Common use of Co-Promote Option Clause in Contracts

Co-Promote Option. (a) In addition to its other reporting obligations under this Agreement, AstraZeneca shall provide to Ardelyx a final report (a “Phase 3 Clinical Study Report”) (i) from the first Phase 3 Clinical Trial Development for the first Licensed Product for the first indication for which such Phase 3 Clinical Trial Development is Completed and (ii) thereafter, if Ardelyx has exercised the Co-Promote Option as set forth below, from any Phase 3 Clinical Trial Development that is subsequently conducted for such Licensed Product for any additional indication and that is Completed within [***] after the date upon which the Phase 3 Clinical Trial Development described in subsection (i) above is completed. Each such Phase 3 Clinical Study Report shall be delivered within thirty (30) days after the date of Completion of the relevant Phase 3 Clinical Trial Development. (b) Ardelyx shall have the option to elect to participate in the marketing and promotion of the Licensed Product (referred to in subsection (a) above) in the U.S. Territory, as set forth below in this Article 7 and subject to a separate Co-Promote Agreement to be executed pursuant to Section 7.8(b) (the “Co-Promote Option”). Ardelyx shall have the right to exercise the Co-Promote Option in respect of such Licensed Product for the first indication for which Phase 3 Clinical Trial Development has been Completed as described in subsection (a) above, by providing to AstraZeneca, within thirty (30) days after its receipt of the Phase 3 Clinical Study Report, a written notice of its election to do so. Ardelyx shall further, if it has exercised the Co-Promote Option for such first indication in a timely manner, have the right to exercise the Co-Promote Option for any additional indication of such Licensed Product in respect of which Phase 3 Clinical Trial Development has been Completed within [***] after the date of the Completion of Phase 3 Clinical Trial Development for the first indication, by providing to AstraZeneca a written notice of its election to do so within [***].

Appears in 3 contracts

Samples: License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.)

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Co-Promote Option. (a) In addition to its other reporting obligations under this Agreement, AstraZeneca Sanofi shall provide to Ardelyx a final report (each a “Phase 3 Clinical Study Report”) (i) from the first for each Phase 3 Clinical Trial Development Completed for (i) the first Licensed Program Product for the first indication for which such to enter a Phase 3 Clinical Trial Development is Completed and (ii) thereafter, if Ardelyx has exercised the Co-Promote Option as set forth below, from any for each Phase 3 Clinical Trial Development Completed that is subsequently conducted for such Licensed Product for any additional indication and that is Completed within [***] after the date upon which the Phase 3 Clinical Trial Development described in subsection (i) above is completedProgram Products. Each such Phase 3 Clinical Study Report shall be delivered within thirty (30) days after the date of Completion of the relevant such Phase 3 Clinical Trial DevelopmentTrial. (b) Ardelyx shall have the non-exclusive option to elect to participate in the marketing and promotion of the Licensed Product Program Products (referred to in subsection (a) above) in the U.S. Territory, as set forth below in this Article 7 5 and subject to a separate Co-Promote Agreement to be executed pursuant to Section 7.8(b5.8(b) (the “Co-Promote Option”). Ardelyx shall have the right to exercise the Co-Promote Option in respect of such Licensed each Program Product for the first indication for which Phase 3 Clinical Trial Development development has been Completed as described in subsection (a) aboveabove in the U.S. Territory, by providing to AstraZenecaSanofi a written notice of its election to do so, within thirty (30) days [***] after its receipt of the Phase 3 Clinical Study Report, a written Report for the final Phase 3 Clinical Study to [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. be Completed for such Program Product indication prior to filing for Regulatory Approval for such indication. If Ardelyx does not provide the above election notice of its election within such [***] period with respect to do so. the first Program Product indication Ardelyx shall further, if it has exercised be deemed to have irrevocably waived its rights under the Co-Promote Option to such Program Product indication and any additional indications for such first indication in a timely mannerProgram Product, have the right to exercise the Co-Promote Option for or any additional indication of such Licensed Product in respect of which Phase 3 Clinical Trial Development has been Completed within [***] after the date of the Completion of Phase 3 Clinical Trial Development for the first indication, by providing to AstraZeneca a written notice of its election to do so within [***]Program Products. .

Appears in 3 contracts

Samples: License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.)

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