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 subm...
Adverse Drug Experience Reports. (a) Mallinckrodt shall notify Horizon: (i) of all Serious Adverse Drug Experiences within twenty four (24) hours of the time such Serious Adverse Drug Experiences become known to Mallinckrodt (including its Sales Representatives or other employees) and (ii) of all Adverse Drug Experiences that are not Serious Adverse Drug Experiences within […***…] days of the time such Adverse Drug Experiences become known to Mallinckrodt (including its Sales Representatives or other employees).
(b) Except as may otherwise be required by Legal Requirements, (i) Mallinckrodt shall not disclose any information concerning any Adverse Drug Experience or Serious Adverse Drug Experience to any Person or Governmental Authority without the prior written consent of 28 *** Confidential Treatment Requested Horizon, and (ii) Horizon shall determine, in its sole discretion, whether any Product Complaint, Adverse Drug Experience or Serious Adverse Drug Experience must be reported to the FDA or any other Governmental Authority.
(c) All follow-up investigations concerning any Adverse Drug Experience and/or Serious Adverse Drug Experience shall be conducted by Horizon or its appointed Third Party vendor to which Horizon has delegated such authority. At Horizon’s request, Mallinckrodt shall provide all reasonable cooperation with any such follow-up investigation, and Horizon shall reimburse Mallinckrodt for its reasonable, out-of-pocket expenses for such cooperation.
(d) Within […***…] days after the Effective Date, the Parties will enter into a separate and more detailed pharmacovigilance agreement, consistent with the terms of this Agreement (which the Parties may agree to combine with the safety data exchange agreement contemplated by Section 5.5(b) into one agreement). In the event of any conflict or inconsistency between the terms of this Agreement and such pharmacovigilance agreement, this Agreement shall prevail in every case. Horizon 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 shall notify the other: (i) of all Serious Adverse Drug Experience Reports within forty-eight (48) hours 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 five (5) calendar days 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) King 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 Depomed; and (ii) Depomed 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 Depomed; provided that King shall have the right to participate in such investigations upon its request. King shall provide all reasonable cooperation with any such follow-up investigation as may be requested by Depomed from time to time.
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) Until the NDA Transfer Date, responsibility for maintaining the Adverse Drug Experience Report database shall be retained by Depomed at its sole expense. Depomed shall maintain the Adverse Drug Experience Report database in accordance with all applicable Legal Requirements. Until the NDA Transfer Date, Depomed shall report Adverse Drug Experience Reports, Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update Reports (PSUR) in accordance with International Conference on Harmonization Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (ICH E2C) and 21 C.F.R. § 314.80.
(c) From and after the NDA Transfer Date, Santarus shall be responsible for maintaining the Adverse Experience Report database at its sole expense; provided, however, that Depomed shall be required to reimburse Santarus for the reasonable, incremental, out-of-pocket and FTE costs incurred by Santarus directly relating to data, information, systems, communications or other interactions from or with other partners of Depomed in connection with the maintenance of such Adverse Experience Report database, to the extent such costs would not have been otherwise incurred by Santarus but for such partners. Such reimbursement by Depomed shall be made within [***] after receipt of invoice from Santarus with supporting documentation in reasonable detail for invoiced amounts.
Adverse Drug Experience Reports. (a) Subject to applicable Law, PFIZER shall:
(i) notify XXXXXX-XXXXXXX of all Serious Adverse Drug Experience Reports (including Serious Adverse Drug Experience Reports occurring in any post-marketing study conducted, sponsored or monitored by PFIZER or XXXXXX-XXXXXXX) within ninety-six hours of the time such Serious Adverse Drug Experience Report becomes known to PFIZER or any of its Affiliates or any employee or agent of PFIZER or any of its Affiliates (the "PFIZER Group"); and
(ii) notify XXXXXX-XXXXXXX of all Adverse Drug Experience Reports (except for Adverse Drug Experience Reports occurring in a post- marketing study conducted, sponsored or monitored by PFIZER or XXXXXX- XXXXXXX) within thirty days of the time such Adverse Drug Experience Report becomes known to any member of the PFIZER Group; and
(iii) notwithstanding any other provision of this Section 3.06, use its best efforts to notify XXXXXX-XXXXXXX of all unexpected fatal or life-threatening experiences occurring in connection with an IND study conducted, sponsored or monitored by PFIZER, as defined in 21 C.F.R. 312.32, within twenty-four (but, in no event, later than thirty-six) hours of the time any such experience becomes known to any member of the PFIZER Group; and
(iv) notwithstanding any other provision in this Section 3.06, notify XXXXXX-XXXXXXX of all other serious and unexpected adverse experiences occurring in connection with an IND study conducted, sponsored or monitored by PFIZER, as defined in 21 C.F.R 312.32, within seventy-two hours of the time any such experience becomes known to any member of the PFIZER Group.
