GI Products in the United States Sample Clauses

GI Products in the United States. Subject to Sections 4.2 and -------------------------------- 5.4, GSK will be solely responsible for and will use Commercially Reasonable Efforts in applying for, obtaining and maintaining Investigational Authorizations and Marketing Authorizations for the GI Products in the United States, including without limitation the responsibility for applying for price approvals for the GI Products if required. Upon request by GSK, Adolor shall use Commercially Reasonable Efforts to assist GSK in applying for, obtaining and maintaining such Investigational Authorizations and Marketing Authorizations (including, with respect to price approvals, as requested by GSK) for the GI Products in the United States. GSK will be the sole owner of any Investigational Authorizations and Marketing Authorizations for the GI Products in the United States. Upon receipt of the initial Investigational Authorization and Marketing Authorization for the GI Products in the United States, GSK shall have exclusive authority and responsibility to and will use Commercially Reasonable Efforts to maintain and seek appropriate revisions of the conditions of each such Investigational Authorization and Marketing Authorization for the GI Products, provided any such revisions are not inconsistent with the provisions of this Agreement or the U.S. Marketing Plan. GSK shall promptly and in accordance with applicable Law provide to Adolor copies of any material documents or correspondence received from any Governmental Authority in the United States, but in no event more than two (2) Business Days after such receipt, that pertains to the GI Products (including without limitation any minutes from a meeting with respect thereto). In addition, GSK shall provide Adolor with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the United States that pertains to the GI Products. GSK will consult in advance with, and consider in good faith any comments of, Adolor with respect to any filings made or other actions taken by GSK in accordance with the terms of this Section 9.2, including without limitation any such filings or actions with respect to any changes or modification to labeling for or the indications of the GI Products.
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Related to GI Products in the United States

  • Outside the United States If you acquired the software in any other country, the laws of that country apply.

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  • Territory 33.1 This Agreement applies to the territory in which CenturyLink operates as an ILEC in the State. CenturyLink shall be obligated to provide services under this Agreement only within this territory. 33.2 Notwithstanding any other provision of this Agreement, CenturyLink may terminate this Agreement as to a specific operating territory or portion thereof pursuant to Section 6.7 of this Agreement.

  • Increasing Seat Belt Use in the United States E.O. 13043, amended by E.O. 13652, requires Recipients to encourage employees and contractors to enforce on-the-job seat belt policies and programs when operating company- owned, rented or personally-owned vehicle.

  • United States Law The determination of whether Information and Inventions are conceived, discovered, developed or otherwise made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purposes of this Agreement, be made in accordance with applicable United States law.

  • Territories The Agreement territory is limited to the United States of America, including the District of Columbia, only. It does not include Canada or U.S. Territories including Guam, Puerto Rico, or U.S. Virgin Islands.

  • Inventions Assigned to the United States I agree to assign to the United States government all my right, title, and interest in and to any and all Inventions whenever such full title is required to be in the United States by a contract between the Company and the United States or any of its agencies.

  • Export 12.1 Export laws and regulations of the United States and any other relevant local export laws and regulations apply to the Services. Such export laws govern use of the Services (including technical data) and any Services deliverables provided under this Agreement, and You and we each agree to comply with all such export laws and regulations (including “deemed export” and “deemed re-export” regulations). You agree that no data, information, software programs and/or materials resulting from the Services (or direct product thereof) will be exported, directly or indirectly, in violation of these laws, or will be used for any purpose prohibited by these laws including, without limitation, nuclear, chemical, or biological weapons proliferation, or development of missile technology. 12.2 You acknowledge that the Services are designed with capabilities for You and Your Users to access the Services without regard to geographic location and to transfer or otherwise move Your Content between the Services and other locations such as User workstations. You are solely responsible for the authorization and management of User accounts across geographic locations, as well as export control and geographic transfer of Your Content.

  • Export/Import 14.1 The Works (including, without limitation, any Software) may be subject to the export or import laws and regulations of: 14.1.1 the United States, including without limitation the International Traffic in Arms Regulations (ITAR) (22 C.F.R. Parts 120-130), the U.S. Export Administration Regulations (15 C.F.R. Parts 730-774), and the economic and trade sanctions administered by the U.S. Department of Treasury Office of Foreign Assets Control; 14.1.2 the European Union and its member states, including without limitation Council Regulation (EC) No. 1334/2000; and 14.1.3 other countries (collectively, “Export/Import Law”). Buyer agrees to comply strictly with all Export/Import Laws applicable to the Works. Buyer shall promptly notify Supplier of any authorisation requirements under Export/Import Laws that may apply to delivery of the Works to Buyer site(s). Buyer acknowledges and agrees that the Works shall not be exported, re-exported, trans-shipped or otherwise transferred to Cuba, Iran, North Korea, Syria, Sudan, or any other countries for which the United States and/or the European Union maintains an embargo (collectively, "Embargoed Countries"), or a national or resident thereof, or to any person or entity on the U.S. Department of Treasury List of Specially Designated Nationals, the U.S. Department of Commerce Denied Parties or Entity List, or to any person on any comparable list maintained by the European Union or its member states (collectively, "Denied or Restricted Parties"). The lists of Embargoed Countries and Denied or Restricted Parties are subject to change without notice. Buyer represents and warrants that neither it nor any of their customers or their users is located in, a national or resident of, or under the control of an Embargoed Country or similarly Denied or Restricted Party. Buyer specifically shall obtain all required authorizations from the U.S. (or EU as applicable) Government before transferring or otherwise disclosing technical data or technology (as those terms are defined in 22 C.F.R. § 120.10 and 15 C.F.R. § 722, respectively), to any Foreign Person (as defined in 22 C.F.R. § 120.16). 14.2 Registration In accordance with 22 C.F.R. Part 122, any person who engages in the United States in the business of either manufacturing or exporting defense articles or furnishing defense services is required to register with the U.S. State Department’s Directorate of Defense Trade controls. Engaging in the business of manufacturing or exporting defense articles or furnishing defense services requires only one occasion of manufacturing or exporting a defense article or furnishing defense services. Manufacturers who do not engage in exporting must nevertheless register. 14.3 Acceptance of these terms and conditions certifies to the Supplier that the Buyer is in compliance with 22 C.F.R. Part 120 as required and the Buyer’s registration will remain valid during the terms of this agreement. 14.4 Further to acceptance, the Buyer further certifies it: 14.4.1 Understands its obligation to protect EAR or ITAR controlled Goods and Services as data as necessary from unauthorized disclosure or access to foreign person employees or visitors. 14.4.2 In the performance of the contract, the Buyer understands its obligation to determine whether it will require the use of third party subcontractors to access any technical data, Goods and Services. If required, the Buyer is responsible for identifying and licensing any activity that requires export authorization from the Department of Commerce, Bureau of Industry and Security or the Department of State, Directorate of Defense Trade Controls. 14.5 The Goods shall not be resold or exported to countries specified in the Country Guidance Chart which can be found at xxxx://xxx.xxxxxx.xxx/about-cobham/aerospace-and-security/about- us/useful-information.aspx without prior written approval of Supplier.

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