EXHIBIT 10.3
AGREEMENT
Xxxxxx Pharmaceutical, Inc. (Xxxxxx) agrees to do the Following within 90 days
of signing this agreement:
1. Cooperate fully with the Food and Drug Administration (FDA) and other
Federal investigations to determine the perpetrators, participants, causes,
and scope of all wrongful acts related to Xxxxxx'x drug approval process and
to assess the effects of such acts on safety, effectiveness, and quality of
its products;
2. Identify all individuals now employed by Xxxxxx who were responsible for
wrongful acts and remove such persons from any authority on matters under
jurisdiction of the FDA;
3. Conduct a review, acceptable to FDA, of twenty drug applications to be
selected by FDA and identify all instances of wrongful acts associated with
these twenty Xxxxxx drug applications submitted to the FDA, including but not
limited to, any discrepancies between manufacturing conditions and controls
identified in approved applications, supplements, or annual reports, and
manufacturing conditions and controls utilized during actual production. The
review shall be done by an outside auditor or team of auditors acceptable to
FDA who are qualified by training and experience to conduct such a review. If
after review of these twenty applications FDA has determined that the
applications accurately reflect the actual and necessary manufacturing and
control procedures and there exists no data integrity problems with any of the
reviewed applications it will deem the review to be completed and require no
further review by Xxxxxx of additional applications. All oral reports related
to the review shall be promptly, accurately, and completely reduced to writing
and all written reports related to the review that are provided to Xxxxxx
shall be provided to both FDA New England District Office and FDA's Center for
Drug Evaluation and Research, Division of Manufacturing and Product Quality,
for evaluation, within 10 days after receipt by Xxxxxx;
4. Develop and implement a comprehensive ethics program to preclude future
instances of wrongful acts related to the drug application process;
5. Correct all current applications by supplement or voluntary withdrawal as
required by the nature of the deficiency;
In addition, Xxxxxx agrees that it will not manufacture or distribute any
Albuterol Sulfate for Inhalation product without first obtaining written
approval from FDA's Center for Drug Evaluation and Research, Division of
Manufacturing and Product Quality. If after one year from the date of signing
this agreement Xxxxxx has not made such a request to FDA for written approval
to manufacture or distribute Albuterol Sulfate for Inhalation product it will
immediately submit a written request to FDA to withdraw voluntarily, pursuant
to the procedures outlined in 00 XXX 000, 000 (x), all applications for
Albuterol Sulfate for Inhalation. Xxxxxx further agrees to take any
additional measures that FDA deems necessary to effectively carry out the
foregoing obligations and to assure that Xxxxxx'x new drug applications,
including amendments and supplements thereto, are in full compliance with the
law and accurately and completely reflect the products that are the subject of
such applications.
6. Report to FDA's New England District Office every 30 days after signing
the plea agreement each of the steps Xxxxxx has taken to implement the
foregoing measures.
Provided that Xxxxxx promptly and completely complies with each of the
terms of this agreement, it is not FDA's present intention to impose civil
money penalties against Xxxxxx, xxxxx Xxxxxx under section 306 (b) of the Act,
or prohibit Xxxxxx from submitting new applications, amendments, or
supplements as a result of the fact of Xxxxxx'x guilty plea to the charge set
forth in a criminal information. However, nothing herein shall preclude FDA
from implementing the Application Integrity Policy, imposing civil money
penalties, debarring Xxxxxx under section 306 (b) of the Act, and/or taking
any other available judicial or administrative remedies that FDA deems
necessary should new facts become known to FDA meriting such actions.
Dated this 22nd Day of May, 1997.
CONSENTED TO AND AGREED BY
AUTHORIZATION OF THE BOARD
OF DIRECTORS OF XXXXXX PHARMACEUTICAL, INC.
/s/ Xxxxxxx X. Xxxxxx
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XXXXXXX X. XXXXXX
Counsel for Xxxxxx Pharmaceutical, Inc.
/s/ Xxxxxxx X. Xxxxxxxxx
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XXXXXXX X. XXXXXXXXX
Director - Division of Manufacturing and Product Quality
Center for Drug Evaluation and Research
Food and Drug Administration
