New indication(s) definition
New indication(s) means an additional indication of the medicinal product which was approved by SIDC after the original registration of the medicinal product.
New indication(s) means any indication for the Product other than the Initial Indications, which is subject to Takeda’s right of first refusal as provided in Section 3.2.
New indication(s) means any indication outside the Field (excluding Autoimmune Indications, Stem Cell Transplantation and Transplantation Indications).
More Definitions of New indication(s)
New indication(s) has the meaning set forth in Section 4.02(c).
New indication(s) means clinical indications, uses and applications for the Product other than what is included in the Field.
New indication(s) means any indication identified by KSB in which the Product may be used in addition to the Indications (including metastatic brain cancers ).
New indication(s) means any indication for the Product other than the Initial Indications, which is subject to Takeda’s right of first refusal as provided in Section 3.2. “Party” or “Parties” shall have the meaning set forth in the introductory paragraph. “Phase IV Studies” shall mean clinical studies performed after obtaining Marketing Authorization for the purpose of supporting the marketing and Commercialization of the Product. For the avoidance of any doubt, “Phase IV Studies” does not include the RRS (as hereinafter defined). “Post-Marketing Surveillance” shall mean all post-marketing safety surveillance in the Initial Territory with respect to the Product that is required by a Regulatory Authority in the Initial Territory or any Additional Territory in which the Products are being Developed or Commercialized. “Primary Detail Equivalent” or “PDE” shall mean (a) one Primary Product Detail or (b) [**] Secondary Product Details.
New indication(s) means IPF, TB, FI and any additional new indications in human beings that may be mutually agreed by the Parties after the Effective Date.
New indication(s) means any indication of a disease state other than the Indications, that is developed as part of the Joint Development Program (excluding diagnosis).
New indication(s) means, with respect to any Product, any Indication (other than the Initial Indications) approved by the JSC pursuant to Sections 3.1(a) and 3.4 in which such Product may be Developed, Manufactured and Commercialized under this Agreement.