01-6274. National Institutes of Health, National Institute on Child Health and Human Development; Opportunity for Cooperative Research and Development Agreement

SUMMARY:

The National Institute of Child Health and Human Development (NICHD) is seeking research statements from parties interested in entering into a Cooperative Research and Development Agreement (CRADA). The purpose of the CRADA is to develop diagnostic and therapeutic uses of the newly identified human MATER (Maternal Effect Gene) gene and protein that are critical for normal oocyte function and fertility. The project is part of the ongoing activities of the Developmental Endocrinology Branch (DEB), Division of Intramural Research, NICHD. The term of the CRADA will be up to five (5) years.

DATES:

Interested parties should notify this office in writing of their intent to file a formal proposal no later than April 13, 2001. Formal proposals must be submitted to this office no later than May 14, 2001.

ADDRESSES:

Research Statements should be submitted to Kate Sinclair Dunn, Technology Development Specialist, Technology Development and Commercialization Branch, National Cancer Institute, National Institutes of Health, Executive Plaza South, Room 450, 6120 Executive Blvd., MSC 7182, Bethesda, MD 20892-7182, Phone: [phone], Fax: [phone], e-mail [e-mail]. Scientific questions should be addressed to Lawrence M. Nelson, M.D., Head, Gynecological Endocrinology Unit Developmental Endocrinology Branch, NICHD, NIH, Building 10, Room 10N262, Bethesda, MD 20892-1862; Phone (direct): 301-402-6608, Office: 301-496-4686; Fax: [phone], e-mail: Lawrence [e-mail]. Inquiries directed to obtaining patent license(s) related to participation in the CRADA opportunity should be addressed to Dennis Penn, Pharm.D., MPH, Senior Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Blvd., Suite 325, Rockville, MD 20852-3804, Phone: [phone], Fax: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

A CRADA is the anticipated joint agreement to be entered into by NICHD and a collaborator pursuant to the Federal Technology Transfer Act of 1986 (15 U.S.C. 3710 a), as amended. A CRADA is an agreement designed to enable certain collaborations between Government laboratories and non-Government laboratories. It is not a grant, and is not a contract for the procurement of goods/services. THE NICHD IS PROHIBITED FROM TRANSFERRING FUNDS TO A CRADA COLLABORATOR. Under a CRADA, the NICHD can offer the selected collaborator access to facilities, staff, materials, and expertise. The collaborator may contribute facilities, staff, materials, expertise, and funding to the collaboration. A CRADA collaborator may elect an option to an exclusive or non-exclusive license to Government intellectual patent rights arising under the CRADA, and may qualify as a co-inventor of new technology developed under the CRADA. As between two or more sufficient, overlapping research proposals (where the overlap cannot be cured), the NICHD, as specified in 15 U.S.C. 3710a(c)(4), will give special consideration to small businesses, and will give preference to business units located in the U.S. that agree to manufacture CRADA products in the U.S.

The CRADA will employ a MATER null mouse line to examine the role of MATER in maintaining oocyte quality so as to support healthy early embryonic development. The project goal is to determine if abnormalities in the amount or quality of oocyte MATER content play a role in some cases of human infertility that is generally ascribed to “poor egg quality” or a failure of early embryonic development. A strategy should be developed to measure MATER's biologic activity, to determine the MATER content of human oocytes, and to detect MATER gene mutations. Preimplantation mouse oocytes and embryos may be used for protein analysis and profiling. Basic science expertise as applied to oocyte function in animal models and in the clinical setting will be required.

The described methods are the subject of a U.S. provisional patent application filed October 18, 2000 by the Public Health Service on behalf of the Federal Government. Furthermore, the initial report and characterization of the invention is described in: Tong et al., Mamm. Genome 11:281-287, 2000. Commercialization of new CRADA technology may require obtaining an appropriate PHS license.

The collaborator in this endeavor is expected to commit scientific personnel commensurate with the level of research activities defined by the CRADA Research Plan. It is anticipated that PHS laboratories and/or those of the collaborator will be utilized, as appropriate, for the research activities as defined by the Research Plan. NICHD anticipates, in addition, that the Collaborator, as appropriate, will provide funding for the project.

Party Contributions: The NICHD anticipates that its role may include, but not be limited to, the following:

(1) Plan research studies, interpret research results, and, as appropriate, jointly publish the conclusions with the collaborator;

(2) Provide collaborator with access to existing NICHD research data (both already collected and yet to be collected);

(3) Provide staff, expertise, and materials for the development and testing of promising products;

(4) Provide work space and equipment for testing of any prototype compositions developed.

The NICHD anticipates that the role of the successful collaborator will include the following:

(1) Provide significant intellectual, scientific, and technical expertise in the development and manufacture of relevant products;

(2) Plan research studies, interpret research results, and, as appropriate, jointly publish the conclusions; and

(3) Provide NICHD a supply of necessary materials, access to necessary proprietary technology and/or data, and as necessary for the project, staff and funding in support of the research goals.

Other contributions may be necessary for particular proposals.

Selection Criteria: Proposals submitted for consideration should address, as best as possible and to the extent relevant to the proposal, each of the following:

(1) Expertise:

A. Scientific advisors and staff with a demonstrated record of research success related to diagnostic and therapeutic interventions associated with human fertility.

(i) The technical expertise of the Collaborator's Principal Investigator and laboratory group in the technology described above,

(2) Reliability as a research partner:

A. Willingness to commit best effort and to provide adequate and sustained resources and/or funding, as appropriate, to support the CRADA studies, and

B. Development of this technology, as outlined in the CRADA Collaborator's proposal, and

C. Ability to develop and produce products in a timely manner, as applicable (for example, as demonstrated by a history of meeting benchmarks in licenses), and

D. Commitment to supporting the advancement of scientific research, as evidenced by a willingness to jointly publish research results in a prompt manner, and

E. Willingness to be bound by DHHS and PHS policies regarding:

(i) The public distribution of unmodified genetic sequences and research tools,

(ii) The care and handling of animals, and

(iii) Testing in human subjects.

(3) Physical Resources:

A. An established headquarters, with office space and basic office equipment, and

B. Access to the organization during business hours by telephone, facsimile, courier, U.S. Post, e-mail, the World-Wide-Web, and, as appropriate, other evolving information technologies, and

C. Sufficient financial and material resources to support, at a minimum, the anticipated activities of the CRADA to meet the needs of NICHD under the proposal.

The collaborator is encouraged to propose, in the written research statement, related applications and technologies other than those specifically described herein.

Dated: February 26, 2001.

Kathleen Sybert,

Chief, TDCB/NCI/NIH.