Analytical Release Testing and Characterization definition

Analytical Release Testing and Characterization means all activities associated with carrying out the analytical testing and release of the Product in the Territory. Such activities shall include: transferring test methods, developing and validating new analytical tests required in the Territory, amending the release specifications to be in compliance with local Applicable Laws, conducting the release testing of the Product in the Territory and final release of the Product (including any of its raw materials, intermediates, drug substance and drug product).
Analytical Release Testing and Characterization means all activities associated with carrying out the analytical testing and release of the Bulk Product in the Territory. Such activities shall include: transferring test methods, developing and validating new analytical tests required in the Territory, amending the release specifications to be in compliance with local Laws, conducting the release testing of the Bulk Product in the Territory and final release of the Bulk Product (including raw materials, intermediates, drug substance, drug product and sterile diluents). For clarity, preparation of reference standards to be used for Analytical Release Testing and Characterization includes analytical tests other than release testing (e.g., mass spectrophotometry, isoelectrofocusing, N- and C-terminal sequencing, amino acid analysis, etc.), which activities shall also be deemed Analytical Release Testing and Characterization hereunder.

Examples of Analytical Release Testing and Characterization in a sentence

  • Licensee or its designated Third Party shall also be responsible for performing the testing and release aspects of Analytical Release Testing and Characterization of the Product.

  • Licensee shall be solely responsible for 100% of all (a) Development costs incurred with respect to any Development Activities or any Analytical Release Testing and Characterization and (b) costs incurred associated with any Manufacturing Development Activities.

  • Licensee or its designated Third Party shall also be responsible for performing the testing and release aspects of Analytical Release Testing and Characterization of the Product and Lilly shall provide reasonable assistance to Licensee (such assistance is subject to Lilly’s [***].

  • Licensee shall be solely responsible for one hundred percent (100%) of all Development costs incurred with respect to any Development Activities or Analytical Release Testing and Characterization associated with the Product for the Licensed Field incurred on or after the Effective Date.

  • Auxilium shall invoice Actelion for Development Costs it incurs in connection with performing any Analytical Release Testing and Characterization, which invoices Actelion shall pay within thirty (30) days of receipt thereof.

  • Auxilium shall invoice Asahi for Development Costs it incurs in connection with performing Territory-Specific Analytical Release Testing and Characterization, which invoices Asahi shall pay within thirty (30) days of receipt thereof.

  • Asahi shall be solely responsible for one hundred percent (100%) of all Development Costs incurred by Asahi or Auxilium (to the extent as described in the next sentence) with respect to any Territory-Specific Analytical Release Testing and Characterization.

  • Asahi shall conduct, in accordance with the Development Plan, the Territory Development Activities, including bridging studies, clinical studies, physician/investigator – initiated studies, Phase IV Clinical Studies (and other post-Regulatory Approval studies) and the Territory-Specific Analytical Release Testing and Characterization necessary for obtaining or maintaining Regulatory Approvals or is otherwise required to conduct to comply with Laws.

  • Actelion shall be solely responsible for one hundred percent (100%) of all Development Costs incurred by Actelion or Auxilium with respect to any Analytical Release Testing and Characterization.

  • Licensee shall be solely responsible for one hundred percent (100%) of all Development costs incurred with respect to any Development Activities or Analytical Release Testing and Characterization associated with the Product for the Licensed Field incurred on or after the Original Effective Date.

Related to Analytical Release Testing and Characterization

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • COVID-19 test means a viral test for SARS-CoV-2 that is:

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • Screening Test means a drug or alcohol test which uses a method of analysis allowed by the Minnesota Drug and Alcohol Testing in the Workplace Act to be used for such purposes.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • Testing laboratory means a laboratory, facility, or entity in the state that offers or performs tests of cannabis or cannabis products and that is both of the following:

  • health and safety file means a file, or other record containing the information in writing required by these Regulations "health and safety plan" means a site, activity or project specific documented plan in accordance with the client's health and safety specification;

  • Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Commissioning test means tests applied to a distributed generation facility by the applicant after construction is completed to verify that the facility does not create adverse system impacts and performs to the submitted specifications. At a minimum, the scope of the commissioning tests performed shall include the commissioning test specified in Institute of Electrical and Electronics Engineers, Inc. (IEEE) Standard 1547 Section 5.4 "Commissioning tests".

  • PDPA means Personal Data Protection Act 2010.

  • Percolation test means a subsurface soil test at the depth of a proposed absorption system or similar component of an OWTS to determine the water absorption capability of the soil, the results of which are normally expressed as the rate at which one inch of water is absorbed. The rate is expressed in minutes per inch.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Outpatient status means, with respect to a covered servicemember who is a current member of the Armed Forces, the status of a member of the Armed Forces assigned to:

  • Substance abuse treatment means outpatient or inpatient services or participation in Alcoholics Anonymous or a similar program.

  • EPP test Means one EPP command sent to a particular “IP address” for one of the EPP servers. Query and transform commands, with the exception of “create”, shall be about existing objects in the Registry System. The response shall include appropriate data from the Registry System. The possible results to an EPP test are: a number in milliseconds corresponding to the “EPP command RTT” or undefined/unanswered.

  • Diagnosis of autism spectrum disorder means medically necessary assessments, evaluations, or tests

  • Screening Test Technician (STT) means anyone who instructs and assists individuals in the alcohol testing process and operates an ASD.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Confirmation test means a drug or alcohol test on a sample to substantiate the results of a prior drug or alcohol test on the same sample and which uses different chemical principles and is of equal or greater accuracy than the prior drug or alcohol test;

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;