Common use of Adverse Drug Experience Reports Clause in Contracts

Adverse Drug Experience Reports. (a) Teva shall maintain a global safety database recording information on any adverse drug experience during clinical trials and post-marketing. Subject to the Act and ICH Guidelines on safety reporting (ICH-E2A and ICH-E2C), Teva shall be responsible for submitting to the FDA any Serious Adverse Drug Experience Reports and Adverse Drug Experience Reports relating to Collaboration Products for both INDs and NDAs as required. Acorda shall, in respect of a Collaboration Product: (i) notify Teva of all Serious Adverse Drug Experience Reports as soon as practicable, but in no event later than two (2) calendar days, after any Serious Adverse Drug Experience Report becomes known to it; and (ii) notify Teva of all Adverse Drug Experience Reports as soon as practicable, but in no event later than four (4) Business Days, after any Adverse Drug Experience Report becomes known to it. Each Party shall keep the other Party informed of all significant safety issues to its knowledge regarding any Collaboration Product. Teva will provide to Acorda copies of all Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports and periodic safety update reports submitted to the FDA or any other regulatory authority related to a Collaboration Product. (b) With regard to a Collaboration Product, (i) Teva has the right to determine whether any complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other governmental or regulatory authority and (ii) Acorda may not disclose any information concerning Adverse Drug Experience Reports or Serious Adverse Drug Experience Reports to a Person or any governmental or regulatory authority without Teva’s prior written consent, except (A) as may be otherwise required by law, in which case Acorda shall provide prompt written notice thereof in sufficient detail to Teva and the Parties shall in good faith decide upon and effect an appropriate response thereto, or (B) in connection with Acorda’s conduct of clinical trials and other activities in accordance with the applicable Development Program, provided, however, that such disclosure is limited to sites participating in the study. (c) Teva shall provide Acorda with periodic summary reports (as outlined in the regulatory protocol) of all fifteen (15) day “Alert Reports” relating to the relevant Collaboration Product and submitted to the FDA in accordance with 21 C.F.R. 314.80(c)(1). Within ten (10) Business Days after submission, Teva shall provide Acorda with copies of all FDA periodic and annual Adverse Drug Experience Reports relating to the relevant Collaboration Product and submitted in accordance with 21 C.F.R. 314.80(c)(2). Acorda agrees to (i) provide Teva with all reasonable assistance, including assisting Teva in meeting its reporting and other obligations as required by applicable law and (ii) take all actions required by law or regulation under the Act to the extent that such law or regulation is applicable to Acorda with respect to any Collaboration Product. (d) Within five (5) Business Days after submission or receipt, as applicable, Teva shall provide Acorda with copies of all correspondence submitted to or received from any governmental or regulatory authority in the Territory related to Collaboration Product safety.

Adverse Drug Experience Reports. (a) Teva Each Party shall maintain a global safety database recording information on any adverse drug experience during clinical trials and post-marketing. Subject to notify the Act and ICH Guidelines on safety reporting (ICH-E2A and ICH-E2C), Teva shall be responsible for submitting to the FDA any Serious Adverse Drug Experience Reports and Adverse Drug Experience Reports relating to Collaboration Products for both INDs and NDAs as required. Acorda shall, in respect of a Collaboration Productother: (i) notify Teva of all Serious Adverse Drug Experience Reports as soon as practicable, but in no event later than two (2) calendar days, after any within [***] of the time such Serious Adverse Drug Experience Report becomes known to itsuch Party (including its employees); and (ii) notify Teva of all Adverse Drug Experience Reports as soon as practicable, but in no event later than four (4) Business Days, after any within [***] of the time such Adverse Drug Experience Report becomes known to it. Each such Party shall keep the other Party informed of all significant safety issues to (including its knowledge regarding any Collaboration Product. Teva will provide to Acorda copies of all Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports and periodic safety update reports submitted to the FDA or any other regulatory authority related to a Collaboration Productemployees). (b) With regard to a Collaboration ProductExcept as may otherwise be required by Legal Requirements, (i) Teva has 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 right prior consent of Zogenix; and (ii) Zogenix shall have the sole discretion to determine whether any complaintProduct Complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other governmental or regulatory authority and Governmental Authority. (iic) Acorda may not disclose any information All follow-up investigations concerning Adverse Drug Experience Reports or and Serious Adverse Drug Experience Reports shall be conducted by Zogenix or its appointed Third Party vendor to a Person or any governmental or regulatory authority without Tevawhich Zogenix has delegated such authority; provided that Astellas shall have the right to participate in such investigations upon its request. At Zogenix’s prior written consentrequest, except (A) as may be otherwise required by law, in which case Acorda Astellas shall provide prompt written notice thereof in sufficient detail to Teva 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 the Parties shall in good faith decide upon and effect an appropriate response thereto, or (B) in connection with Acorda’s conduct of clinical trials and other activities in accordance filed separately with the applicable Development Program, provided, however, that such disclosure is limited to sites participating in the study. (c) Teva shall provide Acorda with periodic summary reports (as outlined in the regulatory protocol) of all fifteen (15) day “Alert Reports” relating to the relevant Collaboration Product and submitted to the FDA in accordance with 21 C.F.R. 314.80(c)(1)Commission. Within ten (10) Business Days after submission, Teva shall provide Acorda with copies of all FDA periodic and annual Adverse Drug Experience Reports relating to the relevant Collaboration Product and submitted in accordance with 21 C.F.R. 314.80(c)(2). Acorda agrees to (i) provide Teva with all reasonable assistance, including assisting Teva in meeting its reporting and other obligations as required by applicable law and (ii) take all actions required by law or regulation under the Act to the extent that such law or regulation is applicable to Acorda Confidential treatment has been requested with respect to any Collaboration Productthe omitted portions. (d) Within five (5) Business Days after submission or receiptThe Parties will enter into a separate and more detailed pharmacovigilance agreement, as applicableconsistent with the terms of this Agreement, Teva reasonably in advance of the Promotion Commencement Date. Zogenix shall provide Acorda maintain, at its sole expense, the global safety database relating to the Product, and shall be responsible for complying with copies of all correspondence submitted to or received from any governmental or regulatory authority in the Territory reporting and other applicable Legal Requirements related to Collaboration Product safetythereto.

Adverse Drug Experience Reports. (a) Teva VeroScience shall maintain a global safety database recording medical information on any adverse drug experience during clinical trials and post-marketing. Subject to the Act and ICH Guidelines on safety reporting call center (ICH-E2A and ICH-E2Ceither itself or through a Third Party provider), Teva shall be responsible for submitting at the sole cost and expense of S2 and VeroScience, to the FDA any Serious handle Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports relating to Collaboration Products for both INDs and NDAs as required. Acorda shall, in respect of a Collaboration ProductReports. (b) Each party shall notify each other party: (i) notify Teva of all Serious Adverse Drug Experience Reports as soon as practicable, but in no event later than two within [***] (2[***]) calendar days, after any hours of the time such Serious Adverse Drug Experience Report becomes known to itsuch party (including its employees); and (ii) notify Teva of all Adverse Drug Experience Reports as soon as practicable, but in no event later than four within [***] (4[***]) Business Days, after any days of the time such Adverse Drug Experience Report becomes known to it. Each Party such party (including its employees). (c) Except as may otherwise be required by Legal Requirements, (i) Santarus shall keep the other Party informed of all significant safety issues to its knowledge regarding not disclose any Collaboration Product. Teva will provide to Acorda copies of all information concerning Adverse Drug Experience Reports or Serious Adverse Drug Experience ReportsReports to any Person or Governmental Authority (other than the parties) without the prior consent of VeroScience; and (ii) as among the parties, Adverse Drug Experience Reports and periodic safety update reports submitted to VeroScience shall have the FDA or any other regulatory authority related to a Collaboration Product. (b) With regard to a Collaboration Product, (i) Teva has the right sole discretion to determine whether any complaintProduct Complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other governmental or regulatory authority and Governmental Authority. (iid) Acorda may not disclose any information All follow-up investigations concerning Adverse Drug Experience Reports or and Serious Adverse Drug Experience Reports to a Person or any governmental or regulatory authority without Teva’s prior written consent, except (A) as may shall be otherwise required conducted by law, in which case Acorda shall provide prompt written notice thereof in sufficient detail to Teva and the Parties shall in good faith decide upon and effect an appropriate response thereto, or (B) in connection with Acorda’s conduct of clinical trials and other activities in accordance with the applicable Development Program, VeroScience; provided, however, that Santarus shall have the right to participate in such disclosure is limited to sites participating in the studyinvestigations upon its reasonable request. (ce) Teva shall provide Acorda Santarus and VeroScience will enter into a separate and more detailed pharmacovigilance agreement, consistent with periodic summary reports the terms of this Agreement, within thirty (as outlined in 30) days following the regulatory protocol) of all fifteen (15) day “Alert Reports” relating to the relevant Collaboration Product and submitted to the FDA in accordance with 21 C.F.R. 314.80(c)(1). Within ten (10) Business Days after submission, Teva shall provide Acorda with copies of all FDA periodic and annual Adverse Drug Experience Reports relating to the relevant Collaboration Product and submitted in accordance with 21 C.F.R. 314.80(c)(2). Acorda agrees to (i) provide Teva with all reasonable assistance, including assisting Teva in meeting its reporting and other obligations as required by applicable law and (ii) take all actions required by law or regulation under the Act to the extent that such law or regulation is applicable to Acorda with respect to any Collaboration ProductEffective Date. (d) Within five (5) Business Days after submission or receipt, as applicable, Teva shall provide Acorda with copies of all correspondence submitted to or received from any governmental or regulatory authority in the Territory related to Collaboration Product safety.

