BI PHARMA KG definition

BI PHARMA KG means BI RCV’s AFFILIATE BI Pharma KG, FRG-88397 Biberach an der Riss, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇▇, owning an FDA inspected and cGMP-certified facility.
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BI PHARMA KG means Boehringer Ingelheim Pharma KG as laid down first above.
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BI PHARMA KG means Boehringer Ingelheim Pharma KG.
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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).

  • Such supply agreement shall contain terms and conditions customary for such a supply agreement and shall be concluded between BioMedicines and BI Pharma KG or, at the sole discretion of BI PHARMA KG, with BII or any other Affiliate of BI Pharma KG as the case may be, provided however, that the main production activities shall remain at BI Pharma KG.

  • BI PHARMA KG shall maintain all records necessary to evidence compliance with all its obligations under this Agreement and relating to the manufacture of the Product.

  • BI PHARMA KG shall retain a sufficient quantity of Product from each batch to perform [...***...] quality control tests as described IN APPENDIX 3.

  • BI PHARMA KG shall certify in writing, that each shipment lot of Product, was produced and tested in compliance with (i) the Specifications (including the respective test methods), (ii) GMP requirements, (iii) all other applicable regulatory documents filed with the BLA and the European regulatory filings with the EMEA, if any, in accordance with procedures agreed between BI PHARMA KG and COUL▇▇▇.

  • Upon receipt of an invoice from BI PHARMA KG pursuant to Article 8.3.1 above by COUL▇▇▇, ▇▇UL▇▇▇ ▇▇▇l pay within [...***...

  • No provision on COUL▇▇▇'▇ ▇▇▇chase order forms or in BI PHARMA KG's General Conditions of Sale which may purport to impose different conditions upon COUL▇▇▇ ▇▇ BI PHARMA KG, nor any other modification of this Agreement, will be of any force and effect, unless in writing and signed by both parties claimed to be bound thereby.

  • Except as set forth in Articles 3.1.2, 3.1.3 and 3.2.2 below and provided, the parties execute a Process [...***...] Agreement, COUL▇▇▇ will purchase and [...***...] to purchase [...***...] of Product from BI PHARMA KG throughout the world for the period of this Agreement provided, however, COUL▇▇▇ ▇▇▇, after agreement with BI PHARMA KG which shall not be unreasonably withheld, enter into an agreement with [...***...] to have such [...***...].

  • For sterile liquid fill services as described in APPENDIX 1, BI PHARMA KG will release (manufacturer release) Finished Product or Final Product, issue a Certificate of Analysis and send an invoice to COUL▇▇▇.

  • In the event Securities and Exchange Commission ("SEC") rules or regulations require COUL▇▇▇ ▇▇ disclose BI PHARMA KG's Confidential Information, COUL▇▇▇ ▇▇▇ll provide to BI PHARMA KG a reasonable opportunity to comment on such disclosures and shall thereafter promptly inform BI PHARMA KG regarding any such disclosure.

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, 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(s) named in the licence.