-403-
definition, it is hard to visualize that [IRC] obtained ownership
156(...continued)
division, continuation, and continuation-in-part.
b. Any patent which is a reissue or an extension
of, a patent of addition to, any patent defined in (a)
above;
c. Any patent application or patent corresponding
to any patent application or patent identified in (a)
or (b) above which is hereafter filed or issued in any
country.
In the licensing agreement between Newport and IRC, entered into
in 1979, the research to be undertaken by Newport was described
as follows:
The research which is the subject of this Agreement
will include, but is not limited to the areas of:
chemical synthesis and analysis of compounds to be
agreed upon; research and development of pharmaceutical
dosage forms and methods of quality control testing for
identity, purity and stability; preclinical
toxicological, pharmacological and biochemical studies
in tissue culture and animal models to determine safety
efficacy and method of action and to provide guidelines
for the investigation of potential applicability to
human subjects; toxicological, pharmacological and
biochemical studies in human subjects to determine
safety and degree of tolerance in man; and clinical
trials to determine range of clinical potential and
conditions for obtaining maximum therapeutic benefit at
minimum risk in clinical usage.
This shall be a fixed price contract and Newport will
provide to * * * [IRC] data on NPT-15392 and such other
substances as may be agreed to, establishing the acute
toxicity (single dose administration to two species);
subacute toxicity (multiple dose administration in two
species for 90 days); single dose administration to
humans designed to establish the level at which the
drug may be safely administered (including laboratory
and physical measurements of potential side effects)
and the results of efficacy testing in at least 12
patients in which laboratory parameters of the immune
response are measured.
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