Internal Compliance Codes definition
Internal Compliance Codes means a Party’s internal policies and procedures intended to ensure that a Party complies with Applicable Laws, Party Specific Regulations, and such Party’s internal ethical, medical and similar standards.
Internal Compliance Codes has the meaning set forth in Section 11.6.4.
Internal Compliance Codes means a Party’s internal policies and procedures intended to ensure that a Party complies with Applicable Laws, Party Specific Regulations, and such Party’s internal ethical, medical and similar standards. “Party Specific Regulations” means all judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities pursuant to this Agreement.
Examples of Internal Compliance Codes in a sentence
The Parties agree to cooperate with each other to help insure that each Party is able to comply with the substance of its respective Internal Compliance Codes and, to the extent practicable, each Party shall operate in a manner consistent with its Internal Compliance Codes applicable to its performance under this Agreement.
All Internal Compliance Codes shall apply only to the Party to which they relate.
More Definitions of Internal Compliance Codes
Internal Compliance Codes means Seller’s internal policies and procedures intended to ensure that the Seller complies with applicable Laws, Industry Codes, and Seller’s internal ethical, medical and similar standards.
Internal Compliance Codes means a Party’s internal policies and procedures intended to ensure that such Party complies with Applicable Laws, Party-Specific Regulations, and such Party’s internal ethical, medical, and similar standards. 1.91. “Invus” has the meaning set forth in Section 1.12 (Affiliate). 1.92. “Joint Arising Know-How” has the meaning set forth in Section 8.2.3 (Joint Arising Technology). 1.93. “Joint Arising Patent Rights” has the meaning set forth in Section 8.2.3 (Joint Arising Technology). 1.94. “Joint Arising Technology” has the meaning set forth in Section 8.2.3 (Joint Arising Technology). 1.95. “JSC” has the meaning set forth in Section 3.1 (Joint Steering Committee). 1.96. “JSC Chair” has the meaning set forth in Section 3.1 (Joint Steering Committee). 1.97. “Know-How” means all commercial, technical, scientific, and other know-how and information, in each case, that is not in the public domain or otherwise publicly known, including concepts, strategies, models, instructions, materials, protocols, inventions, discoveries, trade secrets, knowledge, technology, methods, processes, practices, formulae, amino acid sequences, nucleotide sequences, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, and data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety, manufacturing, and quality control data and know how, including regulatory data, study designs, and protocols), in all cases, whether or not patentable and in written, electronic, or any other form now known or hereafter developed, but expressly excluding all Patent Rights. For clarity, Know-How includes any such information comprised or embodied in any applicable physical materials but excludes Patent Rights. 1.98. “Lexicon” has the meaning set forth in the preamble. 15 1.99. “Lexicon Arising Know-How” has the meaning set forth in Section 8.2.1 (Lexicon Arising Technology). 1.100. “Lexicon Arising Patent Right” has the meaning set forth in Section 8.2.1 (Lexicon Arising Technology). 1.101. “Lexicon Arising Technology” has the meaning set forth in Section 8.2.1 (Lexicon Arising Technology). 1.102. “Lexicon Indemnitees” has the meaning set forth in Section 11.2 (Indemnification by Novo Nordisk). 1.
Internal Compliance Codes has the meaning set forth in Section 13.4.2. "Inventions" means all inventions and discoveries which are made or conceived in the performance of the Study and/or which are made or conceived by a Party through use of the Clinical Data. "Jointly Owned Invention" has the meaning set forth in Section 10.1.1. "Joint Patent" means a patent that issues from a Joint Patent Application. "Joint Patent Application" has the meaning set forth in Section 10.1.2. "Know-How" means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain. "Liability" has the meaning set forth in Section 14.2.1. "Lilly" has the meaning set forth in the preamble. "Lilly Class Compound" means any one or more VEGFR2 antagonist molecule, including an antibody such as an anti-VEGFR2 antibody or a small molecule inhibitor that is a specific and selective antagonist of VEGFR2. "Lilly Compound" means ramucirumab, excluding, however, any biosimilar of ramucirumab other than a biosimilar owned or controlled by Lilly or its Affiliates. "Manufacture," "Manufactured," or "Manufacturing" means all stages of the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable. "Manufacturing Site" means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.4 (Changes to Manufacturing). "Non-Conformance" means, with respect to a given unit of Compound, (i) an event that deviates from an approved cGMP requirement with respect to the applicable Compound, such as a procedure, Specification, or operating parameter, or that requires an investigation to assess impact to the quality of the applicable Compound or (ii) that such Compound failed to meet the applicable representations and warranties set forth in Section 2.4. Classification of a Non- Conformance is detailed in the Quality Agreem...