Common use of Other Licensed Products Clause in Contracts

Other Licensed Products. 3.3.1 Xcel will have the right, but not the obligation, to perform development studies with Licensed Products beyond the activities contemplated by Sections 3.1 and 3.2 (each such study, a “Development Study”), including: (a) development of Licensed Products in injectable formulations and dosage strengths other than those of the Initial Licensed Product; and (b) development of Licensed Products for indications other than the indication for which POZEN has filed the POZEN NDA. Any Development Study [CONFIDENTIAL TREATMENT REQUESTED], including study designs or protocols for such Development Study, will be subject to review and approval by the CMC. 3.3.2 Xcel will give POZEN written notice of any Xcel Post-Approval Study that is not contemplated by a Marketing Plan previously reviewed by POZEN prior to initiating such Xcel Post-Approval Study, and POZEN will have the right to review and [CONFIDENTIAL TREATMENT REQUESTED] such Xcel Post-Approval Study. 3.3.3 If Xcel desires that a Development Study [CONFIDENTIAL TREATMENT REQUESTED] be conducted, then Xcel will notify POZEN of such desire and will accompany such notice with a description of the objectives for the Development Study. Promptly thereafter, the Parties will prepare a development plan and budget for such Development Study for review and approval by the CMC (each such plan a “Study Plan”). If POZEN desires to perform such Study Plan, (a) it will notify Xcel in writing prior to the meeting at which the Study Plan is submitted to the CMC for review and approval and (b) the Parties will negotiate an agreement with customary terms and conditions for the conduct of the Study Plan, including that Xcel will reimburse POZEN monthly on a net 30 days from invoice date payment basis for POZEN’s Development Fees incurred in connection with such Study Plan. During such time as POZEN holds the IND for the Initial Licensed Product, POZEN agrees to make, on Xcel’s behalf, any required filings to such IND as may be required for performance of any Study Plan. 3.3.4 Xcel will, at its own expense, file any NDAs or other regulatory filings for Licensed Products developed in a Development Study under the terms of this Agreement, and upon approval thereof will (a) obtain and maintain such other Regulatory Approvals as are necessary for the Commercialization of the applicable Licensed Product in the Territory, and (b) exercise Commercially Reasonable Efforts to cause any manufacturers of such Licensed Product (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 such Licensed Product (or any components thereof, as applicable) for commercial sale in the Territory. 3.3.5 POZEN will provide Xcel with [CONFIDENTIAL TREATMENT REQUESTED] updates on the clinical development programs conducted by or on behalf of POZEN [CONFIDENTIAL TREATMENT REQUESTED] for Foreign Licensed Products (to the extent known to POZEN), where such activities [CONFIDENTIAL TREATMENT REQUESTED] the development, manufacture or Commercialization of any Licensed Product in the Field in the Territory.

