Inquiries, Adverse Events, etc. As between the Parties, Auxilium shall be responsible for the surveillance, receipt and evaluation of product complaints for Product labeled for use in the Field in the Territory and reporting to Regulatory Authorities Adverse Drug Experiences for the Products in the Field. As between the Parties, BTC shall be responsible for the surveillance, receipt and evaluation of product complaints for Product labeled for use outside the Field and reporting to Regulatory Authorities Adverse Drug Experiences for the Products outside the Field. Each Party shall ensure that, in the Development or Commercialization of the Product, it will record, investigate, summarize, notify, report and review all Adverse Drug Experiences in accordance with Law. Each Party shall (i) adhere to all requirements of Laws which relate to the reporting and investigation of Adverse Drug Experiences, and (ii) keep the Parties informed of such events.
(a) Each Party shall submit reports of all Adverse Drug Experiences associated with the use of the Product and other required safety information (e.g., PSUR’s or annual safety reports) to the Regulatory Authorities in accordance with Law. Each Party shall submit a copy of each such report to the other Party in advance of such submission to permit the other Party to comply with legal requirements applicable to it and comment on such reports.
(b) Each Party shall submit reports of all Adverse Drug Experiences associated with the use of Product for which Regulatory Approval has not been achieved and other required safety information to the Regulatory Authorities in accordance with Law. Each Party shall submit a copy of each such report to the other Party in advance of such submission to permit the other Party to comply with legal requirements applicable to it and comment on such reports.
Inquiries, Adverse Events, etc. (a) Eyetech and Pfizer shall be responsible for the surveillance, receipt, evaluation, and reporting of product complaints and reports of adverse drug experiences, for the Products in the US Territory and the ROW Territory, respectively; provided, however, during the term of the Regulatory Services Agreement, Pfizer shall perform certain of such US Territory responsibilities on behalf of Eyetech under the terms of the Regulatory Services Agreement.
(b) Eyetech shall be responsible for promptly investigating Product complaints and reports of adverse drug experiences and other required safety information (e.g., PSURs and annual safety reports) associated with the use of any Product in the US Territory. As to each Product, Eyetech shall submit reports of all adverse drug experiences associated with the use of the Product(s) and other required safety information to the FDA in accordance with applicable Law. Eyetech shall submit a copy of each such report to Pfizer contemporaneously with its submission of the report to FDA, or in advance of such submission if, and as, reasonably necessary to permit Pfizer to comply with legal requirements applicable to it, if practicable.
(c) Pfizer shall promptly investigate Product complaints and reports of adverse drug experiences and other required safety information (e.g., PSURs and annual safety reports) associated with the use of any Product in the ROW Territory. As to each Product, Pfizer shall submit reports of all adverse drug experiences associated with the use of the Product(s) and other required safety information to the applicable Governmental Authorities in the ROW Territory in accordance with applicable Law. Pfizer shall submit a copy of each such report to Eyetech contemporaneously with its submission of the report to the applicable Governmental Authority in the ROW Territory, or in advance of such submission if, and as, reasonably necessary to permit Eyetech to comply with legal requirements applicable to it, if practicable.
(d) Eyetech shall have the sole responsibility for revising the Product labeling for the US Territory, and Pfizer for the ROW Territory, as needed, to adequately warn of the potential risks identified by reports of adverse drug experiences associated with the use of the Product and from Product complaints. In addition, the Parties agree to jointly develop additional written procedures including the mechanics for the surveillance, receipt, evaluation, and reporting of Product complaints and...
