For Dose Escalation Only Sample Clauses

For Dose Escalation Only. To be eligible for enrollment in dose escalation, a subject must meet ALL of the following criteria in addition to the inclusion criteria listed above for all subjects: 1. Has evaluable disease as defined as lesions that can be accurately measured at least in one dimension by radiographic examination or physical examination or other lesions such as bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonitis or hepatosplenomegaly from disease. 2. Has one of the following histologically confirmed tumors: • Rhabdoid tumor: • Atypical teratoid rhabdoid tumor (ATRT) (Closed to enrollment) • Malignant rhabdoid tumor (MRT) • Rhabdoid tumor of the kidney (RTK) • Selected tumors with rhabdoid features • INI1-negative tumor: • Epithelioid sarcoma (ES) • Epithelioid malignant peripheral nerve sheath tumor (EMPNST) • Extraskeletal myxoid chondrosarcoma (EMC) • Myoepithelial carcinoma • Renal medullary carcinoma (RMC) • Other INI1-negative malignant tumors (e.g., de-differentiated chordoma) • Synovial sarcoma with SS18-SSX rearrangement (closed to enrollment) 3. For subjects with ATRT, MRT, RTK, or tumors with rhabdoid features only: The following test results must be available: • Morphology and immunophenotypic panel consistent with rhabdoid tumor, and • Loss of INI1 or SMARCA4 confirmed by IHC, or • Molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable 4. For subjects with INI1-negative tumor only: The following test results must be available: • Morphology and immunophenotypic panel consistent with INI1-negative tumors, and • Loss of INI1 confirmed by IHC, or • Molecular confirmation of tumor bi-allelic INI1 loss or mutation when INI1 IHC is equivocal or unavailable 5. For subjects with synovial sarcoma only: The following test results must be available: • Morphology consistent with synovial sarcoma, and • Cytogenetics or FISH and/or molecular confirmation (e.g., DNA sequencing) of SS18 rearrangement t(X;18)(p11;q11)
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Related to For Dose Escalation Only

  • PRICE ESCALATION/DE-ESCALATION (CPI) The County may allow a price escalation provision within this award. The original contract prices shall be firm for an initial one (1) year period. A price escalation/de-escalation will be considered at one (1) year intervals thereafter, provided the Contractor notifies the County, in writing, of the pending price escalation/de-escalation a minimum of sixty (60) days prior to the effective date. Price adjustments shall be based on the latest version of the Consumers Price Index (CPI-U) for All Urban Consumers, All Items, U.S. City Average, non-seasonal, as published by the U.S. Department of Labor, Bureau of Labor Statistics. This information is available at xxx.xxx.xxx. Price adjustment shall be calculated by applying the simple percentage model to the CPI data. This method is defined as subtracting the base period index value (at the time of initial award) from the index value at time of calculation (latest version of the CPI published as of the date of request for price adjustment), divided by the base period index value to identify percentage of change, then multiplying the percentage of change by 100 to identify the percentage change. Formula is as follows: Current Index – Base Index / Base Index = % of Change CPI for current period 232.945 Less CPI for base period 229.815 Equals index point change 3.130 Divided by base period CPI 229.815 Equals 0.0136 Result multiplied by 100 0.0136 x 100 Equals percent change 1.4% % of Change x 100 = Percentage Change CPI-U Calculation Example: A price increase may be requested only at each time interval specified above, using the methodology outlined in this section. To request a price increase, Contractor shall submit a letter stating the percentage amount of the requested increase and adjusted price to the Orange County Procurement Division. The letter shall include the complete calculation utilizing the formula above, and a copy of the CPI-U index table used in the calculation. The maximum allowable increase shall not exceed 4%, unless authorized by the Manager, Procurement Division. All price adjustments must be accepted by the Manager, Procurement Division and shall be memorialized by written amendment to this contract. No retroactive contract price adjustments will be allowed. Should the CPI-U for All Urban Consumers, All Items, U.S City Average, as published by the U.S. Department of Labor, Bureau of Labor Statistics decrease during the term of the contract, or any renewals, the Contractor shall notify the Orange County Procurement Division of price decreases in the method outlined above. If approved, the price adjustment shall become effective on the contract renewal date. If the Contractor fails to pass the decrease on to the County, the County reserves the right to place the Contractor in default, cancel the award, and remove the Contractor from the County Vendor List for a period of time deemed suitable by the County. In the event of this occurrence, the County further reserves the right to utilize any options as stated herein.

