Major Challenges Sample Clauses

Major Challenges. (i) Notwithstanding anything to the contrary in this Agreement, and in addition to the deemed Major Challenge set forth in Section 2.2(a) above, in the event that after the Effective Date but prior to US Regulatory Transfer, any of the following occur, it shall be considered to be a “Major Challenge” hereunder: a) Licensor is unable to ship or allow shipment of Product for [ * * * ] days or more due to safety concerns; b) a new clinical trial involving the Product is required by the FDA; c) Product recalls, field actions, Product changes or other similar Product activities required by Applicable Law or any Regulatory Authority, including without limitation, by the FDA in connection with the 510(k) Work or US Regulatory Transfer, are necessary and which (x) cost or are reasonably expected to cost, individually or in the aggregate, [ * * * ] or more, the calculation of which shall exclude any Monthly Fees and Third Party Costs paid by Licensee to Licensor, or (y) individually or in the aggregate, are reasonably expected to take longer than six (6) months to address; or d) currently unforeseen problems that must be addressed by Licensor under Applicable Law to perform the Transition Services in accordance with the provisions of this Agreement which (x) cost, or are reasonably expected to cost, individually or in the aggregate, [ * * * ] or more, the calculation of which shall exclude any Monthly Fees and Third Party Costs paid by Licensee to Licensor, or (y) individually or in the aggregate, are reasonably expected to prevent US Regulatory Transfer from occurring by the earlier of, April 30, 2012, or the date that is six (6) months following Licensor’s submission of the 510(k) Notification referred to in Section 4.1(a) hereof. (ii) In the event of a Major Challenge: a) Licensor shall have the first option to determine in its reasonable discretion whether it elects to do the work and incur the costs necessary to respond to the Major Challenge (the “Major Challenge Option”); b) In the event that Licensor elects not to exercise the Major Challenge Option, then Licensee shall have thirty (30) days to notify Licensor in writing whether it elects to exercise such Option at its own expense (the “Option Notice”), subject to the terms set forth herein. As soon as reasonably practicable following the receipt by Licensor of an Option Notice indicating the Licensee elects to exercise the Major Challenge Option, (1) Licensor will cease the 510(k) Work and will transfer su...
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Major Challenges. Provide efficient, high quality patient care in both inpatient and outpatient settings.
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Major Challenges. The infrastructure of a smart city is a typical cloud-edge environment with a large number of geo- distributed and heterogeneous edge nodes, including both heavy edges and lightweight edges. By taking advantage of edge computing in a smart city platform, city service providers could offer time- sensitive services with largely reduced bandwidth consumption. As compared to the cloud-centric approach, using edge computing could not only improve QoS of their services, but also reduce their operation cost. However, as illustrated in Figure 2, in order to adopt edge computing, they have to face the following challenges due to the heterogeneity, openness, and dynamics of such an environment. • High complexity to realize their services/applications during the development phase • High complexity to manage system resources in order to provide the best service QoS during the deployment phase
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Related to Major Challenges

  • Challenges The Experts may be challenged by either Party if circumstances exist that give rise to justifiable doubts as to any of their impartiality or independence. In such circumstances the challenge shall be brought by written notice to the ICC copied to the other Party within fourteen (14) calendar days of the appointment of the relevant Expert or within fourteen (14) calendar days of the challenging Party becoming aware of the circumstances giving rise to the challenge. Unless the challenged Expert withdraws. or whichever of the Parties that has not brought the challenge agrees to the challenge, within fourteen (14) calendar days of the challenge, the ICC shall decide the challenge and, if appropriate, shall appoint a replacement Expert in accordance with the criteria set out herein.

  • No Challenges In no event shall any Secured Party take any action to challenge, contest or dispute the validity, extent, enforceability, or priority of the Collateral Agent’s Liens hereunder or under any other Security Document with respect to any of the Collateral, or that would have the effect of invalidating any such Lien or support any Person who takes any such action. Each of the Secured Parties agrees that it will not take any action to challenge, contest or dispute the validity, enforceability or secured status of any other Secured Party’s claims against any Obligor (other than any such claim resulting from a breach of this Agreement by a Secured Party, or any challenge, contest or dispute alleging arithmetical error in the determination of a claim), or that would have the effect of invalidating any such claim, or support any Person who takes any such action.

