Common use of Adverse Drug Experience Reports Clause in Contracts

Adverse Drug Experience Reports. (a) Each Party shall notify the other: (i) of all Serious Adverse Drug Experience Reports within [***] of the time such Serious Adverse Drug Experience Report becomes known to such Party (including its employees); and (ii) of all Adverse Drug Experience Reports within [***] of the time such Adverse Drug Experience Report becomes known to such Party (including its employees). (b) Except as may otherwise be required by Legal Requirements, (i) Astellas shall not disclose any information concerning Adverse Drug Experience Reports or Serious Adverse Drug Experience Reports to any Person or Governmental Authority without the prior consent of Zogenix; and (ii) Zogenix shall have the sole discretion to determine whether any Product Complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other Governmental Authority. (c) All follow-up investigations concerning Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports shall be conducted by Zogenix or its appointed Third Party vendor to which Zogenix has delegated such authority; provided that Astellas shall have the right to participate in such investigations upon its request. At Zogenix’s request, Astellas shall provide all reasonable cooperation with any such follow-up investigation. Zogenix shall reimburse Astellas for its reasonable, out-of-pocket expenses for such cooperation. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (d) The Parties will enter into a separate and more detailed pharmacovigilance agreement, consistent with the terms of this Agreement, reasonably in advance of the Promotion Commencement Date. Zogenix shall maintain, at its sole expense, the global safety database relating to the Product, and shall be responsible for complying with all reporting and other applicable Legal Requirements related thereto.

Adverse Drug Experience Reports. (a) VeroScience shall maintain a medical information call center (either itself or through a Third Party provider), at the sole cost and expense of S2 and VeroScience, to handle Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports. (b) Each Party party shall notify the othereach other party: (i) of all Serious Adverse Drug Experience Reports within [***] ([***]) hours of the time such Serious Adverse Drug Experience Report becomes known to such Party party (including its employees); and (ii) of all Adverse Drug Experience Reports within [***] ([***]) days of the time such Adverse Drug Experience Report becomes known to such Party party (including its employees). (bc) Except as may otherwise be required by Legal Requirements, (i) Astellas Santarus shall not disclose any information concerning Adverse Drug Experience Reports or Serious Adverse Drug Experience Reports to any Person or Governmental Authority (other than the parties) without the prior consent of ZogenixVeroScience; and (ii) Zogenix as among the parties, VeroScience shall have the sole discretion to determine whether any Product Complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other Governmental Authority. (cd) All follow-up investigations concerning Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports shall be conducted by Zogenix or its appointed Third Party vendor to which Zogenix has delegated such authorityVeroScience; provided provided, that Astellas Santarus shall have the right to participate in such investigations upon its reasonable request. At Zogenix’s request, Astellas shall provide all reasonable cooperation with any such follow-up investigation. Zogenix shall reimburse Astellas for its reasonable, out-of-pocket expenses for such cooperation. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (de) The Parties Santarus and VeroScience will enter into a separate and more detailed pharmacovigilance agreement, consistent with the terms of this Agreement, reasonably in advance of within thirty (30) days following the Promotion Commencement Effective Date. Zogenix shall maintain, at its sole expense, the global safety database relating to the Product, and shall be responsible for complying with all reporting and other applicable Legal Requirements related thereto.

Adverse Drug Experience Reports. (a) Each Party Depomed shall provide Xxxxxx with a copy of all Adverse Drug Experience Periodic Reports per 21 CFR 314.80 within twenty (20) business days of the such Reports becoming available to Depomed or other Agents or partners for Depomed (including employees). (b) Xxxxxx will notify the other: (i) Depomed of all Serious Adverse Drug Experience Reports (cases or incidents) reported directly to Xxxxxx within [***] forty-eight hours if possible, and in no case beyond two (2) business days of the time such Serious Adverse Drug Experience Report report becomes known to such Party Xxxxxx (including its employees); , and (ii) of all Adverse Drug Experience Reports within [***] five (5) business days of the time such Adverse Drug Experience Report becomes known to such Party Xxxxxx (including its employees)) to allow Depomed Medical and Regulatory Departments sufficient time to triage and report such events to the Agency. (bc) Except as may otherwise be required by Legal Requirements, (i) Astellas Xxxxxx shall not disclose any information concerning Adverse Drug Experience Reports or Serious Adverse Drug Experience Reports to any Person or Governmental Authority without the prior consent of ZogenixDepomed; and (ii) Zogenix Depomed shall have the sole responsibility in its discretion to determine whether any Product Complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other Governmental Authority. (cd) All follow-up investigations concerning Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports shall be conducted by Zogenix or its appointed Third Party vendor to which Zogenix has delegated such authorityDepomed; provided that Astellas Xxxxxx shall have the right to participate in such investigations upon its request. At Zogenix’s request, Astellas Xxxxxx shall provide all reasonable cooperation with any such follow-up investigation. Zogenix shall reimburse Astellas for its reasonable, out-of-pocket expenses for such cooperation. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been investigation as may be requested with respect by Depomed from time to the omitted portionstime. (d) The Parties will enter into a separate and more detailed pharmacovigilance agreement, consistent with the terms of this Agreement, reasonably in advance of the Promotion Commencement Date. Zogenix shall maintain, at its sole expense, the global safety database relating to the Product, and shall be responsible for complying with all reporting and other applicable Legal Requirements related thereto.