Initial Indication definition

Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.

Initial Indication means [***].

Initial Indication means the treatment of Xxxxxxxxx Syndrome in humans in the Territory.

Examples of Initial Indication in a sentence

• Subject to Section 6.1.3, Chiesi shall have the right to: (x) prepare and submit all INDs and Drug Approval Applications and to obtain and maintain all Regulatory Approvals and pricing and reimbursement approvals for (i) Licensed Products for use in any Indication other than the Initial Indication and PH-ILD in the U.S. Territory, (ii) Licensed Products for use in all Indications in the ROW Territory [***], and (iii) [***] (A) [***], and (B) [***].

• Subject to applicable Law, Chiesi shall have the right to have one representative for regulatory matters and one representative for technical subject matters participate in all material meetings (including by telephone), conferences and discussions by Xxxxxxxx or its Affiliate with Regulatory Authorities in the U.S. Territory pertaining to Development or any Regulatory Approval in the U.S. Territory of a Licensed Product for use in the Initial Indication or PH-ILD.

• If Chiesi U.S. or Chiesi SpA receives any orders for a Licensed Product for use in the Initial Indication or PH-ILD in the U.S. Territory, it shall refer such orders to Gossamer U.S., and if Gossamer U.S. or Gossamer Ireland receives any orders for Licensed Product for use in any Indication other than the Initial Indication and PH-ILD in the U.S. Territory, it shall refer such orders to Chiesi U.S.

• Chiesi shall own (a) all Regulatory Filings and Documentation (including Regulatory Approvals) for Licensed Products for use in any Indication other than the Initial Indication and PH-ILD in the U.S. Territory; and (b) all Regulatory Filings and Documentations (including Regulatory Approvals) for the Licensed Products for use in all Indications in the ROW Territory subject to the applicable transition period for the Initial Indication (such transition period to be set forth in the Registration Plan).

• Subject to Section 6.1.3, Xxxxxxxx shall have the sole right to: (a) prepare and submit all INDs and Drug Approval Applications and to obtain and maintain all Regulatory Approvals and pricing and reimbursement approvals for Licensed Products for use in the Initial Indication and PH-ILD in the U.S. Territory; and (b) [***] (c) [***], and (d) [***].

More Definitions of Initial Indication

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

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

Initial Indication means [***] and “Initial Indications” shall mean [***], collectively.

Initial Indication means the disease or condition for which Contrave is first approved by the FDA, as described under the header “INDICATIONS AND USAGE” in the first approved labeling for Contrave.

Initial Indication means Angelman syndrome (AS).

Initial Indication means dry age-related macular degeneration, which is the indication of the first priority for which the Parties hereby agree to Develop Collaboration Compounds and Collaboration Products pursuant to the Development Plan.

Initial Indication means human therapeutic uses for the treatment of glaucoma (including ocular hypertension), which is the indication of the first priority for which the Parties agree to Develop the Licensed Compound and Licensed Products pursuant to the Development Plan. * Confidential Treatment Requested.