Exhibit 10.33
AMENDMENT NO. 1
TO
NICOTINE AGREEMENT BETWEEN
CYGNUS INC. AND [CONFIDENTIAL TREATMENT REQUESTED]
Cygnus Inc. ("Cygnus") and [Confidential Treatment Requested] hereby
agree to amend the Nicotine Agreement between them by adding the following
paragraph as Section 6.7:
6.7 GMP AUDITS. [Confidential Treatment Requested] shall have the right
to audit the facility of Cygnus as may be necessary to assure that all
applicable FDA or similar government regulations have been met with respect to
Final Product. Cygnus shall permit duly authorized representatives of
[Confidential Treatment Requested] to conduct such an audit following the making
of a prior appointment. Such audits may be conducted for the sole purpose of
assuring compliance with all pertinent acts, regulations, and guidelines
promulgated by the FDA and other regulatory authorities concerning the Final
Product. The foregoing audits shall be conducted no more than one (1) time per
calendar year, unless there are observations which the parties mutually agree
require a further audit. Such audits will be permitted during normal business
hours and will be performed with a minimum of disruption. [Confidential
Treatment Requested] shall furnish Cygnus with copies of all reports prepared as
a result of these audits. [Confidential Treatment Requested] agrees to notify
Cygnus within ten (10) working days of any concerns that it may have which were
discovered during an audit. All information disclosed by Cygnus or discovered
or learned by [Confidential Treatment Requested] during such audits shall be
deemed Cygnus Confidential Information governed by Section 11.
DATED: August 21, 1998 DATED: August 25, 1998
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CYGNUS, INC. [Confidential Treatment Requested]
By /s/ Xxxxxxx X. Xxxxxx By /s/ [Confidential Treatment Requested]
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Xxxxxxx X. Xxxxxx
President, Drug Delivery
