Preclinical Studies definition

Preclinical Studies means, with respect to a Product, one or more of the following: (i) synthesis and formulation; (ii) physical and chemical properties, (iii) in vitro activity, (iv) in vivo activity in animals, (v) metabolism, absorption and pharmacokinetics data from animal studies, (vi) toxicology data, and (vii) similar studies that are typically performed before first administration of a Product to humans.
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Preclinical Studies means studies performed in the drug development process of a lead compound or biological product not involving the introduction of a subject compound or biological product into humans (e.g., the dosing of a human patient in clinical trials). Without limiting the generality of the foregoing, preclinical studies consist of: the selection, evaluation and qualification of putative drugs and/or biological products for therapeutic uses; and pharmacokinetic and pharmacodynamic studies of the pharmacological effects and mechanism(s) of action of the drug in animals, and information on the absorption, distribution, metabolism, and excretion of the drug, if known, and, for purposes of certainty include animal studies occurring after first-in-man administration. Preclinical studies specifically exclude any and all toxicology testing, whether in vitro or in vivo.
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Preclinical Studies means Preclinical Development activities undertaken by or on behalf of Five Prime solely for the purpose of (a) evaluating or assessing the feasibility or desirability of pursuing, or scientific rationale for, a potential Five Prime Independent Development Path or (b) provide the basis of, or additional support for, a Five Prime Independent Development Path.
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Examples of Preclinical Studies in a sentence

  • Pfizer shall pay to Quark an amount equal to [ * ] within [ * ] after the Effective Date in order to help fund the Non-Ophthalmic Pre-clinical Studies.

  • The Plans and Budgets shall specify the objectives and work plan activities of the Research to be conducted during the Research Term, Approved Preclinical Studies and Approved Clinical Studies, respectively, including the out-of-pocket costs budgeted to be incurred by MG therefor, and in the case of the Approved Preclinical Studies and Approved Clinical Studies the number and type of FTEs (including in each case by category(ies) of cost or activity, if so decided by the JSC).

  • Within thirty (30) days following the end of each calendar month in which Approved Preclinical Studies or Approved Clinical Studies was performed, MG shall provide Taiho a detailed invoice for the amount of Taiho Budgeted Funds actually incurred by MG during such calendar month for such Studies, classified by using the same categories as used in the Plans and Budgets.

  • The JDT shall be responsible for (a) monitoring and coordinating operational activities of the Approved Preclinical Studies and Approved Clinical Studies, (b) reviewing and approving during the period of the Funded Work regulatory correspondence, final study reports and submissions to Regulatory Authorities in North America relating to Selected Compounds and/or Products, and (c) without limiting Section 5.2.2 below, proposing subsequent candidates for Preclinical Development or clinical trials to the JSC.

  • In the event of termination of this Agreement under this Section 20.3, Taiho shall continue to pay MG the costs required to be paid by Taiho under Article 9 during the six (6)-month period after the notice of termination, to continue any Approved Preclinical Studies and Approved Clinical Studies that were initiated prior to such termination for such period.

  • From time to time, either Party or the JDT may suggest that the JSC consider a particular Compound (whether or not such Compound is then a Selected Compound) to be further advanced into Approved Preclinical Studies and/or Approved Clinical Studies.

  • Notwithstanding, all preclinical data generated from the Territory-Specific Preclinical Studies shall be solely owned by Taiho.

  • The Approved Preclinical Studies and the Approved Clinical Studies shall be designed in a manner to maximize the usefulness of the resulting Data for Taiho’s regulatory efforts for Products in the Territory, and to comply (to the extent practicable) with any clinical or regulatory requirements in the Territory, while at the same time providing data that is directed at obtaining Marketing Approval for the Products in North America.

  • In the event Additional Partner or third party funds the costs of Approved Preclinical Studies, Taiho’s obligation to fund Approved Preclinical Studies shall be […***…].

  • For the avoidance of doubt, it is understood and agreed that in no event shall Taiho be obligated to reimburse MG in excess of […***…] Dollars (US $[…***…]) under this Section 9.1.2, totaling the costs of all Approved Preclinical Studies reimbursed by Taiho during the term of this Agreement (and such limit shall reach […***…] Dollars (US $[…***…]) only in the event both (i) and (ii) above apply).


More Definitions of Preclinical Studies

Preclinical Studies means any preclinical pharmacokinetic, toxicology or other study relating to one or more Licensed Products. B4849167.1
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Preclinical Studies means those certain Preclinical Development studies in the Field, set forth in the Development Plans established in accordance with Article 4 below.
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Preclinical Studies means in vitro and in vivo studies of a Product, not in humans, including those studies conducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokinetics of a Product and whether such Product has a desired effect.
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Preclinical Studies means any non-human studies aiming at determining notably pharmacokinetic, ADME, local tolerability, toxicity and efficacy of the Licensed Product for the purpose of IND filing; "[***]Net Sales Report" means a Sales Report for a Calendar [***]; [***][***] “Regulatory Approval” means, with respect to any Licensed Product, the registrations, authorizations, clearances and approvals of the applicable Regulatory Authority or other Governmental Authority in such country or regulatory jurisdiction (including the FDA, EMA or any notified body) that are necessary to market, sell or otherwise Commercialize such Licensed Product in any country of the Territory (such as a marketing authorization or CE Mark); “Regulatory Authority” means any national, supra national, regional, state or local regulatory authority, department, bureau, commission, council or other Governmental Authority (including the FDA, EMA or any notified body) that is responsible for overseeing the Development, use, Manufacture, transport, storage or Commercialization of the Licensed Product; “Regulatory Filings” means any application for Regulatory Approval, and any notification or other submission made to or with a Regulatory Authority that is necessary or reasonably desirable to Develop (including to conduct Clinical Trials), use, Manufacture, transport, store or Commercialize a particular product for the treatment of human diseases and conditions in a particular country or regulatory jurisdiction, whether made before or after receipt of Regulatory Approval in the country or regulatory jurisdiction. The term “Regulatory Filings” shall include all amendments and supplements to any of the foregoing and all proposed labels, labelling, package inserts, monographs and packaging for a Licensed Product in a particular country; “Reimbursement Approval” means with respect to a particular Licensed Product and a particular country or regulatory jurisdiction, any pricing and reimbursement approvals of the applicable Regulatory Authority, insurance providers or other Governmental Authority in such country or regulatory jurisdiction that are necessary for a sale or transfer of the Licensed Product to any applicable Regulatory Authority or other Governmental Authority, or for a sale or transfer of the Licensed Product to be reimbursable or credited by, charged to or otherwise paid for by, in whole or in part, any applicable Regulatory Authority or other Government Authority in such country or regulatory jurisdi...
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Related to Preclinical Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

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

  • 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 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 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. [***]