67748 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 

Whenever possible, non-exclusive 

licensing should be pursued as a best 

practice. A non-exclusive licensing 

approach favors and facilitates making 

broad enabling technologies and 

research uses of inventions widely 

available and accessible to the scientific 

community. When a genomic invention 

represents a component part or 

background to a commercial 

development, non-exclusive freedom-tooperate licensing may provide an 

appropriate and sufficient complement 

to existing exclusive intellectual 

property rights. 

In those cases where exclusive 

licensing is necessary to encourage 

research and development by private 

partners, best practices dictate that 

exclusive licenses should be 

appropriately tailored to ensure 

expeditious development of as many 

aspects of the technology as possible. 

Specific indications, fields of use, and 

territories should be limited to be 

commensurate with the abilities and 

commitment of licensees to bring the 

technology to market expeditiously. 

For example, patent claims to gene 

sequences could be licensed exclusively 

in a limited field of use drawn to 

development of antisense molecules in 

therapeutic protocols. Independent of 

such exclusive consideration, the same 

intellectual property rights could be 

licensed non-exclusively for diagnostic 

testing or as a research probe to study 

gene expression under varying 

physiological conditions. 

License agreements should be written 

with developmental milestones and 

benchmarks to ensure that the 

technology is fully developed by the 

licensee. The timely completion of 

milestones and benchmarks should be 

monitored and enforced. Best practices 

provide for modification or termination 

of licenses when progress toward 

commercialization is inadequate. 

Negotiated sublicensing terms and 

provisions optimally permit fair and 

appropriate participation of additional 

parties in the technology development 

process.

Funding recipients and the intramural 

technology transfer community may 

find these recommendations helpful in 

achieving the universal goal of ensuring 

that public health consequences are 

considered when negotiating licenses 

for genomic technologies. 

PHS encourages licensing policies 

and strategies that maximize access, as 

well as commercial and research 

utilization of the technology to benefit 

the public health. For this reason, PHS 

believes that it is important for funding 

recipients and the intramural 

technology transfer community to 

reserve in their license agreements the 

right to use the licensed technologies for 

their own research and educational 

uses, and to allow other non-profit 

institutions to do the same. 

Conclusion 

PHS recognizes that these 

recommendations generally reflect 

practices that may already be followed 

by most funding recipients and the 

intramural technology transfer 

community with regard to licensing of 

genomic and other technologies. PHS 

also acknowledges the need for 

flexibility in the licensing negotiation 

process as the requirements of 

individual license negotiations may 

vary and may not always be adaptable 

to these best practices.

Dated: November 14, 2004. 

Mark L. Rohrbaugh, 

Director, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–25671 Filed 11–18–04; 8:45 am] 

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Apoptosis in Liver 

Cells. 

Date: December 14, 2004. 

Time: 3 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Lakshmanan Sankaran, 

PhD, Scientific Review Administrator, 

Review Branch, DEA, NIDDK, National 

Institutes of Health, Room 777, 6707 

Democracy Boulevard, Bethesda, MD 20892–

5452, (301) 594–7799, Is38oz@nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS)

Dated: November 15, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–25668 Filed 11–18–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel, Mortality and 

Fecundity in Two-sided Search for Male. 

Date: December 1, 2004. 

Time: 2 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01, Rockville, 

MD 20852 (Telephone Conference Call). 

Contact Person: Marita R. Hopmann, PhD, 

Scientific Review Administrator, Division of 

Scientific Review, National Institute of Child 

Health and Human Development, 6100 

Building, Room 5B01, Bethesda, MD 20892 

(301) 435–6911, hopmannm@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and