Threatened Agency Action. Vendor and Company shall each immediately notify the other party of any information that each may obtain or learn regarding any threatened or pending action by an Agency which may affect the Products. Vendor shall, at the request of Company and at the cost and expense of Company, cooperate with Company in formulating a procedure for taking appropriate action in response to such information. Unless compelled by law, Vendor shall not respond to an Agency without the prior written consent of Company.
Threatened Agency Action. Each Party shall promptly notify the other Party’s Regulatory Affairs Department contacts designated in writing by the other Party of any information that such Party receives regarding any threatened or pending action by any Regulatory Authority that may affect the proposed labeling or Approved Labeling for a Product or Infusion set in the Field in the U.S. or any Major Market or the continued Commercialization of a Product or Infusion set in the U.S. or any Major Market. Upon receipt of any such information, each Party shall consider in good faith the other Party’s comments with respect to the appropriate action to be taken; provided, however, that nothing herein shall be construed to prevent a Party from complying with its obligations under the SDEA or with such Party’s regulatory reporting obligations under Applicable Laws.
Threatened Agency Action. Cardinal Health shall immediately notify Acorda in writing of any information that Cardinal Health (including the Representatives and Managers) may obtain or learn regarding any threatened or pending action by an Agency which may affect either the Product(s) or the Program (including but not limited to Product recalls). Cardinal Health shall, at the request of Acorda and at the cost and expense of Acorda, cooperate with Acorda in formulating a procedure for taking appropriate action in response to such information; provided, however, that the appropriate responsive action to be taken shall be decided exclusively by Acorda to the extent the information regarding the threatened or pending action relates in whole or in part to the Product(s) (as determined by Acorda in its sole judgment). Unless compelled by law, Cardinal Health shall not respond to an Agency without the prior written consent of Acorda.
Threatened Agency Action. Cardinal Health and Cumberland shall each immediately notify the other party of any information that each may obtain or learn regarding any threatened or pending action by an Agency which may affect the Products. Cardinal Health shall, at the request of Cumberland and at the cost and expense of Cumberland, cooperate with Cumberland in formulating a procedure for taking appropriate action in response to such information. Unless compelled by law, Cardinal Health shall not respond to an Agency without the prior written consent of Cumberland.
Threatened Agency Action. Each Party shall give written notice to the other Party’s Regulatory Affairs Department, with a copy to the other Party’s General Counsel, as promptly as practicable (but in no event later than […***…] Business Days) after becoming aware of the applicable occurrence, of (a) any threatened or pending investigation by an Agency, including the FDA, Federal Trade Commission, U.S. Department of Health and Human Services, or (b) any threatened or pending claims or actions by any Third Parties, including any Agency, including any such claims or actions that (i) relate to any product liability claim, or sales or promotional activities, or (ii) allege violations of (A) the Act or other Applicable Law, including any federal or state anti-kickback laws, or (B) the federal False Claims Act, in each case (a) and (b), that relate to the Product in the Territory and may affect the safety or efficacy claims of the Product or the continued marketing and Promotion of the Product. Upon receipt of any such information, the other Party may consult with such notifying Party in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing in this Section 9.2 shall restrict such notifying Party’s ability to make a timely report of such matter to any Agency or take other action that it deems to be required by Applicable Law, subject to Section 9.1.
Threatened Agency Action. Each party shall notify the other party’s Regulatory Affairs Department, as promptly as practicable after becoming aware of the applicable occurrence, of (a) any threatened or pending investigation by an Agency, including the FDA, Federal Trade Commission, U.S. Department of Health and Human Services, or (b) any threatened or pending claims or actions by any Third Parties, including any Agency, including any such claims or actions that (i) relate to any product liability claim, or sales or promotional activities, or (ii) allege violations of (A) the Act or other Applicable Law, including any federal or state anti-kickback laws, or (B) the federal False Claims Act, in each case (a) and (b), that relate to the Product in the Territory and may affect the safety or efficacy claims of the Product or the continued marketing and Promotion of the Product. Upon receipt of any such information, the other party may consult with such notifying party in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing in this Section 8.2 shall restrict such notifying party’s ability to make a timely report of such matter to any Agency or take other action that it deems to be appropriate or required by Applicable Law, subject to Section 8.1.
Threatened Agency Action. Atley agrees to use commercially reasonable efforts to notify Cornerstone immediately of any information Atley receives through its Representatives or otherwise regarding any threatened or pending action by an Agency which may affect the Cornerstone Product, and Atley shall, at the request of Cornerstone and at the sole cost and expense of Cornerstone (including, without limitation, fees and expenses of counsel for Atley), cooperate with Cornerstone in formulating a procedure for taking appropriate action. In no event shall Atley itself respond to the Agency without the prior written consent of Cornerstone, unless Atley is compelled by law to respond even without Cornerstone’s written consent. Atley and Cornerstone shall each issue appropriate instructions in their various training program and orientation sessions with Representatives with respect to the foregoing,
Threatened Agency Action. Each Party shall promptly notify the other Party’s regulatory affairs department of any information that such Party receives regarding any threatened or pending action by any Regulatory Authority, or any potential request by a Regulatory Authority, that may affect the proposed labeling or approved labeling for a Licensed Product or may affect the continued Commercialization of a Licensed Product. Upon receipt of any such information, each Party shall consider in good faith the other Party’s comments with respect to the appropriate action to be taken; provided, however, that nothing herein shall be construed to prevent a Party from complying with its obligations under the SDEA or with such Party’s regulatory reporting obligations under Applicable Laws.
Threatened Agency Action. ViroPharma shall notify Aventis as soon as practicable after ViroPharma learns of any threatened or pending action by any Regulatory Authority which may materially and adversely affect the Aventis Product. ViroPharma shall, at the request and sole expense of Aventis, cooperate with Aventis in formulating a procedure for taking appropriate action.
Threatened Agency Action. Each Party shall promptly notify the other Party's Regulatory Affairs Department contacts designated in writing by the other Party of any information that such Party receives regarding any threatened or pending action by an Agency that may affect the safety or efficacy claims of the Product or the continued marketing and Promotion of the Product. Upon receipt of any such information, AstraZeneca shall consider in good faith MDCO's comments with respect to the appropriate action to be taken; provided, however, that nothing herein shall restrict AstraZeneca's ability to make a timely report of such matter to any Agency or take other action that it deems to be appropriate or required by Applicable Law.
