Definition of UDCA Failure Clause Samples

Definition of UDCA Failure. UDCA failure includes both inadequate response to UDCA, and intolerance to UDCA. Inadequate UDCA response is defined as: • At least 1 measure of ALP and/or TB >ULN; and • >270 days of UDCA treatment prior to ALP and/or TB elevation UDCA intolerance is defined as: • A maximum of 90 days of UDCA use with ALP>ULN and/or TB >ULN. The first date of prescription of OCA after inadequate UDCA response (ALP>upper limit of normal [ULN] and/or total bilirubin [TB]>ULN after >270 days of treatment) or UDCA intolerance (discontinued UDCA after <90 days despite ALP>ULN and/or TB>ULN) will be defined as the index date for OCA-treated PBC patients. The dates of evidence of inadequate UDCA response or UDCA intolerance during which OCA is not utilized will be used as index dates for the non–OCA-treated comparator group.
View Source

Related to Definition of UDCA Failure

  • Definition of Reportable Event For purposes of this CIA, a “Reportable Event” means anything that involves: a. a substantial Overpayment; b. a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized; c. the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a; or d. the filing of a bankruptcy petition by Good Shepherd. A Reportable Event may be the result of an isolated event or a series of occurrences.

  • Definition of Grievance A grievance shall be defined as any difference arising out of the interpretation, application, administration, or alleged violation of the Collective Agreement.

  • Certification of Funds; Budget and Fiscal Provisions; Termination in the Event of Non-Appropriation This Agreement is subject to the budget and fiscal provisions of the City’s Charter. Charges will accrue only after prior written authorization certified by the Controller, and the amount of City’s obligation hereunder shall not at any time exceed the amount certified for the purpose and period stated in such advance authorization. This Agreement will terminate without penalty, liability or expense of any kind to City at the end of any fiscal year if funds are not appropriated for the next succeeding fiscal year. If funds are appropriated for a portion of the fiscal year, this Agreement will terminate, without penalty, liability or expense of any kind at the end of the term for which funds are appropriated. City has no obligation to make appropriations for this Agreement in lieu of appropriations for new or other agreements. City budget decisions are subject to the discretion of the Mayor and the Board of Supervisors. Contractor’s assumption of risk of possible non-appropriation is part of the consideration for this Agreement. THIS SECTION CONTROLS AGAINST ANY AND ALL OTHER PROVISIONS OF THIS AGREEMENT.

  • Definition of Events of Default “Event of Default” means the occurrence of any of the following:

  • Definition of Default The BUYER shall be deemed to be in default under this CONTRACT in the following cases: (a) If the first, second, third or fourth instalment is not paid to the BUILDER within the respective DUE DATE of such instalments; or (b) If the fifth instalment is not deposited in accordance with Article X.4.(a)(ii) hereof or if the said fifth instalment deposit is not released to the BUILDER against presentation by the BUILDER of a copy of the original PROTOCOL OF DELIVERY AND ACCEPTANCE; or (c) If the BUYER fails to take delivery of the VESSEL when the VESSEL is duly tendered for delivery by the BUILDER under the provisions of Article VII hereof; or (d) If an order or an effective resolution shall be passed for winding up of the BUYER (except for the purpose of reorganization, merger or amalgamation); or In case the BUYER is in default as set out in Paragraph 1 above, the BUILDER is entitled to and shall have the following rights, powers and remedies in addition to such other rights, powers and remedies as the BUILDER may have elsewhere in this CONTRACT and/or at law, at equity or otherwise.