Common use of Communications with Governmental Authorities Clause in Contracts

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 in light of applicable Legal Requirements, have a period of at least [***] (or such shorter period as is practicable under the circumstances) to provide comments to the other party on such communications, which comments the other party shall use commercially reasonable efforts to incorporate into its final communications to the extent such comments are reasonable and consistent with applicable Legal Requirements. Santarus acknowledges that, to the extent required by the Xxxxxxx Agreement and the BI Agreement, Depomed may provide a copy of any such proposed written communication by Santarus to Xxxxxxx or BI, as applicable, for review and comment, provided that Santarus shall have no obligation to communicate directly with Xxxxxxx or BI, and any communications to Xxxxxxx or BI required under the Xxxxxxx Agreement or BI Agreement shall be the sole responsibility of Depomed.

Communications with Governmental Authorities. (a) All communications with 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 concerning the Products and arising from Depomed’s ownership of the Product NDA prior with respect to the NDA Transfer Date shall be Licensed Products in the responsibility of Depomed. Depomed mayTerritory, in its discretionincluding with respect to market access, consult with Santarus regarding any such communication. Depomed shall within [***] upon receipt of 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 from the FDA to be taken in response to such concern 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 Santaruscommunication. (b) From and after the NDA Transfer DateIf CANbridge or its Affiliates initiate, Depomed shall notrespond to, without the consent of Santarus file, submit or unless so required by Legal Requirements, correspond or otherwise communicate with the FDA or with any other Regulatory a Governmental Authority in the Territory concerning in connection with the Licensed Products, such US-DOCS\121531884.1 entity shall promptly notify PUMA and a Designee specified in writing by PUMA prior to making any such filing, submission 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 communication to a Governmental Authority and provide PUMA and such Designee with (i) Depomed a copy of the proposed filing, submission or communication and (ii) expected date filing, submission or communication. CANbridge shall, and shall have the right to communicate with the FDA cause its Affiliates to, consider PUMA’s and such Designee’s comments in good faith. (c) If CANbridge or its Affiliates receive any other Regulatory communications from a Governmental Authority in the Territory regarding the Products if such communication is necessary to comply in connection with the terms of this Agreement or any Legal Requirement or is related to Manufacturing or Commercialization activities undertaken Licensed Products, such entity shall promptly notify PUMA and a Designee specified in writing by Depomed or PUMA. Notwithstanding the Depomed Sales Forceforegoing, CANbridge shall, and shall cause its Affiliates to (i) provide PUMA and a Designee specified in writing by PUMA with written updates as to the transfer of the Regulatory Filings, Marketing Authorization and change of “local agents” in the applicable Region in the Territory, on an ongoing basis, (ii) BLS has the right to communicate with the FDA promptly notify PUMA and such Designee of any material communication (whether written or any other Regulatory oral) from a Governmental Authority in the Territory concerning the CMC portion relation to such transfer or change, (iii) provide PUMA and such Designee reasonable notice of all meetings and telephone calls with any Governmental Authority that may have a material impact upon such transfer or change, (iv) provide PUMA and such Designee a reasonable opportunity to participate at each such meeting or telephone call; and (v) notify PUMA and such Designee in writing of the Product NDA to the extent required under the BLS Supply Agreement. Each party shall within [***] after receipt effectiveness of any communication from the FDA such transfer 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 in light of applicable Legal Requirements, have a period of at least [***] (or such shorter period as is practicable under the circumstances) to provide comments to the other party on such communications, which comments the other party shall use commercially reasonable efforts to incorporate into its final communications to the extent such comments are reasonable and consistent with applicable Legal Requirements. Santarus acknowledges that, to the extent required by the Xxxxxxx Agreement change and the BI Agreementanticipated effective dates, Depomed may provide a copy promptly following the applicable Governmental Authority’s approval of any such proposed written communication by Santarus to Xxxxxxx transfer or BI, as applicable, for review and comment, provided that Santarus shall have no obligation to communicate directly with Xxxxxxx or BI, and any communications to Xxxxxxx or BI required under the Xxxxxxx Agreement or BI Agreement shall be the sole responsibility of Depomedchange.