“Good Laboratory Practices” or “GLP” means, as to the United States and the European Union, applicable good laboratory practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, laboratory practices equivalent to good laboratory practices as then in effect in the United States or the European Union.

conduct under this Agreement, including current Good Clinical Practices, Good Laboratory Practices and Good Manufacturing Practices.

Maintenance of Regulatory Filings, Good Laboratory, and Clinical Practices. Lyra Controls all Regulatory Filings pertaining to the Licensed Product in the Field in the Territory. Lyra and its Affiliates and Sublicensees have generated, prepared, maintained, and retained all Regulatory Filings and Marketing Authorizations relevant to Licensed Products in the Field in the Territory in its control that are required to be maintained or retained pursuant to and in material compliance with applicable Laws, and have conducted in material compliance with applicable Laws, including GLP and GCP all Development of Licensed Products in the Field conducted prior to the Effective Date.

“GLP” or “Good Laboratory Practices” means all applicable current good laboratory practices, including, as applicable, the regulations set forth in 21 C.F.R. Part 58, and the requirements thereunder imposed by the FDA, and the equivalent thereof in any jurisdiction.

“Good Laboratory Practices” or “GLP” means the then-current good laboratory practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.

Section # “GLP” or “Good Laboratory Practices” shall mean good laboratory practices required under the regulations set forth in 21 C.F.R. Part 58, as in effect during the Term, and the requirements thereunder imposed by the FDA, the PMDA and the equivalent thereof in any jurisdiction.

Laboratory Licenses. If QIAGEN has not yet received Regulatory Approval to sell a Product in a country in the Territory, QIAGEN may, subject to the provisions of this Section 6.11, grant a sublicense under the Technology License, but specifically excluding a license to the Intellectual Property Rights, source code or Confidential Information relating to the ​ Interpretive Algorithm, to any laboratory in the Territory to allow such laboratory to purchase and use an ​ to be used in conjunction with a Sequencer in accordance with Applicable Laws. For clarity, the laboratory shall have the right to ​to QIAGEN, ​, ​by the ​ ​in a manner permitted by Applicable Laws pursuant to ​ Each recipient of a Laboratory License shall be referred to as a “Laboratory Licensee”). For clarification, an ​ sold to a Laboratory Licensee shall be considered a “Product” for purposes of Net Sales.

application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect.

“Applicable Law” means all applicable laws, rules and regulations (whether federal, state or local) that may be in effect from time to time, including current Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

“GxP” means all relevant Governmental Authority requirements for # current Good Clinical Practices for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, # current Good Laboratory Practice for laboratory activities for pharmaceuticals, and # current Good Manufacturing Practices, including in each case, as set forth in Title 21 of the United States Code of Federal Regulations.