Phase 1b Dose Escalation Sample Clauses

Phase 1b Dose Escalation. The Phase 1b dose escalation is open label and eligible participants who enroll will receive OPT-302 by IVT injection (0.05 mL) at doses of 0.3 mg (Cohort 1), 1 mg (cohort 2) or 2 mg (Cohort 3) once every 4 weeks (Day 1, 29 and 57) each used in combination with aflibercept (2 mg) for a total of 3 injections. The OPT-302 IVT injection is given sequentially after IVT aflibercept once a post injection safety check has been performed (which may include a check of optic nerve head perfusion, intraocular pressure and/or visual function. Dose escalation will occur at the planned dose levels until the MTD is determined or until the highest dose level is tested.
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Phase 1b Dose Escalation. In the open label Phase 1b, the unmasked patient safety data for each cohort will be reviewed by the data review team After reviewing at least 14 days of safety data (DLT window) for a cohort, the data review team will decide on escalation to the next dose level for the subsequent cohort (or whether to stop dose escalation). Dose escalation will occur at the planned dose levels of OPT-302 until the MTD is determined or until the highest dose level is tested. On completion of Phase 1b the MTD or highest dose tested will be used to inform the OPT- 302 dose selected for Phase 2a dose expansion.

Related to Phase 1b Dose Escalation

  • 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 % of Change x 100 = Percentage Change CPI-U Calculation Example: 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% 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.

  • Escalation/De-escalation Clause In the event that prevailing market conditions warrant an adjustment in bid prices contained in the contract, the following escalation/de- escalation clause shall be the only clause applicable or acceptable:

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Phase 2 Phase 2 is expected to consist of Member Nodes and a select number of Nodes operated by non-Members. The non-Member Nodes will be required to comply with Node hosting terms as set forth by the Council, which may be amended from time to time (the “General Node Terms”).

  • Construction Phase Fee Contractor’s Construction Phase Fee is the maximum amount payable to Contractor for any cost or profit expectation incurred in the performance of the Work that is not specifically identified as being eligible for reimbursement by Owner elsewhere in this Agreement. References in the UGSC to Contractor’s “overhead” and “profit” mean Contractor’s Construction Phase Fee. The Construction Phase Fee includes, but is not limited to, the following items:

  • Phase II A small portion of the work for the Phase II modifications to the Plattsburgh Substation will be performed by Transmission Owner, and the remainder will be performed by Clinton and Xxxxxxxxx. A detailed definition of the specific scope for Transmission Owner and Clinton and Xxxxxxxxx including interface points shall be defined during the design phase and, as such documents become available, copies will be delivered to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The full scope includes the installation of wave traps, CCVT’s and modifications and/or additions to relaying on the MWP-1 and MWP- 2 lines. These lines will be reconfigured at the completion of Phase II to connect to Xxxxx and Xxxxxxx Substations on MWP-1 and the Xxxx Substation on MWP-2. Clinton and Xxxxxxxxx will design the upgrades and purchase the materials based on the outline specification that was prepared and issued by Transmission Owner. The work to be performed by Clinton and Xxxxxxxxx will include both the materials for the exterior and interior installations and items for Transmission Owner installation inside the control building in existing relay panels and communication racks. In addition, Clinton and Xxxxxxxxx will be responsible for the exterior and interior construction work and will provide construction management services in coordination with Transmission Owner. The civil design for the foundations and the electrical design for the cable runs to the control room will be designed by, as approved by Transmission Owner, and installed under the supervision and control of Clinton and Xxxxxxxxx. The equipment will be selected and procured in accordance with the specifications developed during the detailed engineering phase, copies of which shall be furnished to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The construction of the foundations, structures, wave traps, CCTV and cable runs into the control building to the termination cabinets will be completed by Clinton and Xxxxxxxxx. The work at the Plattsburgh Substation will be installed under Transmission Owner’s CPP-1. Transmission Owner will provide Protection and Controls Engineering, install and terminate wiring from the termination cabinets to the control panels and relays, install relays and equipment in the existing panels, and will commission such work inside the 230kV control building. Transmission Owner will develop the communications protocols and data flow over the circuits.

  • Preconstruction Phase Services Preconstruction Phase Services shall mean all services described in Article 3.1, and any similar services described in the Request for Proposals, including such similar services as are described in the Construction Manager at Risk’s Response to the Request for Proposals to the extent they are accepted by Owner, but excluding any Early Work. Early Work shall be considered part of Construction Phase Services.

  • PHASE is a distinct portion of the Work to be provided under this Agreement, as specified in the Statement Of Work.

  • Construction Phase Services 3.1.1 – Basic Construction Services

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