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. 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. [***] 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) 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.
(b) All required filings under the HSR Act shall have been completed, and all applicable time limitations under the HSR Act shall have expired or have been earlier terminated without a request for further information by the relevant federal authorities under the HSR Act, or in the event of such a request for further information, all applicable time limitations under the HSR Act shall have expired without the objection of such federal authorities.
Regulatory Clearance. Agent is responsible for helping Accuray to obtain the regulatory clearance in the Territory for Products in Accuray's name, as detailed in Section 3.4, however Accuray will provide Agent with reasonable assistance in obtaining regulatory clearances.
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. (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 Midstream Contribution as soon as practicable. The Parent Parties shall pay the filing fee applicable to the Contemplated Transactions under the HSR Act.
(b) Notwithstanding anything to the contrary set forth in this Agreement, the Parent Parties shall not have any obligation to, and Xxxxxxxx HoldCo or the Company may not without the Parent Parties’ written consent: (i) agree or commit to sell, divest, or otherwise dispose of any particular asset, properties, category, portion or part of an asset or business of Parent Parties, the Company or their respective Subsidiaries; (ii) terminate, modify, or assign existing relationships, Contracts, or obligations of the Parent Parties, the Company or their respective Subsidiaries; (iii) change or modify any course of conduct regarding future operations of the Parent Parties, the Company or their respective Subsidiaries; or (iv) otherwise take or commit to take any other action that would limit the freedom of action of the Parent Parties with respect to, or their ability to retain, one or more of its respective operations, divisions, businesses, product lines, customers, assets or rights or interests, or their freedom of action with respect to the assets, properties, or busines...
Regulatory Clearance. Hospira shall be responsible for submitting and subsequently obtaining approval from any Regulatory Authority for marketing the Finished Products. CyDex shall provide reasonable amounts of assistance and cooperation with Hospira toward obtaining such approval. Such assistance and cooperation shall include, but not be limited to, pre-approval inspections, technical assistance, etc. CyDex shall also file DMF/CEPs in all Major-Market countries and any other countries in the Territory reasonably requested by Hospira, each such filing to be at CyDex’s cost.
