Pre-Clinical Research definition

Pre-Clinical Research means (i) research preparatory to the filing of an IND to conduct clinical studies including studies on the toxicological, pharmacological, metabolic or clinical aspects of the Product and testing in-vivo in animal models in relation to a New Indication, a line extension of an existing approved indication, or a Global Study or a Territory-specific study; and (ii) research conducted in relation to a clinical study under this Agreement. Pre-clinical Research excludes Basic Research.
Sample 1Sample 2Sample 3
Pre-Clinical Research means any Non-Human Subjects Research which is reasonably anticipated (1) to be a component of a submission to the FDA related to a product or process to be tested on human subjects (including an IND or IDE submission) or (2) to develop into research involving human subjects within the coming twelve (12) months.
Sample 1Sample 2Sample 3
Pre-Clinical Research means preclinical and non-clinical research activities.
Sample 1Sample 2Sample 3

Examples of Pre-Clinical Research in a sentence

  • In the case of any report including Orchard Pre-Clinical Research Costs or NTCR Activities Costs, each such report shall enable the receiving Party to compare the reported Orchard Pre-Clinical Research Costs or NTCR Activities Costs against the Pre-Clinical Budget or NTCR Budget (as applicable), including to break-down the Costs incurred on a per-activity basis, and on both a Quarterly basis and a cumulative basis for each activity.

  • Pharming shall reimburse Orchard for all Costs incurred by Xxxxxxx in the performance of its obligations under this Section 8.1 in accordance with this Agreement to the extent such Costs do not constitute Orchard Pre-Clinical Research Costs or NTCR Activities Costs (the “Orchard CMC Costs”).

  • Subject to Section 12.4, Xxxxxxx shall have the right to make any publications, presentations, or public disclosures related to the Licensed Product, or the Pre-Clinical Research or Development thereof, subject to Pharming’s prior review and approval under Section 12.5.3, such approval not to be unreasonably withheld, conditioned or delayed.

  • Each Party shall report to the other Party, within [_____] days after the end of each Quarter, the Orchard Pre-Clinical Research Costs, NTCR Activities Costs, and the Orchard CMC Costs to the extent incurred by or on behalf of such Party or its Affiliates during such Quarter.

  • Subject to the terms and conditions of this Agreement, the Parties will collaborate with respect to the performance of the Pre-Clinical Research and shall keep the JSC informed of such activities.


More Definitions of Pre-Clinical Research

Pre-Clinical Research means pre-clinical research including gene function, gene expression and target validation research using cells and animals, which may include small pilot toxicology studies but excludes pharmacokinetic and toxicology studies required to meet the regulations for filing an IND, clinical development and commercialization.
Sample 1Sample 2
Pre-Clinical Research means pre-clinical research including gene function, gene expression and target validation research using cells and animals, which may include small pilot toxicology studies but excludes pharmacokinetic and toxicology studies
Sample 1Sample 2
Pre-Clinical Research means the activities carried out by or on behalf of a Party hereunder (whether on its own or jointly with the other Party) pursuant to the Pre-Clinical Plan. 1.125 “Pricing Approval” means, with respect to any country where a Governmental Authority authorizes reimbursement or access, or approves or determines pricing, for pharmaceutical or biologic products, receipt (or, if required to make such authorization, 23 approval of determination effective publication) of such reimbursement or access authorization or pricing approval or determination (as the case may be). 1.126 “Primary Indication” means the diagnosis, prophylaxis, treatment, palliation or cure of hereditary angioedema in humans. 1.127 “Product Specific Patent” means any Orchard Background Patent, Orchard Collaboration Patent, Orchard Conditioning Patent or Platform Patent that specifically and solely claims the composition of matter, manufacture, and/or method of use of the Licensed Product. Without limiting the foregoing: (a) the Product Specific Patent identified by Orchard and existing at the Effective Date is set out in Schedule 1.127; (b) Product Specific Patents include the Patent set out in Schedule 1.127, and all Patents that claim priority from or arise from such Patent, and (c) the Parties may choose to designate any other Orchard Background Patent, Orchard Collaboration Patent, Orchard Conditioning Patent or Platform Patent as a Product Specific Patent, subject to prior written agreement. 1.128 “Proof of Concept NTCR Endpoints” means the endpoints of the preclinical in vivo proof of concept NTCR study set out in the Pre-Clinical Plan, to the extent approved by the JSC for inclusion in the Pre-Clinical Plan under Section 2.2.4, and thereafter as amended by the JSC under Section 2.2.4. 1.129 “Publishing Party” has the meaning set forth in Section 12.5.3. 1.130 “Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Quarter shall commence on the last to occur of the foregoing dates during the Term and shall end on the last day of the Term. 1.131 “Reasonable Efforts” means, with respect to any activities performed by a Party under this Agreement with respect to the Licensed Product, the performance of such ...
Sample 1
Pre-Clinical Research means pre-clinical research including gene function, gene expression and target validation research using cells and
Sample 1

Related to Pre-Clinical Research

  • 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:

  • 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 I Clinical Trial means the initial introduction of a Licensed Product as an investigational new drug into humans as required in 21 C.F.R. § 312, designed to determine the metabolism and pharmacologic actions of the Licensed Product in humans, the side effects associated with increasing doses and, if possible, to gain early evidence on effectiveness, and also includes studies of drug metabolism, structure-activity relationships and mechanism of action in humans.

  • 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 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 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.

  • 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.