Research (NHGRI), (http://www.genome.gov/)

On September 8, 2005, the National Institutes of Health (NIH) issued a Request for Applications entitled, RFA-HG-05-007 Completion of a Comprehensive Mouse Knockout Resource . This Notice is to inform the scientific community that the NIH is amending RFA-HG-05-007, Completion of a Comprehensive Mouse Knockout Resource 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 should 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. The ES cells, embryos, mice, and other resources ( Materials ) generated under this award must be 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.

Awardees will be free to patent any inventions they develop under this award consistent with the Bayh-Dole Act and NIH policies, but funding of an award will be dependent upon an acceptable plan to ensure that the Materials generated under this award will be available for non-commercial research purposes in a manner consistent with the goals of the KOMP.

Investigators responding to this funding opportunity must also address in a plan how applicants will meet the goals of the KOMP by appropriately addressing intellectual property, availability, and accessibility issues known to the Awardee that could materially affect the provision of these research resources from the Awardee to the research community or affect the unencumbered use of the Materials by end-users. Awardees will agree that no reach-through rights to inventions made by end-users of the resources will be permitted under this Award and will not seek reach-through rights to such inventions. To the extent permitted by law, Awardees will grant to the government and the public a non-exclusive, royalty-free license under the patents and other intellectual property rights now owned or controlled by Awardee or developed under this Award to use the Materials for non-commercial research. Without limiting the foregoing, the rights to use Materials, their progeny, and derivatives granted under such license shall extend to breeding of mice whether within a line or with a line of different strain or genetic background.

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 paragraph in Section I. Funding Opportunity Description, 1. Research Objectives, entitled Gene targeting production pipeline should be deleted and replaced as indicated in the following:

Delete:

(a) Generation of the targeting construct using BAC recombineering. The applicant must describe the construction of a targeting vector library consisting of a null mutation marked with a maximally useful reporter for at least the number of unique genes proposed to be mutated. The targeting vector library must be made with genomic DNA from strain C57BL/6. However, while t he sequence of the C57BL/6 genome will be substantially complete by the time applications in response to this RFA will be due, annotation will not be sufficient for all genes by the time that funding could begin. Thus, the applicant should address the issue of generating the constructs for the entire set of genes being proposed over the course of the five-year program, as well as the projected throughput, production goals and explicit milestones, characteristics of the constructs, method(s) for probe generation, method(s) for confirming that the intended mutation has been generated, the expected success rate for targeting vector construction, other quality control measures, the timeline and all other pertinent factors

Replace with:

(a) Generation of the targeting constructs. The applicant must describe the construction of a targeting vector library consisting of a set of clones corresponding to at least the number of unique genes proposed to be mutated. Each clone in the library should comprise a copy of a gene or region of gene to be targeted carrying a null mutation marked with a maximally useful reporter. The approach used should minimize the possibility of introducing significant DNA alterations that could affect neighboring genes and confound the phenotype (for example, using targeting vectors that contain additional deletions, duplications or polymorphisms in the flanking DNA). The applicant should address the issue of generating the constructs for the entire set of genes being proposed over the course of the five-year program, as well as the projected throughput, production goals and explicit milestones, characteristics of the constructs, method(s) for probe generation, method(s) for confirming that the intended mutation has been generated, the expected success rate for targeting vector construction, other quality control measures, the timeline and all other pertinent factors.

The following paragraphs are to be inserted at the end of Section IV. Application and Submission Information , immediately prior to Section V. Application Review Information :

Authorization and Consent".

(a) The Government authorizes and consents to all use and manufacture of any invention described in and covered by a United States patent in the performance of this Cooperative Agreement.

Notice and Assistance Regarding Patent and Copyright Infringement.

(a) The Grantee shall report to the Program Director, promptly and in reasonable written detail, each notice or claim of patent or copyright infringement based on the performance of this Cooperative Agreement of which the Grantee has knowledge.

(b) In the event of any claim or suit against the Government on account of any alleged patent or copyright infringement arising out of the performance of this Cooperative Agreement or out of the use of any supplies furnished or work or services performed under this Cooperative Agreement, the Grantee shall furnish to the Government, when requested by the Program Director, all evidence and information in possession of the Grantee pertaining to such suit or claim. Such evidence and information shall be furnished at the expense of the Government except where the Grantee has agreed to indemnify the Government.

(c) The Grantee agrees to include, and require inclusion of, this clause in all subawards and subcontracts at any tier for supplies or services (including construction and architect-engineer subawards and subcontracts and those for material, supplies, models, samples, or design or testing services).

Patent Indemnity.

(a) The Grantee shall indemnify the Government and its officers, agents, and employees against liability, including costs, for infringement of any United States patent (except a patent issued upon an application that is now or may hereafter be withheld from issue pursuant to a Secrecy Order under 35 U.S.C. 181) arising out of the manufacture or delivery of supplies or materials or the performance of services under this Cooperative Agreement, or out of the use or disposal by or for the account of the Government of such supplies or materials.

(b) This indemnity shall not apply unless the Grantee shall have been informed as soon as practicable by the Government of the suit or action alleging such infringement and shall have been given such opportunity as is afforded by applicable laws, rules, or regulations to participate in its defense. Further, this indemnity shall not apply to

(1) An infringement resulting from compliance with specific written instructions of the Program Director;

(2) An infringement resulting from addition to or change in supplies or components furnished or construction work performed that was made subsequent to delivery or performance; or

(3) A claimed infringement that is unreasonably settled without the consent of the Grantee, unless required by final decree of a court of competent jurisdiction.

Inquiries

Direct questions about scientific/research issues to:

Jane L. Peterson, Ph.D.; Mark W. Moore, Ph.D.
Division of Extramural Research
National Institute of Human Genome Research
5635 Fisher Lane
Suite 4076
Bethesda , MD 20892
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: [email protected]; [email protected]

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