(b) PFIZER shall notify XXXXXX-XXXXXXX of all Adverse Drug Experience Reports occurring in any post-marketing study conducted, sponsored or monitored by PFIZER when such study is completed in a study report issued to XXXXXX-XXXXXXX in connection therewith. Each such final study report shall be provided to XXXXXX-XXXXXXX within fifteen days of its completion. Except for Adverse Drug Experience Reports occurring in any post-marketing study conducted, sponsored or monitored by PFIZER, notification under this Section 3.06 shall be by facsimile and overnight courier and in accordance with instructions to be mutually agreed upon by PFIZER and XXXXXX-XXXXXXX. All follow-up investigations concerning Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports occurring during post-marketing studies shall be conducted by the party initiating, sponsoring or monitor...
Adverse Drug Experience Reports. (a) Each party shall notify the other: (i) of all Serious Adverse Drug Experience Reports within forty-eight (48) hours 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 five (5) days of the time such Adverse Drug Experience Report becomes known to such party (including its employees).
(b) Responsibility for maintaining the Adverse Drug Experience Report database shall be retained by PediatRx. PediatRx shall maintain the Adverse Drug Experience Report database in accordance with all applicable Legal Requirements through its contract with ICS and the Lash Group (as may be assigned to Apricus pursuant to Section 4.4) . PediatRx shall report Adverse Drug Experience Reports, Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update Reports (PSUR) in accordance with International Conference on Harmonization Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (ICH E2C) and 21 C.F.R. § 314.80.
Adverse Drug Experience Reports. (a) Pfizer shall have sole responsibility for evaluation of, and, as required by the FD&C Act and FDA regulations, for reporting of adverse drug experiences to, the FDA. In order to fulfill this obligation, Distributor shall notify Pfizer of all Adverse Drug Experience reports as defined in 21 C.F.R. Section 314.80(a), within two (2) business days after such report becomes known to Distributor.
(b) Subject to SECTION 9.02 above, (i) Distributor shall not disclose any information concerning Adverse Drug Experience Reports or Serious Adverse Drug Experience Reports to any Person or Governmental or Regulatory Authority without Pfizer's prior consent and (ii) Pfizer and its Affiliates shall have the sole discretion 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 or any other Person.
(c) Within ten (10) business days after submission, Pfizer shall provide Distributor with copies of all fifteen (15) day "Alert Reports" relating to the Product and submitted to the FDA in accordance with 21 C.F.R. 314.80(c)(1). Within ten (ten) business days after submission, Pfizer shall provide Distributor with copies of all periodic adverse drug experience reports relating to the Product and submitted in accordance with 21 C.F.R. 314.80(c)(2).
(d) Distributor will train its field force to handle Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports in a manner consistent with Pfizer's practices (including, but not limited to, instruction in using Pfizer's toll-free number for such reports). * Filed under application for confidential treatment.
(e) Within sixty (60) days from execution of this Agreement, Distributor and Pfizer shall enter into such other agreements as are reasonably necessary to ensure that satisfactory systems and procedures are in place to effect the effective exchange of safety and other medical information between the two parties as necessary to fulfill all applicable legal and regulatory requirements.
Adverse Drug Experience Reports. Spectrum shall have the sole responsibility for evaluation of, and, as required by the Act and the Regulations, for reporting of adverse drug experiences to, the FDA. Each party shall notify the other party of all adverse drug experience reports as defined in the Regulations within two (2) business days after such report becomes known to such party. Xxxxxxx shall not disclose any information concerning adverse drug experience reports or serious adverse drug experience reports to any person, the FDA or any Governmental Authority without Spectrum's prior consent and Spectrum shall have the sole discretion 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 Authority. Within ten (10) business days after submission, Spectrum shall provide Xxxxxxx with copies of all fifteen (15) day "Alert Reports" submitted to the FDA that relate to a Product. Within ten (10) days after submission, Spectrum shall provide Xxxxxxx with copies of all periodic adverse drug experience reports submitted to the FDA that relate to a Product.
Adverse Drug Experience Reports. Celgene shall be responsible for filing, with the responsible regulatory body in any country where Celgene markets products, any and all adverse drug reaction reports that it receives.
Adverse Drug Experience Reports
