Second Indication definition

Second Indication means [***].

Second Indication means the treatment of an indication other than Head and Neck cancer, and includes all subsequent indications after the First Indication.

Second Indication means any indication other than the First Indication.

Examples of Second Indication in a sentence

• Celgene and Agios reportedly price Idhifa® at $24,872 per month before discounts.35 Venclexta® has a list price of about $109,500 for the first year of treatment.36 The FSS price is around $11,208 per month (400mg daily), in line with the reported annual cost.Potential Second Indication for OM-301 - Multiple MyelomaBased on results from preclinical studies in cancer experimental models, we plan to evaluate OM-301 as a potential treatment for multiple myeloma.

• Authors can use this understanding to pick and choose what to concentrate on in the discussion.

• If Xxxxxxx notifies ACI that it commits to use Diligent Efforts to Develop, Manufacture and Commercialize a Product for a Second Indication, then Section 2.1 of this Agreement shall be amended to include the obligation to use Diligent Efforts to Develop, Manufacture and Commercialize a Product for a Second Indication.

• Each milestone payment set forth in Table 3.3(b) shall be paid only once during the Term, for the first time any Licensed Product reaches such milestone event for the Second Indication in which such milestone event is achieved, regardless of the number of Licensed Products that achieve such milestone event, the number of times such milestone event is achieved by any Licensed Product, or the number of additional Indications in which such milestone event is subsequently achieved.

• Following the Closing, GW Pharma shall diligently perform its obligations regarding development and Full Regulatory Approval of the Licensed Products as set forth in this Agreement and the First Indication Development Plan and the Second Indication Development Plan and any other Development Plan agreed upon by the Parties.

More Definitions of Second Indication

Second Indication means an Indication listed under the header “INDICATIONS AND USAGE” of a Product’s approved label upon Regulatory Approval for the Product by a Regulatory Authority other than the AD Indication. For purposes of the milestones that occur prior to receipt of Regulatory Approval, “Second Indication” means an Indication that is not the AD Indication and is intended to be included in the regulatory filing for such Product.

Second Indication means the second Indication for which NDA Approval for the Product is obtained.

Second Indication means a new indication (i.e., a generally recognized distinct medical condition) and not an extension of the First Indication or a labeling change covering the First Indication.

Second Indication means the second Indication in which AstraZeneca obtains a Health Registration Approval in respect of the Product or a Combination Product.

Second Indication means label claim(s) that are approved in a Regulatory Approval received for a Product in the Territory, wherein such Regulatory Approval is subsequent to the Initial Approval and such label claims are for a different indication than the indication approved in the Initial Approval.

Second Indication means an indication among such three indications, excluding the one from which the First Indication was drawn, that secondly reaches the corresponding Milestone, and “Third Indication” shall mean the last indication among such three indications, excluding the two from which the First Indication and Second Indication were drawn, that reaches the corresponding Milestone, e.g., if the initial indication to reach a Phase 1 clinical Milestone is a Movement Disorder Indication, such Movement Disorder Indication shall trigger the First Indication Phase 1 Clinical Milestone Fee, if the indication to secondly reach a Phase 1 clinical Milestone is an Addiction Indication, such Addiction Indication shall trigger the Second Indication Phase 1 Clinical Milestone Fee, and thereafter the Third Indication Phase 1 clinical Milestone Fee shall be triggered if and when an Other Indication reaching a Phase 1 clinical Milestone.

Second Indication means the initial indication (other than for the [***]) for which there has been a First Dose in a Registrational Trial of Aeroquin.