For Dose Expansion Only Sample Clauses

For Dose Expansion Only. To be eligible for enrollment in Dose Expansion, a subject must meet ALL of the following criteria in addition to the inclusion criteria for ALL subjects listed above:
AutoNDA by SimpleDocs
For Dose Expansion Only. To be eligible for enrollment in the Dose Expansion part, a subject must meet ALL of the following criteria in addition to the inclusion criteria for all subjects listed above: 1. Has measurable disease as defined in Section 8.5.3 2. Has one of the following histologically confirmed tumors: • Cohort 1 (closed to enrollment): o Atypical teratoid rhabdoid tumor (ATRT) • Cohort 2: o Malignant rhabdoid tumor (MRT) o Rhabdoid tumor of the kidney (RTK) o Selected tumors with rhabdoid features o Epithelioid malignant peripheral nerve sheath tumor (EMPNST) o Extraskeletal myxoid chondrosarcoma (EMC) o Myoepithelial carcinoma o Renal medullary carcinoma (RMC) o Chordoma (poorly differentiated or de-differentiated) o Other INI1-negative malignant tumors NOTE: Requires prior Sponsor approval • Cohort 4 (closed to enrollment): o One of the tumor types defined in Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement 3. For subjects with ATRT/MRT/RTK only - have the following test results 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 tumors only – have the following test results 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/mutation when INI1 IHC is equivocal or unavailable 5. For subjects with synovial sarcoma with SS18-SSX rearrangement (in Cohort 4 only; Cohort 4 is closed to enrollment) - have the following test results 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) 6. For subjects to be enrolled in Cohort 4 (Cohort 4 is closed to enrollment): Able to swallow and retain orally administered tablets. Subjects meeting ANY of the following criteria must NOT be enrolled in this study: 1. Has had prior exposure to tazemetostat or other inhibitor(s) of EZH2. 2. Is being actively treated for another concurrent malignancy or is less than 5 years from completion of treatment for another malignancy. 3. Has participated in another interventional clinical study and received investigational drug within 30 days or five half-lives, whichever is longer, pri...

Related to For Dose Expansion Only

  • Extension Terms County may, at its sole option, extend the term of this Agreement beyond the Initial Term for up to ___ additional one-year terms at the same rates and under the same terms provided for herein (each such period being an “Extension Term”). County shall notify Contractor of its election for an Extension Term(s) as provided for in §6.

  • ADDITIONAL SPECIAL CONTRACT CONDITIONS Special Contract Conditions revisions: the corresponding subsections of the Special Contract Conditions referenced below are replaced in their entirety with the following:

  • Project Specific Milestones In addition to the milestones stated in Section 212.5 of the Tariff, as applicable, during the term of this ISA, Interconnection Customer shall ensure that it meets each of the following development milestones: 6.1 Substantial Site work completed. On or before December 31, 2020 Interconnection Customer must demonstrate completion of at least 20% of project site construction. At this time, Interconnection Customer must submit to Interconnected Transmission Owner and Transmission Provider initial drawings, certified by a professional engineer, of the Customer Interconnection Facilities. 6.2 Delivery of major electrical equipment. On or before December 31, 2021, Interconnection Customer must demonstrate that all generating units have been delivered to Interconnection Customer’s project site.

  • 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.

  • Country Specific Terms Appendix A contains additional terms and conditions of the Agreement applicable to Participants residing in those countries. In addition, Appendix A also contains information and notices of exchange control and certain other issues of which the Participant should be aware.

  • Term of Contract; Contract Extension The Contract will be in effect from the Effective Date (15 December 2016) through 31 December 2018. DAS, in its sole discretion, may extend this Contract for additional terms beyond the original term, prior to Termination or expiration, one or more times for a combined total period not to exceed the complete length of the original term.

  • Extension Term The options to extend the Term of this Lease as described above shall not be deemed exercised by Tenant unless at least twenty-four (24) months prior to the Lease Expiration Date for the Primary Term or at least twenty-four (24) months prior to the expiration of the Extension Term for the first (1st) Extension Term, Tenant shall have delivered written notice to Landlord of Tenant's irrevocable election to so extend this Lease at the end of the Primary Term or the first (1st) Extension Term, as applicable. Tenant's failure to deliver one (1) such timely notice to Landlord shall terminate all future Extension Terms, if any, following the Extension Term to which such notice specifically relates. Subject to the provisions of paragraph 5 of this Lease, the terms and conditions of this Lease shall apply to each Extension Term with the same force and effect as if such Extension Term had originally been included in the Primary Term of the Lease. The right of Tenant to exercise its rights with respect to the Extension Terms shall be conditioned upon this Lease being in full force and effect and no Event of Default then existing as of the Lease Expiration Date (for the first (1st) Extension Term), or expiration of the first (1st) Extension Term (for the second (2nd) Extension Term). The Primary Term, together with any Extension Term with respect to which Tenant properly exercises its option, and for which the conditions related thereto are satisfied, shall constitute the "TERM" of this Lease.

  • CLOUD SPECIFIC TERMS AND CONDITIONS To the extent that Contractor has received an award for Lot 3, Cloud, the following terms and conditions apply to Lot 3, Cloud. For the duration of an Authorized User Agreement, the Cloud Solution shall conform to the Cloud Solution Manufacturer’s specifications, Documentation, performance standards (including applicable license duration, warranties, guarantees, Service Level Agreements, service commitments, and credits). Contractor is responsible for providing physical and logical security for all Data, infrastructure (e.g. hardware, networking components, physical devices), and software related to the services the Contractor is providing under the Authorized User Agreement. All Data security provisions agreed to by the Authorized User and Contractor within the Authorized User Agreement may not be diminished for the duration of the Authorized User Agreement without prior written agreement by the parties amending the Authorized User Agreement.

  • 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.

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!