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. 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. 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. (a) Each party will be responsible for certain communications with certain Regulatory Authorities and governmental agencies as provided in this Agreement and as required by Applicable Law. Radius will cooperate with NB in taking any actions that NB reasonably believes are necessary to comply with Applicable Laws with respect to regulatory obligations that have been transferred to NB pursuant to this Agreement or a Work Statement; and Radius will be responsible for all contacts and communications with any Regulatory Authorities or governmental agencies that are the responsibility of a study drug sponsor under Applicable Law. NB will notify Radius promptly (and in any event within one (1) Business Day) after it receives any notice that a Regulatory Authority or governmental agency has contacted NB, its Affiliates or any third party engaged by NB or its Affiliates that is providing Services with respect to a Project that is the subject of a Work Statement and forward to Radius copies of any communications or correspondence received from any Regulatory Authority or governmental agency relating to such Project, even if they do not specifically mention Radius.
Regulatory Communications. To the extent practical in view of deadlines, the Supplier will provide the other Party (if requested in writing by the other Party) with an opportunity, in advance of submission to a Regulatory Authority, to review and comment on all Regulatory Filings (including written responses to any Regulatory Authority questions) regarding each Alliance Product. The Supplier will provide to the other Party copies of all material written communications from the Supplier to applicable Regulatory Authorities (in advance of filing if possible), copies of all material written communications received by the Supplier from such Regulatory Authorities promptly after receipt, and any adverse finding or communication, oral or written, by such Regulatory Authority regarding each Alliance Product.
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.
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 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. To the extent that either Party receives a written or material oral communication from any Regulatory Jurisdiction relating to the Co-Development Product, the Party receiving such communication shall notify the other Party and provide a copy of any written communication and records of any verbal communication as soon as reasonably practicable or at a time interval agreed to by the Parties.
