[CONFIDENTIAL TREATMENT REQUESTED], against
[CONFIDENTIAL TREATMENT REQUESTED] with respect to the Initial Licensed Product
pursuant to Sections 8.2 or 8.3; provided, however, that Xcel may [CONFIDENTIAL
TREATMENT REQUESTED] that result from development activities agreed upon by the
Parties, with the agreement on the part of POZEN not to be unreasonably
withheld.
3.2 Autoinjector.
3.2.1 Within 90 days after the Effective Date, POZEN will prepare the
development plan for the Autoinjector Presentation (the "Autoinjector
Development Plan") and will submit such plan for review and approval by the CMC
at the next meeting. The outline of the Autoinjector Development Plan with the
target timeline for the submission of the Autoinjector SNDA is attached as
Exhibit B.
3.2.2 POZEN will (a) conduct all development activities relating to the
Autoinjector and the Autoinjector Presentation pursuant to the Autoinjector
Development Plan at POZEN's expense; provided that POZEN will not be required
[CONFIDENTIAL TREATMENT REQUESTED] with respect to the performance of the
Autoinjector Development Plan; (b) prepare the Autoinjector SNDA at its own
expense, deliver to Xcel such SNDA for filing by Xcel with the FDA and
[CONFIDENTIAL TREATMENT REQUESTED]; and (c) subject to the provisions of Section
3.4, be solely responsible for any and all communications with the FDA relating
to the Autoinjector Presentation prior to the filing of the Autoinjector SNDA by
Xcel pursuant to Section 3.2.3.
3.2.3 Xcel will (a) file the Autoinjector SNDA with the FDA, (b) inform POZEN of
any material developments with respect to the Autoinjector Presentation and the
Autoinjector SNDA, including any requirements or suggestions by the FDA
regarding the submission of data or information as a condition to approving the
Autoinjector SNDA; and (c) be the primary point of contact with the FDA relating
to the Autoinjector Presentation and the
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CONFIDENTIAL TREATMENT REQUESTED
Autoinjector SNDA. Upon approval by the FDA of the Autoinjector SNDA, Xcel will
maintain the Autoinjector SNDA during the Term at Xcel's expense and will (x)
obtain and maintain such other Regulatory Approvals as are necessary for the
Commercialization of the Autoinjector Presentation in the Territory, and (y)
exercise Commercially Reasonable Efforts to cause any manufacturers of the
Autoinjector Presentation (or any components thereof, as applicable) to obtain
and maintain such other Regulatory Approvals as are necessary for the
manufacture at their respective facilities of the Autoinjector Presentation (or
any components thereof, as applicable) for commercial sale in the Territory.
3.2.4 If, before or following the initial filing of the Autoinjector SNDA, the
FDA requires or suggests or the Parties agree that data or information be
submitted as a condition to approving the Autoinjector SNDA in addition to the
data or information that is generated in the performance of the Autoinjector
Development Plan, the CMC will discuss how to address such FDA requirements and
suggestions and modify the Autoinjector Development Plan as appropriate. Subject
to Section 3.2.5 below, POZEN will perform the modified Autoinjector Development
Plan at [CONFIDENTIAL TREATMENT REQUESTED]'s expense.
3.2.5 If POZEN determines that (a) the performance of the Autoinjector
Development