Regulatory Letter Sample Clauses
A Regulatory Letter clause outlines the procedures and obligations that arise when a party receives a formal communication from a regulatory authority concerning the subject matter of the agreement. Typically, this clause requires the recipient to promptly notify the other party, share relevant details of the letter, and cooperate in formulating a response or taking necessary remedial actions. By establishing clear steps for handling regulatory inquiries or directives, the clause ensures both parties remain informed and coordinated, thereby minimizing compliance risks and facilitating a unified approach to regulatory challenges.
Regulatory Letter. In the event Sandoz is inspected or receives a regulatory letter or comments from any federal agency or authority in connection with the distribution of the AG Product, Sandoz will notify Eagle promptly upon learning of such inspection or receiving such documentation. Eagle may participate in that portion of such inspection relating to the AG Product (and will be required to participate if requested by Sandoz at Sandoz’s expense). If Sandoz requests Eagle to participate as described above, Eagle and Sandoz will mutually agree on the response with respect to the AG Product and Sandoz will be responsible for submitting any such responses to the regulatory authorities.
Regulatory Letter. 7.3.1 The CMO shall provide the Client with a copy of any letter or other documentation from the Governmental Authority regarding the AB-106 API, within [***] Business Days after its receipt thereof, including but not limited to (i) inspection of the Facilities in terms of GMPs; (ii) recall, exit from market or rectification of the AB-106 API; and (iii) any regulatory opinion on the AB-106 API.
7.3.2 Before submitting any reply/response to the Governmental Authority in respect of the AB-106 API, the CMO shall provide the Client with a copy of each such response for the Client’s review and comments. Where the Client comments on such response in a timely manner, the CMO shall accept such comments and revise accordingly. The CMO shall not submit to any Governmental Authority any reply/response in respect of the AB-106 API which [***].
7.3.3 If the Client receives any regulatory letter or opinion from any Governmental Authority in respect of the AB-106 API requiring a response or action to be taken, the CMO will promptly provide to the Client, within the time limit required by the applicable Governmental Authority, any such data or information under its control or in its possession as necessary to prepare the Client for any response relevant to the AB-106 API, and the CMO will fully cooperate with the Client in preparing such response.
Regulatory Letter. In the event Sandoz is inspected or receives a regulatory letter or comments from any federal agency or authority in connection with the distribution of the Product, Sandoz will notify Innovator promptly upon learning of such inspection or receiving such documentation. Innovator may participate in that portion of such inspection relating to the Product (and will be required to participate if requested by Sandoz at Sandoz’s expense). If Sandoz requests Innovator to participate as described above, Innovator and Sandoz will mutually agree on the response with respect to the Product and Sandoz will be responsible for submitting any such responses to the regulatory authorities.