  • Non-Escalation Unless otherwise specified within the RFP documents, the unit prices reflected on the contract shall remain firm with no provision for price increases during the term of the contract.

  • Switching and Tagging Rules Each Party shall provide the other Parties a copy of its switching and tagging rules that are applicable to the other Parties’ activities. Such switching and tagging rules shall be developed on a non-discriminatory basis. The Parties shall comply with applicable switching and tagging rules, as amended from time to time, in obtaining clearances for work or for switching operations on equipment.

  • Escalation Procedure Tentative Rates for those species and products listed in A4a are subject to quarterly escalation in accordance with the following pro- cedures: The calendar quarter index average for each price index described in A5 is the arithmetic average of the three such monthly price indices preceding January 1, April 1, July 1, and October 1. The difference between calendar quarter index average and Base Index listed in A4a shall be the basis for quarterly escalation. To arrive at Current Contract Rates for timber Scaled during the preceding calendar quarter, Tentative Rates for each species shall be reduced or increased by such difference, except when the calendar quarter index average is: (a) Less than the Base Index, the reduction shall not result in a rate below Base Rate or (b) Greater than the Base Index, the increase shall not exceed the difference between Tentative Rate and Base Rate. In the event of Contract Term Extension, the escala- tion procedure will be used during the extension period, except that adjusted payment rates for any calendar quar- ter cannot be less than Tentative Rates, for each species and product group, established under B8.23 for the ex- tension period.

  • Escalation If parties are unable to resolve the issue in a timely manner, as specified above, either Sourcewell or Supplier may escalate the resolution of the issue to a higher level of management. The Supplier will have 30 calendar days to cure an outstanding issue.

  • Hot Weather Guidelines For the purposes of site based discussions regarding the need to plan and perform work during expected periods of hot weather, the following issues shall be considered in conjunction with proper consideration of Occupational Health and Safety issues.

  • Post-Commercial Operation Date Testing and Modifications Each Party shall at its own expense perform routine inspection and testing of its facilities and equipment in accordance with Good Utility Practice as may be necessary to ensure the continued interconnection of the Large Generating Facility with the Participating TO’s Transmission System in a safe and reliable manner. Each Party shall have the right, upon advance written notice, to require reasonable additional testing of the other Party’s facilities, at the requesting Party’s expense, as may be in accordance with Good Utility Practice.

  • Commercial Operation Date Testing and Modifications Prior to the Commercial Operation Date, the Connecting Transmission Owner shall test the Connecting Transmission Owner’s Attachment Facilities and System Upgrade Facilities and System Deliverability Upgrades and Developer shall test the Large Generating Facility and the Developer Attachment Facilities to ensure their safe and reliable operation. Similar testing may be required after initial operation. Developer and Connecting Transmission Owner shall each make any modifications to its facilities that are found to be necessary as a result of such testing. Developer shall bear the cost of all such testing and modifications. Developer shall generate test energy at the Large Generating Facility only if it has arranged for the injection of such test energy in accordance with NYISO procedures.

  • Switching System Hierarchy and Trunking Requirements For purposes of routing ECI traffic to Verizon, the subtending arrangements between Verizon Tandem Switches and Verizon End Office Switches shall be the same as the Tandem/End Office subtending arrangements Verizon maintains for the routing of its own or other carriers’ traffic (i.e., traffic will be routed to the appropriate Verizon Tandem subtended by the terminating End Office serving the Verizon Customer). For purposes of routing Verizon traffic to ECI, the subtending arrangements between ECI Tandem Switches and ECI End Office Switches shall be the same as the Tandem/End Office subtending arrangements that ECI maintains for the routing of its own or other carriers’ traffic.

  • Payments to Specified Employees Notwithstanding any other Section of this Agreement, if the Employee is a Specified Employee at the time of the Employee’s Separation from Service, payments or distribution of property to the Employee provided under this Agreement, to the extent considered amounts deferred under a non-qualified deferred compensation plan (as defined in Code Section 409A) shall be deferred until the six (6) month anniversary of such Separation from Service to the extent required in order to comply with Code Section 409A and Treasury Regulation 1.409A-3(i)(2).

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