Regulatory Approvals. Graphite will be responsible for obtaining, at its expense, all regulatory and governmental approvals and permits necessary for Graphite's use of any Product Developed and/or Manufactured under this Agreement, including investigational new drug application, biologics license application, new drug application, and abbreviated new drug application submissions in the United States and any analogous submissions filed with the appropriate authority of a country other than the United States. In accordance with the scope and terms of the applicable Work Order, WuXi ATU will provide Graphite or the Regulatory Authority either directly or through access to WuXi ATU’s applicable drug master file(s) (DMFs) with appropriate supporting chemistry, manufacturing, and control (CMC) data and information relating to the Development and/or Manufacture of Product by WuXi ATU to the extent required for such approvals
Regulatory Approvals. The Required Regulatory Approvals shall have been duly obtained, and such approvals shall have become Final Orders or, if applicable, any mandatory waiting period prescribed by Law before the transactions contemplated hereby may be consummated shall have expired or been terminated.
Regulatory Approvals. Notwithstanding anything to the contrary in this Warrant Agreement, no Partnership Units will be issued or delivered upon Exercise of any Warrant unless all filings, notifications, expirations of waiting periods, waivers and approvals necessary under Antitrust Laws have been satisfied, as contemplated by [Section 8(a)].
The implementation of the Plan and the issuance of any shares of common stock under the Stock Issuance Program shall be subject to the Corporation's obtaining all approvals and permits required by regulatory authorities having jurisdiction over the Plan, and the shares of common stock issued pursuant to it.
Regulatory Approvals. As between the Parties, except as expressly set forth herein, Allergan shall have the sole right to prepare, obtain, and maintain Drug Approval Applications and BLAs, as applicable (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, and other submissions to Regulatory Authorities, and to conduct communications with the Regulatory Authorities, for Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities with respect to Development activities). Allergan shall provide UroGen with copies of relevant draft modules (or their equivalent) of original marketing applications (for clarity, excluding amendments to marketing applications) for any Licensed Product in the Territory reasonably in advance of such applications submission. UroGen may provide comments on such applications content within Business Days of receipt, and Allergan shall consider UroGens comments in good faith to the extent applicable to the RTGel Component. UroGen shall support Allergan, as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products and in the activities in support thereof, including providing all documents and other materials in the possession or control of UroGen or any of its Affiliates, and attending any meeting or discussion with any Regulatory Authority, in either case, as may be necessary or useful for Allergan or any of its Affiliates or its or their Sublicensees to obtain Regulatory Approvals for the Licensed Products. In addition, and . Allergan shall provide UroGen with minutes of any meeting with a Regulatory Authority relating to the RTGel Component; provided, that Allergan may redact from such minutes any Information that pertains to products other than a Licensed Product. For purposes of this [Section 3.2.1], Notified Body, means the certification organization designated by the relevant member state of the European Union, authorized to conduct conformity assessments in accordance with the procedures listed in the European Union Directive, 93/42/EEC (OJ No L 169/1, ), as amended. Upon UroGens request, Allergan shall promptly provide UroGen with all documents in accordance with this [Section 3.2.1].
Requisite Regulatory Approvals. All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.
Subject to the terms and conditions of this Agreement, Purchaser and Sellers shall use commercially reasonable efforts take, or cause to be taken, all actions and to do, or cause to be done, all things reasonably necessary or desirable under Law to consummate the transactions contemplated by this Agreement by avoiding and eliminating every impediment under any applicable Law, including # preparing and filing as promptly as practicable with any Governmental Authority all documentation to effect all necessary filings, Notices, petitions, statements, registrations, submissions of information, applications and other documents and # obtaining and maintaining all Permits required to be obtained from any Governmental Authority that are necessary, proper or advisable to consummate the transactions contemplated by this Agreement (collectively, the “Regulatory Approvals”).
Regulatory Matters and Approvals. YourSpace and the Company will give any notices to, make any filings with, and use its commercially reasonable efforts to obtain any authorizations, consents, and approvals of governments and governmental agencies in connection with the matters contemplated by this Agreement.
Grant Subject to Applicable Regulatory Approvals. Any grant of Stock Units under the Plan is specifically conditioned on, and subject to, any regulatory approvals required in the Employee’s country. These approvals cannot be assured. If necessary approvals for grant or payment are not obtained, the Stock Units may be cancelled or rescinded, or they may expire, as determined by the Company in its sole and absolute discretion.
Approvals. The issuance by the Company of authorized and unissued shares or reacquired shares under this Agreement is subject to the approval of the Oregon Public Utility Commission and the Washington Utilities and Transportation Commission, but no such approvals shall be required for the purchase of shares on the open market for delivery to Recipient in satisfaction of its obligations under this Agreement. The obligations of the Company under this Agreement are otherwise subject to the approval of state and federal authorities or agencies with jurisdiction in the matter. The Company will use its best efforts to take steps required by state or federal law or applicable regulations, including rules and regulations of the Securities and Exchange Commission and any stock exchange on which the Company’s shares may then be listed, in connection with the award under this Agreement. The foregoing notwithstanding, the Company shall not be obligated to issue or deliver Common Stock under this Agreement if such issuance or delivery would violate applicable state or federal law.
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