PoC Trial Design definition

PoC Trial Design means the PoC Trial design set forth in each Initial Development Plan, which may be amended from time to time during the Agreement Term as mutually agreed in writing by the Parties (in consultation with the Neurology JDC).
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PoC Trial Design means, after the indications have been selected pursuant to Section 3.6.2(c)(i) or Section 3.6.2(c)(ii), as applicable, the design of each Phase II Trial for each such indication using the OncoMed Clinical Trial Plan as a guideline with respect to the overall scope and scale of all of the PoC Trials for a particular Candidate Selection Compound to provide evidence of efficacy, safety, and tolerability to meet the PoC Criteria for such Candidate Selection Compound.
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PoC Trial Design means the PoC Trial design set forth in each Development Plan, which may be amended from time to time during the Agreement Term as mutually agreed in writing by the Parties (in consultation with the Neurology JSC).
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Examples of PoC Trial Design in a sentence

  • Each PoC Trial will be conducted in accordance with the PoC Trial Design set forth in the applicable Development Plan.

  • Prior to the License Effective Date with respect to a Collaboration Program, in the event the Parties are unable to agree upon the PoC Trial Design for a particular Collaboration Program, in lieu of mediation pursuant to S ection 12.1.2, [***] will have final decision-making authority with respect to the PoC Trial Design.

  • The OncoMed Clinical Trial Plan will serve as a guide for the PoC Trial Design for each Candidate Selection Compound such that, for example, the total number of patients to be treated in the PoC Trials with respect to a Candidate Selection Compound will not exceed the total number of patients set forth in the OncoMed Clinical Trial Plan for such Candidate Selection Compound.

  • They will not need to inform the client of the cost of any of the action.

  • Ionis will notify Biogen within [***] after finalization of the initial PoC Trial Design (or each time there is a material change thereto) for a Collaboration Program pursuant to Section 1.5.2(a) if Ionis elects not to conduct such PoC Trial for such Collaboration Program (such notice, an “Option Acceleration Notice”).

  • Isis will notify Biogen Idec within [***] after finalization of the initial PoC Trial Design pursuant to S ection 1.10.2(d) (or each time there is a material change thereto) for a Collaboration Program that is not an ALS Collaboration Program if Isis elects not to conduct such PoC Trial for such Collaboration Program (such notice, an “Option Acceleration Notice”).

  • She was a nazirite for a total of 21 years.[11] Nazirites who shave their hair are obligated to redo the last 30 days of the nazirite period.

  • The allowance that we ultimately made for Terminal 2 was about 5% less than DAA had sought in its original cost plan.

  • FDLTCC’s most recently approved indirect costs rate is located in the appendix.

  • The PoC Trial Design for Candidate Selection Compounds in any Program cannot be materially amended after Commencement of the PoC Trials, except upon agreement of the Parties.


More Definitions of PoC Trial Design

PoC Trial Design means the PoC Trial design set forth in the ISIS-DMPKRx R&D Plan, which may be amended from time to time during the Agreement Term as mutually agreed in writing by the Parties (in consultation with the JSC).
Sample 1
PoC Trial Design means, after the indications have been selected pursuant to Section 3.6.2(c)(i) or Section 3.6.2(c)(ii), as applicable, the design of each Phase II Trial for each such indication using the OncoMed Clinical Trial Plan as a guideline with respect to the overall scope and scale of all of the PoC Trials for a particular Candidate Selection [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Compound to provide evidence of efficacy, safety, and tolerability to meet the PoC Criteria for such Candidate Selection Compound.
Sample 1

Related to PoC Trial Design

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Universal design means the design of products, environments, programmes and services to be usable by all people, to the greatest extent possible, without the need for adaptation or specialized design. “Universal design” shall not exclude assistive devices for particular groups of persons with disabilities where this is needed.

  • Remedial Design or “RD” shall mean those activities to be undertaken by SDs to develop final plans and specifications for the RA as stated in the SOW.

  • industrial design means features of shape, configuration, pattern or ornament applied to an article by any industrial process or means, being features which in the finished article appeal to and are judged by the eye, but does not include—

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Development Plan has the meaning set forth in Section 3.2.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Development Program means the implementation of the development plan.

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

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

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Development Works means the external development works and internal development works on immovable property;

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Industrial Designs means all right, title and interest (and all related IP Ancillary Rights) arising under any Requirement of Law in or relating to registered industrial designs and industrial design applications.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Schematic Design Documents means drawings prepared by the Trade Contractor that illustrate the scale and relationship of the various Trade Contractor Work components and which also contain square footage and volume calculations for the building interior spaces, building exterior spaces, and major architectural and interior finishes.