Government Communications. WC shall be solely responsible for communicating with any governmental authority concerning the Products or the marketing, distribution, or sale of the Products, and BMSLC shall have no such communications except to the extent that they relate to BMSLC's manufacturing activities under this Agreement or otherwise relate to the Products, in which case BMSLC shall be responsible for such communications (it being understood, however, that, notwithstanding the foregoing, (i) except to the extent that an immediate communication is necessary under the circumstances or required by Law, BMSLC in good faith shall consult in advance with WC regarding such communications insofar as they relate to the Products or to BMSLC's ability to perform its obligations pursuant to this Agreement and (ii) nothing in this paragraph shall be deemed to restrict WC's independent rights to communicate with any governmental authority, provided that to the extent such communications by WC relate to BMSLC's manufacturing activities under this Agreement, WC in good faith shall, except to the extent that an immediate communication is necessary under the circumstances or required by Law, consult in advance with BMSLC regarding such communications).
Government Communications. BMS shall be responsible for all communications with any Governmental Entity relating to BMS’ manufacturing activities, including Facility inspections by Governmental Entities, under this Agreement and the Company shall be responsible for all communication with any Governmental Entity concerning the marketing, distribution, or sale of the Product; provided that the parties agree that the Company and not BMS shall be responsible for and shall engage in all communications with Governmental Entities with respect to the Product Registrations, unless BMS is required to participate in any communications by any Governmental Entity.
Government Communications. During the Transition Period, Braeburn shall notify Titan of the occurrence and content of any material communication between Braeburn on the one hand, and any Governmental Authority (including the FDA), on the other hand, concerning the Licensed Products, the Regulatory Approvals or the Transferred Clinical Trial Authorizations (including communications relating to the transfer thereof to Titan), whether written or oral, as soon as reasonably practicable, but in no event later than three Business Days after the receipt of such communication, and shall promptly provide Titan with copies of all written communications and materials related thereto. Braeburn shall obtain Titan’s prior written consent (which shall not be unreasonably withheld, conditioned or delayed) prior to finalizing and making any regulatory filings or submissions to any Governmental Authority or providing any response to communications from a Governmental Authority relating to Licensed Products, the Regulatory Approvals and the Transferred Clinical Trial Authorizations.
Government Communications. 19 Section 7.2
Government Communications. Making any filing, notice or other material communication with any governmental, regulatory or accreditation authority, or taking any action that would require the Company or any of its Subsidiaries to make any filing, notice or other material communication with any governmental, regulatory or accreditation authority; and
Government Communications. For a period of two (2) years following Closing, Seller shall notify Buyer of the occurrence and content of any material communication between Seller on the one hand, and any Governmental Authority (including the FDA and Health Canada) on the other hand, concerning the Products, the Regulatory Approvals or the Transferred Clinical Trial Authorizations (including communications relating to the transfer thereof to Buyer), whether written or oral, as soon as reasonably practicable, but in no event later than three (3) Business Days after the receipt of such communication, and shall promptly provide Buyer with copies of all written communications and materials related thereto. Seller shall obtain Buyer’s prior written consent (which shall not be unreasonably withheld, conditioned or delayed) prior to finalizing and making any regulatory filings or submissions to any Governmental Authority or providing any response to communications from a Governmental Authority relating to the Products, the Regulatory Approvals and the Transferred Clinical Trial Authorizations.
Government Communications the Parties shall promptly (but in any event not later than [***] provide each other with copies of all Material Communications with any Governmental Authority, including without limitation, adverse event reports and safety reports, regarding a Product, the Facilities, or the procedures or processes used in connection with a Product; and the notification obligation in this Section 7.5(b) shall be twenty-four (24) hours if a Governmental Authority is commencing or threatening seizure of a Product or, with respect to Symatese, closure of or suspension of operations at a Facility.
Government Communications. (i) the Parties shall promptly (but in any event not later than [***] Business Days) provide each other with copies of all Material Communications with any Governmental Authority, including, without limitation, adverse event reports and safety reports, regarding a Product, the Facilities, or the procedures or processes used in connection with a Product; and
Government Communications. Each Party shall promptly notify the other Parties in writing of all contacts and correspondence concerning this Agreement or Covered Contracts underwritten hereunder received from any insurance regulatory authority or other Government Authority.
Government Communications. Nothing in this Agreement shall limit Employee’s exercise of any rights to communicate or file claims with any government agency.
