Completion of Phase II definition

Completion of Phase II means completion of the final statistical results of clinical trials that collectively evaluate the safety and efficacy of a Product’s specific dosage strength in an indication the Product is intended to treat, which data enables the Parties to proceed with pivotal registration Phase III studies, without any objection from the FDA, as documented by FDA contact reports. For the avoidance of doubt, the “Completion of Phase II” for each Product in the Collaboration shall be independent events.
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Completion of Phase II means completion of the final statistical results of clinical trials that collectively evaluate the safety and efficacy of a Product's specific dosage strength in an indication the Product is intended to treat, which data enables the Parties to proceed with pivotal registration Phase III studies, without any objection from the FDA, as documented by FDA contact reports. For the avoidance of doubt, the "Completion of Phase II" for each Product in the Collaboration shall be independent events.
Sample 1
Completion of Phase II means, with respect to an Ophthalmic Product, the completion of data analysis for those Phase II Studies of such Ophthalmic Product that the Parties prospectively identify in the applicable Program Workplan as the studies the data from which would provide a sufficient basis to Initiate a Phase III Study.
Sample 1

Examples of Completion of Phase II in a sentence

  • Completion of Phase II of the Development Services shall be subject to completion of Phase I of the Development Services.

  • Completion of Phase II will allow staff to further refine the proposed construction schedule and stay on track for a project opening date in the next budget cycle.

  • Following the Completion of Phase II for a Product but prior to the Regulatory Approval of an NDA for such Product, King and PTI will assume joint control and responsibility, through the JOC, for all matters described in the Development Plan with respect to such Product; provided that PTI, in Consultation with Xxxx, xxxx continue to be responsible for execution of matters under such plan.

  • Completion of Phase II, if applicable, is approximately month year.

  • Notwithstanding anything to the contrary in the Lease or this Amendment, (a) Tenant shall commence paying Additional Rent as of the date of Substantial Completion of Phase II of the Premises; and (b) Tenant shall commence paying Base Rent as of the date that is [***] from the date of Substantial Completion of Phase II of the Premises.

  • MITSUBISHI'S obligation to share Core Development Costs incurred by or on behalf of VERTEX or a VERTEX Licensee from the Effective Date through the Completion of Phase II Clinical Trials within the Core Development Activities and to pay VERTEX therefor shall be [***].

  • Developer shall be responsible for obtaining all approvals from all governmental approving bodies, including but not limited to Plan Commission for Final Plat Approval.PHASE II (Upon Completion of Phase II (a) – (c), the Village will reimburse Developer$100,000.00.

  • Either Party may terminate this Agreement in the Territory and ROW (together, but not in one or the other) at any time, at will, (x) upon ninety (90) days prior written notice to the other Party if such termination occurs prior to the Completion of Phase II Clinical Trials and (y) upon one-hundred and eighty (180) days prior written notice to the other Party if such termination occurs on or after the Completion of Phase II Clinical Trials.

  • The carrying amount of the provision as at March 31, 2022: INR 115 million (March 31, 2021: INR 121 million) .

  • Until the Completion of Phase II for a Product (but immediately prior to the Phase II Meeting), PTI, in Consultation with Xxxx, xxxx have sole control and responsibility for execution of all matters described in the Development Plan with respect to a Product.


