Agreement

Agreement

by Copley Pharmaceutical Inc
May 30th, 1997

				
                               EXHIBIT 10.3

                                AGREEMENT


Copley Pharmaceutical, Inc. (Copley) 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 Copley's 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 Copley 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 Copley 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 Copley 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 Copley 
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 Copley;

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, Copley 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 Copley 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 21 CFR 314, 150 (d), all applications for 
Albuterol Sulfate for Inhalation.  Copley further agrees to take any 
additional measures that FDA deems necessary to effectively carry out the
foregoing obligations and to assure that Copley's 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 Copley has taken to implement the 
foregoing measures.

     Provided that Copley 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 Copley, debar Copley under section 306 (b) of the Act, 
or prohibit Copley from submitting new applications, amendments, or 
supplements as a result of the fact of Copley's 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 Copley 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 COPLEY PHARMACEUTICAL, INC.


/s/ Richard M. Cooper
- ---------------------
RICHARD M. COOPER
Counsel for Copley Pharmaceutical, Inc.


/s/ Douglas I. Ellsworth
- -----------------------
DOUGLAS I. ELLSWORTH
Director - Division of Manufacturing and Product Quality
Center for Drug Evaluation and Research
Food and Drug Administration