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Autoimmune Indication definition

Autoimmune Indication means the treatment or prophylaxis of any autoimmune disease or condition (i.e., any disease or condition that is caused by dis- or de-regulation of the immune system leading to tissue injury by a reaction to an endogenous antigen but that is not primarily a malignant neoplasia).
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Autoimmune Indication means an Indication for autoimmune disease mediated by immune system cells, including cells with B cell lineage.
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Autoimmune Indication means an Indication for autoimmune disease mediated by immune system cells, including cells with B cell lineage. “BCMA” means B-cell maturation antigen.
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Examples of Autoimmune Indication in a sentence

  • The terms of any such license shall be negotiated in good faith for each parties' mutual benefit, and shall reflect the fair market value with respect to such Other Autoimmune Indication, taking into account factors such as market size, margins, cost of manufacture and price comparables.

  • Thereafter, Corixa and ZKC shall have thirty (30) days from Corixa's receipt of such letter of intent to negotiate and enter into an agreement covering a license for such Other Autoimmune Indication.

  • ZKC shall have one opportunity to exercise its right of first negotiation in connection with such Other Autoimmune Indication by providing Corixa an executed letter of intent to enter into good faith negotiations for a license regarding the Licensed Product related to such Other Autoimmune Indication within thirty (30) days of receipt of such notice from Corixa.

  • Xxxxx'x best good faith estimate of when it would make an election under Section 2B.2 for that Autoimmune Indication, which election it expects to make, and its expected sales of Daclizumab in that country for that Autoimmune Indication for the Initial Forecast Period (it being understood that such stated expectation shall not be binding upon X.

  • Xxxxx'x best good faith estimate of its expected sales of Daclizumab for the ROW Territory for that Autoimmune Indication for the Initial Forecast Period (it being understood that such stated expectation shall not be binding upon X.

  • Xxxxx does not elect to file for approval under Section 2A.7(a)(iii) or to market and sell, co-promote or co-market under Section 2B.2(a), (b) or (c), as the case may be, for a specified Autoimmune Indication, then X.

  • For example, if there is a filing of the first MAA in the 1st Autoimmune Indication, any Xxxxx 0, Xxxxx 2, or Phase 3 Trial milestones for such 1st Autoimmune Indication, if not previously paid, shall be paid at the time of such first MAA filing.*COMPANY would pay [***] percent ([***]%), [***] percent ([***]%) and [***] percent ([***]%) of each European approval milestone upon achievement of Pricing Approval in each of the [***], respectively.

  • Xxxxx has elected to file an application for marketing approval of an Autoimmune Indication pursuant to Section 2A.7(b), X.

  • Xxxxx'x rights to make such filing and to market and sell Daclizumab in such country in the ROW Territory for that Autoimmune Indication shall be deemed to revert to PDL as provided in Section 2A.7(c)).

  • The applicable royalty rates on Net Autoimmune Sales shall depend for each country in the ROW Territory and for each Autoimmune Indication on whether X.

Related to Autoimmune Indication

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

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

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

Most Referenced Clauses

Most Referenced Definitions