Common use of Transfer of Acquired Regulatory Approvals Clause in Contracts

Transfer of Acquired Regulatory Approvals. (a) The Seller and the Purchaser shall establish a mutually acceptable and prompt communication and interaction process to ensure the orderly transfer of the Acquired Regulatory Approvals in accordance with Section 2.01(f) and Section 2.01(g). The Seller and the Purchaser shall use all Commercially Reasonable Efforts to take any actions required by any Governmental Authority to effect the transfer of the Acquired Regulatory Approvals from the Seller to the Purchaser, and shall cooperate with each other in order to effectuate the foregoing transfer of the Acquired Regulatory Approvals. The Seller may retain an archival copy of any Acquired Regulatory Approvals including supplements and records that are required to be kept under 21 C.F.R. §314.81. (b) Following the Closing, each of the Parties shall use its Commercially Reasonable Efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary for it to do under applicable Laws to consummate and make effective the transactions contemplated by this Agreement, which actions shall include making all required registrations and filings with, and seeking all required Consents of, Governmental Authorities and furnishing all information required by applicable Law or requested by such Governmental Authorities. Each Party shall cooperate fully with the other Party and its Affiliates in promptly seeking to make such required registrations and filings and obtain all required Consents. The Parties shall not willfully take any action that will have the effect of delaying, impairing or impeding the making of such required registrations and filings or the receipt of any required Consents. Each of the Parties shall each make an appropriate filing pursuant to the HSR Act with respect to the transactions contemplated by this Agreement promptly (and in any event, within [***] after the Effective Date and shall supply as promptly as practicable to the appropriate Governmental Authorities any additional information and documentary material that may be requested pursuant to the HSR Act or other applicable antitrust laws. (c) Notwithstanding anything in this Agreement to the contrary, Purchaser shall take, or cause to be taken, all actions and shall do, or cause to be done, all things necessary, proper or advisable to eliminate each and every impediment under the HSR Act or any other antitrust law that is asserted by any Governmental Authority to permit the Closing to occur as promptly as reasonably practicable and in any event prior to the date that is [***] after the Effective Date or such other date as mutually agreed to by the Parties in writing (such date, the “Outside Date”), including: (i) proposing, negotiating, committing to, effecting and agreeing to, by consent decree, hold separate order, or otherwise, the sale, divestiture, license, holding separate, and other disposition of or restrictions on the businesses, assets, properties, product lines, and equity or other business interests of, or changes to the conduct of business of the Purchaser (ii) creating, terminating, unwinding, divesting or assigning, subcontracting or otherwise securing substitute parties for relationships, ventures, and contractual or commercial rights or obligations of the Purchaser and (iii) otherwise taking or committing to take any action that would limit Purchaser’s freedom of action with respect to, or its ability to retain, hold or continue, directly or indirectly, any businesses, assets, properties, product lines, and equity or other business interests, relationships, ventures or contractual rights and obligations of the Purchaser. The Purchaser shall not be required to agree to take or enter into any such action described in clauses (i) through (iii) that is not conditioned upon, or that becomes effective prior to, the Closing. (d) The Seller will reasonably cooperate with the Purchaser in disclosing any relevant records and reports which are required to be made, maintained and reported pursuant to applicable Law in the Territory with respect to the Acquired Regulatory Approvals and coordinating with the Purchaser to make an orderly and prompt transition of the Purchased Assets as soon as practicable after the Closing. (e) Following the Closing, upon request by Purchaser, the Seller will reasonably cooperate with the Purchaser and applicable Regulatory Authorities to enable the Purchaser to effectuate a conversion of NDA number 212157 from “discontinued” status to active or “prescription” marketing status with the FDA in order to effectuate First Commercial Sale by the Purchaser in the United States. All fees and expenses associated with the conversion of NDA number 212157 from “discontinued” status to active or “prescription” marketing status with the FDA, including all fees that were deferred during such discontinued status, shall be borne by the Purchaser.

