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 Initial Development Plan.

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

  • 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.

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

  • Any material changes to the ISIS-SMNRx Development Plan, including any material changes to the Phase 1 Trial Design or the PoC Trial Design, must be unanimously agreed to by the JDC.

  • Each PoC Trial will be designed in accordance with the applicable PoC Trial Design set forth in the ISIS-SMNRx Development Plan.

  • Disputes regarding such PoC Trial Design will not be submitted to arbitration under Section 15.3.

  • Isis will notify Biogen Idec within [***] after finalization of the initial PoC Trial Design pursuant to Section 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”).

  • Isis will notify Biogen Idec 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 Isis elects not to conduct such PoC Trial for such Collaboration Program (such notice, an “Option Acceleration Notice”).

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


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 a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.