Test Article(s) definition

Test Article(s) means, in accordance with 21 C.F.R. Part 50.3(j), any drug (including a biological product), medical device, food additive, color additive, electronic product, material or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq., Pub. L.No.75-717, 52 Stat. 1040 (1938), as amended. In this Agreement, Test Article(s) collectively refers to an allogeneic, immunoselected, ex vivo expanded mesenchymal precursor cell product (MPC), produced by Company using its proprietary technology, and cryopreserved and provided in injectable cryoprotective media, and the injectable cryoprotective media alone (Control/sham/comparator), as identified in the Protocol.
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Examples of Test Article(s) in a sentence

  • Except as otherwise provided in this Article 3.3, Tthe Parties agree to use Collaborator Materials, Test Articles, and ICD Materials only in accordance with the Research Plan and Protocol(s), not to transfer these materials to third parties except in accordance with the Research Plan and Protocol(s) or as approved by the owning or providing Party, and, upon expiration or earlier termination of the CRADA, to dispose of these materials as directed by the owning or providing Party.

  • All costs associated with shipping the Test Articles to Company shall be the responsibility of Sponsor, and Company shall not be responsible for any loss, damage or destruction of the Test Articles while in transit.

  • Except as otherwise provided in this Section 3.3, Tthe Parties agree to use Collaborator Materials, Test Articles, and ICD Materials only in accordance with the Research Plan and Protocol(s), not to transfer these materials to any third parties except in accordance with the Research Plan and Protocol(s) or as approved by the owning or providing Party, and, upon expiration or earlier termination of this CRADA, to dispose of these materials as directed by the owning or providing Party.

  • Except as otherwise provided in this Article 3.3, the Parties agree to use Collaborator Materials, Test Articles, and ICD Materials only in accordance with the Research Plan and Protocol(s), not to transfer these materials to third parties except in accordance with the Research Plan and Protocol(s) or as approved by the owning or providing Party, and, upon expiration or earlier termination of the CRADA, to dispose of these materials as directed by the owning or providing Party.

  • NCI agrees and will assure that appropriate records of Test Articles are kept and will take reasonable steps to ensure the Investigational Agent is used in accordance with the applicable protocols and FDA regulations.

  • VIRUSURE neither warrants nor represents that the results of the Study will be acceptable to any regulatory or governmental agency to which they are presented nor that the results of the Study will enable COMPANY to further develop, market or otherwise exploit the Test Articles or any other product or service.

  • Any data, discoveries or inventions developed or generated pursuant to this Agreement which directly relate to any information or materials (including Test Articles) provided by COMPANY under this Agreement or those relating to Deliverables, including, without limitation, new data, uses, processes or compositions directly relating to the information or materials (including Test Articles) provided under this Agreement or those relating to Deliverables shall be the exclusive property of COMPANY.

  • The import and export of technical data or Test Articles may be subject to the receipt of any necessary import and/or export licenses, permits or consents by the importing and/or exporting party.

  • In no event shall either VIRUSURE be liable for any damages arising from or in connection with any decision by COMPANY or any third party, made independently of the Services or VIRUSURE’s confidential information provided under this Agreement, to further research, develop or market Test Articles or any derivative or product or service related thereto or the use of Test Articles or any product or derivative or service related thereto.

  • Storage may be continued by PRA beyond the specified time at Sponsor's expense and PRA shall take commercially reasonable precautions to safeguard Test Articles entrusted to PRA’s control.

Related to Test Article(s)

  • Model Articles means the model articles for private companies limited by guarantee contained in Schedule 2 of the Companies (Model Articles) Regulations 2008 (SI 2008/3229) as amended prior to the date of adoption of these Articles;

  • these Articles means these articles of association as altered from time to time and the expression “this article” shall be construed accordingly;

  • the Articles means these Articles of Association of the Academy Trust;

  • Single-service articles means cups, containers, lids, closures, plates, knives, forks, spoons, stirrers, paddles, straws, napkins, wrapping materials, toothpicks, and similar articles intended for one-time, one-person use and then discarded.

  • Translucent means a substance that allows light to pass through, but does not allow an object or person to be seen through the substance.