Communications with Governmental Authorities. Promptly, but in no event later than five (5) days after submission to any Governmental Authority, or receipt thereof, Borrower shall furnish to Agent all documents and information furnished to or received from such Governmental Authority in connection with any investigation of any Loan Party or inquiries by such Governmental Authority.
Communications with Governmental Authorities. (a) All communications with Governmental Authorities concerning the Products and arising from Depomed’s ownership of the Product NDA prior to the NDA Transfer Date shall be the responsibility of Depomed. Depomed may, in its discretion, consult with Santarus regarding any such communication. Depomed shall within [***] upon receipt of any communication from the FDA or from any other Regulatory Authority relating to the Products, forward a copy of the same to Santarus and reasonably respond to all inquiries by Santarus relating thereto. All communications with Regulatory Authorities concerning the Products and arising from Santarus’ ownership of the Product NDA from and after the NDA Transfer Date shall be the responsibility of Santarus.
Communications with Governmental Authorities. Unless otherwise prohibited by Applicable Law or a Regulatory Authority, Bank shall promptly notify Company of any communications from or with a Regulatory Authority or any official thereof, including without limitation any member of Congress, official of the executive branch of the United States Government, state legislator, or federal or state agency with respect to a Program and promptly provide Company with a summary of any written or verbal correspondence or communications with or from any of the above parties, to the extent such correspondence or communications (a) negatively impact the continuation of the Program; (b) contain criticisms regarding operation of the Program; or (c) provide guidance to make changes to any aspect of the Program.
Communications with Governmental Authorities. Between the date hereof and the Initial Closing Date (with respect to all Transferred Assets or Transferred Subsidiary Assets other than any Deferred Closing Assets subject to an Extension Closing in accordance with Section 2.5) and any Extension Closing (with respect to the applicable Deferred Closing Assets subject to any Extension Closing):
Communications with Governmental Authorities. Except in the case of an emergency situation in which there is a substantial risk of loss of life or severe injury to any Person if reporting is delayed by the following consent process, each of Pfizer and the Company shall not initiate any contact with or initiate any disclosure to any Governmental Authority in relation to any matter at a Co-Located Facility for which the other party would reasonably be expected to have Liability pursuant to the allocation of Liabilities under the Separation Agreement and this Environmental Matters Agreement without the other party’s prior written consent, which consent shall not be unreasonably withheld.
Communications with Governmental Authorities. Except to the extent set forth in this Section 5.4, VeroScience shall be responsible for communications with the FDA concerning the Product. VeroScience shall (a) as soon as practicable, but in any event, within [***] ([***]) business days, provide each of S2 and Santarus with copies of all such material communications to or from the FDA (including summaries of all such verbal communications) to the extent related to the Product (except that routine communications as to such matters (e.g., FDA 2253 correspondence) may be forwarded to each other party within [***] [***]) business days) and (b) reasonably respond to all inquiries by each other party relating thereto. VeroScience will reasonably consult with each other party concerning material communications with the FDA or other Governmental Authorities to the extent relating to the Product, including providing each other party with a copy of all draft responses related to such matters as soon as practicable and considering in good faith any comments provided to VeroScience by any other party. For clarity, during the Term, Santarus shall have the right to communicate with (i) the FDA if required by Legal Requirements, with advance notice to VeroScience, to the extent reasonably practicable, or (ii) any other Governmental Authority regarding the Product if such communication is necessary to comply with the terms of this Agreement or any Legal Requirement (including without limitation state or local Legal Requirements related to marketing activities undertaken by Santarus or the Santarus Sales Force). Santarus shall have the right to attend and participate in all meetings between VeroScience and the FDA pertaining to the Product in the Territory to the extent permitted under applicable Legal Requirements.
Communications with Governmental Authorities. Subject to the provisions of this Section 12. Galena shall be solely responsible for interfacing, corresponding and meeting with all Regulatory Authorities for the NDA. At all times during the Term, Galena shall be responsible, at its expense, for reporting any and all Serious Adverse Drug Events and Adverse Drug Experiences to applicable Regulatory Authorities. Immediately upon receipt of any contact with or communication from any Regulatory Authority relating to the Product or becoming aware of any Serious Adverse Drug Event or Adverse Drug Experience in the Territory, each of the Parties shall forward a copy or description of the same to the other Party and shall use Commercially Reasonable Efforts to respond to all reasonable inquiries from the other Party relating thereto. Both Parties shall use Commercially Reasonable Efforts to cooperate to provide all reasonable assistance and take all actions which are necessary to comply with any Applicable Law. SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS ([***]) DENOTE SUCH OMISSIONS. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THIS OMITTED INFORMATION.
Communications with Governmental Authorities. Promptly after submission to or receipt from any Governmental Authority, all material documents and information furnished to or received from such Governmental Authority in connection with any investigation, notice of enforcement proceedings, complaints, or inspections by any Governmental Authority with respect to any Borrower Party or any Subsidiary of any Borrower Party or relating to any Cannabis License, other than routine inquiries by and filings with, any such Governmental Authority (but including for the avoidance of doubt any notice regarding a Cannabis License).
Communications with Governmental Authorities. (a) All communications with Governmental Authorities concerning the Product and arising from PediatRx’s ownership of the Product ANDA shall be the responsibility of PediatRx. PediatRx shall consult with Apricus regarding any such communication and shall consider in good faith Apricus’ comments.
Communications with Governmental Authorities. (a) CANbridge shall, and shall cause its Affiliates to, inform PUMA and a Designee specified in writing by PUMA, if CANbridge or its Affiliates receive any communication from any Governmental Authorities with respect to the Licensed Products in the Territory, including with respect to market access, within [***] Business Days after it receives such communication. CANbridge shall, and shall cause its Affiliates to, provide to PUMA and such Designee, any information and documents in relation thereto and shall take into account PUMA’s and such Designee’s reasonable input with respect to any action or communication to be taken in response to such concern or communication.
