Common use of FDA Correspondence Clause in Contracts

FDA Correspondence. 3.4.1 To the extent either Party receives any material written or oral communications relating to any Licensed Product from the FDA, such Party will promptly inform the other Party thereof (including by providing a copy of any such written communication or a written account of any such oral communication), but in no event later than five business days after receipt of such communication. The Party that is responsible for communicating with the FDA in connection with the development, registration or Commercialization of any Licensed Product at issue under the terms of this Agreement (i.e., the Party holding the NDA—the “Communicating Party”) will use reasonable efforts to solicit the other Party’s advice and review of the nature and text of any written communications received from or to be sent to the FDA in reasonably sufficient time prior to responding or dispatching such communications to the FDA, and the Communicating Party will [CONFIDENTIAL TREATMENT REQUESTED] the other Party’s [CONFIDENTIAL TREATMENT REQUESTED] comments related thereto. 3.4.2 Each Party will promptly notify the other Party, and provide such other Party with a copy, of any material correspondence or other reports or complaints submitted to or received by the first Party from the FDA or any Third Party claiming that any Promotional Materials are inconsistent with any Licensed Product labeling or are otherwise in violation of applicable law or regulation. 3.4.3 Each Party will provide the other Party with a copy of any material documents or reports filed with the FDA during the Term with respect to any Licensed Product. 3.4.4 Prior to the transfer of the POZEN NDA to Xcel from POZEN pursuant to Section 3.1.2, (a) Xcel will be provided with the opportunity to have an observer in attendance at any in-person meetings or pre-scheduled telephone calls with the FDA with respect to any Licensed Product and (b) the Parties will agree on any change to the labeling for the Initial Licensed Product (as compared with the draft label included in the POZEN NDA as of the Effective Date). [CONFIDENTIAL TREATMENT REQUESTED].

FDA Correspondence. 3.4.1 To the extent either Party receives any material written or oral communications relating to any Licensed Product from the FDA, such Party will promptly inform the other Party thereof (including by providing a copy of any such written communication or a written account of any such oral communication), but in no event later than five business days after receipt of such communication. The Party that is responsible for communicating with the FDA in connection with the development, registration or Commercialization of any Licensed Product at issue under the terms of this Agreement (i.e., the Party holding the NDA—the “Communicating Party”) will use reasonable efforts to solicit the other Party’s advice and review of the nature and text of any written communications received from or to be sent to the FDA in reasonably sufficient time prior to responding or dispatching such communications to the FDA, and the Communicating Party will [CONFIDENTIAL TREATMENT REQUESTED] consider in good faith the other Party’s [CONFIDENTIAL TREATMENT REQUESTED] reasonable comments related thereto. 3.4.2 Each Party will promptly notify the other Party, and provide such other Party with a copy, of any material correspondence or other reports or complaints submitted to or received by the first Party from the FDA or any Third Party claiming that any Promotional Materials are inconsistent with any Licensed Product labeling or are otherwise in violation of applicable law or regulation. 3.4.3 Each Party will provide the other Party with a copy of any material documents or reports filed with the FDA during the Term with respect to any Licensed Product. 3.4.4 Prior to the transfer of the POZEN NDA to Xcel from POZEN pursuant to to Section 3.1.23.1. 2, (a) Xcel will be provided with the opportunity to have an observer in attendance at any in-person meetings or pre-scheduled telephone calls with the FDA with respect to any Licensed Product and (b) the Parties will agree on any change to the labeling for the Initial Licensed Product (as compared with the draft label included in the POZEN NDA as of the Effective Date). If the Parties are unable to agree on a label change, either Party will have the right to refer such disagreement (the “Label Dispute”) by written notice to the CEO of Xcel and the CEO of POZEN for resolution. If the CEOs of the Parties are unable to reach unanimous agreement on how to resolve the Label Dispute [CONFIDENTIAL TREATMENT REQUESTED]***] after such matter has been referred to the CEOs, the CEO of POZEN will make the final decision regarding any change to the label of the Initial Licensed Product. Xcel will have the right to terminate this Agreement by written notice to POZEN [***] after such decision by the CEO of POZEN. [***] of such termination, POZEN will pay to Xcel the withdrawal fee set forth in Exhibit A attached hereto.

FDA Correspondence. 3.4.1 To the extent either Party receives any material written or oral communications relating to any Licensed Product from the FDA, such Party will promptly inform the other Party thereof (including by providing a copy of any such written communication or a written account of any such oral communication), but in no event later than five business days after receipt of such communication. The Party that is responsible for communicating with the FDA in connection with the development, registration or Commercialization of any Licensed Product at issue under the terms of this Agreement (i.e., the Party holding the NDA—NDA – the “Communicating Party”) will use reasonable efforts to solicit the other Party’s advice and review of the nature and text of any written communications received from or to be sent to the FDA in reasonably sufficient time prior to responding or dispatching such communications to the FDA, and the Communicating Party will [CONFIDENTIAL TREATMENT REQUESTED] the other Party’s [CONFIDENTIAL TREATMENT REQUESTED] comments related thereto. 3.4.2 Each Party will promptly notify the other Party, and provide such other Party with a copy, of any material correspondence or other reports or complaints submitted to or received by the first Party from the FDA or any Third Party claiming that any Promotional Materials are inconsistent with any Licensed Product labeling or are otherwise in violation of applicable law or regulation. 3.4.3 Each Party will provide the other Party with a copy of any material documents or reports filed with the FDA during the Term with respect to any Licensed Product. 3.4.4 Prior to the transfer of the POZEN NDA to Xcel from POZEN pursuant to Section 3.1.2, (a) Xcel will be provided with the opportunity to have an observer in attendance at any in-person meetings or pre-scheduled telephone calls with the FDA with respect to any Licensed Product and (b) the Parties will agree on any change to the labeling for the Initial Licensed Product (as compared with the draft label included in the POZEN NDA as of the Effective Date). [CONFIDENTIAL TREATMENT REQUESTED].