More Definitions of Completion of Phase II

Completion of Phase II. (or Phase III) Clinical Trials" means the delivery of a final report to the JPT on the outcome of the Phase II or Phase III Clinical Trial, as the case may be.
Sample 1
Completion of Phase II occurs for a Licensed Product in an Indication with the first administration of such Licensed Product to a patient in a Phase III Clinical Trial of such a Licensed Product for such Indication.
Sample 1
Completion of Phase II means, with respect to a Product in the Field: (a) that one or more Phase II Trials of such Product have been conducted by or on behalf of Introgen and (b) Introgen has met with the FDA to review plans to proceed to a Pivotal Trial of such Product, without receiving objection from the FDA that would prevent the commencement of a Pivotal Trial of such Product. For such purposes, an “objection” from the FDA will mean that the FDA makes clear to Introgen at the time of such meeting, as reflected in the minutes of such meeting (or the FDA otherwise notifies Introgen in writing within sixty (60) days after such meeting), that the Product would not be approvable based on the results of the proposed Pivotal Trial, or that the Product would not be approvable unless additional Phase II studies were undertaken before starting such Pivotal Trial. The “minutes” of such meeting shall be the version of the minutes distributed by the FDA within sixty (60) days after such meeting, or if the FDA does not distribute such meeting minutes (or such written notice) within such 60-day period, then as reflected in the minutes of the meeting prepared by Introgen and provided to the FDA as Introgen’s proposed draft of the minutes, provided that Introgen has received confirmation (by telephone or letter, for example) that the FDA does not disagree in a material way with such minutes.
Sample 1
Completion of Phase II means the date on which the Food & Drug Administration and the Licensee agree that sufficient data and information have been submitted to the FDA to permit the Initiation of a Phase III Clinical Trial of a Licensed Product(s) without requiring the conduct of further Clinical Trials or the submission of additional data or information.
Sample 1
Completion of Phase II means, with respect to an RNAi Therapeutic Product, the completion of data analysis for those Phase II Studies of such RNAi Therapeutic Product that the Parties prospectively identify in the applicable Program Workplan as the studies the data from which would provide a sufficient basis to Initiate a Phase III Study.
Sample 1

Related to Completion of Phase II

  • Construction Phase means that Phase of the Project which shall commence after the Authority provides the Trade Contractor with written Notice to Proceed with the Construction Phase.

  • Construction Completion means physical construction of a cleanup action component is complete.

  • Completion of work means completion of the entire contracted work. Exhaustion of quantity of any particular item mentioned in the bid document shall not imply completion of work or any component thereof.

  • Phase 1 means the phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and 000 xxxxx xx Xxxxxxxx Xxxx xx the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.

  • Phase 2 means the phase of the ATP comprised of: (1) improvements to the State Street Substation to receive Rebuilt Line 972; (2) the rebuilding of NYSEG’s existing Line 972 not performed in Phase 1; (3) construction of Relocated Line 15; (4) the construction of Bused Line 5; (5) improvements to the Elbridge Substation to receive Relocated Line 15; and (6) improvements to the Elbridge Substation to receive Bused Line 5.

  • Substantial Completion means the stage in the progress of the work as determined and certified by the Contracting Officer in writing to the Contractor, on which the work (or a portion designated by the Government) is sufficiently complete and satisfactory. Substantial completion means that the property may be occupied or used for the purpose for which it is intended, and only minor items such as touch-up, adjustments, and minor replacements or installations remain to be completed or corrected which:

  • Project Completion means the date, as determined by the Division after consultation with the Recipient, that operation of the Project is initiated or is capable of being initiated, whichever comes first.

  • Construction Completion Date means the Completion Date of the Construction as specified in the Statutory Declaration of Completion for the Project;

  • Final Completion means the date determined and certified by A/E and Owner on which the Work is fully and satisfactorily complete in accordance with the Contract.

  • Tests after Completion means the tests (if any) which are specified in the Contract and which are carried out in accordance with the Specification after the Works or a Section (as the case may be) are taken over by the Procuring Entity.

  • Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.

  • Construction Phase Services means the coordination, implementation and execution of the Work required by this Agreement, which are further defined in Article 8.

  • project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;

  • Mechanical Completion means that (a) all components and systems of the Project have been properly constructed, installed and functionally tested according to EPC Contract requirements in a safe and prudent manner that does not void any equipment or system warranties or violate any permits, approvals or Laws; (b) the Project is ready for testing and commissioning, as applicable; (c) Seller has provided written acceptance to the EPC Contractor of mechanical completion as that term is specifically defined in the EPC Contract.

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Project Completion Date means the date on which the Completion Certificate is issued;

  • Project Completion Schedule means the progressive Project Milestones set forth in Schedule-J for completion of the Project Highway on or before the Scheduled Completion Date;

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Construction Completion Certificate means a certificate of the I-Bank to the effect that the construction of the Project is complete.

  • Design Phase means the period during which the Transporter shall prepare a draft project proposal for publication in accordance with section 4.3;

  • Substantial Completion Date means the date on which Substantial Completion occurs.

  • Improvement completion assurance means a surety bond, letter of credit,

  • Commissioning means the process for determining the need for and for obtaining the supply of healthcare and related services by the Trust within available resources.

  • Construction Work means any work in connection with⎯

  • Development Phase means the period before a vehicle type is type approved.

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.