Stereotaxis
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S-1/A
STEREOTAXIS, INC. filed this Form S-1/A on 05/12/2004
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or ablation devices as Additional Partnered NL Catheters; and (ii) to ensure
expeditious availability of such candidate devices for non-commercial clinical
use where such expeditious availability is a significant factor in facilitating
adoption or utilization of NIOBE Systems by customers; then Stereotaxis may
during the Term develop such devices and make them available for non-commercial
clinical use in close coordination with Biosense Webster representatives;
provided that Stereotaxis will consult with Biosense Webster regarding such
clinical use and evaluation of the results thereof for purposes of determining
whether such device is nominated as an Additional NL Partnered Catheter.

7. Regulatory: Pursuant to the provisions of Section 9 of the Master
Collaboration Agreement, the Parties will pursue expeditious regulatory approval
of Partnered NL Catheters in the USA and Europe and subject to mutual agreement
in foreign countries (provided that Stereotaxis may in its discretion elect that
the Parties will also pursue regulatory clearance in Japan) and the provisions
related to Marketing, Promotions and Distribution and otherwise as applicable in
this Amendment will apply in respect of such foreign territories; provided
that Stereotaxis, as the Party with primary development responsibility for
Partnered NL Catheters, may elect in its discretion to pursue its own PMA or
other applicable FDA marketing authorization as the filing entity (naming
Biosense Webster as Distributor, as applicable) for any Partnered NL Catheter.
In the event that relevant regulatory approval in the U.S. of a Partnered NL
Catheter comprising a magnetically navigable non-Localized 4mm thermocouple
ablation catheter, or a magnetically navigable non-Localized 8mm thermocouple
ablation catheter or a magnetically navigable non-Localized irrigated catheter
is not achieved by 30 months from the date hereof ("Delay Date"), then either
Party may elect that this Amendment will no longer be of any force or effect,
provided that where at the Delay Date the Parties have reasonable prospects of
obtaining such approval in the near term (to be considered within six (6) months
of the expiration of the thirty (30) month Delay Date expiration), such period
will be extended for an additional 6 months. If at the end of the first six (6)
month extension period, approval is not yet obtained, but it appears the Parties
have reasonable prospects of obtaining such approval within the next six months,
the period will be extended for an additional six (6) months. No further
extensions will be allowed unless the parties agree to such an extension in
writing.

8. Pacing and Other Devices Excluded: For the avoidance of doubt and
notwithstanding anything elsewhere contained in this Amendment, nothing
contained in this Amendment will restrict Stereotaxis in any way in respect of
development and commercialization of: (i) devices used for the delivery of
pacing leads in electrophysiology or comprising such leads or associated with
the placing of any such leads; or (ii) other devices used outside the field of
endovascular ("interventional") non-Localized electrophysiology mapping and
ablation (including without limitation in the fields of surgery, interventional
cardiology, interventional radiology and interventional neuroradiology); or
(iii) accessories to the NIOBE System including without limitation components of
the Stereotaxis' CardioDrive catheter advancement mechanism; and this Amendment
does not relate to or establish any rights or restrictions in respect of such
devices.

8.1. During the Term, at least thirty (30) days (or sixty (60) days in the case
of a Restricted Party) prior to Stereotaxis entering into material and
substantial negotiations regarding a potential agreement for magnetically
enabling interventional devices in cardiology fields outside of non-Localized
electrophysiology and mapping (other than: supply agreements with non-Restricted
Parties related to this field; or the field of delivery of pacing leads)
Stereotaxis agrees to notify


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