Incoming generated [Oct 10, 2002]

0223-EX-PL-2002 Correspondence

Biotronik, Inc.

2002-10-11ELS_58446

From: Mark Johnson

To: John Kennedy
Date: October 10, 2002

Subject:
FCC File #: 0223-EX-PL-2002- Reply
----------------------------------------------------------------------------------------------------------------
Message:

Exhibit in Response to Request for Confidentiality

Per the requirements of Title 47, Chapter I, PART 0, Subpart C, Sec. 0.459(b)

The following statements are responses to items 1 through 9:

1. Please hold confidential the Exhibit entitled “Protocol Summary for Belos T Study”. This
study protocol is competitively sensitive as it provides sensitive information regarding study
objectives and therefore future product claims.

2. This exhibit was submitted as part of application for experimental license.

3. This protocol summary is privileged information, and will not be commercially available
until the conclusion of the study.

4. The protocol outlines the clinical proof sought to make product claims. Identification of
product positioning would be harmful to Biotronik’s competitive situation.

5. As the study will require 2 years to establish, run, document, and publish, competitors using
such information could substantially erode our market leadership position.

6. Parties that will participate in this study will be required to keep protocol and data
confidential.

7. This protocol is not publically available in any form, and has not been disclosed to any third
party.

8. The protocol study requires two years to execute upon receipt of the experimental license,
upon which time the results will be made commercially available and confidentiality will no
longer be required.

9. No additional information is necessary to describe this request for confidentiality.

Document Created: 2002-10-11 06:44:21
Document Modified: 2002-10-11 06:44:21

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