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).
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).
Adverse Drug Experience Reports. (a) Subject to applicable Law, PFIZER shall:
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.
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.
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).
Adverse Drug Experience Reports. (a) Mallinckrodt shall notify Zogenix: (i) of all Serious Adverse Drug Experience Reports within [***] of the time such Serious Adverse Drug Experience Report becomes known to Mallinckrodt and (ii) of all Adverse Drug Experience Reports within [***] of the time such Adverse Drug Experience Report becomes known to Mallinckrodt.
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. (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.
Adverse Drug Experience Reports. (a) 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).
