BI PHARMA KG definition

BI PHARMA KG means BI’s AFFILIATE Boehringer Ingelheim Pharma GmbH & Co. KG, 88397 Biberach an der Riss, Xxxxxxxxxxxx Xxxxxx 00, Xxxxxxx, owning an FDA inspected and cGMP-certified facility.
BI PHARMA KG means Boehringer Ingelheim Pharma KG.
BI PHARMA KG means Boehringer Ingelheim Pharma KG as laid down first above.

Examples of BI PHARMA KG in a sentence

  • VIDARA shall reimburse BI RCV for the costs of such COMPONENTS destroyed or provided to VIDARA to the extent the amount of COMPONENTS that would have been reasonably required for DI RCV and/or BI PHARMA KG to maintain in inventory in order to meet its obligations under this Agreement (consistent with its obligations under Section 4.2 hereof with respect to the COMPONENTS).

  • BI PHARMA KG shall maintain (for safety reasons in two different buildings) the Cell Line in safe and secure storage under its control in its facilities and shall not permit the transfer of the Cell Line to any third party that is not specifically authorized in writing by IMCLONE (except to a contract laboratory used for the characterization of the MCB or MWCB under substantially the same requirement of confidentiality).

  • BI PHARMA KG shall be entitled to rely upon any instructions or directives provided by the IMCLONE Project Manager or the IMCLONE Project Manager's supervisor and, subject to Sections 4.5 and 4.7 below shall not be responsible for failure to achieve any objective or the inability to adhere to any guideline due to technical failures, incomplete direction or documentation of Process variables, or other causes beyond the control of BI PHARMA KG.

  • BI PHARMA KG and IMCLONE may confer to determine if additional work relating to Phase I or Phase II should be undertaken pursuant to subsequent agreement between BI PHARMA KG and IMCLONE.

  • All Product produced in the course of the Project shall be retained by BI PHARMA KG and stored under conditions specified by IMCLONE (and reasonably acceptable to BI PHARMA KG) not longer than 1 (one) year, and delivered to IMCLONE as instructed by IMCLONE and at the cost and risk of IMCLONE.

  • The cost of commercially available materials purchased by IMCLONE for use at BI PHARMA KG to support development in GLP and cGMP shall be creditable to the applicable invoice.

  • IMCLONE hereby grants to BI PHARMA KG a limited, non-exclusive right and license, without the right to sublicense, to use IMCLONE Confidential Information, including but not limited to the Cell Line and Process, solely for the purpose of enabling BI PHARMA KG to carry out its tasks and responsibilities under this Agreement with respect to the Project.

  • In the absence of explicit instructions from IMCLONE, BI PHARMA KG shall be entitled to employ its reasonable judgment in carrying out the Project.

  • Every applicant for a building permit, zoning permit, excavation permit, filling permit, mining permit, sign permit, wetlands activities permit, plat approval, minor subdivision approval, permit for construction of utilities systems, or permit for any land disturbing activities must submit a storm water management plan to the Zoning Administrator.

  • BI PHARMA KG will quarantine and test samples of the Cell Line already provided to it in order to verify that the Cell Line is suitable for introduction into BI PHARMA KG's facilities.

Related to BI PHARMA KG

  • Novartis shall have the meaning set forth in the Preamble.

  • Merck has the meaning set forth in the preamble.

  • GSK or ‘𝐺𝑆𝐾’ means the generation shift key as defined in Article 2(12) of the CACM Regulation;

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • the Licensee means the person (or all the persons) specified in Part 1 of Schedule 1 as licence holder (or joint licence holders);

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • NPS means nominal pipe size.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • Lilly has the meaning set forth in the Preamble.

  • CTI means CTI Logistics Limited (ABN 69 008 778 925) and/or any Affiliate of CTI Logistics Limited as the case may be, which performs all or any of the Services.

  • Shire means Shire of Augusta Margaret River

  • Licensee means a person licensed under this chapter.

  • Siemens means Siemens AG (Germany) and its Affiliates.

  • ISIS means the department’s individualized services information system.

  • Elan means Elan Corp and its Affiliates.

  • GTC means General Terms & Conditions of Contract.

  • Soil scientist means an individual duly qualified in accordance with standards set by the Federal Office of Personnel Management.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Pfizer means Pfizer Inc.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Public research university means Rutgers, The State University

  • DSM means the most current edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association.

  • UBC means the Uniform Building Code. “UL” means the Underwriters’ Laboratories, Inc.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • API means American Petroleum Institute.