Adverse Event Reports. Within ninety (90) days after the date of this Agreement, the Parties shall enter into an agreement to initiate a process for the exchange of adverse event safety data in a mutually agreed format, including, but not limited to, post-marketing spontaneous reports received by the Party or its Affiliates in order to monitor the safety of the Product and to meet reporting requirements with any applicable Regulatory Authority.
Adverse Event Reports. If Seller is the Legal Manufacturer for finished goods, Seller shall be responsible for making all filings and reports of an Adverse Event relating to Products with Regulatory Authorities. Hillrom shall report to Seller any information of which Hillrom becomes aware that may constitute an adverse event relating to Products, including any death or serious injury, or Hillrom Terms and Conditions for Products potential malfunction of Products, whether or not such event has been definitively determined to be associated with Products (each an “Adverse Event”). Unless otherwise agreed in writing, any other reporting obligations relating to Products shall be the responsibility of Seller.
Adverse Event Reports. The Parties shall cooperate in the coordination of common reporting to Regulatory Authorities, on a timely basis, of all safety-related and adverse events occurring during clinical development and subsequent to the grant of Regulatory Approvals. Prior to commencing clinical trials on any Licensed Product, the Parties or their authorized agents shall enter into a written agreement concerning policies and procedures for pharmacovigilance and adverse event reporting, which shall be binding on both Parties.
Adverse Event Reports. In order to comply with adverse event reporting regulations of the FDA (as provided in Title 21 of the Code of Federal Regulations) and other international regulatory agencies, each Party acknowledges that once the parties hereunder are selling and/or clinically testing in humans any Product they must report promptly to each other the occurrence of adverse events regarding Products for timely reporting to the FDA and other reporting agencies.
Adverse Event Reports. In addition to the updates described in Section 3.2(a) hereof, Novartis shall provide ImmunoGen with all Adverse Event information and medical complaint information relating to Licensed Products as such information is compiled or prepared by Novartis in the ordinary course of business in connection with the Development or Commercialization of any Licensed Product, in accordance with the terms of a pharmacovigilance agreement to be negotiated in good faith by the Parties and, in any event, within the time frames consistent with reporting obligations under Applicable Laws. Novartis shall hold the global safety database for all Licensed Products. Novartis shall be responsible for reporting all Adverse Events to Regulatory Authorities worldwide. Novartis shall be responsible for the core safety information to be included in the Investigators’ Brochure and Core Data Sheet. To the extent that it may apply to a Licensed Product, ImmunoGen agrees to provide Novartis with Serious Adverse Event and product complaint information relating to any product containing an Ab-Cytotoxic Product that is compiled and prepared by ImmunoGen or any Third Party collaborator in the ordinary course of business in connection with the development, commercialization or sale of any such product, in accordance with the terms of the pharmacovigilance agreement; provided, however, that the foregoing shall not require ImmunoGen to violate any agreements with or confidentiality obligations owed to any Third Party.
Adverse Event Reports. In addition to the reports described in Section 4.1.2 above, each Party shall provide the JOC with all adverse event information and product complaint information required by such Party to be disclosed to any Regulatory Authority in connection with the Development, Marketing, or sale of any Product, within time frames consistent with reporting obligations under Applicable Law.
Adverse Event Reports. In addition to the updates described in Section 3.3(a), Bayer shall provide ImmunoGen with all Adverse Event information and product complaint information relating to Licensed Products as such information is compiled or prepared by Bayer in the ordinary course of business in connection with the Development or Commercialization of any Licensed Product, in accordance with procedures to be agreed upon by the Parties and, in any event, within the time frames consistent with reporting obligations under Applicable Laws. To the extent that it may apply to a Licensed Product, ImmunoGen agrees to provide Bayer with Serious Adverse Event and product complaint information relating to any product containing a conjugate of an Antibody with a MAY Compound that is compiled and prepared by ImmunoGen or any Third Party collaborator in the ordinary course of business in connection with the development, commercialization or sale of any such product, in accordance with procedures to be agreed upon by the Parties; provided, however, that the foregoing shall not require ImmunoGen to violate any agreements with or confidentiality obligations owed to any Third Party.
Adverse Event Reports. In addition to the updates described in Section 4.5.1, Biotest shall provide ImmunoGen with all Adverse Event information and product complaint information relating to Biotest Products as such information is compiled or prepared by Biotest in the normal course of business in connection with the Development of any Biotest Product and, in any event, within time frames consistent with reporting obligations under Applicable Laws. To the extent that it may apply to a Licensed Product, ImmunoGen agrees to provide Biotest with Serious Adverse Event and product complaint information relating to any product containing a conjugate of an Antibody with a MAY Compound that is compiled and prepared by ImmunoGen or any Third Party in the normal course of business in connection with the development, commercialization or sale of any such product, in accordance with procedures that shall be agreed to by the Parties; provided, however, that the foregoing shall not require ImmunoGen to violate any agreements with or confidentiality obligations owed to any Third Party. The Parties shall jointly discuss and agree upon a pharmacovigilance schedule outlining what shall be considered to be an Adverse Event for the purpose of this Section 4.5.3 and outlining Adverse Event reporting procedures after execution of this Agreement taking into account the specific needs of each Party.
Adverse Event Reports. In addition to the updates described in Section 4.2.1 above, each Party shall provide the JDMC with all Adverse Event information and product complaint information relating to Products as compiled and prepared in the normal course of business in connection with the Development, Marketing or sale of any Product, within time frames consistent with reporting obligations under Applicable Law.
Adverse Event Reports. Upon the transfer of the FDA product registrations, Purchaser shall assume responsibility for compliance with FDA regulations, including without limitation adverse event reporting requirements. To the extent that Vendor receives any adverse event reports, Vendor shall promptly (but in no event later than five Business Days after receipt by SBC) forward copies of such reports to Purchaser at the address set forth in Section 17.3, Attention: Regulatory Affairs. To the extent requested by SB in order to meet SB's obligations with respect to regulatory requirements in countries outside the Territory, to the extent that Purchaser receives any adverse event reports, Purchaser shall promptly (but in no event later than five Business Days after receipt by Purchaser) forward copies of such reports to SBC at the address set forth in Section 17.3, Attention: Regulatory Affairs.