Other Licensed Products. 3.3.1 Xcel will have Warner shall be deemed to be diligent in the right, but not the obligation, to perform development studies with Development of each Licensed Products beyond the activities contemplated by Sections 3.1 and 3.2 (each such study, a “Development Study”), including: (a) development of Licensed Products in injectable formulations and dosage strengths Product other than those of the Initial Licensed Product; and (b) development of Licensed Products for indications other than the indication for which POZEN has filed the POZEN NDA. Any Local/Regional ONYX-015 so long as aggregate Development Study [CONFIDENTIAL TREATMENT REQUESTED], including study designs Costs incurred by Onyx or protocols Warner for such Development Study, will be subject to review and approval by the CMC. 3.3.2 Xcel will give POZEN written notice of any Xcel Post-Approval Study that is not contemplated by a Marketing Plan previously reviewed by POZEN prior to initiating such Xcel Post-Approval Study, and POZEN will have the right to review and [CONFIDENTIAL TREATMENT REQUESTEDproduct equals or exceeds (i) [ * ] such Xcel Post-Approval Study. 3.3.3 If Xcel desires that a Development Study [CONFIDENTIAL TREATMENT REQUESTED] be conducted, then Xcel will notify POZEN of such desire and will accompany such notice with a description of the objectives for the Development Study. Promptly thereafter, the Parties will prepare a development plan and budget for such Development Study for review and approval by the CMC (each such plan a “Study Plan”). If POZEN desires to perform such Study Plan, (a) it will notify Xcel in writing prior to the meeting at which the Study Plan is submitted to the CMC for review and approval and (b) the Parties will negotiate an agreement with customary terms and conditions for the conduct of the Study Plan, including that Xcel will reimburse POZEN monthly on a net 30 days from invoice date payment basis for POZEN’s Development Fees incurred in connection with such Study Plan. During such time as POZEN holds the IND for the Initial Licensed Product, POZEN agrees to make, on Xcel’s behalf, any required filings to such IND as may be required for performance of any Study Plan. 3.3.4 Xcel will, at its own expense, file any NDAs or other regulatory filings for Licensed Products developed in a Development Study under the terms of this Agreement, and upon approval thereof will (a) obtain and maintain such other Regulatory Approvals as are necessary for the Commercialization of the applicable Licensed Product in the Territory, and (b) exercise Commercially Reasonable Efforts to cause any manufacturers first [ * ] period following designation of such Licensed Product for Development and an IND therefor is filed within such period and (ii) [ * ] in each subsequent consecutive 12-month period after allowance of an IND therefor and if, upon written notice from Onyx that Warner has failed to incur Development Costs at the above levels, Warner shall be deemed to be diligent if it covers such shortfall within 30 days of such written notice from Onyx. Warner shall be deemed to be diligent in the research of each Licensed Product other than Local/Regional ONYX-015 so long as research on these Products continues under the Research Program in a manner consistent with Warner's efforts for research on potential products with similar commercial potential. Notwithstanding anything herein to the contrary, Warner shall not be deemed to not be diligent if any clinical trial, any Drug Approval Application or other aspect of [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the Development of a Licensed Product, including, without limitation, Local/Regional ONYX-015, is suspended or delayed after filing of an IND therefor due to the safety or efficacy of a Licensed Product or because the FDA or any components thereofother governmental authority or obligation of law requires such suspension or delay or if the Steering Committee agrees on a different standard of diligence. If such suspension or delay is due to the efficacy of a Licensed Product, as applicable) then within 6 months, Warner shall notify Onyx whether it intends to obtain and maintain proceed with Development of such other Regulatory Approvals as are necessary for the manufacture at their respective facilities Licensed Product. If Warner does intend to so proceed, it shall provide with such notice a plan to resume Development of such Licensed Product (before or any components thereofupon the end of an additional 6 month period, as applicable) for commercial sale in the Territory. 3.3.5 POZEN will provide Xcel and Warner's diligence obligations with [CONFIDENTIAL TREATMENT REQUESTED] updates on the clinical development programs conducted by or on behalf of POZEN [CONFIDENTIAL TREATMENT REQUESTED] for Foreign Licensed Products (respect to the extent known to POZEN), where such activities [CONFIDENTIAL TREATMENT REQUESTED] the development, manufacture or Commercialization of any Licensed Product in under this Section 4.4(c) shall resume at the Field in the Territoryend of such additional 6 month period.

Other Licensed Products. 3.3.1 Xcel will have the right, but not the obligation, to perform development studies with Licensed Products beyond the activities contemplated by Sections 3.1 and 3.2 (each such study, a “Development Study”), including: (a) development of Licensed Products in injectable formulations and dosage strengths other than those of the Initial Licensed Product; and (b) development of Licensed Products for indications other than the indication for which POZEN has filed the POZEN NDA. Any Development Study [CONFIDENTIAL TREATMENT REQUESTED***], including study designs or protocols for such Development Study, will be subject to review and approval by the CMC. 3.3.2 Xcel will give POZEN written notice of any Xcel Post-Approval Study that is not contemplated by a Marketing Plan previously reviewed by POZEN prior to initiating such Xcel Post-Approval Study, and POZEN will have the right to review and [CONFIDENTIAL TREATMENT REQUESTED***] such Xcel Post-Approval Study. 3.3.3 If Xcel desires that a Development Study [CONFIDENTIAL TREATMENT REQUESTED***] be conducted, then Xcel will notify POZEN of such desire and will accompany such notice with a description of the objectives for the Development Study. Promptly thereafter, the Parties will prepare a development plan and budget for such Development Study for review and approval by the CMC (each such plan a “Study Plan”). If POZEN desires to perform such Study Plan, (a) it will notify Xcel in writing prior to the meeting at which the Study Plan is submitted to the CMC for review and approval and (b) the Parties will negotiate an agreement with customary terms and conditions for the conduct of the Study Plan, including that Xcel will reimburse POZEN monthly on a net 30 days from invoice date payment basis for POZEN’s Development Fees incurred in connection with such Study Plan. During such time as POZEN holds the IND for the Initial Licensed Product, POZEN agrees to make, on Xcel’s behalf, any required filings to such IND as may be required for performance of any Study Plan. 3.3.4 Xcel will, at its own expense, file any NDAs or other regulatory filings for Licensed Products developed in a Development Study under the terms of this Agreement, and upon approval thereof will (a) obtain and maintain such other Regulatory Approvals as are necessary for the Commercialization of the applicable Licensed Product in the Territory, and (b) exercise Commercially Reasonable Efforts to cause any manufacturers of such Licensed Product (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 such Licensed Product (or any components thereof, as applicable) for commercial sale in the Territory. 3.3.5 POZEN will provide Xcel with [CONFIDENTIAL TREATMENT REQUESTED***] updates on the clinical development programs conducted by or on behalf of POZEN [CONFIDENTIAL TREATMENT REQUESTED***] for Foreign Licensed Products (to the extent known to POZEN), where such activities [CONFIDENTIAL TREATMENT REQUESTED***] the development, manufacture or Commercialization of any Licensed Product in the Field in the Territory.