BI PHARMA KG definition

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

Examples of BI PHARMA KG in a sentence

  • 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.

  • While visiting the facility of the other party, personnel of BI PHARMA KG and IMCLONE shall comply with all security and safety policies and procedures of the other party.

  • According to a sampling plan to be agreed upon by the Project Team, BI PHARMA KG shall isolate, identify and retain samples of raw materials used in fermentations carried out in the course of the Project, of Process media at appropriate time points in each fermentation, and of Product at each stage of purification.

  • 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.

  • BI PHARMA KG and IMCLONE shall each identify a Project Manager, and if they choose, the supervisor of the Project Manager.

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

  • The Project shall be conducted by BI PHARMA KG for IMCLONE on a fixed fee basis, in consideration of payment by IMCLONE of the Project Fee.

  • 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.

  • 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.

  • BI PHARMA KG and IMCLONE shall each name representatives to a Project Team, which shall consist of knowledgeable specialists in appropriate disciplines who shall be responsible for planning and executing the Project and any subsequent interactions between the parties.

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 has the meaning set forth in the preamble.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, 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 persons to whom this licence is granted, his personal representatives and any person or persons to whom the rights conferred by this licence may lawfully have been assigned;

  • 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 Castle Transmission International Limited.

  • Shire means Shire of Augusta Margaret River

  • Licensee has the meaning set forth in the preamble.

  • 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.

  • PTI means Preliminary Toxicity Investigation. Up to a 30-day period where the permittee investigates the cause(s) of a whole effluent toxicity exceedance and if the toxicity is known, includes a proposal for its elimination.

  • 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, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

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

  • UBC means the University of British Columbia.

  • 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)).