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...
View SourceView Similar (2)
Major Challenges. Provide efficient, high quality patient care in both inpatient and outpatient settings.
View Source
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
View Source

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 ▇▇▇▇▇▇▇ 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.