[Federal Register Volume 62, Number 211 (Friday, October 31, 1997)]
[Notices]
[Page 58982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28949]
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DEPARTMENT OF JUSTICE
Antitrust Division
Notice Pursuant to the National Cooperative Research and
Production Act of 1993--Inter Company Collaboration for Aids Drug
Development
Notice is hereby given that, on September 15, 1997, pursuant to
Section 6(a) of the National Cooperative Research and Production Act of
1993, 15 U.S.C. Sec. 4301 et seq. (``the Act''), Inter Company
Collaboration for Aids Drug Development (The Collaboration) filed
written notifications simultaneously with the Attorney General and the
Federal Trade Commission. The notifications were filed for the purpose
of extending the Act's provisions limiting the recovery of antitrust
plaintiffs to actual damages under specified circumstances.
As indicated in its previous filings, the Collaboration is intended
to facilitate more efficient concomitant and or comparative research on
HIV antiviral compounds through the sharing of scientific information
among its members, the sharing of compounds to conduct appropriate
investigations for clinical research, and the coordination of certain
clinical trials conducted independently by certain of its members. A
purpose of this filing is to confirm that these activities of the
Collaboration encompass gene therapy related to the treatment of HIV
infection and AIDS.
The Collaboration may also engage in the collection, analysis and
exchange of research information, including information on statistical
techniques applicable to AIDS research with other groups or entities
engaged in research on HIV and AIDS, as well as within the
Collaboration.
In addition, the Collaboration may, as an organization, engage in
scientific and policy discussions with governmental agencies (including
FDA and NIH). This activity may involve development, exchange and
analysis of scientific information within the Collaboration, and
presentation, analysis and discussion by the Collaboration with
government agencies. Such discussions may include consideration of the
appropriate surrogate markers for approval of AIDS anti-viral drugs and
innovative statistical techniques to address issues presented by AIDS
drug clinical trials. This activity may also involve the development
and presentation of regulatory positions by the Collaboration to
governmental agencies.
Although no changes have been made in the membership of the
Collaboration, Collaboration member AJI PHARMA USA, Inc. has merged
with its parent, Ajinomoto Co., Inc.; Collaboration member Triangle
Pharmaceuticals Inc. has acquired Avid Corporation by merger with a
subsidiary; and Collaboration member Ciba-Geigy AG has merged with
Sandoz AG to form Novartis AG. As a part of the merger process, the
Ciba-Geigy pharmaceutical operations, including its membership in the
Collaboration, became part of Novartis Pharma AG, Novartis,
pharmaceutical operating subsidiary. Membership in the Collaboration
remains open.
On May 27, 1993, the Collaboration filed its original notification
pursuant to Section 6(a) of the Act. The Department of Justice
published a notice in the Federal Register pursuant to Section 6(b) of
the Act on July 6, 1993 (58 FR 36223). The last notification was filed
with the Department on August 23, 1996. A notice was published in the
Federal Register on September 17, 1996 (61 FR 48982).
Constance K. Robinson,
Director of Operations, Antitrust Division.
[FR Doc. 97-28949 Filed 10-30-97; 8:45 am]
BILLING CODE 4410-11-M