Adverse Drug Experience Reports. (a) Teva Depomed shall maintain provide Xxxxxx with a global safety database recording information on any adverse drug experience during clinical trials and post-marketing. Subject to the Act and ICH Guidelines on safety reporting (ICH-E2A and ICH-E2C), Teva shall be responsible for submitting to the FDA any Serious copy of all Adverse Drug Experience Periodic Reports and Adverse Drug Experience per 21 CFR 314.80 within twenty (20) business days of the such Reports relating becoming available to Collaboration Products Depomed or other Agents or partners for both INDs and NDAs as required. Acorda shall, in respect of a Collaboration Product: Depomed (iincluding employees). (b) Xxxxxx will notify Teva Depomed of all Serious Adverse Drug Experience Reports as soon as practicable(cases or incidents) reported directly to Xxxxxx within forty-eight hours if possible, but and in no event later than case beyond two (2) calendar days, after any Serious Adverse Drug Experience Report business days of the time such report becomes known to it; Xxxxxx (including its employees), and (ii) notify Teva of all Adverse Drug Experience Reports as soon as practicable, but in no event later than four within five (45) Business Days, after any Adverse Drug Experience business days of the time such Report becomes known to it. Each Party Xxxxxx (including its employees) to allow Depomed Medical and Regulatory Departments sufficient time to triage and report such events to the Agency. (c) Except as may otherwise be required by Legal Requirements, (i) Xxxxxx shall keep the other Party informed of all significant safety issues to its knowledge regarding not disclose any Collaboration Product. Teva will provide to Acorda copies of all information concerning Adverse Drug Experience Reports or Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports to any Person or Governmental Authority without the prior consent of Depomed; and periodic safety update reports submitted to (ii) Depomed shall have the FDA or any other regulatory authority related to a Collaboration Product. (b) With regard to a Collaboration Product, (i) Teva has the right sole responsibility in its discretion to determine whether any complaintProduct Complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other governmental or regulatory authority and Governmental Authority. (iid) Acorda may not disclose any information All follow-up investigations concerning Adverse Drug Experience Reports or and Serious Adverse Drug Experience Reports shall be conducted by Depomed; provided that Xxxxxx shall have the right to a Person or participate in such investigations upon its request. Xxxxxx shall provide all reasonable cooperation with any governmental or regulatory authority without Teva’s prior written consent, except (A) such follow-up investigation as may be otherwise required requested by law, in which case Acorda shall provide prompt written notice thereof in sufficient detail Depomed from time to Teva and the Parties shall in good faith decide upon and effect an appropriate response thereto, or (B) in connection with Acorda’s conduct of clinical trials and other activities in accordance with the applicable Development Program, provided, however, that such disclosure is limited to sites participating in the studytime. (c) Teva shall provide Acorda with periodic summary reports (as outlined in the regulatory protocol) of all fifteen (15) day “Alert Reports” relating to the relevant Collaboration Product and submitted to the FDA in accordance with 21 C.F.R. 314.80(c)(1). Within ten (10) Business Days after submission, Teva shall provide Acorda with copies of all FDA periodic and annual Adverse Drug Experience Reports relating to the relevant Collaboration Product and submitted in accordance with 21 C.F.R. 314.80(c)(2). Acorda agrees to (i) provide Teva with all reasonable assistance, including assisting Teva in meeting its reporting and other obligations as required by applicable law and (ii) take all actions required by law or regulation under the Act to the extent that such law or regulation is applicable to Acorda with respect to any Collaboration Product. (d) Within five (5) Business Days after submission or receipt, as applicable, Teva shall provide Acorda with copies of all correspondence submitted to or received from any governmental or regulatory authority in the Territory related to Collaboration Product safety.