First Dosing definition

First Dosing with respect to human clinical trials, means the first administration of a Licensed Product to a subject in a specified clinical trial.
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First Dosing means the first date a Licensed Product is administered or dispensed to, or used involving, one or more human Subjects.
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First Dosing has the meaning set forth in Section 1.147.
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Examples of First Dosing in a sentence

  • Thereafter, unless otherwise agreed by the Parties, the JCC shall meet no less than [*], provided that [*] prior to the anticipated First Dosing, the JCC shall meet no less than [*].

  • The Parties acknowledge and agree that as of the Execution Date, Atara has paid the Research Milestone Payment for First Dosing in a Human Subject for a CTL Product Specifically Directed to EBV for a first Allogeneic CTL Product.

  • For the avoidance of doubt, the applicable Milestone Payment Amount shall only be paid, one time, if at all, subject to the achievement of the applicable Milestone prior to the applicable Milestone Expiration or Termination, and the maximum aggregate potential amount payable under this Agreement shall be $10,000,000 with respect to the First Dosing Milestone, $65,000,000 with respect to the First Registration Purposes Dosing Milestone and $200,000,000 with respect to the Marketing Authorization Milestone.

  • Until the earlier of: (a) any BioNTech Company commercially launches a BioNTech Product; or (b) ten (10) years after the expiration of the Research Term, BCGT will provide Lilly with an annual report summarizing the development stage of any BioNTech Products (excluding any RNA products until such time that any RNA product has achieved First Dosing in Phase III) that it or a BioNTech Company is developing.

  • Study day will be calculated from the first dosing date of study drug and derived as follows: • For post-treatment study days: Assessment Date – First Dosing Date + 1• For days prior to the first dose: Assessment Date – First Dosing Date Therefore, Study Day 1 is the day of first dose of study drug administration.Baseline is defined as the last non-missing record on or prior to the date of Study Day 1, unless otherwise specified.

  • Study Day will be calculated from the first dosing date of GS-9131 in Part 1 Sentinel cohorts as follows: • For postdose study days: Assessment Date First Dosing Date + 1 • For days prior to the first dose: Assessment Date First Dosing DateStudy day 1 is the day of first dose of GS-9131 administration in Part 1 Sentinel cohorts.

  • In addition to scoping new technologies that match the greatest healthcare and social needs for patients and users, UCLP now has world leading experience in running innovation accelerator programmes such as the NHS Innovation Accelerator (NIA) and DigitalHealth.London together with collaboration and delivery within Care City.

  • The Parties acknowledge and agree that as of the Execution Date, Xxxxx has paid the Research Milestone Payment for First Dosing in a Human Subject for a CTL Product Specifically Directed to EBV for a first Allogeneic CTL Product.

  • During the Agreement Term (and notwithstanding anything to the contrary in this Agreement, including Section 9.6 of this Agreement) and solely after the commencement of First Dosing in Phase III for a particular Product, the Party that Controls such Product may publish any information relating to such Product or Selected Target pertaining to such Product without the prior written consent of the other Party.

  • Study day will be calculated from the first dosing date of study drug and derived as follows:• For post-dose study days: Assessment Date – First Dosing Date + 1• For days prior to the first dose: Assessment Date – First Dosing Date Therefore, study day 1 is the day of first dose of study drug administration.


More Definitions of First Dosing

First Dosing means, with respect to a Clinical Trial, or any portion thereof, dosing of the first human subject in such Clinical Trial or such portion thereof.
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First Dosing means the date on which the first subject in the arm of a Clinical Trial Study, in which a patient will be administered with both Product and Checkpoint Blockade Agent, receives the first dose of either agent.
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First Dosing means the first administration of a Product to a human ------------ subject in the Research Program as described in Section 2.1 below.
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Related to First Dosing

  • FMCSA means Federal Motor Carrier Safety Administration.

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Participating Retail Health Clinic means a Retail Health Clinic which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Nutrient management plan means a plan developed or approved by the Department of Conservation and Recreation that requires proper storage, treatment and management of poultry waste, including dry litter, and limits accumulation of excess nutrients in soils and leaching or discharge of nutrients into state waters.

  • Flexi Plan means any individual indemnity hospital insurance plan under the VHIS framework with enhancement(s) to any or all of the protections or terms and benefits that the Standard Plan provides to the Policy Holder and the Insured Person, subject to certification by the Government. Such plan shall not contain terms and benefits which are less favourable than those in the Standard Plan, save for the exception as may be approved by the Government from time to time.

  • Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • PMA means the annual product multiplier and/or seasonal factor as appropriate for Gas Year t, in accordance with the “Gas Product Multipliers and Time Factors Table”.

  • Basic health plan model plan means a health plan as required in RCW 70.47.060(2)(e).

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • First Commercial Sale means the first sale for use or consumption of any Licensed Product in a country after all required Regulatory Approvals for commercial sale of such Licensed Product have been obtained in such country.

  • Participating Prescription Drug Provider means an independent retail Pharmacy, chain of retail Pharmacies, mail-order Pharmacy or specialty drug Pharmacy which has entered into an agreement to provide pharmaceutical services to participants in the benefit program. A retail Participating Pharmacy may or may not be a select Participating Pharmacy as that term is used in the Vaccinations Obtained Through Participating Pharmacies section.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Non-Participating Retail Health Clinic means a Retail Health Clinic which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Hospital pharmacist means an Iowa-licensed pharmacist who meets the requirements for participating in a hospital practice protocol as determined by the hospital’s P&T committee.

  • Medical physicist means a person trained in evaluating the performance of mammography equipment and facility quality assurance programs and who meets the qualifications for a medical physicist set forth in 41.6(3)“c.”

  • Medical flexible spending arrangement or "medical FSA" means a benefit plan whereby eligible state employees may reduce their salary before taxes to pay for medical expenses not reimbursed by insurance as provided in the salary reduction plan established under chapter

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Number of Students Who Began the Program means the number of students who began a program who were scheduled to complete the program within 100% of the published program length within the reporting calendar year and excludes all students who cancelled during the cancellation period.

  • Forest management plan means a written plan prepared and signed by a qualified forester that prescribes measures to optimize production, utilization, regeneration, and harvest of timber. The forest management plan shall include a schedule and timetables for the various silvicultural practices used on forestlands, which shall be a maximum of 20 years in length. A forest management plan shall include all of the following:

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Multiphase professional services contract means a contract for the providing of professional