20278 Federal Register / Vol. 60, No. 79 / Tuesday, April 25, 1995 / Notices

(6) Agreement to be bound by the

DHHS rules involving the use of human

and animal subject, and human tissue.

(7) Ability to obtain background

license to relevant patent rights.

(8) Willingness to agree to Federal

Statutory provisions for the equitable

distribution of patent rights to any

CRADA subject-matter inventions.

Generally, the rights of ownership are

retained by the organization which is

the employer of the inventor, with (A)

an irrevocable, non-exclusive, royaltyfree research license to the Government

(when a company employee is the sole

inventor) or (B) an option for an

exclusive or non-exclusive license to the

company on terms that are appropriate

(when the Government employee is the

sole or joint inventor).

(9) Willingness to cost share in

laboratory studies including the funding

of personnel dedicated to completion of

the CRADA research project.

(10) Submission of an initial response

to the NIH Model CRADA boilerplate

provisions.

Dated: April 13, 1995.

Dr. Thomas Mays,

Director, Office of Technology Development,

National Cancer Institute, National Institutes

of Health.

[FR Doc. 95–10110 Filed 4–24–95; 8:45 am]

BILLING CODE 4140–010–P

National Cancer Institute: Opportunity

for a Clinical Trial Cooperative

Research and Development Agreement

(Clinical Trial ‘‘CRADA’’) for the

Scientific and Commercial

Development of the Signal

Transduction Inhibitor, ‘‘CAI’’, as an

Anticancer Agent

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services (DHHS) seeks a

pharmaceutical company which can

effectively pursue the clinical

development of the signal transduction

inhibitor, carboxyamide-amino triazole

(‘‘CAI’’, NSC 609974), for the treatment

and/or prevention of cancer. The

National Cancer Institute has data

suggesting that CAI may have potential

for the treatment and prevention of

cancer. The selected sponsor will be

awarded a CRADA for the codevelopment of this agent with the

National Cancer Institute.

ADDRESSES: Questions about this

opportunity may be addressed to Mark

W. Noel, Office of Technology

Development, NCI, Building 31/Room

4A51, 9000 Rockville Pike, Bethesda,

Maryland 20892, (301) 496–0477,

facsimile (301) 402–2117, from whom

further information including a

summary copy of the preclinical and

clinical data may be obtained.

DATES: In view of the important priority

of developing new agents for the

treatment or prevention of cancer,

interested parties should notify this

office in writing no later than June 25,

1995. Respondents will then be

provided an additional 60 days for the

filing of formal proposals.

SUPPLEMENTARY INFORMATION:

‘‘Cooperative Research and

Development Agreement’’ or ‘‘CRADA’’

means the anticipated joint agreement to

be entered into by NCI pursuant to the

Federal Technology Transfer Act of

1986 and Executive Order 12591 of

October 10, 1987 to collaborate on the

specific research project described

below. The present opportunity will be

for a Clinical Trial CRADA. The Clinical

Trial CRADA is a modification of the

standard NIH Model Agreement

wherein additional language has been

drafted to enable the Collaborator to

access and utilitize clinical trial data.

The Government is seeking a

pharmaceutical company which, in

accordance with the requirements of the

regulations governing the transfer of

agents in which the Government has

taken an active role in developing (37

CFR 404.8), can further develop CAI

through Federal Food and Drug

Administration approval and to a

commercially available status to meet

the needs of the public and with the

best terms for the Government.

CAI is a novel chemically defined

compound which has shown promising

antitumor activity in several preclinical

trials. The drug is under patent to Merck

& Co., Inc. (U.S. Patent 4,590,201). The

use of CAI in a method of treating

peritoneal carcinomatosis of solid

tumors is claimed in U.S. Patent

5,132,315 assigned to the Dept. of

Health and Human Services. A method

for the detection and quantitation of CAI

levels in blood is claimed in U.S. Patent

5,405,782 which is also assigned to the

Dept. of Health and Human Services. Its

use in the treatment of cancer in

patients with a surgically excised tumor

with a high probability of metastasis

and its use in treatment of cancers

involving the transportation of

individual cells to other tissue from a

metastasizing tumor are claimed in U.S.

