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.
(b) From and after the NDA Transfer Date, Depomed shall not, without the consent of Santarus or unless so required by Legal Requirements, correspond or communicate with the FDA or with any other Regulatory Authority in the Territory concerning the Products, or otherwise take any action concerning any Regulatory Approval under which the Products are sold in the Territory or any application for Regulatory Approval of the Products in the Territory; provided that (i) Depomed shall have the right to communicate with the FDA or any other Regulatory Authority in the Territory regarding the Products if such communication is necessary to comply with the terms of this Agreement or any Legal Requirement or is related to Manufacturing or Commercialization activities undertaken by Depomed or the Depomed Sales Force, and (ii) BLS has the right to communicate with the FDA or any other Regulatory Authority in the Territory concerning the CMC portion of the Product NDA to the extent required under the BLS Supply Agreement. Each party shall within [***] after receipt of any communication from the FDA or from any other Regulatory Authority in the Territory relating to the Products, forward a copy of the same to the other party and reasonably respond to all inquiries by the other party relating thereto. If a party is required by law to communicate with the FDA or with any other Regulatory Authority in the Territory relating to the Products, then such party shall so advise the other party within [***] and provide the other party in advance with a copy of any proposed written communication with the FDA or any other Regulatory Authority in the Territory as soon as reasonably practicable after preparation. Each party shall, to the extent practicable...
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. 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. 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. 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):
13.2.1 Subject to compliance with applicable Laws, each Party shall give reasonable prior notice to the other Parties of any communication from any Governmental Authority regarding any of the Contemplated Transactions. If any of the Parties or Affiliates thereof receive a request for additional information or documentary material from any such Governmental Authority with respect to the Contemplated Transactions, then, subject to compliance with applicable Laws, such Party will endeavor in good faith to make, or cause to be made, as soon as reasonably practicable and after consultation with the other Parties, an appropriate response in compliance with such request; provided, that the Buyer Parties and Buyer Designees, on the one hand, and Seller and the Xxxxxx Entities, on the other hand, shall be required to consider in good faith the views of the other Parties in connection with any such response; and provided, further, that when reasonably practicable, the Buyer Parties and Buyer Designees, on the one hand, and Seller and the Xxxxxx Entities, on the other hand, shall not independently participate in any meeting or conversation, or engage in any substantive conversation with any Governmental Authority in respect of any filings, requests for additional information or documentary material, or inquiry without giving the other Parties prior notice of the meeting or conversation and, unless prohibited by such Governmental Authority or applicable Law, the opportunity to attend and/or participate in such meeting or conversation.
13.2.2 The Parties shall, with respect to any threatened or pending Order (including a preliminary or permanent injunction) that would adversely affect the ability of the Parties to consummate the Contemplated Transactions, use their respective Commercially Reasonable Efforts to prevent the entry, enactment or promulgation thereof, as the case may be.
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.
Communications with Governmental Authorities. Purchaser shall not, through its officers, employees, managers, contractors, consultants, agents, representatives or any other Person (including, without limitation, any Person that conducted inspections by or on behalf of Purchaser), directly or indirectly, communicate with any Governmental Authority or any official, employee or representative thereof, involving any matter with respect to the Property, without Seller’s prior written consent, not to be unreasonably withheld, delayed or conditioned, and without affording Seller a reasonable opportunity to participate in such communications; provided, however, if such communication is required pursuant to any applicable Law, then Purchaser may make such communication without the prior consent of Seller (but with prior notice and an opportunity to participate to Seller).
Communications with Governmental Authorities. Except to the extent covered by other Ancillary Agreements, the holder of the applicable Marketing Authorization will be solely responsible for all contacts and communications with applicable Governmental Authorities with respect to all matters relating to the Product or any regulatory filings relating to the Product for such Marketing Authorization. The other Party shall advise the holder of the applicable Marketing Authorization of any material inquiry, contact or communication that such other Party receives from any Governmental Authority that directly or indirectly relates in any material respect to the Product or any of the holder of the applicable Marketing
Communications with Governmental Authorities. Promptly, but in no event later than five (5) days, after submission to any Governmental Authority, or receipt thereof, all documents and information furnished to or received by such Governmental Authority in connection with any investigation of any Loan Party other than routine inquiries by such Governmental Authority;
