BDX Product definition

BDX Product means BDX300 or BDX301, a novel lipid-protein based adjuvant, as further described in Schedule C.
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Examples of BDX Product in a sentence

  • These purchase prices will give Oragenics access to bulk product stability study data, as well as methods related to the BDX Product, as required.

  • In the event that this Agreement is terminated prior to Commercialization and unless Inspirevax elects to continue the CMC development of the BDX Product, Oragenics will be responsible for all costs relating to the termination of the Combination Product Phase 2b/3 CMC development including the CDMO termination costs and any non-refundable reservation fees.

  • Under the terms of the Research Agreement, Oragenics purchased [***] milligrams (protein content of BDX Product as measured by L▇▇▇▇ Assay) of the BDX Product from Inspirevax produced under Good Manufacturing Practice (GMP) standards to enable pre-clinical studies, final product stability studies, GLP toxicology studies, and the clinical studies at a price of [***] per milligram.

  • The JDC will also discuss strategies for the long-term commercial supply of the BDX Product.

  • If Inspirevax elects to continue CMC development of the BDX Product with its own funding and the CDMO’s activities are not terminated, there will be no termination costs to be paid by either party.

  • In the event that Oragenics wishes to be supplied quantities of BDX Products in addition to the Existing Inventory following the Effective Date, the Parties will negotiate in good faith the terms and conditions of an agreement for the manufacture and availability of the future lots of the BDX Product.

  • To the extent any Third Party is utilized in the future in relation to testing of the BDX Product, the Parties will work together in good faith to enter into separate agreements with any such Third Party, whether it be an agreement between Oragenics and such Third party or an agreement with Inspirevax and such Third Party with Inspirevax charging amounts paid back to Oragenics.

  • Without limiting the generality of the foregoing, Oragenics shall be solely responsible for the Development of the Combination Products, including, without limitation, conducting and financing of the non-clinical and clinical research and trials as well as the process development of the Combination Product, and the BDX Product as a part thereof, by an appropriate CDMO for use in Phase 2b/3 clinical studies conducted under this Agreement with the review and guidance of the JDC as referenced in ARTICLE 2.

  • Inspirevax will have the right to review any patent application regarding the Oragenics IP sufficiently in advance of the filing for the purpose of restricting the terms of a filing that includes unpublished information, Confidential Information, or know-how related, in whole or in part, to the BDX Product, the Licensed Technology, or the Inspirevax Improvements.

  • Oragenics’ financial obligations also includes the costs associated with obtaining a sufficient amount of the BDX Product from Inspirevax to enable Oragenics to perform the research and trials under this Agreement, including, but not limited to the costs for BDX Product to enable the pre-clinical toxicology, clinical development planning and association characterization and stability data.

Related to BDX Product

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

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

  • Licensed Compound means [***].