Discovery Research Plan definition

Discovery Research Plan shall have the meaning assigned in Section 3.2.
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Discovery Research Plan means the research plan setting forth the activities (and timelines) for the conversion of Discovery Antibodies into Discovery Probodies and the conversion of Discovery Probodies into Discovery PDCs for each Accepted Target attached as Schedule 1.64, as the same may be amended from time to time in accordance with the terms hereof.
Sample 1
Discovery Research Plan means, as applicable:
Sample 1

Examples of Discovery Research Plan in a sentence

  • Each Party shall use Commercially Reasonable Efforts to carry out the Manufacturing activities assigned to it under the Discovery Research Plan, the Joint Exploratory Development Plan, each Joint Plan and the Manufacturing Plan in a timely and professional manner.

  • Each Party shall carry out the Manufacturing activities assigned to it under the Discovery Research Plan, the Joint Exploratory Development Plan, each Joint Plan and the Manufacturing Plan in compliance with Applicable Law (including GMPs, if applicable).

  • Licensor shall support AbbVie, as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the Discovery Research Plan.

  • Each Party shall perform or cause to be performed, any and all of its activities under the Discovery Research Plan or any Unilateral Discovery Plan in a good scientific manner and in compliance with Applicable Law.

  • The Parties intend that the Discovery Research Plan, the Joint Exploratory Development Plan and each of the Joint Plans shall set forth the allocation of Manufacturing responsibilities between the Parties for the Manufacture of New Collaboration Compounds (including applicable Lead Compounds, Development Candidates, and Product Candidates) for use under such plan.

  • In the event both Parties wish to continue the Research Collaboration, the Parties shall amend the Discovery Research Plan to extend the Research Term and to include additional Discovery Research Activities to be conducted by the Parties under the Research Collaboration.

  • Following such delivery, Licensor will promptly evaluate whether such Discovery Antibody meets the Antibody Criteria in accordance with the Discovery Research Plan and the timeline set forth therein.

  • Except as expressly set forth in this Agreement, each Party shall bear all costs and expenses associated with the Development activities for which such Party is responsible under this Agreement and the Discovery Research Plan.

  • Once the Discovery Research Plan has been completed for the second Accepted Target (or, if a second Target is not nominated prior to the deadline set forth in Section 2.1.1, the first Accepted Target), the JRC shall have no further responsibilities or authority under this Agreement with respect to that second Accepted Target and the associated Discovery Probodies, Discovery PDCs and Licensed Products.

  • The Coordination Committee will agree on the activities under the Discovery Research Program and will periodically review the progress and recommend future directions of the Discovery Research Plan per Articles 2 and 3.


More Definitions of Discovery Research Plan

Discovery Research Plan means the research plan setting forth the activities (and estimated timelines) for [***], such plan attached as Schedule 1.45, as the same may be amended from time to time in accordance with the terms hereof.
Sample 1
Discovery Research Plan means the research plan setting forth (a) the activities (and estimated timelines) for (i) for the identification, evaluation and validation of Bicycle Constructs directed to a Collaboration Target suitable for progression as Discovery Constructs, (ii) evaluation, validation and optimization of Targeting Arms directed to Antigen Targets, if requested by Genentech, and (iii) characterization, prioritization and optimization of such Discovery Constructs, [***], to identify and validate one or more lead Discovery Constructs suitable to progress into further pre-clinical and clinical Development, and (b) the data, results and information required to be included in (i) the LSR Go Data Package and (ii) the Dev Go Data Package, in each case ((a) and (b)) including the applicable LSR Go Criteria or Dev Go Criteria and as the same may be amended from time to time in accordance with the terms hereof.
Sample 1
Discovery Research Plan is defined in Section 3.2.1 (Discovery Research Plan).
Sample 1
Discovery Research Plan means the research plan setting forth the activities (and timelines) for the conversion of Discovery Antibodies into Discovery Probodies
Sample 1

Related to Discovery Research Plan

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

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

  • Research Program has the meaning set forth in Section 2.1.

  • Research Budget has the meaning set forth in Section 3.2.

  • 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 Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • Development Program means the implementation of the development plan.

  • 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.

  • Research Program Term has the meaning set forth in Section 2.2.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 [***].

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

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

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

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • 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.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.