Transfer of Acquired Regulatory Approvals. (a) The Seller Sellers and the Purchaser Purchasers shall establish a mutually acceptable and prompt communication and interaction process to ensure the orderly transfer of the Acquired Regulatory Approvals in accordance with Section 2.01(fat the Closing. Prior to the Closing, the Parties shall reasonably agree upon the form of the letters to the applicable regulatory authorities relating to the transfer of the Acquired Regulatory Approvals. Sellers and Purchasers hereby agree, from the Closing until the earlier of (i) and Section 2.01(g). The Seller and [***] or (ii) [***] months following the Purchaser shall use all Commercially Reasonable Efforts Closing Date, to take any all actions required by any Governmental Authority Entity to effect the transfer of the Acquired Regulatory Approvals from the a Seller or one of its Affiliates to the Purchasera Purchaser or one of its Affiliates, and shall to cooperate with each other in order to effectuate the foregoing transfer of the Acquired Regulatory Approvals. The ; provided that neither Sellers nor any of their respective Affiliates shall be required to pay money to any Governmental Entity in connection with such actions, except for customary filing or application fees required to be paid by Seller or any of their respective Affiliates, all of which shall be reimbursed upon demand by Purchasers. (b) From the Closing until the earlier of (i) [***] or (ii) [***] months from the Closing Date, a Seller or its applicable Affiliate shall hold and maintain each Acquired Regulatory Approval in its name for the account, risk and benefit of such Purchaser and its Affiliate, and Sellers and their applicable Affiliates shall serve as Purchasers’ and their applicable Affiliates’ agent for all required regulatory submissions relating to the Product. (c) Sellers may retain an archival copy of any Acquired Regulatory Approvals Approval including supplements and records that are required to be kept under 21 C.F.R. §314.81600.81. (b) Following the Closing, each of the Parties shall use its Commercially Reasonable Efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary for it to do under applicable Laws to consummate and make effective the transactions contemplated by this Agreement, which actions shall include making all required registrations and filings with, and seeking all required Consents of, Governmental Authorities and furnishing all information required by applicable Law or requested by such Governmental Authorities. Each Party shall cooperate fully with the other Party and its Affiliates in promptly seeking to make such required registrations and filings and obtain all required Consents. The Parties shall not willfully take any action that will have the effect of delaying, impairing or impeding the making of such required registrations and filings or the receipt of any required Consents. Each of the Parties shall each make an appropriate filing pursuant to the HSR Act with respect to the transactions contemplated by this Agreement promptly (and in any event, within [***] after the Effective Date and shall supply as promptly as practicable to the appropriate Governmental Authorities any additional information and documentary material that may be requested pursuant to the HSR Act or other applicable antitrust laws. (c) Notwithstanding anything in this Agreement to the contrary, Purchaser shall take, or cause to be taken, all actions and shall do, or cause to be done, all things necessary, proper or advisable to eliminate each and every impediment under the HSR Act or any other antitrust law that is asserted by any Governmental Authority to permit the Closing to occur as promptly as reasonably practicable and in any event prior to the date that is [***] after the Effective Date or such other date as mutually agreed to by the Parties in writing (such date, the “Outside Date”), including: (i) proposing, negotiating, committing to, effecting and agreeing to, by consent decree, hold separate order, or otherwise, the sale, divestiture, license, holding separate, and other disposition of or restrictions on the businesses, assets, properties, product lines, and equity or other business interests of, or changes to the conduct of business of the Purchaser (ii) creating, terminating, unwinding, divesting or assigning, subcontracting or otherwise securing substitute parties for relationships, ventures, and contractual or commercial rights or obligations of the Purchaser and (iii) otherwise taking or committing to take any action that would limit Purchaser’s freedom of action with respect to, or its ability to retain, hold or continue, directly or indirectly, any businesses, assets, properties, product lines, and equity or other business interests, relationships, ventures or contractual rights and obligations of the Purchaser. The Purchaser shall not be required to agree to take or enter into any such action described in clauses (i) through (iii) that is not conditioned upon, or that becomes effective prior to, the Closing. (d) The Seller will reasonably cooperate with the Purchaser in disclosing any relevant records and reports which are required to be made, maintained and reported pursuant to applicable Law in the Territory with respect to the Acquired Regulatory Approvals and coordinating with the Purchaser to make an orderly and prompt transition of the Purchased Assets as soon as practicable after the Closing. (e) Following the Closing, upon request by Purchaser, the Seller will reasonably cooperate with the Purchaser and applicable Regulatory Authorities to enable the Purchaser to effectuate a conversion of NDA number 212157 from “discontinued” status to active or “prescription” marketing status with the FDA in order to effectuate First Commercial Sale by the Purchaser in the United States. All fees and expenses associated with the conversion of NDA number 212157 from “discontinued” status to active or “prescription” marketing status with the FDA, including all fees that were deferred during such discontinued status, shall be borne by the Purchaser.

