Required Development in the United States Sample Clauses

Required Development in the United States. If (i) the FDA requires that additional clinical trials or other development work be conducted on the Initial Product as a condition of and prior to approving the Initial Product NDA (such required clinical trials or other development work, “Pre-Approval Required U.S. Development”) or (ii) the FDA requires additional clinical trials or other development work on the Initial Product after approval of the Initial Product NDA to obtain or maintain such Regulatory Approval in the United States (such
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Related to Required Development in the United States

  • 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.

  • United States The term “

  • Preference for United States Industry If LICENSEE sells a Licensed Product or Combination Product in the US, LICENSEE shall manufacture said product substantially in the US.

  • Office of Foreign Assets Control Neither the Company nor any Subsidiary nor, to the Company's knowledge, any director, officer, agent, employee or affiliate of the Company or any Subsidiary is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”).

  • UNITED ARAB EMIRATES Notifications

  • Controlled Foreign Corporation The Company will provide written notice to the Investors as soon as practicable if at any time the Company is notified that it or any Group Company has become a “controlled foreign corporation” (“CFC”) within the meaning of Xxxxxxx 000 xx xxx Xxxxxx Xxxxxx Internal Revenue Code of 1986 (the “Code”). Upon written request of the Investor who is a United States shareholder within the meaning of Section 951(b) of the Code, the Company will (i) use best efforts to provide in writing such information as is in its possession and reasonably available concerning its shareholders to assist the Investor in determining whether the Company is a CFC and (ii) provide the Investor with reasonable access to such other Company information as is in the Company’s possession and reasonably available as may be required by the Investor (A) to determine the Company’s status as a CFC, (B) to determine whether the Investor is required to report its pro rata portion of the Company’s “Subpart F income” (as defined in Section 952 of the Code) on its United States federal income tax return, or (C) to allow the Investor to otherwise comply with applicable United States federal income tax laws.

  • 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.

  • Country Risk – shall have the meaning set forth in the Custodian Agreement.

  • Territory The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

  • Supremacy In the event of any express conflict or inconsistency between this Agreement and any Schedule or Appendix hereto, the terms of this Agreement will apply. The Parties understand and agree that the Schedules and Appendices hereto are not intended to be the final and complete embodiment of any terms or provisions of this Agreement, and are to be updated from time to time during the Agreement Term, as appropriate and in accordance with the provisions of this Agreement.

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