Xxx Xxxxx and Company Good Research Practices definition

Xxx Xxxxx and Company Good Research Practices means the compiled set of shared research quality standards defining how Xxxxx'x research laboratories conduct good science for non-regulated work as set forth in Exhibit A. For purposes of this Agreement, “Xxx Xxxxx and Company Animal Care ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under
Xxx Xxxxx and Company Good Research Practices has the meaning set forth in Section 4.8.
Xxx Xxxxx and Company Good Research Practices means the compiled set of shared research quality standards defining how Prevail’s research laboratories conduct good science for non-regulated work as set forth in Exhibit 4.8 Part A. For purposes of this Agreement, “Lilly Principles for Animal Care and Use for Third Party Organizations” means the guidelines relating to animal care and use for research done on behalf of Prevail as set forth in Exhibit 4.8 Part B. If Prevail reasonably requests, Precision will complete a self-assessment examination form based on such quality standards. If it has not done so prior to the Effective Date, a duly authorized representative of Prevail may make an on-site visit to Precision for the purpose of conducting a quality assessment or quality audit for non-regulated work. Additionally, Prevail may conduct compliance audits of Precision and/or Precision’s Affiliates and Third Party subcontractors engaged in work related to this agreement, during normal business hours, no more than once annually, except in the case of audits for cause to ensure compliance with applicable cGCP, GLP, GRP or cGMP requirements or as otherwise set forth in Section 6.3, provided Prevail has requested such audit with written notice of at least [***] and such audit does not unreasonably interfere with Precision’s or its Affiliates’ or Third Party subcontractors’ operations. Prevail’s representative performing such audit shall keep confidential any information obtained during such inspection. All such audits shall be done at Prevail’s cost and expense and in accordance with Article 14.

Examples of Xxx Xxxxx and Company Good Research Practices in a sentence

  • All Research and Development done by either Party for non-regulated work under this Agreement will be conducted in accordance with the Research Plan, Xxx Xxxxx and Company Good Research Practices, Xxx Xxxxx and Company Animal Care and Use Requirement for Animal Researchers and Suppliers, all applicable data privacy and security laws and regulations and other Applicable Laws.


More Definitions of Xxx Xxxxx and Company Good Research Practices

Xxx Xxxxx and Company Good Research Practices has the meaning set forth in Section 4.8. ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under
Xxx Xxxxx and Company Good Research Practices means the compiled set of shared research quality standards defining how Lilly’s research laboratories conduct good [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. science for non-regulated work as set forth in Schedule 3.6 Part A. For purposes of this Agreement, “Xxx Xxxxx and Company Animal Care and Use Requirement for Animal Researchers and Suppliers” means the guidelines relating to animal care and use for research done on behalf of Lilly as set forth in Schedule 3.6 Part B. If Lilly requests, NextCure will complete a self-assessment examination form based on such quality standards; provided that (a) Lilly may not request such self-assessment more than [***] and (b) such self-assessment shall only cover the activities of NextCure under the Project Plans. If it has not done so prior to the Effective Date, a duly authorized representative of Lilly may make [***] visit to NextCure for the purpose of conducting a quality assessment and/or quality audit for non-regulated work. Lilly may conduct compliance audits of NextCure during business hours no more than [***], except in the case of audits for cause (i.e., a reasonable belief that NextCure has materially violated GxPs, Xxx Xxxxx and Company Good Research Practices or Xxx Lilly and Company Animal Care and Use Requirement for Animal Researchers and Suppliers), to ensure compliance with applicable GxPs, Xxx Xxxxx and Company Good Research Practices and Xxx Lilly and Company Animal Care and Use Requirement for Animal Researchers and Suppliers, provided Lilly has requested such audit with written Notice of at least [***] business days and such audit is conducted for no more than [***] business days. Lilly shall not unreasonably interfere with NextCure’s business and will cooperate with NextCure as may be reasonably appropriate for the protection of Confidential Information of NextCure.
Xxx Xxxxx and Company Good Research Practices means the compiled set of shared research quality standards defining how Lilly’s research laboratories conduct good science for non-regulated work as set forth in Exhibit 4.7 Part A. For purposes of this Agreement, “Xxx Xxxxx and Company Animal Care and Use Requirement for Animal Researchers and Suppliers” means the guidelines relating [*] Certain information in this document has been omitted as the information is not material and would be competitively harmful if publicly disclosed. to animal care and use for research done on behalf of Lilly as set forth in Exhibit 4.7 Part B. If Lilly reasonably requests, [*]. If Merus [*]. Merus maintains all rights to redact information and shield from such audit any confidential information of a Third Party, to the extent Merus deems such measures necessary to protect Merus’s obligations to any such Third Party. Additionally, Lilly may [*], in each case provided that Lilly has requested [*] does not unreasonably interfere with Merus’s operations. Lilly may also request that Merus exercise its rights, upon reasonable notice, to conduct a compliance audit under Merus’s agreements with Third Party subcontractors engaged in performing activities under this Agreement, if any, provided that such request may be made no more than [*]. All such audits shall be done at Lilly’s cost and expense and the parties shall cooperate in good faith with respect to the exercise of any such audit right.
Xxx Xxxxx and Company Good Research Practices means the compiled set of shared research quality standards defining how the research laboratories of Xxx Xxxxx and Company conduct good science for non-regulatory work as set forth in Schedule 3.7.1(i). For purposes of this Agreement, “Xxx Xxxxx and Company Animal Care and Use Requirements for Animal Researchers and Suppliers” means the guidelines relating to animal care and use for research done on behalf of Xxx Xxxxx and Company as set forth in Schedule 3.7.1(ii). If Lilly reasonably requests, Verve will complete a self-assessment examination form based on such quality standards. If Xxxxx has not done so prior to the Effective Date, a duly authorized representative of Xxxxx may make [**] to Verve after the Effective Date at a mutually agreed time during Verve’s regular business hours for the purpose of conducting a quality assessment or quality audit for non-regulated work, which shall be performed at Xxxxx’x cost and expense.
Xxx Xxxxx and Company Good Research Practices means the compiled set of shared research quality standards defining how Lilly’s research laboratories conduct good science for non-regulated work as set forth in Exhibit 4.7 Part A. For purposes of this Agreement, “Xxx Xxxxx and Company
Xxx Xxxxx and Company Good Research Practices means the compiled set of shared research quality standards defining how Lilly’s research laboratories conduct good science for non-regulated work as set forth in Exhibit A. For purposes of this Agreement, “Lilly Principles for Animal Care and Use” means the guidelines relating to animal care and use for research done on behalf of Lilly as set forth in Exhibit C. If Lilly requests, Centrexion will complete a self-assessment examination form based on such quality standards. If it has not done so prior to the Effective Date, as may be reasonably required in connection with the Development or Commercialization of a Product, (a) a duly authorized representative of Lilly may make an on-site visit to Centrexion for the purpose of conducting a quality assessment and/or quality audit for non-regulated work; and (b) Lilly may conduct compliance audits of Centrexion during business hours [***], except in the case of audits for cause, to ensure compliance with applicable GCP, GLP, GRP or GMP, provided Lilly has requested such audit with written notice of at least [***] ([***]) Business Days.