Transfer of Acquired Regulatory Approvals. (a) The Seller and the Purchaser shall establish a mutually acceptable and prompt communication and interaction process to ensure the orderly transfer of the Acquired Regulatory Approvals in accordance with Section 2.01(f) and Section 2.01(g)Approvals. The Seller and the Purchaser shall use all Commercially Reasonable Efforts commercially reasonable efforts to take any actions required by any Governmental Authority to effect the transfer of the Acquired Regulatory Approvals from the Seller to the Purchaser, and shall cooperate with each other in order to effectuate the foregoing transfer of the Acquired Regulatory Approvals. The Seller may retain an archival copy of any Acquired Regulatory Approvals including supplements and records that are required to be kept under 21 C.F.R. §314.81. (b) Following the Closing, each of the Parties shall use its Commercially Reasonable Efforts commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary for it to do under applicable Laws to consummate and make effective the transactions contemplated by this Agreement, which actions shall include making all required registrations and filings with, and seeking all required Consents of, Governmental Authorities and furnishing all information required by applicable Law or requested by such Governmental Authorities. Each Party shall cooperate fully with the other Party and its Affiliates in promptly seeking to make such required registrations and filings and obtain all required Consents. The Parties shall not willfully take any action that will have the effect of delaying, impairing or impeding the making of such required registrations and filings or the receipt of any required Consents. Each of the Parties shall each make an appropriate filing pursuant to the HSR Act with respect to the transactions contemplated by this Agreement promptly (and in any event, within [***] after the Effective Date and shall supply as promptly as practicable to the appropriate Governmental Authorities any additional information and documentary material that may be requested pursuant to the HSR Act or other applicable antitrust laws. (c) Notwithstanding anything in this Agreement to the contrary, Purchaser shall take, or cause to be taken, all actions and shall do, or cause to be done, all things necessary, proper or advisable to eliminate each and every impediment under the HSR Act or any other antitrust law that is asserted by any Governmental Authority to permit the Closing to occur as promptly as reasonably practicable and in any event prior to the date that is [***] after the Effective Date or such other date as mutually agreed to by the Parties in writing (such date, the “Outside Date”), including: (i) proposing, negotiating, committing to, effecting and agreeing to, by consent decree, hold separate order, or otherwise, the sale, divestiture, license, holding separate, and other disposition of or restrictions on the businesses, assets, properties, product lines, and equity or other business interests of, or changes to the conduct of business of the Purchaser (ii) creating, terminating, unwinding, divesting or assigning, subcontracting or otherwise securing substitute parties for relationships, ventures, and contractual or commercial rights or obligations of the Purchaser and (iii) otherwise taking or committing to take any action that would limit Purchaser’s freedom of action with respect to, or its ability to retain, hold or continue, directly or indirectly, any businesses, assets, properties, product lines, and equity or other business interests, relationships, ventures or contractual rights and obligations of the Purchaser. The Purchaser shall not be required to agree to take or enter into any such action described in clauses (i) through (iii) that is not conditioned upon, or that becomes effective prior to, the Closing. (d) The Seller will reasonably cooperate with the Purchaser in disclosing any relevant records and reports which are required to be made, maintained and reported pursuant to applicable Law in the Territory with respect to the Acquired Regulatory Approvals and coordinating with the Purchaser to make an orderly and prompt transition of the Purchased Assets as soon as practicable after the Closing. (e) Following the Closing, upon request by Purchaser, the Seller will reasonably cooperate with the Purchaser and applicable Regulatory Authorities to enable the Purchaser to effectuate a conversion of NDA number 212157 from “discontinued” status to active or “prescription” marketing status with the FDA in order to effectuate First Commercial Sale by the Purchaser in the United States. All fees and expenses associated with the conversion of NDA number 212157 from “discontinued” status to active or “prescription” marketing status with the FDA, including all fees that were deferred during such discontinued status, shall be borne by the Purchaser.