Abandonment of POZEN NDA Sample Clauses

Abandonment of POZEN NDA. (a) If POZEN determines that the studies necessary for generating any additional data or information that are required by the FDA for the approval of the POZEN NDA, or that are deemed necessary by POZEN to address issues or respond to questions raised by the FDA, would jeopardize the commercial viability of the Initial Licensed Product or exceed the financial resources available at POZEN for the Initial Licensed Product, POZEN will inform Xcel thereof without delay. If the Parties are unable to come to a mutually acceptable resolution of the matter within 30 days, POZEN may elect by written notice to Xcel to withdraw the POZEN NDA and abandon the preparation of an NDA for the Initial Licensed Product; provided, however, that in such event Xcel will be given a reasonable opportunity (before such withdrawal or abandonment) to assume control of efforts to seek approval of the POZEN NDA at Xcel’s cost (subject to Section 3.1.6 below). If Xcel elects to assume such control, POZEN will (i) exercise its Commercially Reasonable Efforts (at Xcel’s expense) to assist Xcel with respect to seeking approval of the POZEN NDA, and (ii) transfer the POZEN NDA to Xcel promptly after receipt of such approval. Xcel will provide POZEN with written notice of its election within 90 days after receiving written notice of POZEN’s intent to withdraw the POZEN NDA and abandon the preparation of an NDA for the Initial Licensed Product.
Sample 1
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Related to Abandonment of POZEN NDA

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

  • Environment, Health, and Safety (i) The Seller, and its predecessors and Affiliates has complied with all Environmental, Health, and Safety Laws, and no action, suit, proceeding, hearing, investigation, charge, complaint, claim, demand, or notice has been filed or commenced against any of them alleging any failure so to comply. Without limiting the generality of the preceding sentence, each of the Seller, and its predecessors and Affiliates has obtained and been in compliance with all of the terms and conditions of all permits, licenses, and other authorizations which are required under, and has complied with all other limitations, restrictions, conditions, standards, prohibitions, requirements, obligations, schedules, and timetables which are contained in, all Environmental, Health, and Safety Laws.

  • Environmental, Health and Safety The Policy Board shall review, approve and monitor environmental and workplace health and safety guidelines, the goal of which is to achieve compliance with current national, state and local laws and regulations regarding environmental and workplace health and safety.

  • Environmental and Safety Matters Except as disclosed in Schedule 4.13:

  • Health and Safety All employees and workers have a duty in law to act responsibly and to take reasonable care for the health and safety at work of both themselves and their colleagues. This duty can be carried out by:

  • Environmental, Health and Safety Laws There does not exist any violation by the Borrower or any Subsidiary of any applicable federal, state or local law, rule or regulation or order of any government, governmental department, board, agency or other instrumentality relating to environmental, pollution, health or safety matters which will or threatens to impose a material liability on the Borrower or a Subsidiary or which would require a material expenditure by the Borrower or such Subsidiary to cure. Neither the Borrower nor any Subsidiary has received any notice to the effect that any part of its operations or properties is not in material compliance with any such law, rule, regulation or order or notice that it or its property is the subject of any governmental investigation evaluating whether any remedial action is needed to respond to any release of any toxic or hazardous waste or substance into the environment, the consequences of which non-compliance or remedial action could constitute an Adverse Event.

  • HSR Any applicable waiting period under the HSR Act shall have expired or been terminated.

  • Investigation and Prevention Transfer Agent shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to:

  • Bankruptcy Plan Surveillance With respect to each Mortgage Loan which is the subject of a Deficient Valuation or a Debt Service Reduction, the Servicer shall verify that payments are being made in accordance with the plan approved in the related bankruptcy proceedings.

  • Anti-Money Laundering and Red Flag Identity Theft Prevention Programs The Trust acknowledges that it has had an opportunity to review, consider and comment upon the written procedures provided by USBFS describing various tools used by USBFS which are designed to promote the detection and reporting of potential money laundering activity by monitoring certain aspects of shareholder activity as well as written procedures for verifying a customer’s identity (collectively, the “Procedures”). Further, the Trust has determined that the Procedures, as part of the Trust’s overall anti-money laundering program and the Red Flag Identity Theft Prevention program, are reasonably designed to prevent the Fund from being used for money laundering or the financing of terrorist activities and to achieve compliance with the applicable provisions of the Fair and Accurate Credit Transactions Act of 2003 and the USA Patriot Act of 2001 and the implementing regulations thereunder. Based on this determination, the Trust hereby instructs and directs USBFS to implement the Procedures on the Trust’s behalf, as such may be amended or revised from time to time. It is contemplated that these Procedures will be amended from time to time by the parties as additional regulations are adopted and/or regulatory guidance is provided relating to the Trust’s anti-money laundering and identity theft responsibilities. USBFS agrees to provide to the Trust:

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