Related to Xxx Xxxxx and Company Good Research Practices

  • Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and (ii) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58.

  • Collaborative pharmacy practice agreement means a written and signed

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • Best Management Practices (BMPs means schedules of activities, prohibitions of practices, maintenance procedures, and other management practices to prevent or reduce the pollution of waters of the state. BMPs also include treatment requirements, operating procedures, and practices to control site runoff, spillage or leaks, sludge or waste disposal, or drainage from raw material storage.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Best management practice (BMP means a structural device or nonstructural practice designed to temporarily store or treat stormwater runoff in order to mitigate flooding, reduce pollution, and provide other amenities.

  • Good Clinical Practice or “GCP” means the then current standards for clinical trials for pharmaceuticals, as set forth in the ICH guidelines and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries in which a Licensed Product is intended to be sold to the extent such standards are not less stringent than the ICH guidelines.

  • Group practice means a group of two or more health care providers legally organized as a partnership, professional corporation, or similar association:

  • New Jersey Stormwater Best Management Practices (BMP) Manual or “BMP Manual” means the manual maintained by the Department providing, in part, design specifications, removal rates, calculation methods, and soil testing procedures approved by the Department as being capable of contributing to the achievement of the stormwater management standards specified in this chapter. The BMP Manual is periodically amended by the Department as necessary to provide design specifications on additional best management practices and new information on already included practices reflecting the best available current information regarding the particular practice and the Department’s determination as to the ability of that best management practice to contribute to compliance with the standards contained in this chapter. Alternative stormwater management measures, removal rates, or calculation methods may be utilized, subject to any limitations specified in this chapter, provided the design engineer demonstrates to the municipality, in accordance with Section IV.F. of this ordinance and N.J.A.C. 7:8-5.2(g), that the proposed measure and its design will contribute to achievement of the design and performance standards established by this chapter.

  • Good Laboratory Practices or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the United States, as they may be updated from time to time).

  • Best management practices (BMP) means schedules of activities, prohibitions of practices, maintenance procedures, and other management practices to prevent or reduce the pollution of waters of the United States. BMPs include treatment requirements, operation procedures, and practices to control plant site runoff, spillage or leaks, sludge or waste disposal, or drainage from raw material storage.

  • sustainable development means development which meets the needs of the present without compromising the ability of future generations to meet their own needs.

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.

  • GCP means good clinical practices, which are the then-current standards for Clinical Trials for pharmaceuticals, as set forth in the FD&C Act or other Applicable Law, and such standards of good clinical practice as are required by the Regulatory Authorities of Europe and other organizations and governmental authorities in countries for which the applicable Licensed Agent or Product is intended to be Developed, to the extent such standards are not less stringent than United States standards.

  • standards of generally recognised accounting practice means an accounting practice complying with standards applicable to municipalities or municipal entities as determined by the Accounting Standards Board