Regulatory Clearance. Licensor shall reasonably cooperate with Licensee in obtaining any clearances from governmental agencies to use, market or sell the Distribution Rights.
Regulatory Clearance. PIVOT represents and warrants that PIVOT and its Affiliates have not received or been subject to (i) any Governmental or Regulatory Authority notices of adverse findings indirectly or directly relating to any of its activities, including the commercialization of any product or the storage thereof; or (ii) any warning letters or other written correspondence from any Governmental or Regulatory Authority indirectly or directly relating to any of its activities, including the commercialization of any product or the storage thereof, in which such Governmental or Regulatory Authority asserted that the operations of PIVOT were not in compliance with Applicable Laws with respect to any products, facilities, labeling requirements or such other requirements applicable to it.
Regulatory Clearance. Licensee shall, at Licensee’s expense, comply with all applicable Laws and safety standards concerning Licensed Products developed and commercialized by or under the authority of Licensee and obtain all necessary Governmental Authority approvals for the development, production, distribution, sale, and use of Licensed Products developed and commercialized by or under the authority of Licensee, including any safety or clinical studies. Licensee will have responsibility for and provide suitable warning labels, packaging, and instructions as to the use for such Licensed Products.
Regulatory Clearance. (a) All filings required to be made with the DOJ and the DOD under the Final Judgment shall have been completed, and all applicable time periods for review under the Final Judgment shall have expired or have been earlier terminated without any requests for further information, or in the event of such a request for further information, all applicable time periods for review under the Final Judgment shall have expired without the objection of the DOJ or the DOD.
Regulatory Clearance. Buyer shall be responsible for submitting, obtaining and maintaining regulatory approvals and clearance for the marketing of the Finished Product. Seller will assist and cooperate with Buyer as reasonably required to obtain such regulatory clearance including pre-approval inspections and technical assistance to the extent within Seller’s control.
Regulatory Clearance. Orchid shall be responsible for submitting and subsequently obtaining approval from any Regulatory Authority for marketing the Finished Products. Hospira shall assist and cooperate with Orchid to the extent necessary to obtain such approval. Such assistance and cooperation shall include, but not be limited to, pre-approval inspections, technical assistance, etc. Orchid shall also be responsible for and shall bear the cost of filing DMF/CEPs in all countries in the Territory. 141 CONFIDENTIAL TREATMENT [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the SEC.
Regulatory Clearance. A. Centaur to Secure Regulatory Approvals. Centaur will use its best -------------------------------------- reasonable efforts to obtain all regulatory approvals necessary for the manufacture or supply of Bulk Product for Licensed Products in the Territory, which shall be obtained in due time to avoid any delay in Lundbeck's launch and marketing of Licensed Products as reasonably notified by Lundbeck, and Centaur shall promptly provide Lundbeck with such information regarding the manufacture and quality control of Bulk Product for Licensed Products necessary to permit Lundbeck to seek marketing approval of Licensed Products in the Territory. The undertaking by Centaur shall include, without limitation, the following within the said time-limit:
Regulatory Clearance. (a) Each of the Parties shall, and shall cause each of its respective Affiliates to, (i) file any required Notification and Report Forms with the DOJ and FTC pursuant to the HSR Act within fifteen (15) Business Days after the date of this Agreement; (ii) supply as promptly as reasonably practicable any additional information and documentary material that may be requested pursuant to the HSR Act or any other Antitrust Law; and (iii) use its reasonable best efforts to take or cause to be taken all other actions necessary, proper or advisable consistent with this Section 6.2 to satisfy the Closing condition in Section 7.1(b) as soon as practicable, which reasonable best efforts shall include avoiding and eliminating any impediment under the HSR Act and any other Antitrust Law and refraining from taking actions that would reasonably be expected to delay the expiration or termination of the applicable waiting periods, or receipt of required authorizations, as applicable, under the HSR Act and any other Antitrust Law. Without limiting the foregoing, the Parties shall request and shall use reasonable best efforts to obtain expiration or early termination of the waiting period under the HSR Act in connection with the Contemplated Transactions and the Business Combination as soon as practicable. In the event of a Xxxxx Cross Refinery Divestiture Action (as defined in the Business Combination Agreement), HEP shall transfer to HFC all of HEP’s rights, title and interest in and to the Xxxxx Cross Refinery Assets (as defined in the Business Combination Agreement); provided, however, that under no circumstances shall HEP be required to transfer any of its rights, title or interest in the SLC Pipeline or the Frontier Aspen Pipeline.
Regulatory Clearance. PIVOT and its Affiliates have not received or been subject to
Regulatory Clearance. Receipt by Purchaser or its designated affiliate of either: (i) all required licenses and approvals from the Agency to operate the Property of the type and kind which is consistent with the operations of the Property as of the Closing Date, free of any conditions or restrictions and otherwise on terms and conditions acceptable to Purchaser in its reasonable discretion, or (ii) reasonable assurances by the Agency satisfactory to Purchaser that the Agency will issue a license authorizing Purchaser to operate the Property in a manner substantially consistent with the manner that the Property was previously operated, and permission to commence such operation.
