Secondary Milestone Indication definition

Secondary Milestone Indication means an Indication for any human disease or condition other than Cancer or [*****].† † [*****] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Sample 1

Examples of Secondary Milestone Indication in a sentence

  • For further clarity, if Medarex exercises its Co-Promotion Option with respect to the Lead Product for a Cancer Indication, such Product shall be a Co-Promotion Product only with respect to all Cancer Indications, and not with respect to any Secondary Milestone Indication or [*****] Indication unless and until Medarex exercises its Co-Promotion Option with respect thereto pursuant to the preceding sentence.

  • For further clarity, if Medarex exercises its Co-Promotion Option with respect to an Additional Product for a Cancer Indication, such Additional Product shall be a Co-Promotion Product only with respect to all Cancer Indications, and not with respect to any Secondary Milestone Indication or [*****] Indication unless and until Medarex exercises its Co-Promotion Option with respect thereto pursuant to the preceding sentence.

Related to Secondary Milestone Indication

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Milestone Event has the meaning set forth in Section 8.4.

  • Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

  • Sales Milestone Payment is defined in Section 5.3.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Additional Indication means any indication other than the Initial Indication.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Second Indication means [***].

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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. [***]

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • 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)).

  • Milestone Payments has the meaning set forth in Section 4.2.