Patent 5,045,543 (assigned to Merck &

Co. Inc). The Clinical Trial CRADA will

allow a pharmaceutical company to

provide resources, in collaboration with

the NCI, for the continuing preclinical

and clinical development work for this

agent and its eventual

commercialization. Merck & Co.’s patent

rights will be available for licensing on

terms to be mutually agreed upon by

Merck and the selected Collaborator.

Similarly, the Government will make its

relevant intellectual property rights

available for licensing to the

Collaborator.

Based on the promising data obtained

from the ongoing Phase I clinical trials,

there is a need to obtain greater

quantities of CAI and to continue

clinical development of this agent. The

NCI is interested in establishing a

Clinical Trial CRADA with a

pharmaceutical company to assist in the

continuing development of CAI. The

government will provide all relevant

available expertise and information to

date and will jointly pursue new trials

as required giving the pharmaceutical

company exclusive rights to all

preclinical and clinical data for

regulatory approval and its New Drug

Application (NDA). The successful

pharmaceutical company will provide

the necessary quantities of drug plus the

necessary financial and organizational

support to complete further

development of CAI to establish clinical

efficacy and possible commercial status.

The expected duration of the CRADA

will be three (3) to five (5) years.

The role of the National Cancer

Institute, includes the following:

1. The government has data for the

bulk production of clinical grade CAI.

The successful pharmaceutical company

will be allowed access to this data.

2. The government will provide data

concerning pharmaceutical

manufacturing and controls, including

dosage form development data for the

finished product.

3. The government will allow the

pharmaceutical company to review and

cross-file the NCI’s IND.

4. The government will make the

NCI’s IND proprietary under such

circumstances and make the IND

available (exclusively) to the

pharmaceutical company.

5. The government will continue the

clinical development of this compound

under its clinical trials network in

coordination with the pharmaceutical

company.

6. Relevant Government intellectual

property rights are available for

licensing through the Office of

Technology Transfer, National Institutes

of Health. For further information

contact Jack Spiegel, Office of

Technology Transfer, National Institutes

of Health, Box OTT, Bethesda, MD

20892; (301) 496–7735; facsimile (301)

402–0220.
Federal Register / Vol. 60, No. 79 / Tuesday, April 25, 1995 / Notices 20279

The role of Merck & Co. under the

CRADA will include the following:

1. Participate in the selection of the

CRADA collaborator and in the

development of the CRADA Research

Plan.

2. Provide for the licensing of Merck

intellectual property rights to the

selected Collaborator as necessary for

the clinical development and

commercialization of CAI as an anticancer agent.

The role of the successful

pharmaceutical company under the

CRADA will include the following:

1. Provide plans to independently

secure future continuing supplies of

GMP produced and formulated material

to assure continued collaborative

clinical development of CAI.

2. Provide funds to supplement the

clinical trials support contracts and

offer any other necessary support to the

NCI for continued collaborative clinical

development of this compound. This

includes both financial support as well

as personnel for data management and

clinical care.

3. Provide planning and support for

clinical development leading to FDA

approval for marketing.

Criteria for choosing the

pharmaceutical company include its

demonstrated experience and

commitment to the following:

1. Experience in preclinical and

clinical drug development.

2. Experience and ability to produce,

package, market and distribute

pharmaceutical products.

3. Experience in the monitoring,

evaluation and interpretation of the data

from investigational agent clinical

studies under an IND.

4. A willingness to cooperate with the

NCI in the collection, evaluation,

publication and maintaining of data

from clinical trials of investigational

agents.

5. The provision of adequate

quantities of GMP produced and

formulated CAI as needed for clinical

development of this agent for the

specified field of use to be determined

upon mutual agreement of the parties.

6. Provide defined financial and

personnel support for the clinical trials

to be mutually agreed upon.

7. An agreement to be bound by the

DHHS rules involving human and

animal subjects.

8. The aggressiveness of the

development plan, including the

appropriateness of milestones and

deadlines for preclinical and clinical

development.

