Regulatory Communications Sample Clauses
The Regulatory Communications clause defines how parties must handle communications with regulatory authorities in relation to the agreement. Typically, it requires that each party promptly inform the other of any material correspondence or inquiries from regulators, and may obligate parties to cooperate in preparing responses or disclosures. This clause ensures transparency and coordination between parties when dealing with regulatory matters, helping to prevent misunderstandings and ensuring compliance with applicable laws and regulations.
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Regulatory Communications. Each Party agrees to notify the other immediately by telephone (with prompt written follow-up) of any inquiry, contact or communication received from any governmental regulatory agency or other official body that materially and adversely relates to or impacts upon the Product(s) or any component or ingredient thereof, and will promptly furnish the other Party with copies of all written communications relating thereto sent to or received from said regulatory agency.
Regulatory Communications. Buyer shall be responsible for communicating with the FDA regarding the Supply Products and the Manufacturing performed by the Manufacturers hereunder and no Manufacturer shall initiate contact with the FDA or such other regulatory authority regarding the Supply Products or the Manufacturing without Buyer’s prior written consent, except when required by the terms of this Supply Agreement or by applicable Governmental Rules; provided, however, notwithstanding the preceding, that for any Supply Products supplied pursuant to an ANDA owned by any such Manufacturer, such Manufacturer shall be responsible for communicating with the FDA regarding such Supply Products and the Manufacturing performed by such Manufacturer hereunder and Buyer shall not initiate contact with the FDA or such other regulatory authority regarding the Supply Products or the Manufacturing without such Manufacturer’s prior written consent, except when required by the terms of this Supply Agreement or by applicable Governmental Rules. Each Party shall provide reasonable assistance to any other Party upon such Party’s reasonable request, and at the requesting party’s sole cost and expense, with respect to such regulatory communications.
Regulatory Communications. Each Party will provide the other Party with copies of documents and communications submitted to and received from Regulatory Authorities that materially impact the Development or Commercialization of Products for the other Party’s review and comment, and the submitting Party will consider in good faith including any comments provided by the reviewing Party to such documents and communications.
Regulatory Communications. Subject to Applicable Law and this Section 5.1, Lian will oversee, monitor, and manage all interactions and communications with Regulatory Authorities with respect to the Licensed Products in the Field in the Territory. Unless explicitly provided for differently elsewhere in this Agreement, Lian will have final decision-making authority regarding all regulatory activities for the Licensed Products in the Field in the Territory, including the labeling strategy and the content of Regulatory Filings for Licensed Products.
Regulatory Communications. A. Each party may communicate with any governmental agency, including, but not limited to, governmental agencies responsible for granting regulatory approval for the Products, regarding such Products if in the opinion of that party’s counsel, such communication is necessary to comply with the terms of this Agreement or the requirements of any Applicable Law; provided, however, that unless in the reasonable opinion of its counsel there is a legal prohibition against doing so, such party will permit the other party to review and take part in any communications with the applicable agency, and to receive copies of all such communications from that agency.
B. QPharma will notify TXMD promptly if QPharma receives any warning letters from or on behalf of a governmental agency directly related to the Product or systems utilized in Processing the Product including, without limitation, any Form FDA-483. QPharma will provide TXMD copies of any written communication from a governmental agency relating to a TXMD Product within [***] ([***]) Swedish business days of its receipt.
C. QPharma will promptly notify TXMD upon receipt of a notice from a Regulatory Authority for an inspection of any Facility where the Processing is being performed due to an issue related to the Product or a system used in the performance of such services, or, in the event of an unannounced inspection, QPharma will provide such prior notice as is possible and permissible. If not prohibited by the Regulatory Authority, TXMD will have the right to be present at the Facility and participate in and any wrap-up meeting with such Regulatory Authority as it applies to the Product. If QPharma receives any request by a Regulatory Authority with respect to the Product, including, but not limited to, a notice of deficiency or FDA-483 that requires a written response regarding TXMD-supplied Materials, project, or protocol, QPharma will provide a copy to TXMD of the deficiency notice within [***] ([***]) [***] of QPharma’s receipt of the notice. QPharma will provide TXMD a draft of the response prior to the response being submitted to the Regulatory Authority so as to provide TXMD with reasonable time to review and comment on the response, which comments QPharma, in good faith, will consider incorporating into the response.
Regulatory Communications. Subject to applicable Law and this Section 3.5 (Development Costs), Lian will oversee, monitor, and manage all interactions and communications with Regulatory Authorities with respect to the Licensed Products in the Field in the Territory. Lian will have final decision-making authority regarding all regulatory activities for the Licensed Products in the Field in the Territory, including the labeling strategy and the content of Regulatory Filings for Licensed Products.
Regulatory Communications. As part of INVENIAI’s periodic reports, INVENIAI shall provide to DS summaries of all major communications from or to any GOVERNMENTAL AUTHORITY regarding any GOVERNMENTAL APPROVALS relating to the PRODUCT, or their manufacture or sale, and shall promptly report to DS communications from or to any GOVERNMENTAL AUTHORITY regarding any recalls, facility suspensions or closures, or serious adverse events relating to the PRODUCT.
Regulatory Communications. Biogen Idec will provide Isis with copies of documents and communications submitted to (including drafts thereof) and received from Regulatory Authorities [***] that materially impact the Development or Commercialization of Products for Isis’ review and comment, and Biogen Idec will consider in good faith including any comments provided by Isis to such documents and communications.
Regulatory Communications. Subject to Section 5.2, each Party will provide the other Party with copies of documents and communications submitted to (including such drafts as the providing Party considers reasonably practicable but to include at least one pre-finalization draft thereof) and received from Regulatory Authorities that materially impact the Development or Commercialization of Products for the other Party’s review and comment, and the submitting Party will consider in good faith including any comments provided by the reviewing Party to such documents and communications.
Regulatory Communications. Both Parties shall timely inform the Joint Steering Committee of all of their scheduled meetings with the Competent Authorities (in the case of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇) and the FDA (in the case of Palatin) and provide the Joint Steering Committee with summaries of such meeting with the Competent Authorities or FDA promptly after each meeting. In addition, the Parties shall promptly provide the Joint Steering Committee with copies of all written communications and a summary of material oral discussions with the Competent Authorities (in the case of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇) and the FDA (in the case of Palatin) with respect to the Product. In addition to the information required to be provided to the Joint Steering Committee in other provisions of this Agreement, both Parties shall timely provide the Joint Steering Committee with summaries of any of their communications and correspondence with the Competent Authorities, FDA or other applicable regulatory authorities in the Territory or outside the Territory with respect to the Product. The Parties may use information exchanged pursuant to this Section 4.5 for any purpose in connection with the Development and Commercialization of Products in the Field in the Territory (in the case of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇) and outside the Field in the Territory and outside the Territory (in the case of Palatin).