Robert, is Baxter in compliance?
In the
event Baxter fails to comply with its obligations in this Section 5.3 with
respect to any Product(s), XOMA Ireland may, at its option, notify Baxter in
writing of its intent to terminate or render non-exclusive any license (or
relevant portion thereof) granted to Baxter for such Product(s). Such notice
shall specify in reasonable detail the nature of Baxter's non-compliance. Baxter
shall have (a) sixty days following receipt of such notice to develop and submit
to XOMA Ireland in writing a plan (the "Plan") describing the steps Baxter
intends to take to cure such non-compliance and (b) ninety days after submission
of the Plan to XOMA Ireland to cure such non-compliance. In the event that a
license (or relevant portion thereof) granted to Baxter is terminated or
rendered non-exclusive, Baxter, upon XOMA Ireland's request, will provide
reasonable assistance to XOMA Ireland to enable XOMA Ireland to take advantage
of the activities of Baxter prior to such event and to exploit XOMA Ireland's
rights to the Products, and Baxter and XOMA Ireland shall comply with Section
12.4.2.
5.4 Specific Diligence Requirements.
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5.4.1. Overall Development. (a) Baxter shall commence Clinical Trials for
at least [*] clinical indications in the Field for NEUPREX within [*] years of
the Effective Date and shall continue to conduct Clinical Trials of [*] or more
Products in at least [*] clinical indications continuously thereafter for a
period of at least [*] years following the Effective Date or, if earlier, until
[*] or more Products have received Regulatory Approval for a total of [*]
different label claims (one of which may be Meningococcemia) from either the FDA
or the CEU (e.g., [*] from the FDA and [*] from the CEU).
(b) In the event Baxter fails to comply with its obligation in Section
5.4.1(a) as a result of a Clinical Trial being stopped due to safety concerns,
lack of efficacy or other unanticipated circumstances, XOMA Ireland may, at its
option, notify Baxter in writing of its intent to terminate the licenses granted
to Baxter under this Agreement. Baxter shall have (i) [*] to develop and submit
to XOMA Ireland in writing a plan (the "Clinical Plan") describing the steps
Baxter intends to take to cure such non-compliance, including a specific time
period following submission of the Clinical Plan to XOMA Ireland for commencing
one or more additional Clinical Trials and (ii) [*] to commence such Clinical
Trial(s) and cure such non-compliance; provided that [*]. In the event such
Clinical Trial(s) are not commenced and such compliance is not cured within the
time period set forth in the Clinical Plan, the last sentence of Section 5.3
shall apply.
(c) In the event Baxter fails to comply with its obligation in Section
5.4.1(a) as a result of a Clinical Plan ending (that is, patient follow-up being
completed) in the ordinary course of the conduct of such trial, Baxter shall
have a period of (i) [*] to commence the next Clinical Trial of such Product in
such indication or file an IND thereby commencing, for purposes hereof, an
additional Clinical Trial of a Product in another indication or (ii) [*] to file
an IND thereby commencing, for purposes hereof, an additional Clinical Trial of
a Product in another indication, before XOMA Ireland shall have the right to
terminate the licenses granted hereunder. In the event of any such termination,
the last sentence of Section 5.3 shall apply.
5.4.2. Development Outside the U.S. (a) Baxter shall commence [*] in each
of [*] before [*] and shall file [*] with [*] before [*] and with [*] before
[*]
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(b) In the event Baxter fails to comply with its obligation in Section
5.4.2(a) in respect of either [*] or [*], XOMA Ireland may, at its option,
terminate the licenses granted hereunder with respect to [*] or [*], as
applicable, in which event the provisions of Section 13.7 shall apply with
respect to such region or country, but such termination in respect of such
region or country shall have no effect on this Agreement in respect of the rest
of the world. |