9. Provisions for equitable

distribution of patent rights to any

inventions. Generally the rights of

ownership are retained by the

organization which is the employer of

the inventor, with (1) an irrevocable,

nonexclusive, royalty-free license to the

Government (when a company

employee(s) is (are) the sole inventor(s))

or (2) an option to negotiate an

exclusive or nonexclusive license to the

company on terms that are appropriate

(when the Government employee(s) is

(are) the sole inventor(s) or where a joint

invention arises).

Dated: April 13, 1995.

Thomas D. Mays,

Director, Office of Technology Development,

OD, NCI.

[FR Doc. 95–10109 Filed 4–24–95; 8:45 am]

BILLING CODE 4140–01–P

National Cancer Institute: Opportunity

for a Cooperative Research and

Development Agreement (‘‘CRADA’’)

for the Scientific and Commercial

Development of Certain Signal

Transduction Inhibitors as Anticancer

Agents

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services (DHHS) seeks a

pharmaceutical company which can

effectively pursue the preclinical

development and possible eventual

clinical development of a family of

agents which inhibit the signal

transduction pathways required for the

growth and metastasis of cancer cells.

The National Cancer Institute has

preclinical data suggesting that these

agents may have potential for the

treatment and/or prevention of cancer.

The selected sponsor will be awarded a

CRADA for the co-development of these

agents in a specified field of use to be

determined upon mutual agreement of

the parties.

ADDRESSES: Questions about this

opportunity may be addressed to Mark

W. Noel, Office of Technology

Development, NCI, Building 31/Room

4A51, 9000 Rockville Pike, Bethesda,

Maryland 20892, (301) 496–0477,

facsimile (301) 402–2117, from whom

further information including a

summary copy of the preclinical data

may be obtained.

DATES: In view of the important priority

of developing new drugs for the

treatment or prevention of cancer,

interested parties should notify this

office in writing no later than June 26,

1995. Respondents will then be

provided an additional 60 days for the

filing of formal proposals.

SUPPLEMENTARY INFORMATION:

‘‘Cooperative Research and

Development Agreement’’ or ‘‘CRADA’’

means the anticipated joint agreement to

be entered into by NCI pursuant to the

Federal Technology Transfer Act of

1986 and Executive Order 12591 of

October 10, 1987 to collaborate on the

specific research project described

below.

The Government is seeking a

pharmaceutical company which, in

accordance with the requirements of the

regulations governing the transfer of

Government-developed agents (37 CFR

404.8), can develop the subject agents to

a marketable status to meet the needs of

the public and with the best terms for

the Government. These agents are a

novel, chemically-defined family of

agents being investigated in the

Laboratory of Pathology of the Division

of Cancer Biology, Diagnosis and

Centers, National Cancer Institute.

These agents have been demonstrated to

inhibit the signal transduction pathways

required for the growth and metastasis

of cancer cells and have shown

promising antitumor activity in

preclinical investigations. The majority

of the agents which are the subject of

the CRADA opportunity are the subject

of patent U.S. Patent 5,359,078 which is

assigned to the Dept. of Health and

Human Services. A method for the

detection and quantitation of the levels

of these agents in blood is claimed in

U.S. Patent 5,405,782 which is also

assigned to the Dept. of Health and

Human Services. The Cooperative

Research and Development Agreement

(‘‘CRADA’’) will allow a pharmaceutical

company to provide resources, in

collaboration with the NCI, for the

continuing preclinical development and

possibly the clinical development for

this group of agents.

The government will provide all

relevant available expertise and

information to date and will, jointly

pursue further preclinical development

of these agents with the chosen

Collaborator. Relevant background

patent rights are available for licensing

to the Collaborator.

The successful pharmaceutical

company will provide the necessary

quantities of the agents plus the

necessary technical expertise, financial

and organizational support to complete

further development of these agents to

establish their efficacy and possible

commercial status.

The expected duration of the CRADA

will be three (3) to five (5) years.

The role of the National Cancer

Institute, includes the following:

1. The government will continue

preclinical development of the agents as