Good Laboratory Practice Sample Clauses

Good Laboratory Practice or GLP shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding quality control for laboratories to ensure the consistency and reliability of results, including without limitation the CFR Title 21, national legislation implementing European Community Directive 2004/9/EC of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) as amended and European Community Directive 2004/10/EC of 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances as amended, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring.
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Good Laboratory Practice. This study will be conducted under the guidelines of Good Laboratory Practice as promulgated by the Food and Drug Xxxxxxxxxxxxxx 00 XXX 00.
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Good Laboratory Practice. The term “Good Laboratory Practices” shall mean the then-current standards for good laboratory practices for pharmaceuticals, as set forth in the FD&C Act and applicable regulations and guidance promulgated thereunder, including the Code of Federal Regulations, as amended from time to time, or under any other Applicable Law.
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Good Laboratory Practice. 5.1 Supplier shall: (a) perform the Services with the highest professional standards, in a good scientific manner, in compliance with the provisions of this Agreement and all Applicable Laws, including as applicable, GLP, and (b) ensure that it has all licenses and consents required to provide the Services and otherwise conduct its business, and shall maintain and comply with all such licenses and consents.
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Good Laboratory Practice. ................................ 6 Section 1.28. GOOD MANUFACTURING PRACTICE ................................ 6 Section 1.29. INDEMNIFIED PARTY(IES) ..................................... 6 Section 1.30. INDEMNIFYING PARTY ......................................... 7 Section 1.31. KNOW HOW ................................................... 7 Section 1.32. LICENSED PRODUCT(S) ........................................ 7 Section 1.33. LOCK UP PERIOD ............................................. 7 Section 1.34.
Sample 1
Good Laboratory Practice. (GLP) Scope and coverage The provisions of this Chapter shall apply to the testing of chemicals according to GLP, being either substances or preparations, covered by the legislative, regulatory and administrative provisions listed in Section I. For the purposes of this Chapter the provisions of Article 4 of this Agreement concerning origin do not apply. Unless specific definitions are given, the definition of terms in the "OECD Principles of Good Laboratory Practice" as revised in 1997 [ENV/MC/CHEM(98)17] based on OECD Council Decision of 12 May 1981 C(81)30(Final)] amended on 26. November 1997 [C(97) 186 FINAL], as well as Council Decision- Recommendation of 2 October 1989 [C(89)87(Final)] amended on 9 March 1995 [C(95)8(Final)] and GLP Consensus documents, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, and all amendments made thereto, shall apply. The Parties recognise the equivalence of each other's compliance monitoring programmes on Good Laboratory Practice that are in accordance with the OECD decisions and recommendations mentioned above and the legislative, regulatory and administrative procedures and principles listed in section IV. The Parties mutually accept studies and data generated therefrom, produced by the test facilities of the other Party provided they participate in the Good Laboratory Practice compliance monitoring programme of that Party in accordance with the principles and provisions stated above. The Parties mutually accept the conclusions of study audits and test facility inspections performed by the GLP monitoring authorities
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Good Laboratory Practice. The Research Program shall be conducted by CISTRON at CISTRON's laboratories and/or at Third-Party research laboratories contracted by CISTRON. CISTRON shall use all reasonable efforts to complete research works in accordance with the said Program. Any research work performed by CISTRON pursuant hereto shall be in compliance with current Good Laboratory Practices (cGLP) as applicable in the United States of America.
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Good Laboratory Practice. Good Laboratory Practice shall mean the current good laboratory practice applicable to the Development of the Product under applicable Law, to the extent such standards are not less stringent than the U.S. current good laboratory practice, including without limitation 21 C.F.R. Part 58.
Sample 1
Good Laboratory Practice. (GLP) The generation of test data related to the safety of industrial chemical and biological substances must be performed in compliance with GLP to ensure quality and reliability. 3.6. Health of Employees All activities should be conducted in order to avoid risks to employee health and safety. 3.7. Environment All activities should be respectful of the environment, in compliance with all applicable laws and regulations. 3.8. Animal Welfare Animals used in research activities must be treated respectfully and animal testing should be performed in compliance with the Three Rs principles of Refinement, Reduction and Replacement. 4. INTEGRITY 4.1. Anti-bribery Practices The legal definition of bribery varies from one country to another, but it always means: ‘‘the act of offering something in order to obtain an undue interest or advantage’’. Because bribery distorts fair trade, hinders economic development, and imposes multiple costs on society at large, any form of bribery or corruption will not be tolerated. 4.2. Conflict of Interest Any situation where there is an actual, apparent or perceived conflict of interest must be avoided or disclosed to be dealt with appropriately. 4.3. Fair Competition All activities must be conducted in compliance with applicable competition/antitrust laws and regulations. 4.4. Intellectual Property Rights - Confidentiality - Data Protection Any information protected by patents, trademarks, copyright, trade secret laws or the Intellectual Property Rights shall be respected in compliance with all applicable laws and regulations. Confidential information must be properly used, at all times, in an ethical manner and must be protected against theft, damage, misappropriation or misuse. Data protection laws and regulations should be respected.
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Related to Good Laboratory Practice

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or 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. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Research Plans The Research Plan for the [***] Designated Target is attached as Schedule 2.2.3-1. Subsequent Research Plans agreed upon in accordance with Section 2.4.2.4 will be attached as additional sequentially numbered schedules (Schedule 2.2.3-2, Schedule 2.2.3-3, etc.).

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

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