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. Such activities shall include: transferring test methods, developing and validating new analytical tests required, amending the release specifications to be in compliance with local Applicable Law, conducting the release testing of the Product and final release of the Product (including raw materials, intermediates, drug substance, and drug product).
Sample 1Sample 2Sample 3
Analytical Release Testing and Characterization means all activities associated with carrying out the analytical testing and release of any Licensed Product in the Field in the Territory. Such activities will 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 Law, conducting the release testing of such Licensed Product in [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Exhibit 10.1 the Field in the Territory and final release of such Licensed Product in the Field, including raw materials, intermediates, drug substance, and drug product.
Sample 1
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.
Sample 1

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 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.

  • 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 [***].

  • 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.

  • Auxilium shall invoice Asahi for Regulatory Costs it incurs in connection with the preparation of Regulatory Materials (including the performance of any Territory-Specific Analytical Release Testing and Characterization associated therewith) for, and obtaining of Product Approvals in, the Field in the Territory for the Product, which invoices Asahi shall pay within thirty (30) days of receipt thereof.

  • Auxilium shall, to the extent mutually agreed by the Parties, further use Commercially Reasonable Efforts to perform the Manufacturing Development Activities, the Territory Development Activities and the Territory-Specific Analytical Release Testing and Characterization.

  • 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.

  • 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.

  • 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.

Related to Analytical Release Testing and Characterization

  • Template means a qualified software solution – based on Software - created by Partner in accordance with the solution qualification guidelines for Software. For details contact your Partner Service Advisor.

  • 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;

  • 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 the Generating Facility, after completion of the construction of the Generating Facility, in order to verify that the Generating Facility may be released for Operation.

  • PDPA means the Personal Data Protection Act 2012 (No. 26 of 2012).

  • 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.