Assay Development definition

Assay Development means the development of the Assay (including software development), the technical validation and verification of the RMS Product, Clinical Validation, clinical reproducibility studies of the RMS Product, the manufacturability of the RMS Product and preparing and submitting to the Regulatory Authorities applications for, and obtaining and maintaining, Regulatory Approvals for the RMS Product.
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Assay Development. Scopus Biopharma will contract with a Contract Research Organization (CRO) to develop and validate bioanalytical methods for rat, dog, and human plasma. Pharmacology: Scopus Biopharma will contract with qualified CRO(s) to perform standard Good Laboratory Practice (GLP) safety pharmacology studies. The studies will include in vitro hERG, subcutaneous (sc) rat central nervous system, sc rat respiratory system, and sc dog cardiovascular system, as well as additional studies if warranted by the data. All of the GLP safety pharmacology studies will utilize DS from either the engineering or cGMP batches.
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Assay Development means the activities to be carried out by Evotec to develop, optimize or adapt an Assay to the Evotec Technology as more particularly described in the Project Description(s).
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Examples of Assay Development in a sentence

  • Except as may otherwise be expressly agreed to in writing by the Parties, RMS shall be responsible for the development, Regulatory Approval and commercialization of the RMS Product, including but not limited to the Assay Development.

  • The cost of acquiring such supplementary Samples for the Assay Development will be the responsibility of Pharmaceutical Partners, Pharmaceutical Partners shall hold all right, title and interests in and to such supplementary Samples that are consistent with applicable laws and regulations, which Samples shall be Pharmaceutical Partners Patient Materials, and RMS shall [**].

  • In the event that the Parties determine that Samples from sources available to Pharmaceutical Partners are advantageous for the timely completion of the Assay Development, Pharmaceutical Partners shall use Commercially Reasonable Efforts to acquire and provide supplementary Samples.

  • For Assay Development, including Clinical Validation of the Assay or similar activities involving the RMS Product under the Project Plan, RMS and its Affiliates shall be responsible for initially identifying and for contracting with the Contract Laboratories.

  • RMS shall be responsible for and shall conduct the Assay Development as set forth in the Project Plan, including the Clinical Validation of the RMS Product.

  • Each Party’s Project Team representatives shall have appropriate technical expertise and experience in disciplines relevant to the Project (including without limitation Assay Development, clinical drug development, regulatory matters, and project management).

  • If Qorvo provides an Assay Rejection Notice with regard to a Cartridge Development Request, then such Cartridge Development Request will count towards Zomedica’s fulfillment of the Assay Development Obligation if (a) the projected Cartridge volumes in such Cartridge Development Request are at least [*] cartridges per calendar quarter, and (b) the Proposed Assay Performance Requirements in such Cartridge Development Request require [*].

  • The Company will diligently conduct the HIV Viral Load Assay Development Project.

  • Qorvo may alternatively propose amendments to the Cartridge Development Request for the Assay and if the Parties agree on such amendments, then Qorvo will develop the applicable Assay and no Assay Rejection Notice will be deemed to have been given and instead such Assay will count toward the Assay Development Obligation for the applicable year.

  • The Assay Development Obligation will be deemed fully satisfied if Zomedica selects, and notifies Qorvo of, at least [*] assays for development at any time within the first seven Contract Years of the Term and each of such assays are accepted by Qorvo in accordance with Section 3.3.1 (Request for Development) or are otherwise counted towards the Assay Development Obligation in accordance with Section 3.3.1(2).


More Definitions of Assay Development

Assay Development means the activities to be carried out by Aptuit to develop, optimize or adapt an Assay to the Aptuit Technology as more particularly described in the Project Description(s).
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Assay Development means the process of creating reproducible and quantitative assays, as well as ascertaining pre-analytical variables that affect reproducibility such that the test can be run in a clinical laboratory.
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Assay Development. Licensee will contract with a Contract Research Organization (CRO) to develop and validate bioanalytical methods for rat, dog, and human plasma. Assay development will be concurrent with DS and DP development and manufacture and cost will be approximately [ ]. A-034-2016 NIH Patent License Agreement—Exclusive PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Pharmacology: In addition to the nonclinical primary pharmacodynamic (PD) studies in scleroderma models that will be conducted under the CRADA, VS will contract with qualified CRO(s) to perform standard Good Laboratory Practice (GLP) safety pharmacology studies. The studies will include in vitro hERG, oral rat central nervous system, oral rat respiratory system, and oral dog cardiovascular system, as well as additional studies if warranted by the data. All of the GLP safety pharmacology studies will utilize DS from either the engineering or cGMP batches. Pharmacokinetics: Licensee will contract with qualified CRO(s) to perform various in vitro pharmacokinetic (PK) studies, including metabolic stability studies, drug-drug interaction studies, protein binding studies, and permeation studies. These studies will be initiated early on and will use DS from the scale up efforts. The data package for MRI-1867 includes results that fit into these categories of studies. Depending on the availability of the corresponding study reports (i.e., for Licensee to use in an IND submission), the study designs, and the comparability of the test material used, Licensee may be able to use some of the NIH results in lieu of conducting such studies. Once the engineering batch DS is available, Licensee will contract with qualified CRO(s) to perform oral rat single dose PK, oral dog single dose PK, and absolute bioavailability. Radiolabeled MRI-1867 will be used for mass balance and tissue distribution studies. Additional nonclinical absorption, distribution, metabolism, and excretion (ADME) studies will be contracted as warranted by the data.
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Assay Development means the Formatting of each individual SNP into a working assay through the custom design and testing of specific oligonucleotides for the interrogation of an individual SNP, including one set of PCR Primers and one SNP-IT Primer for the desired SNP, in conjunction with Genotyping against a known sample set.
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Assay Development. Licensee will contract with a Contract Research Organization (CRO) to develop and validate bioanalytical methods for rat, dog, and human plasma. Assay development will be concurrent with DS and DP development and manufacture and cost will be approximately [ ]. A-034-2016 NIH Patent License Agreement—Exclusive
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Related to Assay Development

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Economic development means all powers expressly granted and reasonably inferred pursuant to SDCL § 9-54.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Major development means an individual “development,” as well as multiple developments that individually or collectively result in: