Pre-Clinical Development Plan definition

Pre-Clinical Development Plan shall have the meaning assigned in Section 3.6.
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Pre-Clinical Development Plan means a detailed plan that sets forth the responsibilities of, and activities to be conducted by, Athersys (and Angiotech pursuant to Section 4.3) in advancing one or more Cells and/or Cell Therapies into one or more potential Clinical Development Candidates for a particular Cardiovascular Indication (including a detailed budget corresponding to each such plan). Each such Pre-Clinical Development Plan shall include, without limitation, the following activities (or their equivalents), to the extent applicable:
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Pre-Clinical Development Plan means the JSC-reviewed written pre-clinical development plan for a particular Product, setting forth the pre-clinical development activities to be conducted by SERVIER or its Affiliates. Pre-Clinical Development Plans reviewed by the JSC pursuant to this Agreement shall be attached to and made a part of this Agreement and may be amended from time to time.
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Examples of Pre-Clinical Development Plan in a sentence

  • Sanofi shall use Commercially Reasonable Efforts to complete the Pre-Clinical Development Plan during the Prior Development Phase, and Sanofi shall be responsible for all costs and expenses incurred in the performance of the Pre-Clinical Development Plan (other than unapproved budget overages incurred by Ardelyx with respect to the Assigned Activities).

  • The Pre-Clinical Development Plan shall include a plan for (i) [***], and (ii) [***].

  • The Parties shall thereafter promptly engage in discussions in good faith with the objective to agree on a final Pre-Clinical Development Plan.

  • The DAC shall serve as a joint working group for the purpose of approving the Pre-Clinical Development Plan and the Development Plan ([***] having the final decision in case of any persisting disagreement in that respect), and facilitating interactions between the Parties in relation to the performance of the Program.

  • Ardelyx shall promptly provide its comments on the Pre-Clinical Development Plan proposed by Sanofi.

  • Unless otherwise provided, SERVIER shall fund in the first instance 100% of the costs (i) for the regulatory preclinical trials described in the Pre-Clinical Development Plan and (ii) for Clinical Trials described in the Clinical Development Plan and conducted in SERVIER Territory.

  • Each party each shall keep the other party fully informed as to all discoveries and technical developments (including, without limitation, any Inventions) made in the course of performing activities hereunder or under the Research Plan or Pre-Clinical Development Plan with respect to Shared Programs.

  • In particular, Syrrx and Cubist each shall prepare, and distribute to all members of the JRC, no later than [*] business days prior to the next JRC meeting, a reasonably detailed written summary report regarding any Shared Programs, in such form and format and setting forth such information regarding the results and progress of performance of the Research Plan or the Pre-Clinical Development Plan as determined from time to time by the JRC.

  • Such Pre-Clinical Development Plan shall be designed, structured and conducted in a manner that conforms to the applicable regulations of both the FDA and the EMA.

  • Pre-Clinical Development Plan, or (with respect to Partner) Territory-Specific Clinical Trial under a Territory Development Plan (as applicable) in strict adherence with the study design set forth in the applicable protocol therefor and as set forth in such Global Development Plan or such Territory Development Plan, each as may be amended from time to time, and will comply with each statistical analysis plan implemented by the other Party (as applicable) in connection therewith.


More Definitions of Pre-Clinical Development Plan

Pre-Clinical Development Plan has the meaning set forth in Section 5.2.2 (Territory Pre-Clinical Development).
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Pre-Clinical Development Plan means SCHEDULE 5: PRE-CLINICAL DEVELOPMENT PLAN hereto outlining pre-clinical work remaining as of the New Effective Date in order to file an IND with the FDA for the first Licensed Product in the United States. In the event that Virpax decides in its sole discretion to file an IDE rather than an IND for the Licensed Product, the Pre-clinical Development Plan will be updated accordingly.
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Pre-Clinical Development Plan means the plan for performance of Pre-Clinical Development activities with respect to Shared Products, as amended from time to time by the JRC.
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Pre-Clinical Development Plan means the detailed program of ----------------------------- Pre-Clinical Development activities, as documented by the JDC for each Joint Target and its respective Joint Safety Assessment Compound and including those elements described in Section 4.1.
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Pre-Clinical Development Plan means the written plan, prepared by the Joint Project Team, and [**], in accordance with Section 4.4(b), setting forth in reasonable detail the various Pre-Clinical Development activities to be undertaken by the Parties. The Pre-Clinical Development may be amended or modified from time to time by the Joint Project Team, subject to [**].
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Pre-Clinical Development Plan means Schedule 5 hereto outlining pre-clinical work remaining on the Effective Date in order to file an IND with the FDA for the first Licensed Product in the USA.
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Related to Pre-Clinical Development Plan

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Global Development Plan has the meaning set forth in Section 3.1.

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

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

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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).

  • 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 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.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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.

  • 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).

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • 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 IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • 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.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • 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.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;