United States – Primary Indication Sample Clauses

United States – Primary Indication. During the R&D Pre-Transfer Period, Atara shall be responsible, at Partner’s sole cost and expense in accordance with the Transition Budget, for all activities directed to obtaining Regulatory Approval (including the preparation and filing of all Regulatory Materials, including, without limitation, any BLA, and all Regulatory Interactions and site inspections) for the Product for the Primary Indication in the United States; provided, however, that Atara shall promptly submit to Partner all material correspondence received from a Regulatory Authority with respect to such Regulatory Approvals, as well as all relevant draft filings or draft material correspondence with the Regulatory Authorities with reasonable lead time, which shall not be less than [***] for correspondence with the FDA relating to negotiation of the Label, to allow Partner to comment on such drafts, and take into account Partner’s reasonable comments on such correspondence or filings. To the extent practical and without causing any undue delay, and to the extent permitted by the Regulatory Authority, Atara shall permit an appropriate representative of Partner to attend any meeting with Regulatory Authorities relating to filing or obtaining such Regulatory Approvals as a silent observer under Xxxxx’s supervision. Notwithstanding the foregoing, Atara will provide, at any time within [***] after Partner’s written request therefor, the right for Partner to assume sole responsibility for obtaining Regulatory Approval (including the preparation and filing of all Regulatory Materials, including, without limitation, any BLA, and all Regulatory Interactions) for the Product for the Primary Indication in the United States, and Atara shall transition to Partner all activities related thereto in accordance with a mutually agreed transition plan.
Sample 1
AutoNDA by SimpleDocs

Related to United States – Primary Indication

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

  • 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.

  • Territorial application This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of 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.

  • Preference for United States Industry Notwithstanding any other provision of this clause, neither the Contractor nor any assignee shall grant to any person the exclusive right to use or sell any subject invention in the United States unless the person agrees that any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States. However, in individual cases, the requirement for an agreement may be waived by the agency upon a showing by the Contractor or its assignee that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States, or that under the circumstances domestic manufacture is not commercially feasible.

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • DRUG-FREE WORKPLACE FORM The Drug-Free Workplace Form is attached and shall be completed and submitted with your bid.

  • 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.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • United States and Canada For warranty service or information about how to obtain a refund for software acquired in the United States and Canada, contact Microsoft at

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!