Regulatory Commitments. Seller has complied in all material respects with all obligations arising from or related to any commitments to any Governmental Entity involving any Products. Seller and its Affiliates have been since January 1, 2014 in compliance in all material respects with all Laws applicable to the Transferred Assets, the Product Technology.
Regulatory Commitments. The Company and Parent agree (i) that the applications submitted to FERC and the State Commissions with respect to the Merger shall include the information concerning the Merger, the Company and its Subsidiaries, and Parent required by applicable Laws of the District of Columbia, the States of Delaware, Maryland, and New Jersey, the Commonwealth of Virginia and such other jurisdictions as may be mutually determined by the Company and Parent, as the case may be, (ii) that such applications and any amendments or supplements thereto shall include the Regulatory Commitments to the extent applicable to such jurisdictions and such additional agreements or commitments as the Company and Parent agree are advisable to obtain prompt approval of such applications, and (iii) that neither the Company nor Parent shall agree to, or accept, any additional or different agreements, commitments or conditions in connection with the Merger pursuant to any settlement or otherwise with any State Commissions or any other Person, in the case of any agreement, commitment or condition to which the Company of any of its Subsidiaries is a party or otherwise affecting the Company or any of its Subsidiaries, without the prior written consent of Parent, and in the case of any agreement, commitment or condition to which Parent is a party and affecting the Company or any of its Subsidiaries, without the prior written consent of the Company if such agreement, commitment or condition is effective prior to the Effective Time. Parent further agrees that, subject to obtaining the consent of the Company as required by this Section 6.5(e), it will agree to, or accept, any additional or different agreements, commitments or conditions that do not, individually or in the aggregate, constitute a Burdensome Condition to obtain any governmental approvals necessary to promptly consummate the Merger, including any Parent Approval or the FERC Approval, the State Approvals and the FCC Approval.
Regulatory Commitments. Such Seller has complied in all material respects with all obligations arising from or related to any commitments to any Governmental Entity involving any Products. Such Seller and its Affiliates have been since January 1, 2014 in compliance in all material respects with all Laws applicable to the Transferred Assets of such Seller and the Product Technology. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions.
Regulatory Commitments. (a) From and after the Closing Date, Buyer shall assume control of, and responsibility for, all Assumed Liabilities arising from or related to any commitments or obligations to any Governmental Entities in connection with the MA and the Product and, except as otherwise set forth in Schedule 2.6, for all pharmacovigilance and medical information services for and in respect of the MA and the Product.
(b) On the Closing Date, Buyer shall assume responsibility for all correspondence and communication with Third Parties, including all Governmental Entities, relating to the Product. Buyer shall also thereafter keep such records and make such reports relating to the Product as shall be reasonably necessary to document such communications in compliance with all applicable regulatory requirements.
(c) Following the Closing Date, Buyer shall, as promptly as practicable, register with the FDA to obtain its own labeler code and list with the FDA its own NDC numbers with respect to the Product and to have in place as soon as reasonably practicable all resources such that manufacturing and sales can be accomplished under the NDC numbers of Buyer. Buyer shall be permitted to sell and distribute finished drug product included in Closing Inventory that has been labeled prior to Closing using Sellers’ NDC numbers until the earlier of (i) Buyer having its own labeler code with respect to the Product or (ii) twelve (12) months following the Closing.
(d) Following the Closing Date, Buyer shall, as promptly as practicable, deliver or cause to be delivered to Sellers copies of all confirmations, acknowledgements and other correspondence from the FDA that the transfer of ownership of the MA to Buyer has been completed in full.
Regulatory Commitments. Supplier shall secure Nevro’s written agreement prior to making any commitment to a regulatory agency regarding the Product. Nevro shall be provided with draft responses to regulatory observations that involve the Product and its Manufacture prior to submission to any Regulatory Authority and Supplier shall permit Nevro’s input into responses and corrective actions. Supplier shall retain the final authority and responsibility for the content of the responses to the Regulatory Authority related to a Finished Device. o x x
Regulatory Commitments. From and after the Closing Date, Purchaser will assume control of, and responsibility for, all costs and liabilities arising from or related to any commitments or obligations to any Governmental Authority involving the Compound and/or Products (“Regulatory Commitments”) only to the extent arising from or relating to events occurring after the Closing Date.
Regulatory Commitments. Supplier shall secure Buyer’s written agreement prior to making any commitment to a regulatory agency regarding the Product. Buyer shall be provided with draft responses to regulatory observations that involve the product and its manufacture prior to submission to any regulatory Authority and Supplier shall permit Buyer’s input into responses and corrective actions. Supplier shall retain the final authority and responsibility for the content of the responses to the Authority related to a product.
Regulatory Commitments. Seller and Purchaser agree (a) that the applications submitted to the State Commissions with respect to the Purchase shall include the information concerning the Purchase, the Company and its Subsidiaries, Seller and Purchaser required by applicable laws of the Commonwealth of Kentucky, the Commonwealth of Virginia and the State of Tennessee, as the case may be, (b) that such applications and any amendments or supplements thereto shall include the commitments and agreements set forth in Exhibit B hereto to the extent applicable to such jurisdictions and such additional agreements or commitments as Seller and Purchaser agree are advisable to obtain prompt approval of such applications, and (c) that neither Seller nor Purchaser shall agree to, or accept, any additional or different agreements, commitments or conditions in connection with the Purchase pursuant to any settlement or otherwise with the State Commissions or any other Person without the prior written consent of the other party hereto, which consent shall not be unreasonably withheld, conditioned or delayed. Purchaser further agrees that, subject to obtaining the consent of Seller as required by this Section 5.14, it will agree to, or accept, any additional or different agreements, commitments or conditions reasonably necessary, proper or advisable to obtain any Governmental Authorizations necessary to promptly consummate the Purchase, including any Company Required Regulatory Approvals or any Purchaser Required Regulatory Approvals, except to the extent that any such agreements, commitments or conditions, individually or in the aggregate, would cause the condition set forth in Section 7.2(c) to fail to be satisfied.
Regulatory Commitments. (a) Annual Reports and Periodic Safety Update Reports.
Regulatory Commitments. (a) From and after the NDA Transfer Date, Cumberland shall assume control of, and responsibility for, all obligations to any Governmental Authorities in connection with the NDA and the Product including all pharmacovigilance and medical information services for and in respect of the NDA and the Product.
(b) On the NDA Transfer Date, Cumberland shall assume responsibility for all correspondence and communication with Third Parties, including all Governmental Authorities, relating to the Product, and shall assume all new obligations occurring on or after the NDA Transfer Date with regard to the NDA. Any obligation of KKUS with respect to the NDA that arises prior to the NDA Transfer Date, including but not limited to pharmacovigilance, clinical studies, quality assurance, deficiency letters, corrective action plan agreements, shall remain KKUS’s obligation.
(c) Future Manufacturing Campaigns., Cumberland shall register with the FDA to obtain its own labeler code and list with the FDA its own National Drug Code (“NDC”) numbers with respect to Product it manufactures Cumberland shall be permitted to sell and distribute finished drug product included in the Assets using KKUS’s NDC numbers.
(d) Following the NDA Transfer Date, Cumberland shall, as promptly as practicable, deliver or cause to be delivered to KKUS copies of all confirmations, acknowledgements, and other correspondence from the FDA that the transfer of ownership of the NDA to Cumberland has been completed in full.