  • No Challenge Each Stockholder agrees not to commence, join in, facilitate, assist or encourage, and agrees to take all actions necessary to opt out of any class in any class action with respect to, any claim, derivative or otherwise, against Parent, Merger Sub, the Company or any of their respective successors or directors (a) challenging the validity of, or seeking to enjoin the operation of, any provision of this Agreement or the Merger Agreement or (b) alleging a breach of any fiduciary duty of any person in connection with the evaluation, negotiation or entry into the Merger Agreement.

  • Challenge If Executive violates or challenges the enforceability of any provisions of the Restrictive Covenants or this Release, no further payments, rights or benefits under Section 5 of the Agreement will be due to Executive (except where such provision would be prohibited by applicable law, rule or regulation).

  • Patent Challenge 6.5.1 Licensor may terminate this Agreement, effective immediately upon written notice to Licensee, upon the commencement by Licensee or any of its Affiliates of a Patent Challenge. 6.5.2 Licensee shall include in each sublicense agreement entered into with a Sublicensee a right of Licensee to terminate such sublicense agreement if such Sublicensee commences a Patent Challenge; and Licensee shall terminate the sublicense agreement, effective immediately upon written notice to the Sublicensee, if the Sublicensee commences a Patent Challenge. In addition, if the Sublicensee’s commencement of a Patent Challenge gives Licensor’s licensor a right of termination under the Penn Agreement and such licensor threatens to terminate the Penn Agreement, then, upon receipt of notice to such effect, Licensor may terminate this Agreement, effective immediately upon written notice to Licensee, if the Sublicensee commences a Patent Challenge. 6.5.3 For purposes of this Section 6.5, “Patent Challenge” means any action against Licensor or the University of Pennsylvania or SmithKline Xxxxxxx Corporation (or their successors under the Existing Licenses), including an action for declaratory judgment, to declare or render invalid or unenforceable the Licensed Patents, or any claim thereof.

  • Third Party Proceedings The Company shall indemnify Indemnitee if Indemnitee is or was a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Company) by reason of the fact that Indemnitee is or was a director, officer, employee or agent of the Company, or any subsidiary of the Company, by reason of any action or inaction on the part of Indemnitee while an officer or director or by reason of the fact that Indemnitee is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement (if such settlement is approved in advance by the Company, which approval shall not be unreasonably withheld) actually and reasonably incurred by Indemnitee in connection with such action, suit or proceeding if Indemnitee acted in good faith and in a manner Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action or proceeding, had no reasonable cause to believe Indemnitee’s conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, or, with respect to any criminal action or proceeding, that Indemnitee had reasonable cause to believe that Indemnitee’s conduct was unlawful.

  • No Proceedings or Litigation No action, suit or proceeding before any arbitrator or any governmental authority shall have been commenced, and no investigation by any governmental authority shall have been threatened, against the Company or any Subsidiary, or any of the officers, directors or affiliates of the Company or any Subsidiary seeking to restrain, prevent or change the transactions contemplated by this Agreement, or seeking damages in connection with such transactions.

  • Infringement Proceedings Each Party agrees to promptly notify the other Party of any unauthorized use of the other Party's Marks of which it has actual knowledge. Each Party will have the sole right and discretion to bring proceedings alleging infringement of its Marks or unfair competition related thereto; provided, however, that each Party agrees to provide the other Party with its reasonable cooperation and assistance with respect to any such infringement proceedings.

  • No Proceeding or Litigation No suit, action, investigation, inquiry or other proceeding by any Authority or other person or entity will have been instituted or threatened which delays or questions the validity or legality of the transactions contemplated hereby or which, if successfully asserted, would, in the reasonable judgment of the Company, individually or in the aggregate, otherwise have a Material Adverse Effect on Parent's business, financial condition, prospects, assets or operations or prevent or delay the consummation of the transactions contemplated by this Agreement.

  • No Litigation Threatened No action or proceedings shall have been instituted or threatened before a court or other government body or by any public authority to restrain or prohibit any of the transactions contemplated hereby.

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